Trial Outcomes & Findings for Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse (NCT NCT00099372)

Results Overview

Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery

Recruitment status

TERMINATED

Target enrollment

215 participants

Primary outcome timeframe

24 months

Results posted on

2021-03-22

Participant Flow

Participant milestones

Participant milestones
Measure	Abdominal Sacral Colpopexy With Burch Colposuspension Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	Abdominal Sacral Colpopexy With No Burch Colposuspension Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Enrolled in Extended CARE Trial STARTED	104	111
Enrolled in Extended CARE Trial COMPLETED	104	111
Enrolled in Extended CARE Trial NOT COMPLETED	0	0
Followed up 5 Years After Index Surgery STARTED	104	111
Followed up 5 Years After Index Surgery COMPLETED	89	92
Followed up 5 Years After Index Surgery NOT COMPLETED	15	19
Followed up 7 Years After Index Surgery STARTED	89	92
Followed up 7 Years After Index Surgery COMPLETED	66	60
Followed up 7 Years After Index Surgery NOT COMPLETED	23	32

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BURCH URETHROPEXY n=104 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=111 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse	Total n=215 Participants Total of all reporting groups
Age, Continuous	62.9 years STANDARD_DEVIATION 9.4 • n=99 Participants	60.9 years STANDARD_DEVIATION 10.5 • n=107 Participants	61.9 years STANDARD_DEVIATION 10 • n=206 Participants
Sex/Gender, Customized Female	104 Participants n=99 Participants	111 Participants n=107 Participants	215 Participants n=206 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=99 Participants	9 Participants n=107 Participants	13 Participants n=206 Participants
Race/Ethnicity, Customized Other	1 Participants n=99 Participants	3 Participants n=107 Participants	4 Participants n=206 Participants
Race/Ethnicity, Customized White	99 Participants n=99 Participants	99 Participants n=107 Participants	198 Participants n=206 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=99 Participants	7 Participants n=107 Participants	8 Participants n=206 Participants
Race/Ethnicity, Customized Not Hispanic	103 Participants n=99 Participants	104 Participants n=107 Participants	207 Participants n=206 Participants
Married or living as married Missing	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Married or living as married No	23 Participants n=99 Participants	31 Participants n=107 Participants	54 Participants n=206 Participants
Married or living as married Yes	80 Participants n=99 Participants	80 Participants n=107 Participants	160 Participants n=206 Participants
Education level College degree or higher	53 Participants n=99 Participants	63 Participants n=107 Participants	116 Participants n=206 Participants
Education level High school degree or equivalent	36 Participants n=99 Participants	44 Participants n=107 Participants	80 Participants n=206 Participants
Education level Less than High School	15 Participants n=99 Participants	4 Participants n=107 Participants	19 Participants n=206 Participants
Number of vaginal deliveries	3 deliveries n=99 Participants	3 deliveries n=107 Participants	3 deliveries n=206 Participants
Number of cesarean deliveries	0 deliveries n=99 Participants	0 deliveries n=107 Participants	0 deliveries n=206 Participants
Number of previous births	3 births n=99 Participants	3 births n=107 Participants	3 births n=206 Participants
Hysterectomy Missing	17 Participants n=99 Participants	15 Participants n=107 Participants	32 Participants n=206 Participants
Hysterectomy No	7 Participants n=99 Participants	17 Participants n=107 Participants	24 Participants n=206 Participants
Hysterectomy Yes	80 Participants n=99 Participants	79 Participants n=107 Participants	159 Participants n=206 Participants
Prior SUI Surgery No	95 Participants n=99 Participants	104 Participants n=107 Participants	199 Participants n=206 Participants
Prior SUI Surgery Yes	9 Participants n=99 Participants	7 Participants n=107 Participants	16 Participants n=206 Participants
Prior POP Surgery No	56 Participants n=99 Participants	75 Participants n=107 Participants	131 Participants n=206 Participants
Prior POP Surgery Yes	48 Participants n=99 Participants	36 Participants n=107 Participants	84 Participants n=206 Participants
Pelvic Organ Prolapse-Q stage 2	9 Participants n=99 Participants	15 Participants n=107 Participants	24 Participants n=206 Participants
Pelvic Organ Prolapse-Q stage 3	75 Participants n=99 Participants	78 Participants n=107 Participants	153 Participants n=206 Participants
Pelvic Organ Prolapse-Q stage 4	20 Participants n=99 Participants	18 Participants n=107 Participants	38 Participants n=206 Participants
Body Mass Index	26.6 kg/m^2 STANDARD_DEVIATION 4 • n=99 Participants	26.8 kg/m^2 STANDARD_DEVIATION 4.8 • n=107 Participants	26.7 kg/m^2 STANDARD_DEVIATION 4.4 • n=206 Participants
BMI >= 30 (obesity) No	85 Participants n=99 Participants	85 Participants n=107 Participants	170 Participants n=206 Participants
BMI >= 30 (obesity) Yes	19 Participants n=99 Participants	26 Participants n=107 Participants	45 Participants n=206 Participants

PRIMARY outcome

Timeframe: 24 months

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=104 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=111 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Symptomatic Failure Failure	15 Participants	16 Participants
Number of Participants With Symptomatic Failure Non-failure	89 Participants	95 Participants

PRIMARY outcome

Timeframe: 3 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=101 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=108 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Symptomatic Failure Failure	16 Participants	19 Participants
Number of Participants With Symptomatic Failure Non-failure	85 Participants	89 Participants

PRIMARY outcome

Timeframe: 4 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=94 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=103 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Symptomatic Failure Failure	19 Participants	20 Participants
Number of Participants With Symptomatic Failure Non-failure	75 Participants	83 Participants

PRIMARY outcome

Timeframe: 5 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=91 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=96 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Symptomatic Failure Failure	25 Participants	21 Participants
Number of Participants With Symptomatic Failure Non-failure	66 Participants	75 Participants

PRIMARY outcome

Timeframe: 6 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=86 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=90 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Symptomatic Failure Non-failure	59 Participants	69 Participants
Number of Participants With Symptomatic Failure Failure	27 Participants	21 Participants

PRIMARY outcome

Timeframe: 7 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

Symptom of bulge on Pelvic Floor Distress Inventory, interval prolapse surgery, or pessary used after index surgery

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=73 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=71 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Symptomatic Failure Failure	27 Participants	22 Participants
Number of Participants With Symptomatic Failure Non-failure	46 Participants	49 Participants

PRIMARY outcome

Timeframe: 24 months

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. The original and updated versions of anatomic failure could have different denominators for the same time point because a prior anatomic failure means the patient is assigned a failure in all subsequent visits regardless of whether the patient had completed the visits.

Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends \>= 2 cm, or the anterior or posterior vaginal wall decends \>1 cm beyond the hymen

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=101 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=110 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Anatomic Failure (Original Definition) Failure	6 Participants	9 Participants
Number of Participants With Anatomic Failure (Original Definition) Non-failure	95 Participants	101 Participants

PRIMARY outcome

Timeframe: 3 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. The original and updated versions of anatomic failure could have different denominators for the same time point because a prior anatomic failure means the patient is assigned a failure in all subsequent visits regardless of whether the patient had completed the visits.

Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends \>= 2 cm, or the anterior or posterior vaginal wall decends \>1 cm beyond the hymen

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=84 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=90 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Anatomic Failure (Original Definition) Non-failure	75 Participants	80 Participants
Number of Participants With Anatomic Failure (Original Definition) Failure	9 Participants	10 Participants

PRIMARY outcome

Timeframe: 4 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. The original and updated versions of anatomic failure could have different denominators for the same time point because a prior anatomic failure means the patient is assigned a failure in all subsequent visits regardless of whether the patient had completed the visits.

Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends \>= 2 cm, or the anterior or posterior vaginal wall decends \>1 cm beyond the hymen

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=64 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=77 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Anatomic Failure (Original Definition) Failure	10 Participants	12 Participants
Number of Participants With Anatomic Failure (Original Definition) Non-failure	54 Participants	65 Participants

PRIMARY outcome

Timeframe: 5 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. The original and updated versions of anatomic failure could have different denominators for the same time point because a prior anatomic failure means the patient is assigned a failure in all subsequent visits regardless of whether the patient had completed the visits.

Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends \>= 2 cm, or the anterior or posterior vaginal wall decends \>1 cm beyond the hymen

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=58 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=69 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Anatomic Failure (Original Definition) Failure	12 Participants	13 Participants
Number of Participants With Anatomic Failure (Original Definition) Non-failure	46 Participants	56 Participants

PRIMARY outcome

Timeframe: 6 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. The original and updated versions of anatomic failure could have different denominators for the same time point because a prior anatomic failure means the patient is assigned a failure in all subsequent visits regardless of whether the patient had completed the visits.

Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends \>= 2 cm, or the anterior or posterior vaginal wall decends \>1 cm beyond the hymen

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=55 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=56 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Anatomic Failure (Original Definition) Failure	15 Participants	14 Participants
Number of Participants With Anatomic Failure (Original Definition) Non-failure	40 Participants	42 Participants

PRIMARY outcome

Timeframe: 7 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. The original and updated versions of anatomic failure could have different denominators for the same time point because a prior anatomic failure means the patient is assigned a failure in all subsequent visits regardless of whether the patient had completed the visits.

Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex decends \>= 2 cm, or the anterior or posterior vaginal wall decends \>1 cm beyond the hymen

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=44 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=46 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Anatomic Failure (Original Definition) Failure	15 Participants	14 Participants
Number of Participants With Anatomic Failure (Original Definition) Non-failure	29 Participants	32 Participants

PRIMARY outcome

Timeframe: 24 months

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. The original and updated versions of anatomic failure could have different denominators for the same time point because a prior anatomic failure means the patient is assigned a failure in all subsequent visits regardless of whether the patient had completed the visits.

Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=101 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=110 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Anatomic Failure (Updated Definition) Failure	5 Participants	8 Participants
Number of Participants With Anatomic Failure (Updated Definition) Non-failure	96 Participants	102 Participants

PRIMARY outcome

Timeframe: 3 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria. The original and updated versions of anatomic failure could have different denominators for the same time point because a prior anatomic failure means the patient is assigned a failure in all subsequent visits regardless of whether the patient had completed the visits.

Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=84 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=91 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Anatomic Failure (Updated Definition) Failure	8 Participants	10 Participants
Number of Participants With Anatomic Failure (Updated Definition) Non-failure	76 Participants	81 Participants

PRIMARY outcome

Timeframe: 4 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=64 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=79 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Anatomic Failure (Updated Definition) Failure	10 Participants	12 Participants
Number of Participants With Anatomic Failure (Updated Definition) Non-failure	54 Participants	67 Participants

PRIMARY outcome

Timeframe: 5 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=56 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=71 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Anatomic Failure (Updated Definition) Failure	14 Participants	12 Participants
Number of Participants With Anatomic Failure (Updated Definition) Non-failure	42 Participants	59 Participants

PRIMARY outcome

Timeframe: 6 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=54 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=59 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Anatomic Failure (Updated Definition) Failure	18 Participants	13 Participants
Number of Participants With Anatomic Failure (Updated Definition) Non-failure	36 Participants	46 Participants

PRIMARY outcome

Timeframe: 7 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

Reoperation or pessary for POP or POP-Q measurements as follows: Vaginal apex descends below the upper third of the vagina, or the anterior (Ba) or posterior (Bp) vaginal wall prolapses beyond the hymen

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=45 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=49 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Anatomic Failure (Updated Definition) Failure	18 Participants	13 Participants
Number of Participants With Anatomic Failure (Updated Definition) Non-failure	27 Participants	36 Participants

PRIMARY outcome

Timeframe: 24 months

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

Anatomic failure (updated definition) or symptomatic failure

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=102 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=110 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Composite Failure Failure	14 Participants	15 Participants
Number of Participants With Composite Failure Non-failure	88 Participants	95 Participants

PRIMARY outcome

Timeframe: 3 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

Anatomic failure (updated definition) or symptomatic failure

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=89 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=92 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Composite Failure Failure	16 Participants	18 Participants
Number of Participants With Composite Failure Non-failure	73 Participants	74 Participants

PRIMARY outcome

Timeframe: 4 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

Anatomic failure (updated definition) or symptomatic failure

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=70 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=82 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Composite Failure Failure	19 Participants	19 Participants
Number of Participants With Composite Failure Non-failure	51 Participants	63 Participants

PRIMARY outcome

Timeframe: 5 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

Anatomic failure (updated definition) or symptomatic failure

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=63 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=75 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Composite Failure Failure	27 Participants	20 Participants
Number of Participants With Composite Failure Non-failure	36 Participants	55 Participants

PRIMARY outcome

Timeframe: 6 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

Anatomic failure (updated definition) or symptomatic failure

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=61 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=66 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Composite Failure Failure	30 Participants	21 Participants
Number of Participants With Composite Failure Non-failure	31 Participants	45 Participants

PRIMARY outcome

Timeframe: 7 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

Anatomic failure (updated definition) or symptomatic failure

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=54 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=61 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Composite Failure Failure	30 Participants	21 Participants
Number of Participants With Composite Failure Non-failure	24 Participants	40 Participants

PRIMARY outcome

Timeframe: 24 months

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe.

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=104 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=111 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index Failure	48 Participants	66 Participants
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index Non-failure	56 Participants	45 Participants

PRIMARY outcome

Timeframe: 3 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe.

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=101 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=109 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index Failure	52 Participants	70 Participants
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index Non-failure	49 Participants	39 Participants

PRIMARY outcome

Timeframe: 4 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe.

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=99 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=105 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index Failure	55 Participants	70 Participants
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index Non-failure	44 Participants	35 Participants

PRIMARY outcome

Timeframe: 5 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe.

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=98 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=104 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index Non-failure	40 Participants	32 Participants
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index Failure	58 Participants	72 Participants

PRIMARY outcome

Timeframe: 6 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe.

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=97 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=102 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index Failure	59 Participants	73 Participants
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index Non-failure	38 Participants	29 Participants

PRIMARY outcome

Timeframe: 7 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

Failure is indicated by a score of 3 or greater on the Incontinence Severity Index (formerly called Hunskaar). The score is calculated as the product of the answers to two incontinence-related questions resulting in a range from 0 to 12 (higher scores indicating more severe symptoms). A score of 3 or greater corresponds to a severity classification of moderate, severe, or very severe.

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=91 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=92 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index Failure	62 Participants	73 Participants
Number of Participants Considered as Failures For Urinary Incontinence Using the Incontinence Severity Index Non-failure	29 Participants	19 Participants

PRIMARY outcome

Timeframe: 24 months

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=104 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=110 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Stress Urinary Incontinence (SUI) Prevention Failure	39 Participants	63 Participants
Number of Participants With Stress Urinary Incontinence (SUI) Prevention Non-failure	65 Participants	47 Participants

PRIMARY outcome

Timeframe: 3 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=102 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=109 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Stress Urinary Incontinence (SUI) Prevention Failure	47 Participants	69 Participants
Number of Participants With Stress Urinary Incontinence (SUI) Prevention Non-failure	55 Participants	40 Participants

PRIMARY outcome

Timeframe: 4 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=99 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=107 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Stress Urinary Incontinence (SUI) Prevention Failure	49 Participants	76 Participants
Number of Participants With Stress Urinary Incontinence (SUI) Prevention Non-failure	50 Participants	31 Participants

PRIMARY outcome

Timeframe: 5 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=98 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=105 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Stress Urinary Incontinence (SUI) Prevention Failure	53 Participants	77 Participants
Number of Participants With Stress Urinary Incontinence (SUI) Prevention Non-failure	45 Participants	28 Participants

PRIMARY outcome

Timeframe: 6 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=95 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=105 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Stress Urinary Incontinence (SUI) Prevention Failure	55 Participants	78 Participants
Number of Participants With Stress Urinary Incontinence (SUI) Prevention Non-failure	40 Participants	27 Participants

PRIMARY outcome

Timeframe: 7 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

One or more SUI symptoms reported on the Pelvic Floor Distress Inventory, receipt of interval anti-incontinence surgery, or receipt of an urethral bulking agent injection for SUI

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=89 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=96 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Stress Urinary Incontinence (SUI) Prevention Failure	57 Participants	79 Participants
Number of Participants With Stress Urinary Incontinence (SUI) Prevention Non-failure	32 Participants	17 Participants

PRIMARY outcome

Timeframe: 24 months

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

One or more SUI symptoms reported on the Pelvic Floor Distress Inventory

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=104 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=110 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Stress Urinary Incontinence (SUI) Failure	39 Participants	63 Participants
Number of Participants With Stress Urinary Incontinence (SUI) Non-failure	65 Participants	47 Participants

PRIMARY outcome

Timeframe: 3 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

One or more SUI symptoms reported on the Pelvic Floor Distress Inventory

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=102 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=109 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Stress Urinary Incontinence (SUI) Failure	47 Participants	68 Participants
Number of Participants With Stress Urinary Incontinence (SUI) Non-failure	55 Participants	41 Participants

PRIMARY outcome

Timeframe: 4 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

One or more SUI symptoms reported on the Pelvic Floor Distress Inventory

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=99 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=107 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Stress Urinary Incontinence (SUI) Failure	49 Participants	75 Participants
Number of Participants With Stress Urinary Incontinence (SUI) Non-failure	50 Participants	32 Participants

PRIMARY outcome

Timeframe: 5 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

One or more SUI symptoms reported on the Pelvic Floor Distress Inventory

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=98 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=105 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Stress Urinary Incontinence (SUI) Non-failure	45 Participants	29 Participants
Number of Participants With Stress Urinary Incontinence (SUI) Failure	53 Participants	76 Participants

PRIMARY outcome

Timeframe: 6 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

One or more SUI symptoms reported on the Pelvic Floor Distress Inventory

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=95 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=105 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Stress Urinary Incontinence (SUI) Failure	55 Participants	78 Participants
Number of Participants With Stress Urinary Incontinence (SUI) Non-failure	40 Participants	27 Participants

PRIMARY outcome

Timeframe: 7 year

Population: This outcome is analyzed in randomized participants who completed the visit at this time point, or who were failures prior to the time point. Excluded from the analyses are prior dropouts who had not yet met the failure criteria.

One or more SUI symptoms reported on the Pelvic Floor Distress Inventory

Outcome measures

Outcome measures
Measure	BURCH URETHROPEXY n=89 Participants Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	NO URETHROPEXY n=96 Participants Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Number of Participants With Stress Urinary Incontinence (SUI) Failure	57 Participants	79 Participants
Number of Participants With Stress Urinary Incontinence (SUI) Non-failure	32 Participants	17 Participants

Adverse Events

Abdominal Sacral Colpopexy With Burch Colposuspension

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Abdominal Sacral Colpopexy With No Burch Colposuspension

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Abdominal Sacral Colpopexy With Burch Colposuspension n=104 participants at risk Participants had an Abdominal Sacral Colpopexy with Burch colposuspension for treatment of pelvic organ prolapse	Abdominal Sacral Colpopexy With No Burch Colposuspension n=111 participants at risk Participants had an Abdominal Sacral Colpopexy without Burch colposuspension for treatment of pelvic organ prolapse
Surgical and medical procedures Medical device site reaction	0.96% 1/104 • Number of events 1	2.7% 3/111 • Number of events 3

Additional Information

Dr. Marie Gantz

RTI International

Phone: 919-597-5110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place