Trial Outcomes & Findings for Minimally Invasive Burch Colposuspension to Reduce Occult Stress Incontinence (NCT NCT03841513)
NCT ID: NCT03841513
Last Updated: 2025-08-26
Results Overview
Rate of Stress Urinary Incontinence, as defined as a participant satisfying one or more of the following: * A positive retro-fill cough stress test at 300mL * Answer of "yes" to question #17 of Pelvic Floor Distress Inventory 20 (PFDI-20) * Any treatment for stress urinary incontinence after the study surgery
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
3 months following study intervention
Results posted on
2025-08-26
Participant Flow
Participant milestones
| Measure |
Control
Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, without the addition of a laparoscopic/robotic Burch colposuspension
|
Laparoscopic Burch Colposuspension
Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, with the addition of a laparoscopic/robotic Burch colposuspension
Laparoscopic Burch Colposuspension: The Burch Colposuspension is an anti-incontinence procedure where non-absorbable monofilament suture is used in the retropubic space to form a suture bridge between the anterior vagina and Cooper's ligament, thereby gently elevating the anterior vaginal wall and providing urethral support.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
26
|
|
Overall Study
COMPLETED
|
24
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Minimally Invasive Burch Colposuspension to Reduce Occult Stress Incontinence
Baseline characteristics by cohort
| Measure |
Control
n=24 Participants
Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, without the addition of a laparoscopic/robotic Burch colposuspension
|
Laparoscopic Burch Colposuspension
n=26 Participants
Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, with the addition of a laparoscopic/robotic Burch colposuspension
Laparoscopic Burch Colposuspension: The Burch Colposuspension is an anti-incontinence procedure where non-absorbable monofilament suture is used in the retropubic space to form a suture bridge between the anterior vagina and Cooper's ligament, thereby gently elevating the anterior vaginal wall and providing urethral support.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
n=99 Participants
|
66 years
n=107 Participants
|
64 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
BMI
|
25.1 kg/m^2
n=99 Participants
|
25.6 kg/m^2
n=107 Participants
|
25.4 kg/m^2
n=206 Participants
|
|
Baseline POP-Q Stage
|
3 stage
n=99 Participants
|
3 stage
n=107 Participants
|
3 stage
n=206 Participants
|
|
POPDI
|
47.7 scores on a scale
STANDARD_DEVIATION 23.0 • n=99 Participants
|
35.7 scores on a scale
STANDARD_DEVIATION 24.3 • n=107 Participants
|
41.7 scores on a scale
STANDARD_DEVIATION 23.6 • n=206 Participants
|
|
CRADI
|
23.4 score on a scale
n=99 Participants
|
14.1 score on a scale
n=107 Participants
|
18.8 score on a scale
n=206 Participants
|
|
UDI
|
22.9 score on a scale
n=99 Participants
|
25.0 score on a scale
n=107 Participants
|
24.0 score on a scale
n=206 Participants
|
|
PISQ-12
|
13.8 score on a scale
STANDARD_DEVIATION 5.8 • n=99 Participants
|
15.1 score on a scale
STANDARD_DEVIATION 6.2 • n=107 Participants
|
14.5 score on a scale
STANDARD_DEVIATION 6.0 • n=206 Participants
|
PRIMARY outcome
Timeframe: 3 months following study interventionRate of Stress Urinary Incontinence, as defined as a participant satisfying one or more of the following: * A positive retro-fill cough stress test at 300mL * Answer of "yes" to question #17 of Pelvic Floor Distress Inventory 20 (PFDI-20) * Any treatment for stress urinary incontinence after the study surgery
Outcome measures
| Measure |
Control
n=24 Participants
Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, without the addition of a laparoscopic/robotic Burch colposuspension
|
Laparoscopic Burch Colposuspension
n=26 Participants
Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, with the addition of a laparoscopic/robotic Burch colposuspension
Laparoscopic Burch Colposuspension: The Burch Colposuspension is an anti-incontinence procedure where non-absorbable monofilament suture is used in the retropubic space to form a suture bridge between the anterior vagina and Cooper's ligament, thereby gently elevating the anterior vaginal wall and providing urethral support.
|
|---|---|---|
|
Number of Participants With Stress Urinary Incontinence
|
10 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 3 months following study interventionRate of Urgency Urinary Incontinence, as defined as a participant satisfying one or more of the following: * Answer of "yes" to question #16 of Pelvic Floor Distress Inventory 20 (PFDI-20) * Any treatment for urgency urinary incontinence after the study surgery
Outcome measures
| Measure |
Control
n=24 Participants
Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, without the addition of a laparoscopic/robotic Burch colposuspension
|
Laparoscopic Burch Colposuspension
n=26 Participants
Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, with the addition of a laparoscopic/robotic Burch colposuspension
Laparoscopic Burch Colposuspension: The Burch Colposuspension is an anti-incontinence procedure where non-absorbable monofilament suture is used in the retropubic space to form a suture bridge between the anterior vagina and Cooper's ligament, thereby gently elevating the anterior vaginal wall and providing urethral support.
|
|---|---|---|
|
Number of Participants With Urinary Urgency Incontinence
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 3 months following study interventionValues based on response of "moderately" or "quite a bit" to Question #15 of PFDI-20: "Do you usually experience frequent urination?"
Outcome measures
| Measure |
Control
n=24 Participants
Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, without the addition of a laparoscopic/robotic Burch colposuspension
|
Laparoscopic Burch Colposuspension
n=26 Participants
Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, with the addition of a laparoscopic/robotic Burch colposuspension
Laparoscopic Burch Colposuspension: The Burch Colposuspension is an anti-incontinence procedure where non-absorbable monofilament suture is used in the retropubic space to form a suture bridge between the anterior vagina and Cooper's ligament, thereby gently elevating the anterior vaginal wall and providing urethral support.
|
|---|---|---|
|
Number of Participate With Urinary Frequency
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 3 months following study interventionRate of Urinary Retention, defined as a post void residual greater than 150 mL obtained via straight catheterization
Outcome measures
| Measure |
Control
n=24 Participants
Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, without the addition of a laparoscopic/robotic Burch colposuspension
|
Laparoscopic Burch Colposuspension
n=26 Participants
Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, with the addition of a laparoscopic/robotic Burch colposuspension
Laparoscopic Burch Colposuspension: The Burch Colposuspension is an anti-incontinence procedure where non-absorbable monofilament suture is used in the retropubic space to form a suture bridge between the anterior vagina and Cooper's ligament, thereby gently elevating the anterior vaginal wall and providing urethral support.
|
|---|---|---|
|
Number of Participants With Urinary Retention
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 3 months following study interventionRate of Urinary Tract Infection, defined as a positive urine culture obtained from a straight catheterized urine specimen, from participants with symptoms of urinary tract infection (fever, dysuria, urinary urgency, urinary frequency).
Outcome measures
| Measure |
Control
n=24 Participants
Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, without the addition of a laparoscopic/robotic Burch colposuspension
|
Laparoscopic Burch Colposuspension
n=26 Participants
Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, with the addition of a laparoscopic/robotic Burch colposuspension
Laparoscopic Burch Colposuspension: The Burch Colposuspension is an anti-incontinence procedure where non-absorbable monofilament suture is used in the retropubic space to form a suture bridge between the anterior vagina and Cooper's ligament, thereby gently elevating the anterior vaginal wall and providing urethral support.
|
|---|---|---|
|
Number of Participants With Urinary Tract Infection
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 months following study interventionCompare Pelvic Organ Prolapse Symptoms utilizing the Pelvic Floor Distress Inventory 20 (PFDI-20), questions #1-6. Participants respond to each question on a scale of 0 to 4, with higher scores indicating greater dysfunction. The sum of scores is reported for this subscale, with a minimum score of 0 and maximum score of 24.
Outcome measures
| Measure |
Control
n=24 Participants
Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, without the addition of a laparoscopic/robotic Burch colposuspension
|
Laparoscopic Burch Colposuspension
n=26 Participants
Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, with the addition of a laparoscopic/robotic Burch colposuspension
Laparoscopic Burch Colposuspension: The Burch Colposuspension is an anti-incontinence procedure where non-absorbable monofilament suture is used in the retropubic space to form a suture bridge between the anterior vagina and Cooper's ligament, thereby gently elevating the anterior vaginal wall and providing urethral support.
|
|---|---|---|
|
Pelvic Organ Prolapse Symptoms
|
8.3 score on a scale
Interval 0.0 to 11.9
|
2.1 score on a scale
Interval 0.0 to 12.5
|
SECONDARY outcome
Timeframe: 3 months following study interventionCompare Bowel Symptoms utilizing the Pelvic Floor Distress Inventory 20 (PFDI-20), questions #7-14. Participants respond to each question on a scale of 0 to 4, with higher scores indicating greater dysfunction. The sum of scores is reported for this subscale, with a minimum score of 0 and maximum score of 32.
Outcome measures
| Measure |
Control
n=24 Participants
Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, without the addition of a laparoscopic/robotic Burch colposuspension
|
Laparoscopic Burch Colposuspension
n=26 Participants
Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, with the addition of a laparoscopic/robotic Burch colposuspension
Laparoscopic Burch Colposuspension: The Burch Colposuspension is an anti-incontinence procedure where non-absorbable monofilament suture is used in the retropubic space to form a suture bridge between the anterior vagina and Cooper's ligament, thereby gently elevating the anterior vaginal wall and providing urethral support.
|
|---|---|---|
|
Bowel Symptoms
|
6.3 score on a scale
Interval 0.0 to 17.2
|
6.7 score on a scale
Interval 0.0 to 24.2
|
SECONDARY outcome
Timeframe: 3 months following study interventionCompare Sexual Function utilizing the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire 12 (PISQ-12). Participants respond to each question on a scale of 0 to 4, with higher scores indicating greater dysfunction. The sum of scores is reported for this subscale, with a minimum score of 0 and maximum score of 48.
Outcome measures
| Measure |
Control
n=24 Participants
Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, without the addition of a laparoscopic/robotic Burch colposuspension
|
Laparoscopic Burch Colposuspension
n=26 Participants
Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, with the addition of a laparoscopic/robotic Burch colposuspension
Laparoscopic Burch Colposuspension: The Burch Colposuspension is an anti-incontinence procedure where non-absorbable monofilament suture is used in the retropubic space to form a suture bridge between the anterior vagina and Cooper's ligament, thereby gently elevating the anterior vaginal wall and providing urethral support.
|
|---|---|---|
|
Sexual Function
|
10.5 score on a scale
Interval 8.8 to 15.2
|
12.0 score on a scale
Interval 11.0 to 17.0
|
SECONDARY outcome
Timeframe: 3 months following study interventionCompare rate of intraoperative and short-term surgical complications, as defined by the Dindo classification system.
Outcome measures
| Measure |
Control
n=24 Participants
Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, without the addition of a laparoscopic/robotic Burch colposuspension
|
Laparoscopic Burch Colposuspension
n=26 Participants
Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, with the addition of a laparoscopic/robotic Burch colposuspension
Laparoscopic Burch Colposuspension: The Burch Colposuspension is an anti-incontinence procedure where non-absorbable monofilament suture is used in the retropubic space to form a suture bridge between the anterior vagina and Cooper's ligament, thereby gently elevating the anterior vaginal wall and providing urethral support.
|
|---|---|---|
|
Number of Participants With Surgical Complication
|
3 Participants
|
5 Participants
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Laparoscopic Burch Colposuspension
Serious events: 0 serious events
Other events: 0 other events
Deaths: 5 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place