Trial Outcomes & Findings for Vaginally Assisted Laparoscopic Hysteropexy Versus Vaginal Hysterectomy (NCT NCT03436147)

NCT ID: NCT03436147

Last Updated: 2020-09-25

Results Overview

Number of Participants with Recurrence of Pelvic Organ Prolapse

Recruitment status

COMPLETED

Target enrollment

49 participants

Primary outcome timeframe

Postoperative first year

Results posted on

2020-09-25

Participant Flow

Participant milestones

Participant milestones
Measure	Vaginal Assisted Laparoscopic Sacrohysteropexy(VALH) Patients who were performed vaginal assisted laparoscopic sacrohysteropexy (VALH)	Vaginal Hysterectomy and Vaginal Vault Suspension(VAH+VVS) Patients who were performed a vaginal hysterectomy and Vaginal vault suspension
Overall Study STARTED	19	30
Overall Study COMPLETED	15	19
Overall Study NOT COMPLETED	4	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vaginally Assisted Laparoscopic Hysteropexy Versus Vaginal Hysterectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vaginal Assisted Laparoscopic Sacrohysteropexy(VALH) n=15 Participants Patients who were performed vaginal assisted laparoscopic sacrohysteropexy (VALH) POP-Q: Pelvic Organ Prolapse Quantification	Vaginal Hysterectomy and Vaginal Vault Suspensio (VAH+VVS) n=19 Participants Patients who were performed a vaginal hysterectomy and Vaginal Vault Suspension (VAH + VVS) POP-Q: Pelvic Organ Prolapse Quantification	Total n=34 Participants Total of all reporting groups
Age, Continuous	53.2 years STANDARD_DEVIATION 9.1 • n=39 Participants	64.0 years STANDARD_DEVIATION 9.5 • n=41 Participants	59.2 years STANDARD_DEVIATION 10.7 • n=35 Participants
Sex: Female, Male Female	15 Participants n=39 Participants	19 Participants n=41 Participants	34 Participants n=35 Participants
Sex: Female, Male Male	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Black or African American	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) White	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Unknown or Not Reported	15 Participants n=39 Participants	19 Participants n=41 Participants	34 Participants n=35 Participants
Region of Enrollment Turkey	15 participants n=39 Participants	19 participants n=41 Participants	34 participants n=35 Participants
International Consultation on Incontinence Questionnaire Vaginal Symptoms (ICIQ-VS)	20.9 units on a scale STANDARD_DEVIATION 7.6 • n=39 Participants	22.6 units on a scale STANDARD_DEVIATION 6.2 • n=41 Participants	21.8 units on a scale STANDARD_DEVIATION 6.8 • n=35 Participants

PRIMARY outcome

Timeframe: Postoperative first year

Number of Participants with Recurrence of Pelvic Organ Prolapse

Outcome measures

Outcome measures
Measure	Vaginal Assisted Laparoscopic Sacrohysteropexy(VALH) n=15 Participants Patients who were performed vaginal assisted laparoscopic sacrohysteropexy (VALH) POP-Q: Pelvic Organ Prolapse Quantification	Vaginal Hysterectomy and Vaginal Vault Suspension (VAH+VVS) n=19 Participants Patients who were performed vaginal hysterectomy and vaginal vault suspension(VAH+VVS) POP-Q: Pelvic Organ Prolapse Quantification
Number of Participants With Recurrence of Pelvic Organ Prolapse	0 Participants	0 Participants

SECONDARY outcome

Timeframe: change from preoperative measurement of pop-q point c at postoperative first year

The POP-Q system is an objective, site-specific system for describing and staging POP in women. The measurement is then taken of the distance from the point to the hymenal plane. Point C is defined as the most distal (ie, most dependent) edge of the cervix or the leading edge of the vaginal cuff (posthysterectomy). Preoperative and postoperative one year measurement of point C according to POP-Q system will be recorded and the change from preoperative measurement at postoperative first year is secondary outcome of this study.

Outcome measures

Outcome measures
Measure	Vaginal Assisted Laparoscopic Sacrohysteropexy(VALH) n=15 Participants Patients who were performed vaginal assisted laparoscopic sacrohysteropexy (VALH) POP-Q: Pelvic Organ Prolapse Quantification	Vaginal Hysterectomy and Vaginal Vault Suspension (VAH+VVS) n=19 Participants Patients who were performed vaginal hysterectomy and vaginal vault suspension(VAH+VVS) POP-Q: Pelvic Organ Prolapse Quantification
POP-Q SYSTEM Point C MEASUREMENT	-8.5 centimeters Standard Deviation 3.4	-7 centimeters Standard Deviation 3.2

SECONDARY outcome

Timeframe: change from preoperative ICIQ-VS vaginal symptom subscale score at postoperative first year

International Consultation on Incontinence Questionnaire-Vaginal Symptoms (ıcıq-vs ) score of the patient after postoperative one year. This score includes 14 questions as Dragging abdominal pain, Vaginal soreness, Reduced sensation around vagina, Vagina too loose/lax, Lump coming down in vagina, Lump coming out of vagina, Dry vagina, Digitation for bowel opening, Tight vagina, Current sex life, Worries about vagina affect sex life, Relationship Sex life spoilt, Overall impact on everyday life. ICIQ-VS score ranges between 0 and 53. Higher ICIQ-VS scores represent worse outcome.

Outcome measures

Outcome measures
Measure	Vaginal Assisted Laparoscopic Sacrohysteropexy(VALH) n=15 Participants Patients who were performed vaginal assisted laparoscopic sacrohysteropexy (VALH) POP-Q: Pelvic Organ Prolapse Quantification	Vaginal Hysterectomy and Vaginal Vault Suspension (VAH+VVS) n=19 Participants Patients who were performed vaginal hysterectomy and vaginal vault suspension(VAH+VVS) POP-Q: Pelvic Organ Prolapse Quantification
ICIQ-VS Vaginal Symptom Subscale	-13.8 score on a scale Standard Deviation 7.6	17.7 score on a scale Standard Deviation 5.4

Adverse Events

Vaginal Assisted Laparoscopic Sacrohysteropexy(VALS)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vaginal Hysterectomy and Vaginal Vault Suspension(VAH+VVS)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ismail Alay

bakirkoy dr sadi konuk training and research hospital

Phone: +905462375638

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place