Transperineal Ultrasound Evaluation of Vesicourethral Angle and de Novo SUI After Colpocleisis Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-01-01

Brief Summary

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This prospective observational study aims to evaluate changes in the vesicourethral angle using transperineal ultrasound before and after colpocleisis surgery, and to assess the relationship of these changes with the development of de novo stress urinary incontinence.

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Detailed Description

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Colpocleisis is a surgical method used for treating pelvic organ prolapse (POP) in elderly women who are no longer sexually active. POP may mask stress urinary incontinence (SUI) by affecting urethral support. After colpocleisis, correction of the prolapse may alter the vesicourethral angle, potentially leading to de novo urinary incontinence.

This prospective observational study aims to evaluate changes in the vesicourethral angle using transperineal ultrasound (TPUS) before and after colpocleisis surgery, and to investigate its association with new-onset urinary incontinence. Assessments will be conducted at three time points: Preoperative Visit: Clinical evaluation, POP-Q measurements, PFDI-20 questionnaire, stress test, and TPUS measurement of the vesicourethral angle.

Postoperative 1st Month: General recovery and healing assessment. Postoperative 6th Month: Repeat POP-Q, PFDI-20, stress test, TPUS, and evaluation for de novo SUI.

The study aims to explore the role of TPUS in identifying anatomical changes that may contribute to urinary symptoms following colpocleisis.

Conditions

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Prolapse, Vaginal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a prospective, observational cohort study designed to evaluate anatomical and functional changes in patients undergoing colpocleisis surgery. Patients will be followed at predefined intervals (preoperative, 1 month, and 6 months postoperatively) to assess changes in the vesicourethral angle using transperineal ultrasound, and to determine the incidence of de novo stress urinary incontinence. The same cohort of patients will be observed over time without any randomization or intervention beyond standard surgical care.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Colpocleisis Group

This study has a single intervention cohort consisting of patients undergoing colpocleisis. All participants in this group will receive standard surgical care (colpocleisis), and no additional intervention will be administered as part of the research. The same protocol will be applied to all participants: vesicourethral angle will be measured using transperineal ultrasound before and six months after surgery. There is no comparison group or randomization.

Group Type OTHER

Colpocleisis Group

Intervention Type PROCEDURE

Participants will undergo colpocleisis surgery as part of routine clinical care. The study involves transperineal ultrasound (TPUS) to measure the vesicourethral angle preoperatively and postoperatively, along with assessments for de novo stress urinary incontinence, POP-Q staging, PFDI-20 questionnaire, and stress testing.

Interventions

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Colpocleisis Group

Participants will undergo colpocleisis surgery as part of routine clinical care. The study involves transperineal ultrasound (TPUS) to measure the vesicourethral angle preoperatively and postoperatively, along with assessments for de novo stress urinary incontinence, POP-Q staging, PFDI-20 questionnaire, and stress testing.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Postmenopausal women with stage 3 or 4 pelvic organ prolapse (according to POP-Q score), who are not sexually active and do not desire future vaginal intercourse, and who consent to undergo colpocleisis surgery will be included in the study.

Exclusion Criteria

Those with a history of stress incontinence surgery Those who underwent an additional vesicourethral intervention in addition to colpocleisis surgery Those who wanted sexual intercourse

Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No