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

July 15, 2025 updated by: Serkan Kumbasar, Gaziosmanpasa Research and Education Hospital

Evaluation of the Vesicourethral Angle by Preoperative and Postoperative Transperineal Ultrasound in Patients Undergoing Colpocleisis Surgery and Assessment of de Novo Urinary Incontinence

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • Gaziosmanpasa Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Vesicourethral Angle Measured by Transperineal Ultrasound
Time Frame: Baseline (Preoperative), 6 Months Postoperative
The primary outcome is the change in the vesicourethral angle measured via transperineal ultrasound before and after colpocleisis surgery. The angle will be measured in degrees using standardized TPUS imaging protocols.
Baseline (Preoperative), 6 Months Postoperative
Incidence of de Novo Stress Urinary Incontinence
Time Frame: 6 Months Postoperative
The proportion of patients who develop new-onset (de novo) stress urinary incontinence following colpocleisis surgery, as determined by physical examination (stress test) and patient-reported symptoms.
6 Months Postoperative
Change in PFDI-20 (Pelvic Floor Distress Inventory-20) Score
Time Frame: Preoperative, 6 Months Postoperative
Evaluation of changes in pelvic floor symptoms and distress based on patient responses to the validated PFDI-20 questionnaire administered before and after surgery.
Preoperative, 6 Months Postoperative
Change in POP-Q Stage
Time Frame: Preoperative, 6 Months Postoperative
Assessment of anatomical improvement in pelvic organ prolapse using POP-Q staging system, comparing pre- and postoperative values.
Preoperative, 6 Months Postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gaziosmanpasa Research and Education Hospital

Investigators

  • Principal Investigator: yağmur acıyiyen, md, Gaziosmanpasa Training and Research Hospital
  • Principal Investigator: ecenur çelikoğlu, md, Gaziosmanpasa Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

July 4, 2025

First Submitted That Met QC Criteria

July 15, 2025

First Posted (Actual)

July 17, 2025

Study Record Updates

Last Update Posted (Actual)

July 17, 2025

Last Update Submitted That Met QC Criteria

July 15, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • gopcolpoultra

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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