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

NCT07071818 | Recruiting

• 1 other identifier: gopcolpoultra
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prolapse, Vaginal

Keywords

Colpocleisis; Transperineal Ultrasound; de Novo Incontinence; Vesicourethral Angle

Outcome Measures

Primary Outcomes (4)

• Change in Vesicourethral Angle Measured by Transperineal Ultrasound

  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

  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

  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

  Assessment of anatomical improvement in pelvic organ prolapse using POP-Q staging system, comparing pre- and postoperative values.

  Preoperative, 6 Months Postoperative

Study Arms (1)

Colpocleisis Group

OTHER

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

Interventions

Colpocleisis Group 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.

Colpocleisis Group

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Gaziosmanpaşa Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Uterine Prolapse

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• ecenur çelikoğlu, md

  Gaziosmanpaşa training and research hospital

  PRINCIPAL INVESTIGATOR

• yağmur acıyiyen, md

  Gaziosmanpaşa training and research hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

serkan kumbasar, md

CONTACT

5067873216; drserkankumbasar@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: July 17, 2025
• Study Start: July 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)