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NCT Number: NCT07071818

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

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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Key information

Conditions

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

Age range

60 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gaziosmanpaşa Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

Serkan kumbasar, Assistant Professor

CONTACT

[email protected]

5067873216

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

serkan kumbasar, md

CONTACT

[email protected]

5067873216

Sponsors and collaborators

Lead sponsor

Gaziosmanpasa Research and Education Hospital

Other Gov

Registry information

Official study title

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

Acronym: colpocleisis

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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