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

Official title

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

Overview

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.

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.

Interventions

• 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.

Primary outcome measures

• Change in Vesicourethral Angle Measured by Transperineal Ultrasound [Time frame: Baseline (Preoperative), 6 Months Postoperative]
• Incidence of de Novo Stress Urinary Incontinence [Time frame: 6 Months Postoperative]
• Change in PFDI-20 (Pelvic Floor Distress Inventory-20) Score [Time frame: Preoperative, 6 Months Postoperative]
• Change in POP-Q Stage [Time frame: Preoperative, 6 Months Postoperative]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Gaziosmanpaşa Training and Research Hospital — Istanbul

Identifiers

NCT: NCT07071818 · gopcolpoultra

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗