Transperineal ultrasound of the vesicourethral angle and new stress urinary incontinence after colpocleisis
Evaluation of the Vesicourethral Angle by Preoperative and Postoperative Transperineal Ultrasound in Patients Undergoing Colpocleisis Surgery and Assessment of de Novo Urinary Incontinence
This project will use transperineal ultrasound to see if changes in the vesicourethral angle after colpocleisis lead to new stress urinary incontinence in postmenopausal women with advanced pelvic organ prolapse.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 31 (estimated) |
| Ages | 60 Years to 75 Years |
| Sex | Female |
| Sponsor | Gaziosmanpasa Research and Education Hospital Government |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT07071818 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational study that measures the vesicourethral angle with transperineal ultrasound before colpocleisis and again at 1 and 6 months after surgery. Clinical exams (POP-Q), a pelvic floor symptom questionnaire (PFDI-20), and standardized stress tests will be performed at the same visits to document symptoms and anatomical change. The study will correlate angle changes with the occurrence of de novo stress urinary incontinence. Results aim to clarify whether TPUS-detected anatomical shifts contribute to postoperative urinary symptoms and could guide counseling.
Who should consider this trial
Good fit: Postmenopausal women with stage 3 or 4 pelvic organ prolapse who are not sexually active, consent to undergo colpocleisis, and can attend the scheduled preoperative and postoperative visits are ideal candidates.
Not a fit: Women who wish to remain sexually active, those with prior stress incontinence surgery, or those having additional vesicourethral procedures are excluded and unlikely to benefit from these results.
Why it matters
Potential benefit: If successful, the findings could help clinicians identify patients at higher risk of developing de novo stress urinary incontinence after colpocleisis and improve preoperative counseling and management.
How similar studies have performed: Ultrasound measurements of urethral and bladder angles have been used in POP and SUI research, but using TPUS specifically to predict de novo SUI after colpocleisis is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Istanbul
- Gaziosmanpaşa Training and Research Hospital — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: ecenur çelikoğlu, md — Gaziosmanpaşa training and research hospital
- Study coordinator: serkan kumbasar, md
- Email: drserkankumbasar@hotmail.com
- Phone: 5067873216
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.