NCT06044987

Effect of Cystocele Repair With Trans Obturator Tape VS. Trans Obturator Tape Alone on Stress Urinary Incontinence.

The Effect of Concurrent Cystocele Repair on Transobturator Tape in Patients With Stress Urinary Incontinence - A Comparative Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Al-Mustafa University College · Academic / Other
• Sex: Female
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The goal of this interventional study is to compare the effect of Concurrent cystocele repair and trans obturator tape (TOT) and TOT alone in a sample of Iraqi Female participants with diagnosed stress urinary incontinence and cystocele. The main questions to answer are: 1-What are the effects of the tested Interventions on the outcomes measured by The Pelvic Organ Prolapse Quantification (POP-Q) System? 1. What are the effects of the tested Interventions on the degree of pelvic organ prolapse? 2. What are the effects of the tested Interventions on the frequency, severity, and effect of Stress urinary incontinence on the quality of life of the patients? 3. What are the effects of the tested Interventions on the impact of lower urinary tract symptoms on the quality of the patient's life? Female Patients diagnosed with SUI indicated for intervention were divided into 2 groups Group I: (n=49) offered TOT alone Group II: (n=49) offered concurrent TOT and Cystocele Repair Patients were then followed up and evaluated using The Pelvic Organ Prolapse Quantification (POP-Q) System, The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), and the King Health Questionnaire (KHQ). The efficacy of both procedures and their impact on SUI and quality of life was measured.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
PROCEDURE	Trans Obturator Tape Procedure (TOT)	Done under Spinal anesthesia in the dorsal lithotomy position.
PROCEDURE	Cystocele Repair	Done under Spinal anesthesia in the dorsal lithotomy position..

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2023-09-21
• Last updated: 2025-02-19

Locations

1 site across 1 country: Iraq