MedTrace Logo

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

NCT06044987 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2025-02-19

No results posted yet for this study

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

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..

Sponsors & Collaborators

  • Al-Sadr Teaching Hospital

    collaborator OTHER_GOV

  • Al-Mustafa University College

    lead OTHER

Principal Investigators

  • Hayder Adnan Fawzi, Ph.D · Al-Mustafa University College

  • Thaer Saleh Sabor Al-Omary, Ph.D · Al-Sadr Teaching Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2022-09-01
Completion
2022-09-01

Countries

  • Iraq

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06044987 on ClinicalTrials.gov