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

February 15, 2025 updated by: Hayder Adnan Fawzi, Al-Mustafa University College

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
    • Maysan
      • Al 'Amārah, Maysan, Iraq, 62001
        • Al-Sadr Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female patients.
  • Pure stress and/or stress-predominant mixed urinary incontinence (MUI) associated with cystocele.
  • Had not undergone a previous SUI surgery.
  • BMI less than 35 kg/m2

Exclusion Criteria:

  • Patients out of the age limit.
  • Patients refused to participate in the study.
  • Severe comorbid disease (heart failure HYHA class II and above, etc.).
  • Patients with a previous surgical history of transvaginal mesh.
  • Patients suffering detrusor overactivity.
  • Patients diagnosed with the female genital system or urinary bladder Malignancies.
  • Patients diagnosed with the presence of neurological disorders that caused voiding dysfunction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group I (TOT alone)
49 Female Patients diagnosed with Stress urinary incontinence and cystocele and offered repair by Trans obturator tape procedure
Procedure: Trans Obturator Tape Procedure (TOT)
Done under Spinal anesthesia in the dorsal lithotomy position.
Experimental: Group II (TOT+ Cystocele Repair)
49 Female Patients diagnosed with Stress urinary incontinence and cystocele and offered repair by Trans obturator tape procedure concurrently with cystocele repair.
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..

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of Pelvic organ Prolapse (POP-Q)
Time Frame: At baseline, and at 9 months

Assessed using the pelvic organ prolapse quantification system, in which it classified into:

  1. Stage 0: No prolapse is observed
  2. Stage 1: The most proximal portion of prolapse is greater than 1 cm above the level of the hymen
  3. Stage 2: The most proximal portion of prolapse is found between 1 cm higher than hymen and 1cm beneath hymen
  4. Stage 3: The most distal part of the prolapse extends more than 1cm beneath the hymen but no further than 2 cm
  5. Stage 4: vaginal eversion has taken place or eversion to with 2cm of TVL
At baseline, and at 9 months
Frequency, severity, and effect of urine incontinence on quality of life.
Time Frame: At baseline, and at 9 months
Assessed using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF). The score runs from "0 to 21", with higher values indicating more severe illness
At baseline, and at 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of lower urinary tract symptoms including urinary incontinence on health-related quality of life.
Time Frame: At baseline, and after 9 months
Assessed using the King Health Questionnaire (KHQ). It contains ten patient-rated domains. Each score value from 0% (best outcome) to 100% (worst outcome), except for Q10 from "0 to 30" with 30 being the worst.
At baseline, and after 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Mustafa University College

Collaborators

Al-Sadr Teaching Hospital

Investigators

  • Study Chair: Hayder Adnan Fawzi, Ph.D, Al-Mustafa University College
  • Principal Investigator: Thaer Saleh Sabor Al-Omary, Ph.D, Al-Sadr Teaching Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

September 20, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 15, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-202301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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