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

NCT06044987 | Terminated DMC

• 1 other identifier: A-202301
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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. 1.What are the effects of the tested Interventions on the degree of pelvic organ prolapse?
2. 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. 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?

Conditions

Stress Urinary Incontinence

Keywords

Urinary Incontinence, Stress; Cystocele; Trans Obturator Tape; Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (2)

• Degree of Pelvic organ Prolapse (POP-Q)

  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.

  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 Outcomes (1)

• Impact of lower urinary tract symptoms including urinary incontinence on health-related quality of life.

  At baseline, and after 9 months

Study Arms (2)

Group I (TOT alone)

ACTIVE COMPARATOR

49 Female Patients diagnosed with Stress urinary incontinence and cystocele and offered repair by Trans obturator tape procedure

Procedure: Trans Obturator Tape Procedure (TOT)

Group II (TOT+ Cystocele Repair)

EXPERIMENTAL

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); Procedure: Cystocele Repair

Interventions

Trans Obturator Tape Procedure (TOT) PROCEDURE

Done under Spinal anesthesia in the dorsal lithotomy position.

Group I (TOT alone); Group II (TOT+ Cystocele Repair)

Cystocele Repair PROCEDURE

Done under Spinal anesthesia in the dorsal lithotomy position..

Group II (TOT+ Cystocele Repair)

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Mustafa University College: lead
• Al-Sadr Teaching Hospital: collaborator

Study Sites (1)

Al-Sadr Teaching Hospital

Amarah, Maysan Governorate, 62001, Iraq

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress; Cystocele; Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases; Prolapse; Pathological Conditions, Anatomical

Study Officials

• Hayder Adnan Fawzi, Ph.D

  Al-Mustafa University College

  STUDY CHAIR

• Thaer Saleh Sabor Al-Omary, Ph.D

  Al-Sadr Teaching Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof.

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 21, 2023
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

IR (1)