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

Al-Mustafa University College

Status: Terminated

Conditions: Stress Urinary Incontinence

Treatments: Procedure: Cystocele Repair; Procedure: Trans Obturator Tape Procedure (TOT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06044987

A-202301

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

98 participants in 2 patient groups

Group I (TOT alone)

Active Comparator group

Description:

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

Treatment:

Procedure: Trans Obturator Tape Procedure (TOT)

Group II (TOT+ Cystocele Repair)

Experimental group

Description:

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

Treatment:

Procedure: Trans Obturator Tape Procedure (TOT)

Procedure: Cystocele Repair