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

Al-Mustafa University College98 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stress Urinary Incontinence

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: At baseline, and at 9 months

Secondary Outcomes

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

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.

Time frame: At baseline, and after 9 months