Clinical trial NCT06044987: Effect of Cystocele Repair With Trans Obturator Tape VS. Trans Obturator Tape Alone on Stress Urinary Incontinence.
Official title: The Effect of Concurrent Cystocele Repair on Transobturator Tape in Patients With Stress Urinary Incontinence - A Comparative Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Urinary Incontinence, Stress
Cystocele
Trans Obturator Tape
Pelvic Organ Prolapse
Lead sponsor: Al-Mustafa University College
Sponsor class: OTHER
Collaborators: name: Al-Sadr Teaching Hospital
First posted: 2023-09-21
Enrollment: 98
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Degree of Pelvic organ Prolapse (POP-Q)
timeFrame: At baseline, and at 9 months
measure: Frequency, severity, and effect of urine incontinence on quality of life.
timeFrame: At baseline, and at 9 months
Secondary outcomes:
measure: Impact of lower urinary tract symptoms including urinary incontinence on health-related quality of life.
timeFrame: At baseline, and after 9 months
Other outcomes:
Locations:
city: Al 'Amārah
country: Iraq
facility: Al-Sadr Teaching Hospital
state: Maysan
Study officials:
affiliation: Al-Mustafa University College
name: Hayder Adnan Fawzi, Ph.D
role: STUDY_CHAIR
affiliation: Al-Sadr Teaching Hospital
name: Thaer Saleh Sabor Al-Omary, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: