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

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06044987
• Other study ID #: A-202301
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: September 2023
• Source: Al-Mustafa University College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cystocele
• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Procedure:
• Trans Obturator Tape Procedure (TOT)
Done under Spinal anesthesia in the dorsal lithotomy position.
• Cystocele Repair
Done under Spinal anesthesia in the dorsal lithotomy position..

Locations

Country	Name	City	State
Iraq	Al-Sadr Teaching Hospital	Al 'Amarah	Maysan

Sponsors (2)

Lead Sponsor	Collaborator
Al-Mustafa University College	Al-Sadr Teaching Hospital

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of Pelvic organ Prolapse (POP-Q)	Assessed using the pelvic organ prolapse quantification system, in which it classified into: Stage 0: No prolapse is observed; Stage 1: The most proximal portion of prolapse is greater than 1 cm above the level of the hymen; Stage 2: The most proximal portion of prolapse is found between 1 cm higher than hymen and 1cm beneath hymen; Stage 3: The most distal part of the prolapse extends more than 1cm beneath the hymen but no further than 2 cm; Stage 4: vaginal eversion has taken place or eversion to with 2cm of TVL	At baseline, and at 9 months
Primary	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	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.	At baseline, and after 9 months