Correction of Asymptomatic 2nd Degree Cystocele in Patient With Stress Incontinence

Stress Urinary Incontinence Clinical Trial

Official title:

Is There Any Value of Concomitant Repair of Asymptomatic Grade II Anterior Vaginal Wall Prolapse During Mid Urethral Sling Surgery for Stress Urinary Incontinence ?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03296748
• Other study ID #: 151115
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 25, 2017
• Last updated: October 23, 2017
• Start date: June 1, 2016
• Est. completion date: September 2017

Study information

• Verified date: October 2017
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of our study is to assess the value of concomitant surgical correction of asymptomatic grade II anterior vaginal wall prolapse with the placement of midurethral sling for treatment of female patients with stress incontinence

Description:

female patients with stress urinary incontinence and asymptomatic grade II anterior vaginal wall prolapse were divided into Group A: treated only with trans-obturator tape (TOT) and group B where` TOT was associated with anterior colporrhaphy and the outcome is compared.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 23 Years to 56 Years

Eligibility

Inclusion Criteria:

• female patients

• genuine stress incontinence

• asymptomatic cystocele

Exclusion Criteria:

• mixed incontinence

Related Conditions & MeSH terms

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

Intervention

Procedure:
• trans-obturator tape inside-out usingsoft tapes.
trans-obturator tape inside-out soft tapes is applied under spinal anesthesia. After the procedure, the vaginal gauze packing and Foley catheter were removed on the morning of the next day.
• anterior colporraphy

Locations

Country	Name	City	State
Egypt	Kasr El Ainiy Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cure rate of stress incontinence	by clinical assessment	3 months after surgery
Primary	Denovo urgency	by clinical assessment	3 months after surgery
Secondary	cure rate of stress incontinence	by clinical assessment	6 months after surgery
Secondary	cure rate of stress incontinence	by clinical assessment	12 months after surgery
Secondary	Denovo urgency	by clinical assessment	6 months after surgery
Secondary	Denovo urgency	by clinical assessment	12 months after surgery