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

NCT03296748 | Completed Phase 2

• 1 other identifier: 151115
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Stress Urinary Incontinence

Keywords

asymptomatic cystocele.; stress urinary incontinence

Outcome Measures

Primary Outcomes (2)

• cure rate of stress incontinence

  by clinical assessment

  3 months after surgery

• Denovo urgency

  by clinical assessment

  3 months after surgery

Secondary Outcomes (4)

• cure rate of stress incontinence

  6 months after surgery

• cure rate of stress incontinence

  12 months after surgery

• Denovo urgency

  6 months after surgery

• Denovo urgency

  12 months after surgery

Study Arms (2)

TOT only group

ACTIVE COMPARATOR

60 patients with stress incontinence and asymptomatic grade 2 cystocele.

Procedure: trans-obturator tape inside-out usingsoft tapes.

concomitant repair group

ACTIVE COMPARATOR

63 patients with stress incontinence and asymptomatic grade 2 cystocele.

Procedure: trans-obturator tape inside-out usingsoft tapes.; Procedure: anterior colporraphy

Interventions

trans-obturator tape inside-out usingsoft tapes. PROCEDURE

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.

Also known as: anterior colporrhaphy

TOT only group; concomitant repair group

anterior colporraphy PROCEDURE

concomitant repair group

Eligibility Criteria

• Age: 23 Years - 56 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• female patients
• genuine stress incontinence
• asymptomatic cystocele

You may not qualify if:

• mixed incontinence

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr El Ainiy Hospital

Cairo, 11562, Egypt

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of obstetrics and gynecology Cairo university

Model Details: 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 .

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: September 28, 2017
• Study Start: June 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 24, 2017

Record last verified: 2017-10

Locations

EG (1)