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

Primary Purpose

Stress Urinary Incontinence

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
trans-obturator tape inside-out usingsoft tapes.
anterior colporraphy
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring asymptomatic cystocele., stress urinary incontinence

Eligibility Criteria

23 Years - 56 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • female patients

  • genuine stress incontinence

    • asymptomatic cystocele

Exclusion Criteria:

  • mixed incontinence

Sites / Locations

  • Kasr El Ainiy Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

TOT only group

concomitant repair group

Arm Description

60 patients with stress incontinence and asymptomatic grade 2 cystocele.

63 patients with stress incontinence and asymptomatic grade 2 cystocele.

Outcomes

Primary Outcome Measures

cure rate of stress incontinence
by clinical assessment
Denovo urgency
by clinical assessment

Secondary Outcome Measures

cure rate of stress incontinence
by clinical assessment
cure rate of stress incontinence
by clinical assessment
Denovo urgency
by clinical assessment
Denovo urgency
by clinical assessment

Full Information

First Posted
September 25, 2017
Last Updated
October 23, 2017
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03296748
Brief Title
Correction of Asymptomatic 2nd Degree Cystocele in Patient With Stress Incontinence
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 ?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
asymptomatic cystocele., stress urinary incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model 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 .
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TOT only group
Arm Type
Active Comparator
Arm Description
60 patients with stress incontinence and asymptomatic grade 2 cystocele.
Arm Title
concomitant repair group
Arm Type
Active Comparator
Arm Description
63 patients with stress incontinence and asymptomatic grade 2 cystocele.
Intervention Type
Procedure
Intervention Name(s)
trans-obturator tape inside-out usingsoft tapes.
Other Intervention Name(s)
anterior colporrhaphy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
anterior colporraphy
Primary Outcome Measure Information:
Title
cure rate of stress incontinence
Description
by clinical assessment
Time Frame
3 months after surgery
Title
Denovo urgency
Description
by clinical assessment
Time Frame
3 months after surgery
Secondary Outcome Measure Information:
Title
cure rate of stress incontinence
Description
by clinical assessment
Time Frame
6 months after surgery
Title
cure rate of stress incontinence
Description
by clinical assessment
Time Frame
12 months after surgery
Title
Denovo urgency
Description
by clinical assessment
Time Frame
6 months after surgery
Title
Denovo urgency
Description
by clinical assessment
Time Frame
12 months after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
56 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: female patients genuine stress incontinence asymptomatic cystocele Exclusion Criteria: mixed incontinence
Facility Information:
Facility Name
Kasr El Ainiy Hospital
City
Cairo
ZIP/Postal Code
11562
Country
Egypt

12. IPD Sharing Statement

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

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