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

NCT ID: NCT03296748

Last Updated: 2017-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2017-09-30

Brief Summary

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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

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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.

Conditions

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Stress Urinary Incontinence

Keywords

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asymptomatic cystocele. stress urinary incontinence

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 .
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TOT only group

60 patients with stress incontinence and asymptomatic grade 2 cystocele.

Group Type ACTIVE_COMPARATOR

trans-obturator tape inside-out usingsoft tapes.

Intervention Type 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.

concomitant repair group

63 patients with stress incontinence and asymptomatic grade 2 cystocele.

Group Type ACTIVE_COMPARATOR

trans-obturator tape inside-out usingsoft tapes.

Intervention Type 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.

anterior colporraphy

Intervention Type PROCEDURE

Interventions

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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.

Intervention Type PROCEDURE

anterior colporraphy

Intervention Type PROCEDURE

Other Intervention Names

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anterior colporrhaphy

Eligibility Criteria

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Inclusion Criteria

* female patients
* genuine stress incontinence

* asymptomatic cystocele

Exclusion Criteria

* mixed incontinence
Minimum Eligible Age

23 Years

Maximum Eligible Age

56 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role lead

Responsible Party

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sarah mohamed hassan

lecturer of obstetrics and gynecology Cairo university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kasr El Ainiy Hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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151115

Identifier Type: -

Identifier Source: org_study_id