ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03296748
Recruitment Status : Completed
First Posted : September 28, 2017
Last Update Posted : October 24, 2017
Sponsor:
Information provided by (Responsible Party):
sarah mohamed hassan, Kasr El Aini Hospital

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

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Procedure: trans-obturator tape inside-out usingsoft tapes. Procedure: anterior colporraphy Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
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 ?
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: TOT only group
60 patients with stress incontinence and asymptomatic grade 2 cystocele.
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.
Other Name: anterior colporrhaphy

Active Comparator: concomitant repair group
63 patients with stress incontinence and asymptomatic grade 2 cystocele.
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.
Other Name: anterior colporrhaphy

Procedure: anterior colporraphy



Primary Outcome Measures :
  1. cure rate of stress incontinence [ Time Frame: 3 months after surgery ]
    by clinical assessment

  2. Denovo urgency [ Time Frame: 3 months after surgery ]
    by clinical assessment


Secondary Outcome Measures :
  1. cure rate of stress incontinence [ Time Frame: 6 months after surgery ]
    by clinical assessment

  2. cure rate of stress incontinence [ Time Frame: 12 months after surgery ]
    by clinical assessment

  3. Denovo urgency [ Time Frame: 6 months after surgery ]
    by clinical assessment

  4. Denovo urgency [ Time Frame: 12 months after surgery ]
    by clinical assessment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   23 Years to 56 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female patients
  • genuine stress incontinence

    • asymptomatic cystocele

Exclusion Criteria:

  • mixed incontinence

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03296748


Locations
Egypt
Kasr El Ainiy Hospital
Cairo, Egypt, 11562
Sponsors and Collaborators
Kasr El Aini Hospital

Responsible Party: sarah mohamed hassan, lecturer of obstetrics and gynecology Cairo university, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT03296748     History of Changes
Other Study ID Numbers: 151115
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017

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

Keywords provided by sarah mohamed hassan, Kasr El Aini Hospital:
asymptomatic cystocele.
stress urinary incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders