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Completed

NCT Number: NCT03296748

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

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

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Key information

Conditions

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

Age range

23 year–56 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Kasr El Ainiy Hospital

Cairo, 11562, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • female patients
  • genuine stress incontinence
  • asymptomatic cystocele

Exclusion criteria

  • mixed incontinence

Treatment and study plan

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.

Other names: anterior colporrhaphy

Anterior colporraphy

Procedure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study 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 ?

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 28, 2017
Registry last updated
Oct 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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