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Completed

NCT Number: NCT02775526

TOT, TVT And Burch Colpo-Suspension for Treatment of Female Mixed Urinary Incontinence

This prospective interventional randomized controlled trial will recruit women with MUI scheduled for surgical treatment where patients will be randomized to either Burch colposuspension, TOT or TVT. Regular postoperative follow up will be planned for at least 2 years. The primary outcome measures will be the objective and subjective cure rates.

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Key information

Conditions

Treatment 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 Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University Maternity Hospital

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women with mixed urinary incontinence.

Exclusion criteria

  • Women with associated gynecological surgery e.g. uterine prolapse, previous anti-incontinence surgery, intrinsic sphincter deficiency (ISD), and medical disorders affecting the bladder innervation as diabetes mellitus were excluded from the study.
  • Women who improved on medical treatment with persistence of stress element only were also excluded.

Treatment and study plan

TOT

Procedure

70 patients

Other names: Trans-Obturator Tape

TVT

Procedure

70 patients

Other names: Tension-Free Vaginal Tape

Burch Colposuspension

Procedure

70 patients

Primary outcomes

  1. objective cure rate

    Time frame: 2 years

  2. subjective cure rate

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Trans-Obturator Tape, Tension-Free Vaginal Tape and Burch Colposuspension for Treatment of Female Mixed Urinary Incontinence: A Randomized Clinical Trial

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
May 17, 2016
Registry last updated
Jan 28, 2020

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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