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NCT Number: NCT02263534

Comparing Minisling to Tension Free Vaginal Tape in Mangement of Stress Urinary Incontinence

Based on previous studies the single incision minisling is an easy less invasive procedure with fewer complications and cure rate similar to conventional midurethral slings in the treatment of female stress urinary incontinence. The aim of this study is to test the hypothesis that the single incision mini-sling placed in the "U" position is not inferior to TVT in this patient population.

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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

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

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

  • Patients with urodynamic stress urinary incontinence, with or without pelvic organ prolapse

Exclusion criteria

  • Patients with overactive bladder on urodynamic study.
  • Patients with voiding dysfunction.
  • Patients with intrinsic sphincteric deficiency.
  • Patients with previous anti-incontinence surgery.
  • Patients on anti-coagulant therapy.
  • Immune-compromised patients (DM, patients on corticosteroids treatment).
  • Refusal of surgery.

Treatment and study plan

single incision minisling

Procedure

midline incision of the vagina at midurethral level dissection of the vagina from perivesical fascia insertion of the tape (polypropylene macropore mesh tape) in the retropubic direction with its end grasped with an artery forceps till level of perineal membrane closure of the vagina 2 sham incisions if the skin only will be made at suprapubic to maintain blindness posterior colpoperneorraphy will be carried out if needed

tension free vaginal tape

Procedure

midline incision of the vagina at midurethral level dissection of the vagina from perivesical fascia insertion of the tape (polypropylene macropore mesh tape) with the applicators in the retropubic direction and 2 skin incision will be made supra pubic through which the applicators will be passed and removed and the tape will be cut at level just below the skin closure of the vagina posterior colpoperneorraphy will be carried out if needed

Other names: TVT

Primary outcomes

  1. objective cure rate of urinary incontinence at 12 months after surgery

    Time frame: 12 months

    Objective cure is indicated by a negative stress test and the absence of any additional surgical or nonsurgical treatment for stress urinary incontinence

  2. subjective cure rate of urinary incontinence at 12 months after surgery

    Time frame: 12 months

    subjective cure is indicated by an Incontinence Severity Index score of 0 and the absence of any additional surgical or nonsurgical treatment for stress urinary incontinence

Secondary outcomes

  1. Number of participants with short- term complications

    Time frame: 12 months

    short-term complications (less than 6 weeks): post-operative pain, urinary retention, denovo urgency and wound sepsis

  2. Number of participants with long-term complications

    Time frame: 12 months

    long-term complications: erosion, dyspareunia and recurrence

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Randomized Controlled Trial Comparing Minisling to Tension Free Vaginal Tape in Mangement of Stress Urinary Incontinence

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 13, 2014
Registry last updated
Sep 19, 2018

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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