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Completed

NCT Number: NCT01057550

Randomised Controlled Trial Comparing Tension-Free Vaginal Tape (TVT), Pelvicol & Autologous Slings for Stress Urinary Incontinence(SUI)

The purpose of this trial was to discover which type of operation for stress urinary incontinence in women offered better results: autologous slings, TVT or Pelvicol slings.

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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

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

ABM University Hospital NHS trust

Swansea, Wales, SA2 8QA, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Women requiring surgery for SUI following failed conservative treatment

Exclusion criteria

  • Under 18 years of age
  • Previous surgery for SUI
  • Evidence of neurological disease
  • Pelvic Organ Prolapse (POP) greater than Grade 2
  • Women with any evidence of Detrusor Overactivity or bladder hypocompliance on urodynamic assessment

Treatment and study plan

Autologous fascial sling

Procedure

Retropubic bottom up mid urethral sling made using autologous rectus sheath fascia

TVT

Procedure

Standard TVT as described by Ulmsten 1996

Pelvicol

Procedure

retropubic mid urethral sling made from Pelvicol

Primary outcomes

  1. success rate at improving symptom of stress urinary incontinence

    Time frame: 1 year

Secondary outcomes

  1. completely dry rates

    Time frame: 1 year

  2. quality of life scores

    Time frame: 1 year

  3. intra & post-operative complications

    Time frame: 1 year

  4. re-operation rates

    Time frame: 1 year

  5. hospital stay

    Time frame: 5 days

  6. operative time

    Time frame: hours

Sponsors and collaborators

Lead sponsor

Abertawe Bro Morgannwg University NHS Trust

Other Gov

Collaborators

  • C. R. Bard

Registry information

Official study title

A Randomised Controlled Trial Comparing TVT, Pelvicol and Autologous Fascial Slings for the Treatment of Stress Urinary Incontinence in Women

Important dates

Study start
2001
Primary completion
2006
Study completion
2006
First posted
Jan 27, 2010
Registry last updated
Jan 27, 2010

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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