Outcomes of tension-free vaginal tape for stress incontinence

• Research type

  Research Study

• Full title

  A retrospective cohort study with up to date follow up of the outcomes of tension-free vaginal tape for stress urinary incontinence

• IRAS ID

  181530

• Contact name

  Ash Monga

• Sponsor organisation

  Research and Development

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research summary

  Stress urinary incontinence (SUI) can be defined as the involuntary leakage of urine during sudden rises in intra-abdominal pressure. It affects women to different extents, restricting both work and leisure aspects of life, which can cause psychological distress.
  It is a common condition but women often live with the problem because they are embarrassed and others view it as a normal part of ageing, so do not seek medical help. It is estimated that 3.5 million women in the UK suffer from UI. A postal survey found 11.6% of women aged over 65 reported UI. Stress urinary incontinence is reported to be the most common type of UI.
  Tension-free vaginal tape (TVT) was introduced into clinical practice in the UK in 1996 and is now the gold standard surgical procedure for SUI. Synthetic mid-urethral tape is a minimally invasive procedure involving small incisions through which a mesh is inserted around the urethra lifting and supporting it to the bladder.
  There are a number of studies, which show good success rates both subjectively and objectively at short term follow up. The York report summarises the complications of the TVT to evaluate the safety of the procedure. The main complications included in this report were: mesh erosion, pain and de novo overactive bladder symptoms, the latter being the most significant.
  The majority of studies published thus far have little long term follow up. The longer-term studies are considered by NICE to provide low quality evidence, this could be due to small sample sizes. There is still limited evidence demonstrating the long-term success rates and complications for TVT to manage SUI.
  We propose a study to gain further data on the long-term success rates and any complications of the TVT procedure for SUI. The study will involve writing to patients who have had the TVT procedure to treat SUI between five and seventeen years ago to invite them to participate in the study. Participants of the study will then undergo a questionnaire, stress test and vaginal inspection to gain both subjective and objective information on cure rate and complications. This will then be statistically analysed using SPSS and written up into a report.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  15/SC/0760

• Date of REC Opinion

  8 Jan 2016

• REC opinion

  Further Information Favourable Opinion