New and Original Transvaginal Tapes for the treatment of Stress urinary incontinence-a feasibility study (NOTTS study)

  • Deepa Gopinath

Student thesis: Unknown

Abstract

ABSTRACTObjectives: This is a single centre randomised pilot study to assess the feasibility of a future randomised trial with the following objectives. 1) To compare the efficacy and safety of Single Incision Sling (SIS) - Solyx under local anaesthetic (LA) with retropubic Tension free Vaginal Tape (TVT) under general anaesthetic (GA) for the treatment of female stress urinary incontinence (SUI). 2) To identify reasons for refusal to participate in this pilot.Design: 1) Randomised controlled trial. 2) Qualitative interview study.Population and Setting: Women eligible to have TVT for SUI attending the urogynaecology unit in a tertiary referral hospital, UK between July 2010 and March 2012.Methods: Standardised counselling was given to eligible women. Non-participants of the RCT were interviewed using a semi-structured proforma. Participants of the RCT were randomised. Data was collected on initial post-operative recovery, and surgical outcome was assessed using validated questionnaires and urodynamics.Main outcome measure: Overall subjective cure rate of SUI at six months using Patient Global Impression of Improvement (PGI-I) scale. Results: Thirty women participated in the randomised trial with 15 cases in each arm. The overall subjective cure rates were similar for TVT and Solyx SIS at six months '(RR 0.92(0.60-1.41)'. Complication rates were similar and initial recovery time was quicker in the Solyx SIS arm. Twenty three non-participants of the RCT were interviewed. Common themes for non-participation were a preference for TVT and request for GA. Additional tests and follow-up visits were not cited as a reason for non-participation.Conclusion: The success rates of SIS from this study justify a larger multicentre trial to evaluate the efficacy further. However, the primary modifiable factor resulting in non-participation was the desire for GA. Hence, a trial of efficacy should be done before health economic studies, to determine whether SISs can be offered in the "office setting" in routine clinical practice.
Date of Award31 Dec 2012
Original languageEnglish
Awarding Institution
  • The University of Manchester
SupervisorFiona Reid (Supervisor)

Keywords

  • Stress urinary incontinence
  • Tension free Vaginal tape
  • Single incision sling
  • Randomised controlled trial

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