Patients experience of symptoms between top-ups sessions of PTNS v1.1

• Research type

  Research Study

• Full title

  Evaluate patients' experience of continence symptom burden between top-ups sessions of Percutaneous Tibial Nerve Stimulation

• IRAS ID

  160313

• Contact name

  Pauline McCulloch

• Contact email

  pauline.mcculloch@homerton.nhs.uk

• Sponsor organisation

  Homerton University Hospital

• Research summary

  Evaluate patients’ experience of continence symptom burden between top-ups sessions of Percutaneous Tibial Nerve Stimulation (PTNS).

  The purpose of this study is to understand the patients’ experiences and changes in continence symptoms after completion of the initial 12 week treatment programme using Percutaneous Tibial Nerve Stimulation (PTNS) for either faecal or urinary incontinence. PTNS is a less invasive mechanism used to stimulate the posterior tibial nerve, producing a motor and/or sensory response. It is offered to patients with either faecal incontinence or over active bladder,following specialist assessment and having tried a range of conservative management treatment.
  Currently treatment schedules are one a week for 12 sessions on current evidence (Allison et al 2009). There is a suggestion that if symptoms are reduced following the treatment, then the reduction in symptom burden can last for up to 6 months and that a further 2 or 3 treatments will manage any further deterioration.

  The study will be conducted at Homerton Hospital, to include all patients with incontinence symptoms attending top-up visits following the 12 treatment sessions. Currently patients attend for a top-up monthly which is an arbitrary figure with no solid evidence. Therefore the authors will explore patients’ experiences, in order to provide an effective service and establish a recommended schedule for top-up sessions. This will inform our current practice and may result in a change in how we manage top-up sessions.

  Patients will take part in an interview or focus group when attending for treatment sessions. It is expected that each interview will take around 30 minutes.
  All patients who have completed the 12 week initial treatment sessions, in the last 2 years, but have not attended for top-ups will be sent a letter and questionnaire regarding their symptoms. It is expected the study should last until April 2015.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  14/EE/1089

• Date of REC Opinion

  5 Sep 2014

• REC opinion

  Further Information Favourable Opinion