TPoTS Study

• Research type

  Research Study

• Full title

  Transcutaneous Posterior Tibial Nerve Stimulation: Home vs Hospital Treatment

• IRAS ID

  227347

• Contact name

  Veenu Veenu Tyagi

• Contact email

  veenu.tyagi@ggc.scot.nhs.uk

• Sponsor organisation

  Clinical Research & Development, R&D Management Office

• Duration of Study in the UK

  1 years, 6 months, 0 days

• Research summary

  Comparison home vs hospital transcutaneous posterior tibial nerve (TPTNS) stimulation. TPTNS has been shown to be an effective treatment of overactive bladder in hospital. We aim to see if this effect is replicated at home.

  80 patients will be recruited, 40 into each arm.

  Inclusion criteria:

  1. Women aged > 18 years

  2. Clinical diagnosis of OAB

  3. Must have failed to improve sufficiently with Conservative management including

  a. Bladder Retraining
  b. Trial of 2 Anticholinergics &/ or Mirabegron

  4. Post-void residual urine volume of < 100ml

  5. Able to do questionnaires

  6. Able to consent and willing to participate

  Exclusion Criteria

  1. Cardiac pacemaker in situ

  2. Leg ulcer/skin condition affecting both lower legs

  3. Diagnosed peripheral vascular disease

  4. Absent sensation at the electrode site

  5. Current UTI – must be treated with appropriate antibiotics as per the unit protocol prior to commencing study

  6. Pregnancy

  7. Previous PTNS /SNS

  8. Previous intravesical botox treatment

  9. Unable to complete questionnaires

  TPTNS will be taught to the home group and delivered to the patient in the hospital group in individual appointments: 12 treatment sessions of 30 minutes duration, delivered twice weekly over a 6 week period. Two surface electrodes are applied to the right ankle. These electrodes are attached to an electrical stimulator, programmed to safely deliver electric pulses.

  On completion of 6 sessions, all women will be contacted and asked to do a Patient Global Impression of Improvement Scale(PGIIS). After 12 sessions (the final treatment session) all women will be reviewed by the research team in the hospital and the outcome measures repeated. Women receiving home treatment will be posted out 3 day bladder diary to complete. At this point the women receiving home treatment will return the machine. All women will complete and return a 72-hour bladder diary and validated questionnaires routinely used at the study centre to measure lower urinary tract symptoms (ICIQ-FLUTS questionnaire) 17, incontinence episodes and severity (ICIQ-UI short-form questionnaire) 18 and screen for anxiety and depression (HADS)

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  18/SC/0053

• Date of REC Opinion

  6 Mar 2018

• REC opinion

  Further Information Favourable Opinion