Overactive Bladder Clinical Trial
Official title:
"Transcutaneous Tibial Nerve Stimulation as a Conservative Treatment for Overactive Bladder Dysfunction -A Randomised Controlled Trial Comparing Home Versus Hospital Based Treatment"
Comparison of home versus hospital Transcutaneous Posterior Tibial Nerve Stimulation (TPTNS).
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 Overactive Bladder (OAB)
3. Post-void residual urine volume of < 100ml
4. Able to do questionnaires
5. 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 Urinary Tract Infection (UTI) - must be treated with appropriate antibiotics as
per the unit protocol prior to commencing study
6. Pregnancy
7. Previous Percutaneous Tibial Nerve Stimulation (PTNS) /Sacral Nerve Stimulation (SNS)
course
8. Previous intravesical botox treatment
9. Unable to complete questionnaires
TPTNS will be taught to the home group and delivered to the participants 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 participants will be contacted and asked to do a Patient
Global Impression of Improvement Scale (PGIIS) and Patient Perception of Bladder Condition
(PPBC). After 12 sessions (the final treatment session) all participants will be reviewed by
the investigators in the hospital and the outcome measures repeated. Participants receiving
home treatment will be posted out a 3 day bladder diary to complete. At this point the
participants receiving home treatment will return the machine. All participants will complete
and return a 72-hour bladder diary and validated questionnaires routinely used at the study
centre to measure lower urinary tract symptoms - The International Consultation of
Incontinence Modular Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) long
form, the International Consultation of Incontinence Modular Questionnaire - Urinary
Incontinence questionnaire (ICIQ-UI short-form. The Hospital Anxiety and Depression Scale
(HADS) and the European Quality of Life - 5D Questionnaire (EQ-5D) will also be measured.
n/a
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