TPTNS: Home vs Hospital Treatment for Overactive Bladder

NHS Trust

Status: Unknown

Conditions: Detrusor, Overactive; Overactive Bladder

Treatments: Other: TPTNS

Study type: Interventional

Funder types: Other

Identifiers

NCT03727711

GN15UR229

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 1. Women aged greater than or equal to 18 years

  2. Clinical diagnosis of 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Home Treatment

Experimental group

Description:

Participants will be taught home treatment with TPTNS - twice weekly, 30 minute sessions for 6 weeks

Treatment:

Other: TPTNS

Hospital Treatment

Active Comparator group

Description:

Participants will receive hospital treatment with TPTNS - twice weekly, 30 minute sessions for 6 weeks

Treatment:

Other: TPTNS