TPTNS: Home vs Hospital Treatment for Overactive Bladder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-03

Study Completion Date

2019-08-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Overactive Bladder Detrusor, Overactive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Home Treatment

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

Group Type EXPERIMENTAL

TPTNS

Intervention Type OTHER

We will be comparing hospital treatment to TPTNS at home

Hospital Treatment

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

Group Type ACTIVE_COMPARATOR

TPTNS

Intervention Type OTHER

We will be comparing hospital treatment to TPTNS at home

Interventions

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TPTNS

We will be comparing hospital treatment to TPTNS at home

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes