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TPTNS: Home vs Hospital Treatment for Overactive Bladder

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ClinicalTrials.gov Identifier: NCT03727711
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : November 1, 2018
Sponsor:
Collaborators:
University of Glasgow
Glasgow Caledonian University
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Overactive Bladder Detrusor, Overactive Other: TPTNS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: "Transcutaneous Tibial Nerve Stimulation as a Conservative Treatment for Overactive Bladder Dysfunction -A Randomised Controlled Trial Comparing Home Versus Hospital Based Treatment"
Actual Study Start Date : September 3, 2018
Estimated Primary Completion Date : March 3, 2019
Estimated Study Completion Date : August 4, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Home Treatment
Participants will be taught home treatment with TPTNS - twice weekly, 30 minute sessions for 6 weeks
Other: TPTNS
We will be comparing hospital treatment to TPTNS at home

Active Comparator: Hospital Treatment
Participants will receive hospital treatment with TPTNS - twice weekly, 30 minute sessions for 6 weeks
Other: TPTNS
We will be comparing hospital treatment to TPTNS at home




Primary Outcome Measures :
  1. Change in the International Consultation of Incontinence Modular - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) Long Form Questionnaire total score [ Time Frame: At 6 weeks (i.e. after the last TPTNS treatment) and at 12 weeks (i.e. 6 weeks after last the TPTNS treatment) ]
    The ICIQ-FLUTS Long Form is a patient-completed questionnaire for evaluating female lower urinary tract symptoms and impact on quality of life (QoL) - 18 questionnaire items are asked and summed to calculate total score. Total score range (0-69) - a higher score indicates a worse outcome. Bother scales are not incorporated in the overall score but indicate impact of individual symptoms for the patient .


Secondary Outcome Measures :
  1. Change in number of urgency incontinence episodes recorded on 72 hour bladder diary. [ Time Frame: At 6 weeks (i.e. after the last TPTNS treatment) and at 12 weeks (i.e. 6 weeks after last the TPTNS treatment) ]
    Patient Perception of Intensity of Urgency Severity (PPIUS) Scores on the bladder diary are recorded when a participant experiences incontinence (range 0-4): 0 indicates no urgency, 1-4 indicate urgency experienced (at increasing severity). Number of episodes of urge incontinence are identified and summed.

  2. Change in individual urgency score on International Consultation of Incontinence Modular Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) Long Form Questionnaire [ Time Frame: At 6 weeks (i.e. after the last TPTNS treatment) and at 12 weeks (i.e. 6 weeks after last the TPTNS treatment) ]
    Change in numerical scores for Urgency. Scoring range on questionnaire (0-4) - a higher number indicates a worse outcome.

  3. Change in individual frequency score on International Consultation of Incontinence Modular Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ - FLUTS) Long Form Questionnaire [ Time Frame: At 6 weeks (i.e. after the last TPTNS treatment) and at 12 weeks (i.e. 6 weeks after last the TPTNS treatment) ]
    Change in numerical score on the questionnaire. Scoring range on questionnaire (0-4) - a higher number indicates a worse outcome.

  4. Change in individual nocturia score on International Consultation of Incontinence Modular Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ - FLUTS) Long Form Questionnaire [ Time Frame: At 6 weeks (i.e. after the last TPTNS treatment) and at 12 weeks (i.e. 6 weeks after last the TPTNS treatment) ]
    Change in numerical score on the questionnaire. Scoring range on questionnaire (0-4) - a higher number indicates a worse outcome.

  5. Change in incontinence symptom severity [ Time Frame: At 6 weeks (i.e. after the last TPTNS treatment) and at 12 weeks (i.e. 6 weeks after last the TPTNS treatment) ]
    Change in International Consultation of Incontinence Modular Questionnaire - Urinary Incontinence short-form (ICIQ-UI SF) numerical scores. Scoring range (0-21) - 4 subscales summed for overall score on questionnaire; a higher score indicates increased severity. Self-diagnostic item un-scored.

  6. Change in Mean urgency perception scores recorded on 72 hour bladder diary • [ Time Frame: At 6 weeks (i.e. after the last TPTNS treatment) and at 12 weeks (i.e. 6 weeks after last the TPTNS treatment) ]
    Change in Patient Perception of Intensity of Urgency Severity (PPIUS) Scores on the bladder diary. Range for PPIUS (0-4); a higher score indicates increased severity.

  7. PGIS (Patient Global Impression of Improvement Scale) Score [ Time Frame: At 6 weeks (i.e. after the last TPTNS treatment) and at 12 weeks (i.e. 6 weeks after last the TPTNS treatment) ]
    Change in numerical score on the questionnaire. Range (1-7); higher scores indicate least improvement.

  8. Change in HADS (Hospital Anxiety and Depression) scores [ Time Frame: At 6 weeks (i.e. after the last TPTNS treatment) and at 12 weeks (i.e. 6 weeks after last the TPTNS treatment) ]
    The HADS is a 14 item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Individual item score range (0-3) which are summed for total score. Total score range (0-21) for either Anxiety or Depression. Higher scores indicate a worse outcome.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727711


Contacts
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Contact: Maureen Travers 0141 232 1813 Maureen.Travers@ggc.scot.nhs.uk

Locations
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United Kingdom
Queen Elizabeth University Hospital Recruiting
Glasgow, Scotland, United Kingdom, G51 4TF
Contact: Ciara Daly, MB Bch BAO    0141 201 1100    ciara.daly@nhs.net   
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
University of Glasgow
Glasgow Caledonian University
Investigators
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Principal Investigator: Ciara M Daly, MB Bch BAO Queen Elizabeth University Hospital, Glasgow

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Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT03727711     History of Changes
Other Study ID Numbers: GN15UR229
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by NHS Greater Glasgow and Clyde:
transcutaneous posterior tibial nerve stimulation
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms