NCT03727711

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. 1.Women aged ≥18 years
  2. 2.Clinical diagnosis of Overactive Bladder (OAB)
  3. 3.Post-void residual urine volume of \< 100ml
  4. 4.Able to do questionnaires
  5. 5.Able to consent and willing to participate
  6. 6.Cardiac pacemaker in situ
  7. 7.Leg ulcer/skin condition affecting both lower legs
  8. 8.Diagnosed peripheral vascular disease
  9. 9.Absent sensation at the electrode site
  10. 10.Current Urinary Tract Infection (UTI) - must be treated with appropriate antibiotics as per the unit protocol prior to commencing study
  11. 11.Pregnancy
  12. 12.Previous Percutaneous Tibial Nerve Stimulation (PTNS) /Sacral Nerve Stimulation (SNS) course
  13. 13.Previous intravesical botox treatment
  14. 14.Unable to complete questionnaires

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2017

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 3, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2019

Completed
Last Updated

November 1, 2018

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

August 11, 2017

Last Update Submit

October 30, 2018

Conditions

Overactive BladderDetrusor, Overactive

Keywords

transcutaneous posterior tibial nerve stimulation

Outcome Measures

Primary Outcomes (1)

  • Change in the International Consultation of Incontinence Modular - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) Long Form Questionnaire total score

    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 .

    At 6 weeks (i.e. after the last TPTNS treatment) and at 12 weeks (i.e. 6 weeks after last the TPTNS treatment)

Secondary Outcomes (8)

  • Change in number of urgency incontinence episodes recorded on 72 hour bladder diary.

    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 individual urgency score on International Consultation of Incontinence Modular Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) Long Form Questionnaire

    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 individual frequency score on International Consultation of Incontinence Modular Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ - FLUTS) Long Form Questionnaire

    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 individual nocturia score on International Consultation of Incontinence Modular Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ - FLUTS) Long Form Questionnaire

    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 incontinence symptom severity

    At 6 weeks (i.e. after the last TPTNS treatment) and at 12 weeks (i.e. 6 weeks after last the TPTNS treatment)

  • +3 more secondary outcomes

Study Arms (2)

Home Treatment

EXPERIMENTAL

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

Other: TPTNS

Hospital Treatment

ACTIVE COMPARATOR

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

Other: TPTNS

Interventions

TPTNSOTHER

We will be comparing hospital treatment to TPTNS at home

Home TreatmentHospital Treatment

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Women aged greater than or equal to 18 years
  • \. Clinical diagnosis of OAB
  • \. Post-void residual urine volume of \< 100ml
  • \. Able to do questionnaires
  • \. Able to consent and willing to participate

You may not qualify if:

  • \. Cardiac pacemaker in situ
  • \. Leg ulcer/skin condition affecting both lower legs
  • \. Diagnosed peripheral vascular disease
  • \. Absent sensation at the electrode site
  • \. Current UTI - must be treated with appropriate antibiotics as per the unit protocol prior to commencing study
  • \. Pregnancy
  • \. Previous PTNS /SNS
  • \. Previous intravesical botox treatment
  • \. Unable to complete questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Elizabeth University Hospital

Glasgow, Scotland, G51 4TF, United Kingdom

RECRUITING

Related Publications (1)

  • Daly CME, Loi L, Booth J, Saidan D, Guerrero K, Tyagi V. Self-management of overactive bladder at home using transcutaneous tibial nerve stimulation: a qualitative study of women's experiences. BMC Womens Health. 2021 Oct 27;21(1):374. doi: 10.1186/s12905-021-01522-y.

    PMID: 34706709DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ciara M Daly, MB Bch BAO

    Queen Elizabeth University Hospital Glasgow

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maureen Travers

CONTACT

0141 232 1813Maureen.Travers@ggc.scot.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2017

First Posted

November 1, 2018

Study Start

September 3, 2018

Primary Completion

March 3, 2019

Study Completion

August 4, 2019

Last Updated

November 1, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)