Overactive BladderNCT03727711
TPTNS: Home vs Hospital Treatment for Overactive Bladder
A study testing TPTNS in people with Overactive Bladder and Detrusor, Overactive, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder, Detrusor, Overactive
- What is being tested?
- TPTNS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Sep 2018to 4 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 7. Previous PTNS /SNS
- 8. Previous intravesical botox treatment
- 9. Unable to complete questionnaires
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Queen Elizabeth University Hospital
Glasgow, Scotland, G51 4TF
Ciara Daly, MB Bch BAO, 0141 201 1100, ciara.daly@nhs.net
About this study
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.
Read more
Inclusion criteria:
- Women aged ≥18 years
- Clinical diagnosis of Overactive Bladder (OAB)
- Post-void residual urine volume of < 100ml
- Able to do questionnaires
- Able to consent and willing to participate
Exclusion Criteria
- Cardiac pacemaker in situ
- Leg ulcer/skin condition affecting both lower legs
- Diagnosed peripheral vascular disease
- Absent sensation at the electrode site
- Current Urinary Tract Infection (UTI) - must be treated with appropriate antibiotics as per the unit protocol prior to commencing study
- Pregnancy
- Previous Percutaneous Tibial Nerve Stimulation (PTNS) /Sacral Nerve Stimulation (SNS) course
- Previous intravesical botox treatment
- 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.
- Conditions
- Overactive Bladder, Detrusor, Overactive
- Being tested
- TPTNS
- Keywords
- transcutaneous posterior tibial nerve stimulation
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPTNSOther
We will be comparing hospital treatment to TPTNS at home
| Study group | Role | What they receive |
|---|---|---|
| Home Treatment | Experimental | Participants will be taught home treatment with TPTNS - twice weekly, 30 minute sessions for 6 weeks Receives: Other: TPTNS |
| Hospital Treatment | Active comparator | Participants will receive hospital treatment with TPTNS - twice weekly, 30 minute sessions for 6 weeks Receives: Other: TPTNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 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.
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.
Measured: 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
Change in numerical scores for Urgency. Scoring range on questionnaire (0-4) - a higher number indicates a worse outcome.
Measured: 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
Change in numerical score on the questionnaire. Scoring range on questionnaire (0-4) - a higher number indicates a worse outcome.
Measured: 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
Change in numerical score on the questionnaire. Scoring range on questionnaire (0-4) - a higher number indicates a worse outcome.
Measured: 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
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.
Measured: 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 Mean urgency perception scores recorded on 72 hour bladder diary •
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.
Measured: At 6 weeks (i.e. after the last TPTNS treatment) and at 12 weeks (i.e. 6 weeks after last the TPTNS treatment)
PGIS (Patient Global Impression of Improvement Scale) Score
Change in numerical score on the questionnaire. Range (1-7); higher scores indicate least improvement.
Measured: 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 HADS (Hospital Anxiety and Depression) scores
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.
Measured: At 6 weeks (i.e. after the last TPTNS treatment) and at 12 weeks (i.e. 6 weeks after last the TPTNS treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start3 Sep 2018
- Primary completion3 Mar 2019 (estimated)
- Study completion4 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow, Glasgow Caledonian University
- Responsible party
- Sponsor
- Investigators
- Ciara M Daly, MB Bch BAO, Principal investigator, Queen Elizabeth University Hospital Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727711
- Sponsor's protocol ID
- GN15UR229
- Status last verified
- Oct 2018
- First submitted
- 11 Aug 2017
- Last updated
- 1 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34706709
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Transcutaneous Tibial Nerve Stimulation as a Conservative Treatment for Overactive Bladder Dysfunction -A Randomised Controlled Trial Comparing Home Versus Hospital Based Treatment"
- ClinicalTrials.gov ID
- NCT03727711
- Acronym / sponsor ID
- GN15UR229
- Conditions
- Overactive Bladder, Detrusor, Overactive
- Keywords
- transcutaneous posterior tibial nerve stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow, Glasgow Caledonian University
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 3 Mar 2019 (estimated)
- Study completion
- 4 Aug 2019 (estimated)
- First posted
- 1 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Women aged ≥18 years
- Clinical diagnosis of Overactive Bladder (OAB)
- Post-void residual urine volume of < 100ml
- Able to do questionnaires
- Able to consent and willing to participate
Exclusion Criteria
- Cardiac pacemaker in situ
- Leg ulcer/skin condition affecting both lower legs
- Diagnosed peripheral vascular disease
- Absent sensation at the electrode site
- Current Urinary Tract Infection (UTI) - must be treated with appropriate antibiotics as per the unit protocol prior to commencing study
- Pregnancy
- Previous Percutaneous Tibial Nerve Stimulation (PTNS) /Sacral Nerve Stimulation (SNS) course
- Previous intravesical botox treatment
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home Treatment | Experimental | Other: TPTNSParticipants will be taught home treatment with TPTNS - twice weekly, 30 minute sessions for 6 weeks |
| Hospital Treatment | Active comparator | Other: TPTNSParticipants will receive hospital treatment with TPTNS - twice weekly, 30 minute sessions for 6 weeks |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TPTNSWe will be comparing hospital treatment to TPTNS at home | Other | Home Treatment, Hospital Treatment |
Primary outcome
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 .
8 secondary outcomes
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)
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 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 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 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 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)
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 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2018.
- Derived from this study: PubMed 34706709Daly 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ciara M Daly, MB Bch BAO principal investigator
Queen Elizabeth University Hospital Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TPTNS in people with Overactive Bladder and Detrusor, Overactive, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maureen Travers (0141 232 1813, Maureen.Travers@ggc.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03727711, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2018.