Urge IncontinenceTTeNSNCT04936464
Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence
A study testing transcutaneous tibial nerve stimulation (TTNS) and transcutaneous electrical stimulation (TENS) in people with Urge Incontinence and Overactive Bladder, run by Kaiser Permanente at 1 site in United States.
Trial summary
This is a single-center, double-blinded, randomized controlled trial evaluating the efficacy of TTNS versus a sham intervention. Both interventions will be performed by participants in their homes after standardized instruction. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urge Incontinence, Overactive Bladder
- What is being tested?
- transcutaneous tibial nerve stimulation (TTNS) and transcutaneous electrical stimulation (TENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2021to 30 Jun 2024
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 6 episodes urgency incontinence on 3-day voiding diary
- Duration of symptoms ≥ 3 months
- Off antimuscarinic or 3-adrenoreceptor agonist therapy for 2 weeks
- No known neurologic disease
- Ability to complete home sessions and clinic follow up
- Ability to complete voiding diaries
- Internet access and proficiency
- English or Spanish-speaking
Who cannot join
- Pregnant
- Known or suspected urinary retention
- Symptomatic urinary tract infection unresolved at the time of randomization
- Recurrent urinary tract infection (≥ 3/12 months)
- Bladder pain syndrome
- Known or suspected advanced (stage III or IV) pelvic organ prolapse
Show all 13Show fewer
- Neurogenic bladder
- Current or prior bladder malignancy
- Current or previous use of bladder Botox injections, percutaneous tibial nerve stimulation, or sacral neuromodulation
- Pacemaker or other implantable device
- Disease affecting lower extremities
- Bilateral metallic lower limb implant
- Incarceration
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente San Diego
San Diego, California, 92110
About this study
Official title: Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence: A Sham-Controlled Trial
This is a single-center, double-blinded, randomized controlled trial evaluating the efficacy of TTNS versus a sham intervention. Both interventions will be performed by participants in their homes after standardized instruction. The primary outcome is a comparison of the mean change in OAB-q scores before and after treatment between the intervention and control groups. Changes in the number of urgency incontinence episodes and an estimation of cost effectiveness will additionally be measured. Intention to treat analysis will be performed.
- Conditions
- Urge Incontinence, Overactive Bladder
- Being tested
- transcutaneous tibial nerve stimulation (TTNS), transcutaneous electrical stimulation (TENS)
- Keywords
- tibial nerve stimulation, transcutaneous electrical nerve stimulation, overactive bladder, urgency urinary incontinence
- Medical subject headings
- Urinary Incontinence, Urge, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous tibial nerve stimulation (TTNS)Device
TTNS is a non-invasive, surface electrode therapeutic stimulation technique available for home administration that has been proposed as a treatment for overactive bladder.
transcutaneous electrical stimulation (TENS)Device
The sham intervention is designed to appear almost identical to the TTNS intervention.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 30-minute treatments, twice weekly x12 weeks Receives: Device: transcutaneous tibial nerve stimulation (TTNS) |
| Sham Group | Sham comparator | 30-minute treatments, twice weekly x12 weeks Receives: Device: transcutaneous electrical stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overactive Bladder Questionnaire (OAB-q)
To evaluate the efficacy of a 12-week course of TTNS in reducing urgency urinary incontinence (UUI) symptom bother in the intervention versus sham group.
Measured: 12 weeks
Secondary outcomes (1)
Voiding diary
To evaluate the efficacy of a 12-week course of TTNS in reducing the frequency of UUI episodes in the intervention versus sham group.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start20 Sep 2021
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (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 Urge IncontinenceStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- American Urogynecologic Society
- Responsible party
- Sponsor
- Investigators
- Nemi M Shah, MD, Principal investigator, University of California San Diego/Kaiser Permanente San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936464
- Sponsor's protocol ID
- 12791
- Acronym
- TTeNS
- Status last verified
- Oct 2023
- First submitted
- 15 Jun 2021
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Shah NM, Lukacz ES, Ferrante KL, Menefee SA. Transcutaneous Tibial Nerve Stimulation for Urge Incontinence: A Randomized Clinical Trial. Urogynecology (Phila). 2025 Mar 1;31(3):225-233. doi: 10.1097/SPV.0000000000001616. Epub 2024 Dec 13.
PubMed 39621424
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence: A Sham-Controlled Trial
- ClinicalTrials.gov ID
- NCT04936464
- Acronym / sponsor ID
- TTeNS / 12791
- Conditions
- Urge Incontinence, Overactive Bladder
- Keywords
- tibial nerve stimulation, transcutaneous electrical nerve stimulation, overactive bladder, urgency urinary incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- American Urogynecologic Society
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 23 Jun 2021 (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.
This is a single-center, double-blinded, randomized controlled trial evaluating the efficacy of TTNS versus a sham intervention. Both interventions will be performed by participants in their homes after standardized instruction. The primary outcome is a comparison of the mean change in OAB-q scores before and after treatment between the intervention and control groups. Changes in the number of urgency incontinence episodes and an estimation of cost effectiveness will additionally be measured. Intention to treat analysis will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: transcutaneous tibial nerve stimulation (TTNS)30-minute treatments, twice weekly x12 weeks |
| Sham Group | Sham comparator | Device: transcutaneous electrical stimulation (TENS)30-minute treatments, twice weekly x12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 6 episodes urgency incontinence on 3-day voiding diary
- Duration of symptoms ≥ 3 months
- Off antimuscarinic or 3-adrenoreceptor agonist therapy for 2 weeks
- No known neurologic disease
- Ability to complete home sessions and clinic follow up
Key exclusion criteria (13 listed)
- Pregnant
- Known or suspected urinary retention
- Symptomatic urinary tract infection unresolved at the time of randomization
- Recurrent urinary tract infection (≥ 3/12 months)
- Bladder pain syndrome
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 |
|---|---|---|
| transcutaneous tibial nerve stimulation (TTNS)TTNS is a non-invasive, surface electrode therapeutic stimulation technique available for home administration that has been proposed as a treatment for overactive bladder. | Device | Intervention Group |
| transcutaneous electrical stimulation (TENS)The sham intervention is designed to appear almost identical to the TTNS intervention. | Device | Sham Group |
Primary outcome
Overactive Bladder Questionnaire (OAB-q)
Time frame: 12 weeks
To evaluate the efficacy of a 12-week course of TTNS in reducing urgency urinary incontinence (UUI) symptom bother in the intervention versus sham group.
1 secondary outcome
Voiding diary
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 39621424Shah NM, Lukacz ES, Ferrante KL, Menefee SA. Transcutaneous Tibial Nerve Stimulation for Urge Incontinence: A Randomized Clinical Trial. Urogynecology (Phila). 2025 Mar 1;31(3):225-233. doi: 10.1097/SPV.0000000000001616. Epub 2024 Dec 13.
- 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.
Nemi M Shah, MD principal investigator
University of California San Diego/Kaiser Permanente San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous tibial nerve stimulation (TTNS) and transcutaneous electrical stimulation (TENS) in people with Urge Incontinence and Overactive Bladder, run by Kaiser Permanente at 1 site in United States.
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 8 inclusion and 13 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 23 Oct 2023. 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 States. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overactive Bladder Questionnaire (OAB-q) (time frame: 12 weeks). 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 NCT04936464, 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 23 Oct 2023; AzTrials last refreshed its copy on 6 Nov 2026.