Transcutaneous Tibial Nerve Stimulation for Overactive Bladder

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Pregnancy, Pacemaker, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

38 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new at-home treatment for overactive bladder, a condition causing frequent bathroom trips. The treatment uses Transcutaneous Tibial Nerve Stimulation (TTNS), a method that stimulates nerves with electrical signals. This trial targets women in rural areas who have not previously tried other treatments for their overactive bladder and experience frequent urination (8 or more times a day). Participants must communicate in English or Spanish and complete specific questionnaires and diaries.

As an unphased study, this trial provides a unique opportunity to contribute to research that could enhance treatment options for overactive bladder.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for managing overactive bladder?

Research has shown that Transcutaneous Tibial Nerve Stimulation (TTNS) is generally safe for treating overactive bladder. Studies have found TTNS to be a well-tolerated and non-invasive treatment. It uses surface electrodes, which are safe and easy to use at home.

One study found TTNS safe and effective for adults with overactive bladder, even for those with certain nerve-related conditions. Another study confirmed the TTNS device was safe and acceptable for patients, showing positive effects on symptoms.

Overall, TTNS appears to be a safe treatment option with a low risk of serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcutaneous Tibial Nerve Stimulation (TTNS) is unique because it offers a non-invasive, at-home treatment option for managing overactive bladder (OAB), particularly among rural women. Unlike standard treatments like medications or more invasive procedures, TTNS involves stimulating the tibial nerve through the skin, which can help control bladder function with minimal side effects. Researchers are excited about TTNS because it empowers patients to manage their condition independently, potentially improving access to care and quality of life without the need for frequent doctor visits or the complications associated with surgery.

What evidence suggests that Transcutaneous Tibial Nerve Stimulation is effective for overactive bladder?

Research has shown that Transcutaneous Tibial Nerve Stimulation (TTNS), which participants in this trial will undergo, effectively treats overactive bladder (OAB). Studies found that 48-93% of participants experienced significant improvements in their OAB symptoms, with some achieving a 25-45% cure rate for urinary incontinence. TTNS proved more effective than bladder training alone, consistently reducing OAB symptoms across various study locations. Importantly, no negative side effects were reported, indicating that TTNS is a safe treatment option. ^{1 4 6 7 8}

Who Is on the Research Team?

Sara Cichowski

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for rural women with overactive bladder who haven't tried other treatments. They must pee at least 8 times a day, be able to fill out forms in English or Spanish, have phone or email access, and can use the toilet without help. Women with leg ulcers, UTIs, stress incontinence, neurogenic bladder issues, pelvic organ prolapse complaints, pregnancy plans during the study period or certain medical devices and conditions are excluded.

Inclusion Criteria

I have been diagnosed with OAB and go to the bathroom 8 or more times a day.

I can complete forms and interviews in English or Spanish.

I have reliable access to a phone or email.

Exclusion Criteria

I am unable to give consent by myself.

I have tried treatments for overactive bladder, including medication, Botox, or nerve stimulation.

I have leg ulcers, open wounds, or skin conditions on my lower legs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Phone screening

Treatment

Participants receive self-implemented at-home Transcutaneous Tibial Nerve Stimulation (TTNS) using a TENS unit for 12 weeks

12 weeks

Remote monitoring with phone check-ins every 2-3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Interviews

Selected participants undergo one-on-one interviews to provide insights on their experiences with the intervention

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Tibial Nerve Stimulation (TTNS)

Trial Overview The trial tests an at-home nerve stimulation treatment called TTNS for women living in rural areas with overactive bladder. It's a single-arm study where all participants receive TTNS while their symptoms and experiences are monitored through questionnaires and interviews.

How Is the Trial Designed?

Group I: Rural Women Treated with Transcutaneous Tibial Nerve Stimulation Experimental Treatment 1 Intervention

Participants will undergo a self-implemented at-home Transcutaneous Tibial Nerve Stimulation (TTNS) treatment protocol for management of treatment naive overactive bladder (OAB) among rural dwelling women.

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

American Urogynecologic Society

Collaborator

Trials

11

Recruited

690+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28731583/

The effectiveness of transcutaneous tibial nerve stimulation ... Significant improvements in OAB symptoms were reported by 48-93% participants and UI cure rates of 25-45%. No adverse events were reported.

2. sciencedirect.com sciencedirect.com/science/article/pii/S187706572100004X

Efficacy of percutaneous and transcutaneous tibial nerve ... PTNS and transcutaneous tibial nerve stimulation (TTNS) were more effective than bladder training alone in women with idiopathic overactive bladder.

3. nature.com nature.com/articles/s41598-024-78492-2

Efficacy of the combination of transcutaneous tibial nerve ... TTNS reduced the clinical symptoms of OAB, and the difference was statistically significant at all study sites (p < 0.05). Regarding secondary ...

4. eurjmedres.biomedcentral.com eurjmedres.biomedcentral.com/articles/10.1186/s40001-024-02262-z

Efficacy and safety of non-invasive low-frequency tibial nerve ... The TNS-01 device is effective and safe in relieving OAB symptoms after 12 weeks of stimulation. Trial registration number: NCT04999657.

5. frontiersin.org frontiersin.org/journals/urology/articles/10.3389/fruro.2024.1352701/full

Efficacy and sex-specific outcomes after six episodes of ... This study aimed to investigate the efficacy of six episodes of percutaneous tibial nerve stimulation (PTNS) treatment for overactive bladder (OAB) symptoms in ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2772973724002741

Long term safety, continuation rates and subjective ... PTNS remains a safe treatment option for patients with refractory OAB with evidence of both subjective and objective improvement to most symptoms.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04936464

Transcutaneous Tibial Nerve Stimulation for Urgency ... TTNS is a non-invasive, surface electrode therapeutic stimulation technique available for home administration that has been proposed as a treatment for ...

8. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2022.872200/full

Feasibility of a Transcutaneous Tibial Nerve Stimulation ... The preliminary results demonstrated that the TTNS device was safe, effective, and acceptable to use in OAB patients.