TENS for Stress Urinary Incontinence

(TENSUB Trial)

Overseen By Jared M Floch, DO, MS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Rochester

Must not be taking: Opioids

Disqualifiers: Cutaneous damage, Cardiac pacemaker, Altered sensation, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to manage pain during a procedure for women with stress urinary incontinence (SUI). Researchers are testing whether a device called TENS (transcutaneous electrical nerve stimulation), which delivers mild electrical currents to relieve pain, can assist during a transurethral bulking procedure. Participants will be divided into two groups: one receiving active TENS treatment and the other a placebo version. Women diagnosed with SUI and scheduled for this specific procedure might be suitable candidates. As an unphased trial, this study allows participants to contribute to innovative research that could enhance pain management techniques.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used opioids for pain management within 8 hours before the procedure.

What prior data suggests that TENS is safe for stress urinary incontinence?

Research shows that transcutaneous electrical nerve stimulation (TENS) is generally safe for most people. Studies have found TENS to be safe and acceptable for treating bladder problems. For example, a study with 93 women who had mild urinary incontinence found TENS to be effective and well-tolerated.

Another review observed 199 patients, with only 24 reporting side effects, such as infections. About 12% of participants experienced issues, which is relatively low. The FDA has approved TENS for treating stress urinary incontinence in women, indicating its safety for this condition.

Overall, TENS has minimal side effects and is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using TENS (Transcutaneous Electrical Nerve Stimulation) for stress urinary incontinence because it offers a non-invasive approach that could be more convenient and comfortable compared to current treatments like pelvic floor exercises, medications, or surgery. Unlike these traditional methods, TENS delivers mild electrical pulses to stimulate nerves and muscles, potentially improving bladder control without the need for medication or invasive procedures. This method could provide a safe, easy-to-use alternative that patients can manage at home, making it an attractive option for those seeking less intrusive solutions.

What evidence suggests that TENS is effective for stress urinary incontinence?

Research has shown that transcutaneous electrical nerve stimulation (TENS) can help with stress urinary incontinence. In a previous study, 93 women with mild to moderate stress urinary incontinence experienced improvement with TENS treatment. This approach not only alleviated their incontinence symptoms but also enhanced their quality of life. TENS works by sending gentle electrical pulses through the skin, which can assist with bladder issues. This trial will compare an active TENS treatment group with a control group receiving sham stimulation. Although more research is needed to optimize its use, these early results suggest TENS could be a promising option for managing stress urinary incontinence. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for women with stress urinary incontinence scheduled for an outpatient urethral bulking procedure. Participants will be under the care of University of Rochester Urologists and Urogynecologists involved in the study.

Inclusion Criteria

I am scheduled for a bladder control procedure in the doctor's office.

Able to read/write English

I am a woman aged 18 or older.

Exclusion Criteria

Participants with altered sensation below the umbilicus

Currently implanted cardiac pacemaker or defibrillator

I have open sores or broken skin in the area that needs treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo transurethral bulking with either active TENS or placebo TENS for analgesia

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain levels and side effects immediately after the procedure

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• TENS

Trial Overview The study is testing if TENS, a method using electrical nerve stimulation, can reduce pain during cystoscopy compared to placebo (fake) TENS. Women are randomly assigned to one of these two groups without knowing which one they're getting.

How Is the Trial Designed?

Group I: Active TENS Experimental Treatment 1 Intervention

In the active treatment group, the TENS unit will remain on up to 30 minutes (10 minutes pre-procedure, during the procedure and during the questionnaires).

Group II: Control TENS Placebo Group 1 Intervention

The sham stimulation group will undergo the same procedure; however, the TENS stimulation current will be reduced to a minimal detectable level and turned off after 20 seconds.

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Published Research Related to This Trial

Both biofeedback and TENS (transcutaneous electrical nerve stimulation) are effective treatments for children with lower urinary tract dysfunction, showing similar rates of symptom resolution after 6 months in a study of 64 children.

Biofeedback therapy required significantly fewer treatment sessions (about 11 sessions) compared to TENS (about 18 sessions) to achieve comparable improvements, suggesting it may be a more efficient option for managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EMG biofeedback or parasacral transcutaneous electrical nerve stimulation in children with lower urinary tract dysfunction: A prospective and randomized trial. Dos Reis, JN., Mello, MF., Cabral, BH., et al.[2020]

Transcutaneous electrical nerve stimulation (TENS) significantly improved urinary incontinence symptoms in 61 poststroke patients over 60 days, showing better results in daily micturition, nocturia, and urge UI compared to a control group.

TENS therapy not only enhanced incontinence symptoms but also improved patients' self-care abilities and urodynamic parameters, making it a recommended treatment option for poststroke urinary incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation in the treatment of patients with poststroke urinary incontinence. Guo, ZF., Liu, Y., Hu, GH., et al.[2021]

Transcutaneous electrical nerve stimulation (TENS) significantly reduced irritative urinary symptoms and improved the frequency of micturition, incontinence episodes, and the need for changing clothes in patients with urinary symptoms due to neurological diseases, based on a study of 44 patients over six weeks.

While TENS showed minimal impact on urodynamic measures, half of the patients reported continued benefits from the treatment one year later, suggesting it can be a useful intervention for managing urinary symptoms in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation in the treatment of neurological patients with urinary symptoms. Skeil, D., Thorpe, AC.[2019]

Transcutaneous electrical nerve stimulation (TENS) shows promise in treating neurogenic lower urinary tract dysfunction, with studies indicating significant improvements in bladder capacity and pressure metrics, although the evidence is still preliminary and based on a limited number of studies involving 450 patients.

No serious adverse events related to TENS were reported, suggesting it is a safe option; however, the overall quality of the evidence is low, highlighting the need for more rigorous randomized controlled trials to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Nerve Stimulation for Treating Neurogenic Lower Urinary Tract Dysfunction: A Systematic Review. Gross, T., Schneider, MP., Bachmann, LM., et al.[2022]

Transcutaneous electrical nerve stimulation (TENS) shows potential benefits for conditions like detrusor overactivity and interstitial cystitis, although the exact mechanism of action and optimal stimulation parameters are still unclear.

Some studies indicate that TENS may be effective in managing bladder dysfunction, suggesting that further clinical trials are warranted to explore its efficacy, especially in patients who do not respond to conventional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TENS: a treatment option for bladder dysfunction. Bristow, SE., Hasan, ST., Neal, DE.[2019]

Transcutaneous electrical nerve stimulation (TENS) significantly reduced the number of wet days per week and incontinence episodes per day in 76 children aged 5-16 with daytime urinary incontinence and overactive bladder that did not respond to standard treatments.

After 3 months of TENS treatment, 12 children became completely dry, although some relapsed by the 6-month follow-up, indicating that while TENS can be effective, individual factors like a history of constipation may influence treatment success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation as add-on therapy in children receiving anticholinergics and/or mirabegron for refractory daytime urinary incontinence: A retrospective cohort study. Pedersen, N., Breinbjerg, A., Thorsteinsson, K., et al.[2022]

In a study of 42 patients with refractory overactive bladder syndrome, transcutaneous electrical nerve stimulation (TENS) was effective, with 50% of patients showing improvement after 12 weeks, and benefits lasting for an average of 21 months.

TENS significantly reduced the average number of daily voids from 15 to 11 and increased the average voided volume from 160 mL to 230 mL, with no reported adverse events, indicating it is a safe treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation: an effective treatment for refractory non-neurogenic overactive bladder syndrome? Tellenbach, M., Schneider, M., Mordasini, L., et al.[2021]

In a study of 21 children aged 6 to 16 with overactive bladder, home-based Transcutaneous Electrical Nerve Stimulation (TENS) significantly improved urinary symptoms, as shown by a decrease in the Pediatric Lower Urinary Tract Scoring System (PLUTSS) scores from 17.8 at baseline to 5.6 after 6 months.

All patients experienced an increase in maximum voiding volume and reported improved quality of life, indicating that TENS is a safe and effective treatment option for managing overactive bladder in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

At-home transcutaneous electrical nerve stimulation: a therapeutic alternative in the management of pediatric overactive bladder syndrome. Casal-Beloy, I., Somoza Argibay, I., García-González, M., et al.[2022]

In a Phase II clinical trial involving 25 children aged 5 to 14, 20 sessions of parasacral TENS significantly reduced urinary leakage, with a p-value of 0.04, indicating effectiveness in treating urinary urgency and urge-incontinence.

Most participants (92%) were female and had urge-incontinence, and caregivers reported a decline in urinary leakage after treatment, suggesting that TENS may be a promising non-invasive option for managing these symptoms in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical neural stimulation for the treatment of urinary urgency or urge-incontinence in children and adolescents: a Phase II clinica. Alcantara, AC., Mello, MJ., Costa e Silva, EJ., et al.[2017]

In a study involving 24 children with overactive bladder (OAB) and daytime urinary incontinence (DUI), transcutaneous electrical nerve stimulation (TENS) did not show any immediate objective effects on bladder capacity or function during urodynamic testing.

The results indicated that TENS did not significantly alter bladder contraction patterns or the number of contractions that did not lead to voiding, suggesting it may not be an effective treatment for improving bladder activity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No immediate effect on urodynamic parameters during transcutaneous electrical nerve stimulation (TENS) in children with overactive bladder and daytime incontinence-A randomized, double-blind, placebo-controlled study. Borch, L., Rittig, S., Kamperis, K., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4041286/

Transcutaneous electrical nerve stimulation in the ... TENS improved incontinence symptoms, enhanced the quality of life, and decreased adverse effects; hence, it is recommended in treating poststroke UI.

2. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1594422/full

An update comprehensive review on the effects of ... In a previous study, 93 female patients with mild to moderate stress urinary incontinence were treated with TENS combined with biofeedback ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5121741/

Efficacy of Transcutaneous Electrical Nerve Stimulation in the ... It is a prospective experimental study to evaluate the effectiveness of TENS v/s placebo in reducing OAB symptoms.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1807593222002149

Comparison of transcutaneous electrical tibial nerve ... One-leg stimulation improved the daily urinary frequency, urgency, and incontinence, and the two-leg stimulation once and twice weekly improved nocturia.

5. nature.com nature.com/articles/s41598-024-78358-7

Comparison of nonimplantable electrical stimulation in ... To date, no comprehensive evidence has indicated the method that yields the most effective outcomes in terms of alleviating urinary incontinence ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN170049.pdf

DEN170049 - FDA The Innovo is a transcutaneous electrical stimulator indicated for the treatment of stress urinary incontinence in adult females. The Innovo is indicated for ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2772973724006180

Pudendal nerve stimulation for treatment of lower urinary ... Safety data were reported by eight studies with a total of 24 adverse events reported in 199 patients (12.1%). These included infections (n=3; 1.5%), lead ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04936464

Transcutaneous Tibial Nerve Stimulation for Urgency ... Also called a data safety and monitoring board, or DSMB. Early Phase 1 ... Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence (TTeNS).