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

Trial Summary

What is the purpose of this trial?

This will be a double-blind randomized control trial in women with stress urinary incontinence who are undergoing an outpatient transurethral bulking procedure for stress urinary incontinence. Subjects will be identified by the University of Rochester urologists and urogynecologists participating in the study who currently oversee stress incontinence care. Subjects will be randomized into two groups. One group will be undergoing the cystoscopy with transcutaneous electrical nerve stimulation (TENS) for analgesia, and the second group will have the cystoscopy with placebo TENS.

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 data supports the effectiveness of the treatment TENS for stress urinary incontinence?

Research shows that TENS (a therapy using mild electrical currents) has been effective in treating various urinary issues, like overactive bladder and urinary incontinence, in both children and adults. This suggests it might also help with stress urinary incontinence. ^{1 2 3 4 5}

Is TENS generally safe for treating urinary conditions?

TENS has been studied for various urinary conditions, including in children and neurological patients, and is generally considered safe, though its effectiveness can vary. ^{4 6 7 8 9}

How is the TENS treatment different for stress urinary incontinence?

TENS (transcutaneous electrical nerve stimulation) is unique because it uses electrical impulses to stimulate nerves through the skin, which can help manage urinary symptoms by improving nerve function, unlike traditional treatments that may rely on medications or surgery. ^{1 4 8 9 10}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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 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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation: an effective treatment for refractory non-neurogenic overactive bladder syndrome? [2021]

2. Brazil 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. [2017]

3. United States 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. [2022]

4. United States 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. [2020]

5. United States 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. [2022]

6. Spain pubmed.ncbi.nlm.nih.gov

At-home transcutaneous electrical nerve stimulation: a therapeutic alternative in the management of pediatric overactive bladder syndrome. [2022]

7. England pubmed.ncbi.nlm.nih.gov

TENS: a treatment option for bladder dysfunction. [2019]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation in the treatment of patients with poststroke urinary incontinence. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation in the treatment of neurological patients with urinary symptoms. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Nerve Stimulation for Treating Neurogenic Lower Urinary Tract Dysfunction: A Systematic Review. [2022]