TENS for Pain Management During Overactive Bladder Treatment

No longer recruiting at 1 trial location

Overseen By Karen P Ishitani, MSN

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: TENS therapy, Pacemaker, Epilepsy, Pregnancy, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Transcutaneous Electric Nerve Stimulation (TENS), a device that sends small electrical currents to nerves, can help manage pain during Botox injections for overactive bladder treatment. It examines whether TENS reduces pain and increases satisfaction with the procedure. Participants will use either an active TENS unit or a placebo, alongside standard pain control methods. The trial seeks women scheduled for Botox injections for an overactive bladder who are comfortable with English and can provide informed consent. As an unphased trial, it offers participants the chance to contribute to innovative pain management research.

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.

What prior data suggests that Transcutaneous Electric Nerve Stimulation (TENS) is safe for pain management during overactive bladder treatment?

Research has shown that Transcutaneous Electric Nerve Stimulation (TENS) is generally a safe treatment. One study found it helpful in easing symptoms of an overactive bladder after 12 weeks of use. Typically, treatments like TENS can reduce frequent urination and are safe for most people. Most patients tolerate it well, with few reports of serious side effects. This suggests TENS is a well-tolerated option for managing pain during treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Transcutaneous Electric Nerve Stimulation (TENS) as a pain management technique during bladder treatments because it offers a non-invasive way to potentially reduce pain without medication. Unlike traditional painkillers or local anesthetics, TENS works by sending mild electrical impulses through the skin to disrupt pain signals in the nervous system. This approach could provide a safe, drug-free alternative to managing discomfort during procedures like the injection of Onabotulinumtoxin A for overactive bladder.

What evidence suggests that TENS is effective for pain management during overactive bladder treatment?

Research shows that Transcutaneous Electric Nerve Stimulation (TENS) can help manage pain. A TENS device sends small electrical currents through the skin to stimulate nerves. Studies have found that TENS can reduce symptoms of an overactive bladder, such as frequent urination, urgency, and incontinence. Although these studies focus on bladder symptoms, TENS is also commonly used for pain relief in various conditions. In this trial, participants will receive either an activated TENS unit or a sham TENS unit, both with standard pain control measures, to evaluate its effectiveness in managing pain during procedures like Botox injections for treating an overactive bladder. ^{3 4 6 7 8}

Who Is on the Research Team?

John A Occhino, MD, MS

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for women aged 18 or older who are scheduled to receive Botox injections for Overactive Bladder at an outpatient clinic, can communicate in English, understand the study's requirements including randomization, and consent to participate. It excludes those with pacemakers, epilepsy history, recent pregnancy or postpartum period, unwillingness to be randomized, or personal/family TENS therapy use within a year.

Inclusion Criteria

I am scheduled for a Botox injection for Overactive Bladder.

Reads, speaks, and understands the English language

I understand what participating in this study involves.

Exclusion Criteria

I have a history of epilepsy.

I am not willing to be assigned to a treatment by chance.

Currently has an implanted pacemaker or automatic cardiac defibrillator

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cystoscopic intra-detrusor onabotulinumtoxin A injection with either activated or sham TENS unit for pain management

1 day

1 visit (in-person)

Follow-up

Participants are monitored for satisfaction and pain levels post-procedure

10 minutes

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Electric Nerve Stimulation (TENS)

Trial Overview The study is testing how Transcutaneous Electric Nerve Stimulation (TENS) affects pain management and patient satisfaction during office cystoscopic Botox injections for Overactive Bladder. Participants will be randomly assigned to either active TENS treatment or a sham (placebo) version of TENS.

How Is the Trial Designed?

Group I: Activated TENS Unit with standard pain control measures Active Control 1 Intervention

Activated TENS Unit with standard pain control measures during Office Based Cystoscopic Intra-detrusor Onabotulinumtoxin A Injection

Group II: Sham TENS Unit with standard pain control measures Placebo Group 1 Intervention

Sham TENS Unit with standard pain control measures during Office Based Cystoscopic Intra-detrusor Onabotulinumtoxin A Injection

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Transcutaneous electrical nerve stimulation (TENS) significantly improved maximum cystometric capacity (MCC) in patients with neurogenic bladder dysfunction due to spinal cord injury, based on a meta-analysis of six randomized controlled trials involving 353 participants.

TENS was found to be a safe intervention with no major adverse events reported, suggesting it could be a beneficial treatment option for this condition, although further research is needed to optimize treatment parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Stimulation for Neurogenic Bladder Dysfunction Following Spinal Cord Injury: Meta-Analysis of Randomized Controlled Trials. Parittotokkaporn, S., Varghese, C., O'Grady, G., et al.[2022]

In a study of 83 children with overactive bladder (OAB) treated with parasacral TENS, 56.6% achieved complete resolution of symptoms, demonstrating the efficacy of this non-invasive treatment.

Nocturnal enuresis was identified as a significant predictor of poor treatment response, suggesting that children with this symptom may require additional therapeutic strategies for effective management of OAB.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of outcome in children and adolescents with overactive bladder treated with parasacral transcutaneous electrical nerve stimulation. Hoffmann, A., Sampaio, C., Nascimento, AA., et al.[2022]

Transcutaneous tibial nerve stimulation (TENS) is a safe and effective non-invasive treatment for children under 15 with refractory overactive bladder, showing a 70% success rate without any reported side effects.

In a study of 19 patients treated over an average of 6 months, 94% reported symptomatic improvement after one month, and 12 out of 17 patients met healing criteria by the end of treatment, with no relapses within 9 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Tibial nerve transcutaneous stimulation for refractory idiopathic overactive bladder in children and adolescents]. Bouali, O., Even, L., Mouttalib, S., et al.[2015]

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]

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 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]

Transcutaneous electrical nerve stimulation (TENS) shows potential for treating overactive bladder (OAB) symptoms, particularly through sacral or tibial nerve stimulation, but significant benefits from a single application have not been observed in acute studies.

Long-term studies indicate variability in stimulation parameters and patient conditions, highlighting the need for standardized protocols to better understand the efficacy and mechanisms of TENS therapy for OAB.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive transcutaneous electrical stimulation in the treatment of overactive bladder. Slovak, M., Chapple, CR., Barker, AT.[2022]

In a study of 137 women with overactive bladder, tibial nerve TENS applied to one leg once a week significantly reduced urgency and incontinence episodes compared to a placebo.

Two-leg TENS stimulation, whether once or twice a week, effectively improved nocturia, indicating that the frequency and site of application can influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of transcutaneous electrical tibial nerve stimulation for the treatment of overactive bladder: a multi-arm randomized controlled trial with blinded assessment. Pierre, ML., Friso, B., Casarotto, RA., et al.[2022]

In a study involving 86 female patients with overactive bladder (OAB), the combination of transcutaneous electrical nerve stimulation (TENS) and solifenacin significantly improved OAB symptoms compared to solifenacin alone, as measured by various assessment tools.

The combination treatment led to better outcomes in maximum bladder volume and symptom scores, with only mild adverse effects reported, indicating it is a safe and effective option for managing OAB.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation and solifenacin succinate versus solifenacin succinate alone for treatment of overactive bladder syndrome: A double-blind randomized controlled study. Zhang, Y., Wang, S., Zu, S., et al.[2021]

In a study of 21 pediatric patients aged 5-13 with overactive bladder, a practical at-home regimen of transcutaneous electrical nerve stimulation (TENS) showed that nearly half of the participants reported subjective improvement in their symptoms after one month of treatment.

While there was a statistically significant reduction in the Vancouver Symptom Score (from 23 to 21), the objective measures of bladder function did not show significant changes, suggesting that TENS may be more effective as a complementary treatment rather than a standalone solution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Practical, At-Home Regimen of Parasacral Transcutaneous Electrical Nerve Stimulation in Pediatric Overactive Bladder. Ebert, KM., Terry, H., Ching, CB., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34225282/

Efficacy of Transcutaneous Electrical Nerve Stimulation in ... Applying daily transcutaneous electrical nerve stimulation over the sacral region for 90 days to patient with neurogenic overactive bladder improved overactive ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5730708/

Non-invasive transcutaneous electrical stimulation in the ... We reviewed the literature on transcutaneous electrical nerve stimulation (TENS) used as a therapy for overactive bladder (OAB) symptoms.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02377765

Use of Transcutaneous Posterior Tibial Nerve Stimulation ... Our primary outcome variable will be changes in 24-hour voiding frequency, number of episodes of urgency, as well as number of episodes of urge urinary ...

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. clinicaltrials.gov clinicaltrials.gov/study/NCT01940367

Electrical Nerve Stimulation for Overactive Bladder a ... Previous short-term studies suggest that these therapies have equal efficacy in improving OAB symptoms, but we hypothesize that long-term efficacy and success ...

6. 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.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12291541/

a systematic review and meta-analysis Transcutaneous Tibial Nerve Stimulation (TTNS) is a promising treatment for Overactive Bladder Syndrome symptoms, potentially suitable for self- ...

8. medicalnewstoday.com medicalnewstoday.com/articles/electrical-stimulation-for-overactive-bladder

Electrical stimulation for overactive bladder (OAB) Electrical stimulation for an overactive bladder can reduce the need to urinate as frequently. It is usually a safe and effective treatment.