TENS for Pain Management During Overactive Bladder Treatment
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byJohn A Occhino, MD, MS
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Mayo Clinic
Disqualifiers: TENS therapy, Pacemaker, Epilepsy, Pregnancy, others
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this study is to determine how Transcutaneous Electric Nerve Stimulation (TENS) units affects pain management during office cystoscopic Botox injections and patient satisfaction with the procedure .
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 data supports the effectiveness of the treatment Transcutaneous Electric Nerve Stimulation (TENS) for overactive bladder?
Research suggests that TENS can be effective for treating overactive bladder, especially when used over a longer period. Studies show it can improve symptoms like frequent urination and urgency, although the exact way it works is not fully understood.
12345Is TENS generally safe for humans?
Research indicates that TENS (Transcutaneous Electrical Nerve Stimulation) is generally safe for managing overactive bladder in both children and adults, with studies focusing on its safety and tolerability.
26789How does TENS differ from other treatments for overactive bladder?
TENS (Transcutaneous Electrical Nerve Stimulation) is unique because it uses electrical impulses to stimulate nerves through the skin, offering a non-drug, at-home treatment option for overactive bladder. This method can be more convenient and less invasive compared to traditional medications or surgical interventions.
125610Eligibility Criteria
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.
+2 more
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
+3 more
Trial Timeline
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)
Participant Groups
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.
2Treatment groups
Active Control
Placebo Group
Group I: Activated TENS Unit with standard pain control measuresActive Control1 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 measuresPlacebo Group1 Intervention
Sham TENS Unit with standard pain control measures during Office Based Cystoscopic Intra-detrusor Onabotulinumtoxin A Injection
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo Clinic RochesterRochester, MN
Mayo Clinic in RochesterRochester, MN
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
References
Transcutaneous electrical nerve stimulation: an effective treatment for refractory non-neurogenic overactive bladder syndrome? [2021]To assess the effect of transcutaneous electrical nerve stimulation (TENS) for treating refractory overactive bladder syndrome (OAB).
Comparison of transcutaneous electrical tibial nerve stimulation for the treatment of overactive bladder: a multi-arm randomized controlled trial with blinded assessment. [2022]To compare the effectiveness of tibial nerve transcutaneous electrical nerve stimulation (TENS) for an overactive bladder, considering the sites of application and frequency of attendance.
Predictors of outcome in children and adolescents with overactive bladder treated with parasacral transcutaneous electrical nerve stimulation. [2022]Parasacral transcutaneous electrical nerve stimulation (TENS) has emerged as an effective treatment for overactive bladder (OAB) in view of its high success rates in improving lower urinary tract symptoms and constipation, with no direct side effects. However, the clinical characteristics associated with the outcomes remain to be established.
Non-invasive transcutaneous electrical stimulation in the treatment of overactive bladder. [2022]We reviewed the literature on transcutaneous electrical nerve stimulation (TENS) used as a therapy for overactive bladder (OAB) symptoms, with a particular focus on: stimulation site, stimuli parameters, neural structures thought to be targeted, and the clinical and urodynamic outcomes achieved. The majority of studies used sacral or tibial nerve stimulation. The literature suggests that, whilst TENS therapy may have neuromodulation effects, patient are unlikely to benefit to a significant extent from a single application of TENS and indeed clear benefits from acute studies have not been reported. In long-term studies there were differences in the descriptions of stimulation intensity, strategy of the therapy, and positioning of the electrodes, as well as in the various symptoms and pathology of the patients. Additionally, most studies were uncontrolled and hence did not evaluate the placebo effect. Little is known about the underlying mechanism by which these therapies work and therefore exactly which structures need to be stimulated, and with what parameters. There is promising evidence for the efficacy of a transcutaneous stimulation approach, but adequate standardisation of stimulation criteria and outcome measures will be necessary to define the best way to administer this therapy and document its efficacy.
Transcutaneous electrical nerve stimulation and solifenacin succinate versus solifenacin succinate alone for treatment of overactive bladder syndrome: A double-blind randomized controlled study. [2021]We evaluated a combination of transcutaneous electrical nerve stimulation (TENS) and solifenacin succinate versus solifenacin alone in the treatment of overactive bladder (OAB).
At-home transcutaneous electrical nerve stimulation: a therapeutic alternative in the management of pediatric overactive bladder syndrome. [2022]In recent years, bladder electroneurostimulation or TENS (Transcutaneous Electrical Nerve Stimulation) has emerged as a new alternative in the management of lower urinary tract dysfunctions. Our objective was to evaluate the efficacy and safety of this therapy in children with overactive bladder.
[Tibial nerve transcutaneous stimulation for refractory idiopathic overactive bladder in children and adolescents]. [2015]The purpose of this study was to evaluate safety and tolerability of transcutaneous tibial nerve stimulation (TENS) in patients under 15years of age with refractory overactive bladder.
Transcutaneous Electrical Stimulation for Neurogenic Bladder Dysfunction Following Spinal Cord Injury: Meta-Analysis of Randomized Controlled Trials. [2022]To assess the efficacy of transcutaneous electrical nerve stimulation (TENS) for neurogenic bladder dysfunction secondary to spinal cord injury (SCI).
TENS: a treatment option for bladder dysfunction. [2019]To ascertain the mode of action and benefits of transcutaneous electrical nerve stimulation (TENS) in detrusor overactivity, stress incontinence and interstitial cystitis, an English-language literature search using Medline (1984-1995) was undertaken with detrusor instability, incontinence, interstitial cystitis, neuromodulation, transcutaneous electrical nerve stimulation and urodynamics as keywords and the material so identified was reviewed. The mode of action of TENS and optimal stimulation parameters in bladder dysfunction remain unclear. Lack of strict selection criteria and deficient reporting of subjective and objective outcomes precluded full assessment of therapeutic efficacy. A beneficial effect was evident in some studies of detrusor overactivity and interstitial cystitis. A trial of TENS in detrusor overactivity and interstitial cystitis refractory to conventional therapy would seem justified. Continued experimental research and further clinical studies will lead to refinement of the treatment modality.
Effectiveness of a Practical, At-Home Regimen of Parasacral Transcutaneous Electrical Nerve Stimulation in Pediatric Overactive Bladder. [2022]To describe and evaluate efficacy of a more practical, at-home regimen of parasacral transcutaneous electrical nerve stimulation (TENS) for pediatric overactive bladder (OAB).