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TENS for Pain Management During Overactive Bladder Treatment

N/A
Recruiting
Led By John A Occhino, MD, MS
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
History of epilepsy
Unwilling to be randomized
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to intra-procedure
Awards & highlights

Summary

This trial is testing if using a TENS unit during a Botox injection can help with pain management and satisfaction with the procedure.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not explicitly stated here, common side effects of TENS may include skin irritation where the electrodes are placed. Since it's non-invasive and drug-free, serious side effects are rare but could involve muscle twitching if improperly used.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of epilepsy.
Select...
I am not willing to be assigned to a treatment by chance.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~postprocedure, 10 minutes following completion of cystoscopy
This trial's timeline: 3 weeks for screening, Varies for treatment, and postprocedure, 10 minutes following completion of cystoscopy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assess whether the TENS units is effective over standard pain control measures for intra-procedure pain management during office cystoscopic Intra-detrusor Onabotulinumtoxin A in women with OAB.
Secondary study objectives
Evaluate the effect of TENS units on participant satisfaction following cystoscopic intra-detrusor onabotulinumtoxin A injection in women with OAB.

Trial Design

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 Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,298 Previous Clinical Trials
3,958,385 Total Patients Enrolled
Rubin Raju, MBBS, MDStudy ChairMayo Clinic
John A Occhino, MD, MSPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
58 Total Patients Enrolled

Media Library

Activated TENS Unit with standard pain control measures Clinical Trial Eligibility Overview. Trial Name: NCT04448171 — N/A
Overactive Bladder Research Study Groups: Activated TENS Unit with standard pain control measures, Sham TENS Unit with standard pain control measures
Overactive Bladder Clinical Trial 2023: Activated TENS Unit with standard pain control measures Highlights & Side Effects. Trial Name: NCT04448171 — N/A
Activated TENS Unit with standard pain control measures 2023 Treatment Timeline for Medical Study. Trial Name: NCT04448171 — N/A
~9 spots leftby Jun 2025
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