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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

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.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ postprocedure, 10 minutes following completion of cystoscopy

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.