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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up postprocedure, 10 minutes following completion of cystoscopy

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to intra-procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to intra-procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to intra-procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,207 Previous Clinical Trials

3,766,800 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this trial still open?

"Yes, according to clinicaltrials.gov data this clinical trial is actively recruiting participants. This particular research was first posted on October 28th 2020 and the last update occurred on July 11th 2022. The study requires 60 individuals between 2 sites in total."

Answered by AI

What is the current enrollment rate for this research study?

"Affirmative. According to the clinical trials website, this experimental trial is actively recruiting from two different sites. It was initially posted on October 28th 2020 and updated for the last time on July 11th 2022 with a total of 60 patients needed for enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

TENS Used for Pain Management During Office Cystoscopy Botox Injections

John A. Occhino 2020. "TENS Used for Pain Management During Office Cystoscopy Botox Injections". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04448171.

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