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Behavioural Intervention

TENS vs PTNS for Overactive Bladder (INTENSE Trial)

N/A

Recruiting

Led By Kate V Meriwether, MD

Research Sponsored by University of New Mexico

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Failed trial of conservative therapy (including bladder training, fluid modification, diet modification, caffeine restriction, or pelvic floor training)

Failed trial of at least one pharmacologic treatment (anticholinergics, β3- adrenoceptor agonist) either due to inability to take the medication, adverse reaction to medication, or no improvement on medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks, 12 weeks

Awards & highlights

INTENSE Trial Summary

This trial will compare the quality of life of women with idiopathic overactive bladder before and after treatment with percutaneous tibial nerve stimulation or transcutaneous electrical nerve stimulation of tibial nerve.

Who is the study for?

This trial is for women over 18 with overactive bladder (OAB) who've tried and not benefited from standard treatments like medication or pelvic floor training. They should be willing to attend multiple treatment sessions and complete questionnaires, but can't join if they're pregnant, have certain medical conditions like uncontrolled diabetes or neurological disorders, use specific medications, or have metal implants in the area where TENS/PTNS would be applied.Check my eligibility

What is being tested?

The study compares two non-surgical treatments for OAB: transcutaneous electrical nerve stimulation (TENS) and percutaneous tibial nerve stimulation (PTNS). Women participating will receive one of these therapies after failing traditional treatments to see which better improves their quality of life.See study design

What are the potential side effects?

Possible side effects from TENS/PTNS may include discomfort at the site of application, mild pain or skin irritation. Since it's a non-invasive therapy, serious side effects are uncommon but could involve allergic reactions to pads used for TENS.

INTENSE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have tried and not improved with basic treatments like diet changes or bladder exercises.

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I tried a medication for my condition but stopped because it didn't work, I had side effects, or I couldn't take it.

INTENSE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks, 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks, 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 12 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Overactive bladder Questionnaire (OAB-q) Health-Related Quality of Life (HRQOL) score

Secondary outcome measures

Adverse events

Number of urinary incontinence episodes

Number of voids per day

+5 more

INTENSE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Home transcutaneous electrical nerve stimulation (TENS)Experimental Treatment1 Intervention

Women randomized to the TENS group will be asked to purchase a TENS 7000 device (estimated cost $30) and will administer self-treatment at home, daily for 20 minutes, for 12 weeks total. TENS treatment will be performed as follows (adapted from the most common setting from a s systematic review of TENS for OAB): - Surface electrodes, 2 x 2 in diameter, will be placed 5 cm cephalad to the medial malleolus of the right or left ankle (patient's choice). The second surface electrode is placed on the medial aspect of the ipsilateral calcaneus. The electrodes are connected to the TENS device with pre-set settings. Women will complete 20-minute daily TENS treatment for 12 weeks total.

Group II: Posterior Tibial Nerve Stimulation (PTNS)Active Control1 Intervention

Women randomized to the PTNS will be scheduled for sessions once weekly for 30 minutes, for 12 weeks total. The patient sits reclined with their legs elevated on a foot rest. After alcohol swab, a 34 gauge needle is inserted percutaneously 5 cm cephalad to the medial malleolus of the right or left ankle (patient's choice) at a 60 degree angle. A surface electrode is placed on the medial ipsilateral heel. The needle and electrode are connected to a low voltage (9V) electrical stimulator. Stimulation current with a fixed frequency of 20 Hz and a pulse width of 200 μsec is increased until flexion of the big toe or fanning of all toes visualized, or until the woman reports a tingling sensation across the heel or sole of the foot. The current is then set to the highest level of tolerable to the patient (0-10 mA) and then she undergoes therapy for 30 minutes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TENS

2011

Completed Phase 2

~2040

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of New MexicoLead Sponsor

372 Previous Clinical Trials

3,528,659 Total Patients Enrolled

Kate V Meriwether, MDPrincipal InvestigatorUniversity of New Mexico

1 Previous Clinical Trials

184 Total Patients Enrolled

Media Library

PTNS (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05309993 — N/A

Overactive Bladder Research Study Groups: Posterior Tibial Nerve Stimulation (PTNS), Home transcutaneous electrical nerve stimulation (TENS)

Overactive Bladder Clinical Trial 2023: PTNS Highlights & Side Effects. Trial Name: NCT05309993 — N/A

PTNS (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05309993 — N/A

Frequently Asked Questions

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

Is this research opportunity currently available to participants?

"The clinical trial is open for participation, as indicated by the data on clinicaltrials.gov. The first post about this medical research was made in late June of 2022 and it was recently updated again a short while after that."

Answered by AI

How many participants are being treated under this research trial?

"Affirmative. According to the details posted on clinicaltrials.gov, this medical trial is actively recruiting volunteers and was initially listed on June 30th 2022. As of July 16th 2022, 130 individuals are needed from a single site for participation in the study."

Answered by AI

Recent research and studies

Journal of UrologyJournal

Long-term Durability of Percutaneous Tibial Nerve Stimulation for the Treatment of Overactive Bladder

MacDiarmid, Scott A., Kenneth M. Peters, S. Abbas Shobeiri, Leslie S. Wooldridge, Eric S. Rovner, Fah Che Leong, Steven W. Siegel, Susan B. Tate, and Brian A. Feagins. 2010. “Long-term Durability of Percutaneous Tibial Nerve Stimulation for the Treatment of Overactive Bladder”. Journal of Urology. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.juro.2009.08.160.

Journal of UrologyJournal

Determining the Importance of Change in the Overactive Bladder Questionnaire

Coyne, Karin S., Louis S. Matza, Christine L. Thompson, Zoe S. Kopp, and Vikram Khullar. 2006. “Determining the Importance of Change in the Overactive Bladder Questionnaire”. Journal of Urology. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.juro.2006.03.088.

Neurourology and UrodynamicsJournal

Global Ratings of Patient Satisfaction and Perceptions of Improvement with Treatment for Urinary Incontinence: Validation of Three Global Patient Ratings

Burgio, Kathryn L., Patricia S. Goode, Holly E. Richter, Julie L. Locher, and David L. Roth. 2006. “Global Ratings of Patient Satisfaction and Perceptions of Improvement with Treatment for Urinary Incontinence: Validation of Three Global Patient Ratings”. Neurourology and Urodynamics. Wiley. doi:10.1002/nau.20243.

Neurourology and UrodynamicsJournal