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Behavioural Intervention

PTNS for Urinary Incontinence (BUTTON Trial)

N/A

Recruiting

Led By G. Sarah Napoe, MD

Research Sponsored by Gnankang Sarah Napoe

Eligibility Criteria Checklist

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

Must have

Female patients over the age of 18 who have previously tried and failed, or were unable to tolerate, behavioral therapy

Be older than 18 years old

Must not have

Patients with neurogenic bladder

Patients who have received Botox or have an implant for sacral nerve stimulation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effectiveness of two types of nerve stimulation to see which works better at treating overactive bladder and urinary incontinence.

Who is the study for?

This trial is for women over 18 with overactive bladder or urge urinary incontinence who didn't get better with behavior therapy. They can still be on medication. It's not for pregnant women, those with pacemakers/defibrillators, neurogenic bladder, recent Botox/sacral nerve implants, bleeding disorders, or unhealed ulcers/leg edema near the ankle.

What is being tested?

The study tests if stimulating both sides of the ankle nerves (bilateral PTNS) is more effective than just one side (unilateral PTNS) for treating symptoms like frequent urination and loss of bladder control.

What are the potential side effects?

PTNS may cause discomfort at the stimulation site, minor bleeding or skin inflammation post-treatment. Rarely it might lead to adverse effects related to nerve damage.

Eligibility Criteria

Inclusion Criteria

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

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I am a woman over 18 who has not benefited from or tolerated behavioral therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a condition where my bladder doesn't function properly due to nerve damage.

Select...

I have received Botox or have a sacral nerve stimulation implant.

Select...

I have a bleeding disorder that is not under control.

Select...

I have open sores or swelling around my inner ankle.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in OAB symptom severity score

Secondary study objectives

Change in daily number of voids

Change in nocturia episodes

Change in number of incontinence episodes per 24 hours

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Bilateral PTNSExperimental Treatment1 Intervention

34 gauge needle inserted 3cm above the medial ankle on both ankles, and cables are connected to the PTNS stimulator device. Stimulation is provided, per manufacturer directions, over a 30-minute treatment period

Group II: Unilateral PTNSActive Control1 Intervention

34 gauge needle inserted 3cm above the medial ankle on the ankle, and cables are connected to the PTNS stimulator device. Stimulation is provided, per manufacturer directions, over a 30-minute treatment period

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PTNS

2017

N/A

~340

0 / 5Eligibility criteria met