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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
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 belowSelect...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in OAB symptom severity score
Secondary outcome measures
Change in daily number of voids
Change in nocturia episodes
Change in number of incontinence episodes per 24 hours
+1 moreTrial 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
Find a Location
Who is running the clinical trial?
Gnankang Sarah NapoeLead Sponsor
G. Sarah Napoe, MDPrincipal InvestigatorUniversity of Pittsburgh
Kyle Wohlrab, MDPrincipal InvestigatorWomen and Infants Hospital of Rhode Island
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition where my bladder doesn't function properly due to nerve damage.I have received Botox or have a sacral nerve stimulation implant.I am a woman over 18 who has not benefited from or tolerated behavioral therapy.You have a pacemaker or implantable defibrillator.I have a bleeding disorder that is not under control.I have open sores or swelling around my inner ankle.I am currently on medication and can continue taking it.
Research Study Groups:
This trial has the following groups:- Group 1: Unilateral PTNS
- Group 2: Bilateral PTNS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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