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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

BUTTON Trial 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.Check my eligibility
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.See study design
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.

BUTTON Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman over 18 who has not benefited from or tolerated behavioral therapy.

BUTTON Trial Timeline

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

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 more

BUTTON 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

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

PTNS (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03535857 — N/A
Overactive Bladder Research Study Groups: Unilateral PTNS, Bilateral PTNS
Overactive Bladder Clinical Trial 2023: PTNS Highlights & Side Effects. Trial Name: NCT03535857 — N/A
PTNS (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03535857 — N/A
~4 spots leftby Dec 2024
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