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Neuromodulation Device
Superficial Peroneal Nerve Stimulation for Urinary Retention
N/A
Recruiting
Led By Katherine Shapiro, MD
Research Sponsored by Michael Pintauro
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 3 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new, non-invasive treatment for underactive bladder that doesn't require surgery.
Eligible Conditions
- Urinary Retention
- Underactive Bladder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Bladder Voiding efficiency
Bladder capacity
Catheterized Post Void Residual volume
+3 moreSecondary study objectives
Efficacy of Foot Stimulation
Post-stimulation effect
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Transcutaneous Nerve Stimulator(TENS)Experimental Treatment1 Intervention
Adult females who have difficulty emptying their bladder due to non-obstructive urinary retention or because of an under-active bladder will be given transcutaneous nerve stimulation (TENS) therapy.
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Who is running the clinical trial?
Michael PintauroLead Sponsor
Society of Urodynamics, Female Pelvic Medicine & Urogenital ReconstructionUNKNOWN
MARIA PERELead Sponsor
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a neurologic condition, including diabetes.You had surgery for a urinary blockage within the past year.You have a pacemaker or implantable defibrillator.Currently using percutaneous tibial nerve stimulation (PTNS) or transcutaneous electrical nerve stimulation (TENS) in the pelvis, back, or legs.You have had surgery on your foot or leg, or have nerve damage in those areas.You are currently using Interstim.You have been diagnosed with difficulty urinating that is not caused by a blockage.You need to use a catheter every day to empty your bladder.You have been diagnosed with a condition where you have trouble urinating, but it's not caused by a blockage.You have used onabotulinumtoxinA in your bladder or pelvic floor muscles in the last year.You have a current infection in your urinary tract or vagina.You have over 300 milliliters of urine left in your bladder after you go to the bathroom.
Research Study Groups:
This trial has the following groups:- Group 1: Transcutaneous Nerve Stimulator(TENS)
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.
Urinary Retention Patient Testimony for trial: Trial Name: NCT04000763 — N/A
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