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Behavioural Intervention
Pudendal Nerve Stimulation for Stress Urinary Incontinence
N/A
Recruiting
Led By Kenneth Peters, MD
Research Sponsored by William Beaumont Hospitals
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 at stimulation visit, 1 day
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at how electrical stimulation of near the urethra affects pressure in the urethra.
Who is the study for?
This trial is for women over 18 with Stress Urinary Incontinence (SUI) or stress predominant mixed incontinence, lasting at least 6 months. Participants must understand and consent to the study's procedures. Exclusions include recent bacterial UTIs, severe coagulation disorders, pregnancy/breastfeeding, certain medical conditions like Multiple Sclerosis or uncontrolled diseases that affect protocol compliance.
What is being tested?
The study tests how peri-urethral neurostimulation affects intra-urethral pressure in women with urinary issues. It involves urodynamic testing both with and without stimulation of the pudendal nerve to see if this can help control urination.
What are the potential side effects?
Potential side effects may include discomfort from the urodynamic testing procedure and possible irritation or reaction from the neurostimulation device used during testing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at stimulation visit, 1 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at stimulation visit, 1 day
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The effect of acute peri-urethral neurostimulation on intra-urethral pressure.
Secondary study objectives
Safety and tolerability will be assessed in relation to the incidence of adverse events occurring within one week of stimulation visit.
Valsalva leak point pressure (LLP) in response to acute peri-urethral neurostimulation compared to no stimulation
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: Urodynamic testing and LLP with and without pudendal nerve stimulationExperimental Treatment1 Intervention
Commercially available stimulation needles or leads will be inserted into the peri-urethral space targeting the perineal branch of the pudendal nerve. An external neurostimulator settings will be adjusted to deliver acute stimulation. Urodynamic testing will be completed by filling the bladder to a set volume and observing for urinary leakage. The assessment will be completed with stimulation turned on and off. The neurostimulator device settings will be adjusted by the investigator to stay within safe and comfortable levels for each individual study participant.
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Who is running the clinical trial?
William Beaumont HospitalsLead Sponsor
151 Previous Clinical Trials
112,590 Total Patients Enrolled
Kenneth Peters, MDPrincipal InvestigatorWilliam Beaumont Hospitals
26 Previous Clinical Trials
2,006 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any current infections like urethritis, cystitis, or vaginitis.I have had radiation treatment in my pelvic area.I do not have any health conditions that would stop me from following the study's requirements.I have bladder control issues that are not managed.I have taken medication for stress urinary incontinence within the last 4 weeks.I understand the study procedures and can give my consent.I am currently being treated for bladder cancer.My diabetes is severe or uncontrolled, with an A1c of 10% or higher.I have a diagnosed neurological disorder.I have a severe blood clotting disorder.I have been diagnosed with stress urinary incontinence for at least 6 months.I am currently pregnant or have given birth in the last year.I am a woman aged 18 or older.I currently have symptoms of genital herpes.I have a severe pelvic organ prolapse.
Research Study Groups:
This trial has the following groups:- Group 1: Urodynamic testing and LLP with and without pudendal nerve stimulation
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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