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Neuromodulation Device
Active PTNS for Multiple Sclerosis (PTNS-MS Trial)
N/A
Recruiting
Led By Priya Padmanabhan, 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
Self-reported bladder symptoms > 3 months
Women with diagnosis for Multiple Sclerosis (CIS, RRMS, SPMS, and/or PPMS), 18 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one week after completing all 12 treatments, visit 13
Awards & highlights
PTNS-MS Trial Summary
This trialtests if a nerve stimulation treatment helps MS patients with overactive bladder symptoms. It will help set up future research to confirm the results.
Eligible Conditions
- Multiple Sclerosis
- Overactive Bladder
PTNS-MS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have been experiencing bladder symptoms for more than 3 months and have reported them.
Select...
Women who are 18 years or older and have been diagnosed with Multiple Sclerosis (different types like CIS, RRMS, SPMS, or PPMS).
PTNS-MS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline and one week after completing all 12 treatments, visit 13
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and one week after completing all 12 treatments, visit 13
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The overall patient reported change of OAB symptoms in MS patients as reported on the Patient Global Impression of Improvement (PGI-I) questionnaire
Secondary outcome measures
Change in overactive bladder symptoms in response to the treatment using the Overactive Bladder Quality of Life short form questionnaire.
Change in urinary symptoms in response to the treatment using a 3-day voiding diary
PTNS-MS Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active PTNSActive Control1 Intervention
Once a week induction consisting of active PTNS treatments for 30 minutes for 12 consecutive weeks.
Group II: Sham PTNSPlacebo Group1 Intervention
Once a week induction consisting of Sham PTNS treatments for 30 minutes for 12 consecutive weeks.
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Who is running the clinical trial?
William Beaumont HospitalsLead Sponsor
149 Previous Clinical Trials
113,002 Total Patients Enrolled
Priya Padmanabhan, MDPrincipal InvestigatorBeaumont Hospital, Royal Oak
Media Library
Awards:
This trial has 0 awards, including:Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current enrollment of participants in this trial?
"That is correct. Per the clinicaltrials.gov website, this clinical trial was originally posted on December 1st 2022 and has most recently been modified on November 13th 2022. 34 individuals are required for the study at one location."
Answered by AI
Is the recruitment stage of this experiment underway?
"Clinicaltrials.gov confirms that this medical trial is still looking for participants, with the original post dating back to December 1st 2022 and a recent update on November 13th 2022."
Answered by AI
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