Status:
TERMINATED
PTNS for Female Patients Suffering From Multiple Sclerosis
Lead Sponsor:
Corewell Health East
Conditions:
Multiple Sclerosis
Overactive Bladder
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This is a pilot, single blind, randomized, sham-controlled trial to assess the benefit of Percutaneous Tibial Nerve Stimulation (PTNS) in treating bladder overactivity (OAB) symptoms in multiple scler...
Detailed Description
Multiple Sclerosis (MS) is a chronic, progressive inflammatory disorder of the central nervous system. It is caused by loss of myelin, the outer protective layer of the neuron, resulting in a disrupti...
Eligibility Criteria
Inclusion
- Women with diagnosis for Multiple Sclerosis (Clinically isolated syndrome (CIS), relapsing remitting (RRMS), secondary progressive (SPMS), and/or primary progressive (PPMS)), 18 years of age or older
- Self-reported bladder symptoms \> 3 months
- Discontinued antimuscarinics/beta-3 agonists for \> 2 weeks, and remain off for the duration of the study
- Capable of giving informed consent
- Ambulatory and able to use toilet independently without difficulty
- Capable and willing to follow all study-related procedures
- If of childbearing age, agree to practice approved birth-control methods (oral contraceptives, condom barrier, injection, diaphragm or cervical cap, vaginal contraceptive ring, intrauterine device (IUD), implantable contraceptive, surgical sterilization (bilateral tubal ligation), vasectomized partner(s))
- Subject agrees not to start any new treatments for urinary symptoms (medication or otherwise) during the treatment and follow-up periods.
- Subject agrees to maintain a stable dose on all current medications throughout the treatment and follow-up period.
Exclusion
- Pregnant or planning to become pregnant during study duration
- Botox (BTX) use in bladder or pelvic floor muscles within past 6 months
- Pacemakers or implantable defibrillators
- Current urinary tract infection
- Active use of neuromodulation in any other form. If patient has InterStim, must be turned off for 2 weeks for a washout period and remain off during the entirety of the study.
- Current use of Transcutaneous Electrical Nerve Stimulation (TENS) in pelvic region, back or legs
- Previous PTNS treatment
- Participation in any clinical investigation involving or impacting gynecologic, urinary, or renal function within past 4 weeks
- Note: For the sake of preserving scientific integrity, one or more of the eligibility criteria have been left off the list posted while the trial is ongoing. A full list of eligibility criteria will be posted upon completion of the trial.
Key Trial Info
Start Date :
January 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2023
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT05422625
Start Date
January 9 2023
End Date
August 3 2023
Last Update
October 9 2024
Active Locations (1)
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1
Beaumont Hospital - Royal Oak
Royal Oak, Michigan, United States, 48073