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PTNS for Female Patients Suffering From Multiple Sclerosis

TerminatedNA

Sponsor: Corewell Health East

Conditions: Multiple Sclerosis, Overactive Bladder

Interventions: PTNS Treatment, Sham PTNS Treatment

Countries: United States

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 sclerosis (MS) patients. The data generated by this study would provide support for a future multi-institutional, randomized prospective trial.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Locations (1)

Royal Oak, Michigan, United States