Multiple Sclerosis Clinical Trial
PTNS for Female Patients Suffering From Multiple Sclerosis
Summary
This is a pilot, single blind, randomized, sham-controlled trial to assess the benefit of PTNS in treating OAB symptoms in MS patients. The data generated by this study would provide support for a future multi-institutional, randomized prospective trial.
Full 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 disruption of the signal potentials that flow through the neurons. This can lead to a variety of sensory, visual, and motor disturbances. MS affects almost 1 million people in the United States with the prevalence being two to three times higher in women than in men. Over 80% of MS patients suffer from lower urinary tract symptoms, with bladder overactivity (OAB) and urinary incontinence (UI) being the predominant bladder dysfunctions. OAB is characterized by sudden feeling of urgency, frequent urination, and urge incontinence. Percutaneous Tibial Nerve Stimulation (PTNS) is an FDA approved treatment for OAB and is recommended as third line treatment for OAB by the American Urological Association (AUA) and Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU). However, it is not approved for MS and as such these treatments are not covered by insurance.
Here the investigators propose a pilot, double blind, randomized, sham-controlled trial to assess the benefit of PTNS in treating OAB symptoms in MS patients. The data generated by this study would provide support for a future multi-institutional, randomized prospective trial.
Eligibility Criteria
Inclusion Criteria:
Women with diagnosis for Multiple Sclerosis (CIS, RRMS, SPMS, and/or 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, 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
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.
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There is 1 Location for this study
Royal Oak Michigan, 48073, United States More Info
Principal Investigator
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