PTNS for Female Patients Suffering From Multiple Sclerosis (PTNS-MS)

William Beaumont Hospitals

Status: Terminated

Conditions: Multiple Sclerosis; Overactive Bladder

Treatments: Device: Sham PTNS Treatment; Device: PTNS Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05422625

2022-168

Details and patient eligibility

About

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.

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 OAB and urinary incontinence (UI) being the predominant bladder dysfunctions. OAB is characterized by sudden feeling of urgency, frequent urination, and urge incontinence. 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.

Enrollment: 2 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2 participants in 2 patient groups, including a placebo group

Active PTNS

Active Comparator group

Description:

Once a week induction consisting of active PTNS treatments for 30 minutes for 12 consecutive weeks.

Treatment:

Device: PTNS Treatment

Sham PTNS

Placebo Comparator group

Description:

Once a week induction consisting of Sham PTNS treatments for 30 minutes for 12 consecutive weeks.

Treatment:

Device: Sham PTNS Treatment