Clinical trial NCT05422625: PTNS for Female Patients Suffering From Multiple Sclerosis
Official title: Percutaneous Tibial Nerve Stimulation (PTNS) Therapy for Female Patients Suffering From Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Multiple Sclerosis
Overactive Bladder
Keywords: Multiple Sclerosis
MS
Overactive bladder
OAB
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2022-06-16
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, single-blind, sham controlled.
Primary purpose: TREATMENT

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

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 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.

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.

Primary outcomes:
measure: The Overall Patient Reported Change of Bladder Overactivity (OAB) Symptoms in MS Patients as Reported on the Patient Global Impression of Improvement (PGI-I) Questionnaire
timeFrame: One week after completing all 12 treatments
Secondary outcomes:
measure: Change in Urinary Voids in Response to the Treatment Using a 3-day Voiding Diary
timeFrame: At baseline and one week after completing all 12 treatments, Visit 13
measure: Change in Urinary Incontinence Episodes in Response to the Treatment Using a 3-day Voiding Diary
timeFrame: At baseline and one week after completing all 12 treatments, Visit 13
measure: Change in Urinary Urgency Episodes in Response to the Treatment Using a 3-day Voiding Diary
timeFrame: At baseline and one week after completing all 12 treatments, Visit 13
measure: Change in Overactive Bladder Symptoms in Response to the Treatment Using the Overactive Bladder Quality of Life Short Form Questionnaire.
timeFrame: At baseline and one week after completing all 12 treatments, Visit 13
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Beaumont Hospital - Royal Oak
state: Michigan
Study officials:
affiliation: Beaumont Hospital, Royal Oak
name: Priya Padmanabhan, MD
role: PRINCIPAL_INVESTIGATOR
References: