PTNS for Female Patients Suffering From Multiple Sclerosis

NCT05422625 | Terminated Results FDA Device

• 1 other identifier: 2022-168
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Overactive Bladder

Keywords

Multiple Sclerosis; MS; Overactive bladder; OAB

Outcome Measures

Primary Outcomes (1)

• 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

  The PGI-I is a self-reported measure of symptom change after treatment completion. This is a validated 1-question tool. Subjects score their urinary condition now compared to how it was before starting treatment. The score ranges from 1-7. 1= very much better, 2 = much better, 3 = a little better, 4=no change, 5= a little worse, 6= much worse, 7 = very much worse. A higher score indicates a worse outcome. Only one participant completed the primary outcome, thus that subject score will be reported.

  One week after completing all 12 treatments

Secondary Outcomes (4)

• Change in Urinary Voids in Response to the Treatment Using a 3-day Voiding Diary

  At baseline and one week after completing all 12 treatments, Visit 13

• Change in Urinary Incontinence Episodes in Response to the Treatment Using a 3-day Voiding Diary

  At baseline and one week after completing all 12 treatments, Visit 13

• Change in Urinary Urgency Episodes in Response to the Treatment Using a 3-day Voiding Diary

  At baseline and one week after completing all 12 treatments, Visit 13

• Change in Overactive Bladder Symptoms in Response to the Treatment Using the Overactive Bladder Quality of Life Short Form Questionnaire.

  At baseline and one week after completing all 12 treatments, Visit 13

Study Arms (2)

Active PTNS

ACTIVE COMPARATOR

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

Device: PTNS Treatment

Sham PTNS

PLACEBO COMPARATOR

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

Device: Sham PTNS Treatment

Interventions

PTNS Treatment DEVICE

Patients will be placed in a comfortable position, sitting or supine. The treatment leg will be propped up comfortably on a footrest but draped and out of view from the patient. A 34-gauge needle electrode will be inserted at a 60-degree angle 5 cm cephalad to the medial malleolus and slightly posterior to the tibia. A PTNS surface electrode will be placed on the ipsilateral calcaneus as well as 2 inactive sham surface electrodes, 1 under the little toe and 1 on the top of the foot. When the PTNS lead set is connected to the Urgent PC stimulator, a current level of 0.5 to 9 mA at 20 Hz is selected based on each patient's foot and plantar motor and sensory responses. Treatment lasts 30 minutes and given once weekly for 12 consecutive weeks.

Also known as: Urgent PC Neuromodulation System

Active PTNS

Sham PTNS Treatment DEVICE

Patients will be positioned similarly as PTNS patients. A Streitberger needle will be used at the tibial nerve insertion site as described above to simulate needle placement. Three electrodes will be placed on the patient's foot, two active TENS electrodes and one inactive TENS electrode. The TENS "grounding pad" will be a gel electrode pad from a TENS unit device that is placed on the bottom of the foot just below the smallest toe. Another gel electrode will be placed on the top of the foot just above the small toe for conduction. These two electrodes will be connected to the TENS unit lead wires for sham stimulation. A third, inactive, gel electrode, will be placed near the medial aspect of the calcaneus to mimic the PTNS treatment. The TENS electrode will be connected by lead wires to the TENS unit set at 20 HZ. The TENS unit will be turned on and stimulation slowly increased to the patient's first sensory level and then turned off.

Also known as: Biostim Transcutaneous electrical nerve stimulation (TENS) Unit

Sham PTNS

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women assigned female at birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

Beaumont Hospital - Royal Oak

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Urinary Bladder, Overactive

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed. Recruiting challenges.

Results Point of Contact

• Title: Jennifer Giordano RN BSN/ Clinical Research Manager
• Organization: William Beaumont University Hospital

Jennifer.Giordano@corewellhealth.org

248-551-3517

Study Officials

• Priya Padmanabhan, MD

  Beaumont Hospital, Royal Oak

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will be blinded to treatment group. Only the clinician providing the treatment will be aware of the treatment group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellowship Director, Female Pelvic Medicine and Reconstructive Surgery

Model Details: Randomized, single-blind, sham controlled.

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 16, 2022
• Study Start: January 9, 2023
• Primary Completion: April 10, 2023
• Study Completion: August 3, 2023
• Last Updated: October 9, 2024
• Results First Posted: October 9, 2024

Record last verified: 2024-09

Locations

US (1)