PTNS for Female Patients Suffering From Multiple Sclerosis

Percutaneous Tibial Nerve Stimulation (PTNS) Therapy for Female Patients Suffering From Multiple Sclerosis

Stopped earlyNot a drug-phase studyRelapsing and progressiveNCT05422625

What it found

Stopped

The trial ended early for another reason (see below).

Reason given: Lack of patients

What was tested

Treatment tested

  • PTNS Treatment

Placebo

  • Sham PTNS Treatment

Results by group

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

One week after completing all 12 treatments

GroupValueIntervalNumber analysed
Active PTNS4 score1

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Active PTNS20 (0.0%)0
Sham PTNS000

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • 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

    One week after completing all 12 treatments

    Bladder, bowel and sexual functionQuality of life (reported by participants)

Other measures (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

    Bladder, bowel and sexual function

  • 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

    Bladder, bowel and sexual function

  • 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

    Bladder, bowel and sexual function

  • 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

    Bladder, bowel and sexual functionQuality of life (reported by participants)

Who could take part

Relapsing and progressive · 18 and over

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Jan 2023

    2. Main results due

      Apr 2023

    3. Finished

      Aug 2023

    4. Results posted

      Oct 2024

    Assembled by software from public sources.