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

Primary Purpose

Multiple Sclerosis, Overactive Bladder

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PTNS Treatment

Sham PTNS Treatment

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, MS, Overactive bladder, OAB

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Beaumont Hospital - Royal OakRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active PTNS

Sham PTNS

Arm Description

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

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

Outcomes

Primary Outcome Measures

The overall patient reported change of 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

Secondary Outcome Measures

Change in urinary symptoms in response to the treatment using a 3-day voiding diary

Study participants will complete a 3-day voiding diary to record number of voids, and the number of urgency and urinary incontinence episodes over a 3-day period. Investigators will analyze the change in urinary symptoms from before to after treatment.

Change in overactive bladder symptoms in response to the treatment using the Overactive Bladder Quality of Life short form questionnaire.

Patients will complete the Overactive Bladder quality of life questionnaire to help determine the impact of PTNS treatment on patients quality of life. Patients will score severity of symptoms and the impact of the symptom on patient quality of life on a scale from 1-6, with 1 = not at all, 2 = A little bit, 3 = somewhat, 4 = quite a bit, 5 = a great deal, and 6 = a very great deal.

Full Information

NCT ID

NCT05422625

First Posted

June 13, 2022

Last Updated

February 6, 2023

Sponsor

William Beaumont Hospitals

1. Study Identification

Unique Protocol Identification Number

NCT05422625

Brief Title

PTNS for Female Patients Suffering From Multiple Sclerosis

Acronym

PTNS-MS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 9, 2023 (Actual)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

William Beaumont Hospitals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis, Overactive Bladder

Keywords

Multiple Sclerosis, MS, Overactive bladder, OAB

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized, single-blind, sham controlled.

Masking

Participant

Masking Description

Participant will be blinded to treatment group. Only the clinician providing the treatment will be aware of the treatment group assignment.

Allocation

Randomized

Enrollment

34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active PTNS

Arm Type

Active Comparator

Arm Description

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

Arm Title

Sham PTNS

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

PTNS Treatment

Other Intervention Name(s)

Urgent PC Neuromodulation System

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Sham PTNS Treatment

Other Intervention Name(s)

Biostim TENS Unit

Intervention Description

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.

Primary Outcome Measure Information:

Title

The overall patient reported change of OAB symptoms in MS patients as reported on the Patient Global Impression of Improvement (PGI-I) questionnaire

Description

Time Frame

One week after completing all 12 treatments, Visit 13

Secondary Outcome Measure Information:

Title

Change in urinary symptoms in response to the treatment using a 3-day voiding diary

Description

Time Frame

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

Title

Change in overactive bladder symptoms in response to the treatment using the Overactive Bladder Quality of Life short form questionnaire.

Description

Time Frame

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

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Women assigned female at birth

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Amanda Schonhoff, RN, BSN

Phone

248-551-1225

amanda.schonhoff@beaumont.org

First Name & Middle Initial & Last Name or Official Title & Degree

Bernadette Zwaans, PhD

Phone

248-551-1488

bernadette.zwaans@beaumont.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Priya Padmanabhan, MD

Organizational Affiliation

Beaumont Hospital, Royal Oak

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beaumont Hospital - Royal Oak

City

Royal Oak

State/Province

Michigan

ZIP/Postal Code

48073

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Amanda Schonhoff, RN BSN

Phone

248-551-1225

amanda.schonhoff@beaumont.org

First Name & Middle Initial & Last Name & Degree

Priya Padmanabhan, MD

12. IPD Sharing Statement

Learn more about this trial

PTNS for Female Patients Suffering From Multiple Sclerosis

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