Multiple SclerosisPTNS-MSNCT05422625
PTNS for Female Patients Suffering From Multiple Sclerosis
A study testing PTNS Treatment in people with Multiple Sclerosis and Overactive Bladder, run by Corewell Health East at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Multiple Sclerosis, Overactive Bladder
- What is being tested?
- PTNS Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2023to 3 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Beaumont Hospital - Royal Oak
Royal Oak, Michigan, 48073
About this study
Official title: Percutaneous Tibial Nerve Stimulation (PTNS) Therapy for Female Patients Suffering From Multiple Sclerosis
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.
Read the 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.
- Conditions
- Multiple Sclerosis, Overactive Bladder
- Being tested
- PTNS Treatment, Sham PTNS Treatment
- Keywords
- Multiple Sclerosis, MS, Overactive bladder, OAB
- Medical subject headings
- Multiple Sclerosis, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTNS TreatmentDevice
Also called Urgent PC Neuromodulation System
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.
Sham PTNS TreatmentDevice
Also called Biostim Transcutaneous electrical nerve stimulation (TENS) Unit
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.
| Study group | Role | What they receive |
|---|---|---|
| Active PTNS | Active comparator | Once a week induction consisting of active PTNS treatments for 30 minutes for 12 consecutive weeks. Receives: Device: PTNS Treatment |
| Sham PTNS | Placebo comparator | Once a week induction consisting of Sham PTNS treatments for 30 minutes for 12 consecutive weeks. Receives: Device: Sham PTNS Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Study participants will complete a 3-day voiding diary to record number of voids. Investigators will analyze the change in urinary voids from before to after treatment. A positive number indicates more voids, and a negative number indicates fewer voids.
Measured: 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
Study participants will complete a 3-day voiding diary to record number of urinary incontinence episodes over a 3-day period. Investigators will analyze the change in urinary incontinence episodes from before to after treatment. A positive number indicates more episodes, and a negative number indicates fewer episodes.
Measured: 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
Study participants will complete a 3-day voiding diary to record the number of urgency episodes over a 3-day period. Investigators will analyze the change in urinary urgency episodes from before to after treatment. A positive number indicates more episodes, and a negative number indicates fewer episodes.
Measured: 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.
The Overactive Bladder quality of life questionnaire measures the impact of PTNS treatment on patient quality of life. Patients score symptom severity and impact on quality of life on a scale 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. Symptom severity raw score is calculated from questions 1-6; the lowest possible raw score is 6, the highest score is 36. The health-related quality of life (HRQL) raw score is calculated similarly from questions 1-13; the lowest possible score is 13 and highest score is 78. The formula (actual raw score - lowest possible raw score)/highest possible raw score times 100 is applied to each raw score, which are added to give a final score in the range 0 to 166.6, with low scores indicating fewer symptoms and impact, and high scores indicating more symptoms and impact. Change from baseline is reported, with a positive number indicating worsening and a negative number indicating improvement.
Measured: At baseline and one week after completing all 12 treatments, Visit 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start9 Jan 2023
- Primary completion10 Apr 2023
- Study completion3 Aug 2023
Why it stopped: Lack of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, single-blind, sham controlled.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Priya Padmanabhan, Corewell Health East
- Investigators
- Priya Padmanabhan, MD, Principal investigator, Beaumont Hospital, Royal Oak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422625
- Sponsor's protocol ID
- 2022-168
- Acronym
- PTNS-MS
- Status last verified
- Sep 2024
- First submitted
- 13 Jun 2022
- Last updated
- 9 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Tibial Nerve Stimulation (PTNS) Therapy for Female Patients Suffering From Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05422625
- Acronym / sponsor ID
- PTNS-MS / 2022-168
- Conditions
- Multiple Sclerosis, Overactive Bladder
- Keywords
- Multiple Sclerosis, MS, Overactive bladder, OAB
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of patients
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 3 Aug 2023 (actual)
- First posted
- 16 Jun 2022 (actual)
- Results
- Posted 9 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, single-blind, sham controlled.
| Arm | Type | Receives |
|---|---|---|
| Active PTNS | Active comparator | Device: PTNS TreatmentOnce a week induction consisting of active PTNS treatments for 30 minutes for 12 consecutive weeks. |
| Sham PTNS | Placebo comparator | Device: Sham PTNS TreatmentOnce a week induction consisting of Sham PTNS treatments for 30 minutes for 12 consecutive weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTNS TreatmentAlso: Urgent PC Neuromodulation SystemPatients 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. | Device | Active PTNS |
| Sham PTNS TreatmentAlso: Biostim Transcutaneous electrical nerve stimulation (TENS) UnitPatients 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. | Device | Sham PTNS |
Primary outcome
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
Time frame: One week after completing all 12 treatments
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.
4 secondary outcomes
Change in Urinary Voids in Response to the Treatment Using a 3-day Voiding Diary
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: At baseline and one week after completing all 12 treatments, Visit 13
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Priya Padmanabhan, MD principal investigator
Beaumont Hospital, Royal Oak
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTNS Treatment in people with Multiple Sclerosis and Overactive Bladder, run by Corewell Health East at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: One week after completing all 12 treatments). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.