An interventional study of PTNS Treatment and Sham PTNS Treatment in Multiple Sclerosis and Overactive Bladder, sponsored by William Beaumont Hospitals. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-09.
Sponsored by William Beaumont Hospitals · Not applicable, Interventional, and Treatment
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.
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.
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's enrollment of 2 is below the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →William Beaumont Hospitals is the lead sponsor of 111 studies on the registry; none are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 30 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Once a week induction consisting of active PTNS treatments for 30 minutes for 12 consecutive weeks.
Device: PTNS Treatment
Once a week induction consisting of Sham PTNS treatments for 30 minutes for 12 consecutive weeks.
Device: Sham PTNS Treatment
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
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
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.
Time frame: One week after completing all 12 treatments
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.
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
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.
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
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.
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.
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.
Time frame: At baseline and one week after completing all 12 treatments, Visit 13
Subjects were recruited from December 2022 through December 2023.
| Milestone | Active PTNS | Sham PTNS |
|---|---|---|
| Started | 2 | 0 |
| Completed | 1 | 0 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
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.
| score | Active PTNS | Sham PTNS |
|---|---|---|
| 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 | 4 | — |
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.
| number of voids | Active PTNS | Sham PTNS |
|---|---|---|
| Change in Urinary Voids in Response to the Treatment Using a 3-day Voiding Diary | 1 ± 0 | — |
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.
| number of urgency incontinence episodes | Active PTNS | Sham PTNS |
|---|---|---|
| Change in Urinary Incontinence Episodes in Response to the Treatment Using a 3-day Voiding Diary | -3 ± 0 | — |
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.
| number of urgency episodes | Active PTNS | Sham PTNS |
|---|---|---|
| Change in Urinary Urgency Episodes in Response to the Treatment Using a 3-day Voiding Diary | 1 ± 0 | — |
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.
| score on a scale | Active PTNS | Sham PTNS |
|---|---|---|
| Change in Overactive Bladder Symptoms in Response to the Treatment Using the Overactive Bladder Quality of Life Short Form Questionnaire. | -47.69 ± 0 | — |
Collected over Approximately 14 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active PTNS | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Sham PTNS | — | — | — |
There were zero patients randomized to the sham PTNS group.
| Age, Categorical(Participants) | Active PTNS | Sham PTNS | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 0 | 2 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Active PTNS | Sham PTNS | Total |
|---|---|---|---|
| Mean | 47 ± 12 | — | 47 ± 12 |
| Sex: Female, Male(Participants) | Active PTNS | Sham PTNS | Total |
|---|---|---|---|
| Female | 2 | 0 | 2 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Active PTNS | Sham PTNS | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 2 | 0 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Active PTNS | Sham PTNS | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 2 | 0 | 2 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Active PTNS | Sham PTNS | Total |
|---|---|---|---|
| United States | 2 | — | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jan 2023 to primary completion in Apr 2023, 3 months.
Results were first posted in Oct 2024, 1 year 5 months after primary completion.
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This study is terminated, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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