Multiple SclerosisPTNSinMSNCT04063852
PTNS on Urinary and Global Quality of Life in MS Patients
An observational study of Multiple Sclerosis and Lower Urinary Tract Symptoms, run by University of Michigan at 1 site in United States.
Trial summary
This is a single-centered, prospective, longitudinal, observational cohort study of patients with MS who suffer from lower urinary tract symptoms (LUTS) and are refractory to two prior treatment modalities who have elected to pursue PTNS therapy for LUTS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Lower Urinary Tract Symptoms, Neurogenic Bladder
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2019to 27 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- All sexes
- Adult, Older adult
Study population: Patients presenting to the urology clinic at a tertiary care referral center.
Who may be able to join
- Diagnosis of Multiple Sclerosis
- Lower urinary tract symptoms (urinary frequency, urgency and/or incontinence)
- Failed prior first and second line therapy (behavioral and pharmacotherapy)
- Electing for Posterior Tibial Nerve Stimulation therapy for urinary symptoms
- Patients performing Intermittent Catheterization are Eligible
Who cannot join
- Indwelling catheters (urethral or suprapubic)
- Currently pregnant or planning pregnancy
- Unable to attend weekly office visits for PTNS
- Urodynamic findings of bladder outlet obstruction
- History of:
- bladder reconstruction (augmentation cystoplasty, catheterizable channel) cystectomy bladder stones pacemaker or defibrillator malignancy of bladder sacral neuromodulation intravesical injection of onabotulinum toxin within 9 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Percutaneous Posterior Tibial Nerve Stimulation on Urinary and Global Quality of Life in Multiple Sclerosis Patients
This is a single-centered, prospective, longitudinal, observational cohort study of patients with MS who suffer from lower urinary tract symptoms (LUTS) and are refractory to two prior treatment modalities who have elected to pursue PTNS therapy for LUTS.
- Conditions
- Multiple Sclerosis, Lower Urinary Tract Symptoms, Neurogenic Bladder, Overactive Bladder, Urinary Incontinence, Urinary Urge Incontinence
- Medical subject headings
- Multiple Sclerosis, Lower Urinary Tract Symptoms, Urinary Bladder, Neurogenic, Urinary Bladder, Overactive, Urinary Incontinence, Urinary Incontinence, Urge
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Frequency and/or Urinary Incontinence Episodes on 3 day voiding diary
Change from baseline in the median number of urinary frequency and/or urinary incontinence episodes on a 3 day voiding diary at 3, 12, and 24 months
Measured: up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start27 Feb 2019
- Primary completion27 Nov 2022
- Study completion27 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction
- Responsible party
- Principal investigator, Giulia Lane, University of Michigan
- Investigators
- John Stoffel, MD, Principal investigator, University of MichiganGiulia Lane, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063852
- Sponsor's protocol ID
- HUM00153287
- Acronym
- PTNSinMS
- Status last verified
- Feb 2023
- First submitted
- 19 Aug 2019
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ippolito GMR, Palanjian RR, Mao-Draayer Y, Capizzano A, Barboglio-Romo P, Clemens JQ, Gupta P, Dunn R, O'Dell D, Daignault-Newton S, Van Til M, Cameron AP, Stoffel JT. A Prospective Observational Study of Posterior Tibial Nerve Stimulation in Multiple Sclerosis. Int Urogynecol J. 2024 Aug;35(8):1605-1612. doi: 10.1007/s00192-024-05836-x. Epub 2024 Jun 28.
PubMed 38942931Lane GI, Mao-Draayer Y, Barboglio-Romo P, Clemens JQ, Gupta P, Dunn R, Qin Y, Cameron AP, Stoffel JT. A prospective observational cohort study of posterior tibial nerve stimulation in patients with multiple sclerosis: design and methods. BMC Urol. 2020 May 27;20(1):58. doi: 10.1186/s12894-020-00629-y.
PubMed 32460741
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Percutaneous Posterior Tibial Nerve Stimulation on Urinary and Global Quality of Life in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT04063852
- Acronym / sponsor ID
- PTNSinMS / HUM00153287
- Conditions
- Multiple Sclerosis, Lower Urinary Tract Symptoms, Neurogenic Bladder, Overactive Bladder, Urinary Incontinence, Urinary Urge Incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 27 Nov 2022 (actual)
- Study completion
- 27 Nov 2022 (actual)
- First posted
- 21 Aug 2019 (actual)
- Results
- Not posted in the source record
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 single-centered, prospective, longitudinal, observational cohort study of patients with MS who suffer from lower urinary tract symptoms (LUTS) and are refractory to two prior treatment modalities who have elected to pursue PTNS therapy for LUTS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the urology clinic at a tertiary care referral center.
Key inclusion criteria (5 listed)
- Diagnosis of Multiple Sclerosis
- Lower urinary tract symptoms (urinary frequency, urgency and/or incontinence)
- Failed prior first and second line therapy (behavioral and pharmacotherapy)
- Electing for Posterior Tibial Nerve Stimulation therapy for urinary symptoms
- Patients performing Intermittent Catheterization are Eligible
Key exclusion criteria (6 listed)
- Indwelling catheters (urethral or suprapubic)
- Currently pregnant or planning pregnancy
- Unable to attend weekly office visits for PTNS
- Urodynamic findings of bladder outlet obstruction
- bladder reconstruction (augmentation cystoplasty, catheterizable channel) cystectomy bladder stones pacemaker or defibrillator malignancy of bladder sacral neuromodulation intravesical injection of onabotulinum toxin within 9 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Urinary Frequency and/or Urinary Incontinence Episodes on 3 day voiding diary
Time frame: up to 24 months.
Change from baseline in the median number of urinary frequency and/or urinary incontinence episodes on a 3 day voiding diary at 3, 12, and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Derived from this study: PubMed 38942931Ippolito GMR, Palanjian RR, Mao-Draayer Y, Capizzano A, Barboglio-Romo P, Clemens JQ, Gupta P, Dunn R, O'Dell D, Daignault-Newton S, Van Til M, Cameron AP, Stoffel JT. A Prospective Observational Study of Posterior Tibial Nerve Stimulation in Multiple Sclerosis. Int Urogynecol J. 2024 Aug;35(8):1605-1612. doi: 10.1007/s00192-024-05836-x. Epub 2024 Jun 28.
- Derived from this study: PubMed 32460741Lane GI, Mao-Draayer Y, Barboglio-Romo P, Clemens JQ, Gupta P, Dunn R, Qin Y, Cameron AP, Stoffel JT. A prospective observational cohort study of posterior tibial nerve stimulation in patients with multiple sclerosis: design and methods. BMC Urol. 2020 May 27;20(1):58. doi: 10.1186/s12894-020-00629-y.
- Individual participant dataSharing planned: No
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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.
John Stoffel, MD principal investigator
University of Michigan
Giulia Lane, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Lower Urinary Tract Symptoms, run by University of Michigan 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 14 Feb 2023. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Urinary Frequency and/or Urinary Incontinence Episodes on 3 day voiding diary (time frame: up to 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04063852, which also lists 2 linked publications.
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 14 Feb 2023.