PTNS on Urinary and Global Quality of Life in MS Patients
PTNSinMS
Impact of Percutaneous Posterior Tibial Nerve Stimulation on Urinary and Global Quality of Life in Multiple Sclerosis Patients
1 other identifier
observational
23
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 27, 2019
CompletedFirst Submitted
Initial submission to the registry
August 19, 2019
CompletedFirst Posted
Study publicly available on registry
August 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 27, 2022
CompletedFebruary 14, 2023
February 1, 2023
3.8 years
August 19, 2019
February 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
up to 24 months.
Other Outcomes (6)
American Urological Association (AUA) Symptom Score
up to 24 months
Michigan Incontinence Symptom Index
up to 24 months
Neurogenic Bladder Symptom Score
up to 24 months
- +3 more other outcomes
Eligibility Criteria
Patients presenting to the urology clinic at a tertiary care referral center.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
Related Publications (1)
Lane 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.
PMID: 32460741DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Stoffel, MD
University of Michigan
- PRINCIPAL INVESTIGATOR
Giulia Lane, MD
University of Michigan
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 19, 2019
First Posted
August 21, 2019
Study Start
February 27, 2019
Primary Completion
November 27, 2022
Study Completion
November 27, 2022
Last Updated
February 14, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share