PTNS on Urinary and Global Quality of Life in MS Patients (PTNSinMS)
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|ClinicalTrials.gov Identifier: NCT04063852|
Recruitment Status : Recruiting
First Posted : August 21, 2019
Last Update Posted : August 18, 2020
|Condition or disease|
|Multiple Sclerosis Lower Urinary Tract Symptoms Neurogenic Bladder Overactive Bladder Urinary Incontinence Urinary Urge Incontinence|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Impact of Percutaneous Posterior Tibial Nerve Stimulation on Urinary and Global Quality of Life in Multiple Sclerosis Patients|
|Actual Study Start Date :||February 27, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
- 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
- American Urological Association (AUA) Symptom Score [ Time Frame: up to 24 months ]
Change from baseline of the total AUA Symptom Score at 3, 12, and 24 months
7 question scale. Score Ranges 0-35. Higher scores indicate worse lower urinary tract symptoms.
AUA Bother Subscore: Single question item that is part of the AUA symptom score, but not calculated for the overall score. range is 0-6 with 6 indicating terrible bother from urinary symptoms.
- Michigan Incontinence Symptom Index [ Time Frame: up to 24 months ]Change from baseline of the total Michigan Incontinence Symptom Index at 3, 12, and 24 months
- Neurogenic Bladder Symptom Score [ Time Frame: up to 24 months ]
Change from baseline of the total Neurogenic Bladder Symptom Score at 3, 12, and 24 months
The NBSS consists of 24 questions. The first question classifies patients by bladder management, but does not make up part of the numeric score. The remaining questions address 3 domains: incontinence, storage and voiding, and consequences. The final question is an overall quality of life question. The total score can range from 0 (no symptoms at all) to 74 (maximum symptoms). The median time to complete the NBSS is 6 minutes.
- Health Status Questionnaire (SF-12), [ Time Frame: up to 24 months ]
Change in from baseline of the total Health Status Questionnaire (SF-12) at 3, 12, and 24 months
12 item scale with ranges from 0-100. where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
- Sexual Satisfaction Scale (SSS) [ Time Frame: up to 24 months ]
Change from baseline of the total Sexual Satisfaction Scale (SSS) at 3, 12, and 24 months
Raw scores on the 4 sexual satisfaction items (Items 2-5) are summed to create a total score. Thus, this scale can range from 4-24. Higher scores indicate greater problems with sexual satisfaction.
- Bowel Control Scale (BCS) [ Time Frame: up to 24 months ]
Change from baseline of the total Bowel Control Scale (BCS) at 3, 12, and 24 months
Raw scores on the 5 items are summed to create a Bowel Control Scale (BWCS) total score. Scores can range from 0-26, with higher scores indicating greater bowel control problems.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04063852
|Contact: Giulia I Lane, M.D.||(734) firstname.lastname@example.org|
|Contact: Diana O'Dell||(734) email@example.com|
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Giulia Lane, M.D. 734-647-6402 firstname.lastname@example.org|
|Contact: Diana O'Dell (734) 763-7144 email@example.com|
|Sub-Investigator: Giulia Lane, MD|
|Principal Investigator: John Stoffel, MD|
|Principal Investigator:||John Stoffel, MD||University of Michigan|
|Principal Investigator:||Giulia Lane, MD||University of Michigan|