PTNSinMS: PTNS on Urinary and Global Quality of Life in MS Patients

Sponsor

University of Michigan (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04063852

Collaborator

Society for Urodynamics & Female Urology (SUFU) Research Foundation (Other)

Enrollment

Location

46.1

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis Lower Urinary Tract Symptoms Neurogenic Bladder Overactive Bladder Urinary Incontinence Urinary Urge Incontinence

Study Design

Study Type:

Observational

Actual Enrollment :

23 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Impact of Percutaneous Posterior Tibial Nerve Stimulation on Urinary and Global Quality of Life in Multiple Sclerosis Patients

Actual Study Start Date :

Feb 27, 2019

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Outcome Measures

Primary Outcome Measures

Urinary Frequency and/or Urinary Incontinence Episodes on 3 day voiding diary [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

Other Outcome Measures

American Urological Association (AUA) Symptom Score [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 [up to 24 months]
Change from baseline of the total Michigan Incontinence Symptom Index at 3, 12, and 24 months
Neurogenic Bladder Symptom Score [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), [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) [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

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

Exclusion Criteria:

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