Lower Urinary Tract Symptoms, Multiple Sclerosis, Neurogenic Bladder, Overactive Bladder, Urinary Incontinence, Urinary Urge Incontinence
Conditions
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.
Interventions
None listed
Sponsors
Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction
University of Michigan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed