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| Name | Class |
|---|---|
| Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction | OTHER |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| American Urological Association (AUA) Symptom Score | 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. |
Inclusion Criteria:
Exclusion Criteria:
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
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Patients presenting to the urology clinic at a tertiary care referral center.
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| Name | Affiliation | Role |
|---|---|---|
| John Stoffel, MD | University of Michigan | Principal Investigator |
| Giulia Lane, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38942931 | Derived | 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. | |
| 32460741 |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D059411 | Lower Urinary Tract Symptoms |
| D001750 | Urinary Bladder, Neurogenic |
| D053201 | Urinary Bladder, Overactive |
| D014549 | Urinary Incontinence |
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| up to 24 months |
| Michigan Incontinence Symptom Index | Change from baseline of the total Michigan Incontinence Symptom Index at 3, 12, and 24 months | up to 24 months |
| Neurogenic Bladder Symptom Score | 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. | up to 24 months |
| Health Status Questionnaire (SF-12), | 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. | up to 24 months |
| Sexual Satisfaction Scale (SSS) | 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. | up to 24 months |
| Bowel Control Scale (BCS) | 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. | up to 24 months |
| 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. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014555 | Urination Disorders |