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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Overactive Bladder; Lower Urinary Tract Symptoms; Urinary Incontinence; Neurogenic Bladder; Urinary Urge Incontinence

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the urology clinic at a tertiary care referral center.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Society for Urodynamics & Female Urology (SUFU) Research Foundation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 27, 2019
• Primary Completion (ACTUAL): November 27, 2022
• Study Completion (ACTUAL): November 27, 2022

Study Registration Dates

• First Submitted: August 19, 2019
• First Submitted That Met QC Criteria: August 19, 2019
• First Posted (ACTUAL): August 21, 2019

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Urologic Diseases; Urinary Bladder Diseases; Urological Manifestations; Neurologic Manifestations; Urination Disorders; Multiple Sclerosis; Sclerosis; Urinary Bladder, Overactive; Urinary Incontinence; Lower Urinary Tract Symptoms; Urinary Bladder, Neurogenic; Urinary Incontinence, Urge
• Other Study ID Numbers: HUM00153287

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No