PTNS on Urinary and Global Quality of Life in MS Patients

Completed

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

• Registration Number: NCT04063852
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-27
• Study First Submitted: 2019-08-19
• Study First Submitted QC: 2019-08-19
• Study First Posted: 2019-08-21
• Primary Completion: 2022-11-27
• Study Completion: 2022-11-27
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-13
• Last Update Posted: 2023-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States