PTNS on Urinary and Global Quality of Life in MS Patients

Multiple Sclerosis Clinical Trial

— PTNSinMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04063852
• Other study ID #: HUM00153287
• Status: Completed
• Start date: February 27, 2019
• Est. completion date: November 27, 2022

Study information

• Verified date: February 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 27, 2022
• Est. primary completion date: November 27, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Multiple Sclerosis
• Neurogenic Bladder
• Overactive Bladder
• Sclerosis
• Urinary Bladder, Neurogenic
• Urinary Bladder, Overactive
• Urinary Incontinence
• Urinary Incontinence, Urge
• Urinary Urge Incontinence

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Society for Urodynamics & Female Urology (SUFU) Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Michigan Incontinence Symptom Index	Change from baseline of the total Michigan Incontinence Symptom Index at 3, 12, and 24 months	up to 24 months
Other	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
Other	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
Other	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
Other	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
Primary	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.