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PTNS on Urinary and Global Quality of Life in MS Patients (PTNSinMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04063852
Recruitment Status : Recruiting
First Posted : August 21, 2019
Last Update Posted : August 18, 2020
Sponsor:
Information provided by (Responsible Party):
Giulia Lane, University of Michigan

Study Description
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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.

Condition or disease
Multiple Sclerosis Lower Urinary Tract Symptoms Neurogenic Bladder Overactive Bladder Urinary Incontinence Urinary Urge Incontinence

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Percutaneous Posterior Tibial Nerve Stimulation on Urinary and Global Quality of Life in Multiple Sclerosis Patients
Actual Study Start Date : February 27, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Urinary Frequency and/or Urinary Incontinence Episodes on 3 day voiding diary [ Time Frame: 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 Outcome Measures:
  1. American Urological Association (AUA) Symptom Score [ Time Frame: 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.


  2. Michigan Incontinence Symptom Index [ Time Frame: up to 24 months ]
    Change from baseline of the total Michigan Incontinence Symptom Index at 3, 12, and 24 months

  3. Neurogenic Bladder Symptom Score [ Time Frame: 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.


  4. Health Status Questionnaire (SF-12), [ Time Frame: 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.


  5. Sexual Satisfaction Scale (SSS) [ Time Frame: 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.


  6. Bowel Control Scale (BCS) [ Time Frame: 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting to the urology clinic at a tertiary care referral center.
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04063852


Contacts
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Contact: Giulia I Lane, M.D. (734) 647-6402 giuliala@med.umich.edu
Contact: Diana O'Dell (734) 763-7144 dcovalsc@med.umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Giulia Lane, M.D.    734-647-6402    giuliala@med.umich.edu   
Contact: Diana O'Dell    (734) 763-7144    dcovalsc@med.umich.edu   
Sub-Investigator: Giulia Lane, MD         
Principal Investigator: John Stoffel, MD         
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: John Stoffel, MD University of Michigan
Principal Investigator: Giulia Lane, MD University of Michigan
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Giulia Lane, Urology Fellow, University of Michigan
ClinicalTrials.gov Identifier: NCT04063852    
Other Study ID Numbers: HUM00153287
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: August 18, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Urinary Bladder, Neurogenic
Urinary Incontinence
Urinary Bladder, Overactive
Urinary Incontinence, Urge
Sclerosis
Lower Urinary Tract Symptoms
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Urination Disorders
Urologic Diseases
Urological Manifestations
Urinary Bladder Diseases
Neurologic Manifestations