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Completed

NCT Number: NCT04063852

PTNS on Urinary and Global Quality of Life in MS 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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Immune System Diseases Lower Urinary Tract Symptoms Male Urogenital Diseases Nervous System Diseases Neurogenic Bladder Neurologic Manifestations Overactive Bladder Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Neurogenic Urinary Bladder, Overactive Urinary Incontinence Urinary Incontinence, Urge Urinary Urge Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction

Registry information

Official study title

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

Acronym: PTNSinMS

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 21, 2019
Registry last updated
Feb 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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