Clinical trial NCT04063852: PTNS on Urinary and Global Quality of Life in MS Patients
Official title: Impact of Percutaneous Posterior Tibial Nerve Stimulation on Urinary and Global Quality of Life in Multiple Sclerosis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lower Urinary Tract Symptoms
Neurogenic Bladder
Overactive Bladder
Urinary Incontinence
Urinary Urge Incontinence
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction
First posted: 2019-08-21
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the urology clinic at a tertiary care referral center.

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.


Eligibility 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

Primary outcomes:
measure: Urinary Frequency and/or Urinary Incontinence Episodes on 3 day voiding diary
timeFrame: up to 24 months.
Secondary outcomes:
Other outcomes:
measure: American Urological Association (AUA) Symptom Score
timeFrame: up to 24 months
measure: Michigan Incontinence Symptom Index
timeFrame: up to 24 months
measure: Neurogenic Bladder Symptom Score
timeFrame: up to 24 months
measure: Health Status Questionnaire (SF-12),
timeFrame: up to 24 months
measure: Sexual Satisfaction Scale (SSS)
timeFrame: up to 24 months
measure: Bowel Control Scale (BCS)
timeFrame: up to 24 months
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: John Stoffel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Giulia Lane, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.