PTNS on Urinary and Global Quality of Life in MS Patients

NCT ID: NCT04063852

Last Updated: 2023-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-27

Study Completion Date

2022-11-27

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Giulia Lane

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Stoffel, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Giulia Lane, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32460741 (View on PubMed)

Other Identifiers

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HUM00153287

Identifier Type: -

Identifier Source: org_study_id

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