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PTNS vs Botox of Refractory OAB

NCT ID: NCT04451382

Last Updated: 2020-06-30

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

TERMINATED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2018-12-31

Brief Summary

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This is a prospective cohort study of women with overactive bladder OAB (dry or wet) who have failed 2 prior treatments, including behavioral modification, pelvic floor physical therapy, and/or OAB medication (anticholinergics or mirabegron), and have chosen either OnabotulinumtoxinA (BTX) injection or percutaneous tibial nerve stimulation (PTNS) as their next treatment. OAB-dry refers to patients with OAB who do not have urge urinary incontinence; OAB-wet refers to patients with OAB and urge urinary incontinence. Eligible patients will be approached for study participation after they have decided to proceed with BTX or PTNS.

Detailed Description

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Prior to initiation of BTX or PTNS, patients will undergo a standardized evaluation including urodynamics study (UDS) if not previously done in the past year and pelvic organ prolapse quantification (POPq) exam if not previously done in past 6 months. Subjects will also complete quality of life questionnaires and 3-day voiding diary prior to initial treatment. Follow up questionnaires will be completed at 3 months either in office, if patient has a routine visit scheduled with provider and questionnaires can be completed at that visit or questionnaires will be mailed with return postage for participant to mail completed questionnaires back.

Conditions

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Overactive Bladder (OAB)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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OnabotulinumtoxinA (BoNTA)

DRUG: OnabotulinumtoxinA (BoNTA) is an injection into the bladder which blocks the presynaptic release of acetylcholine. BoNTA was approved for the treatment of OAB by the FDA in 2013.

OnabotulinumtoxinA (BoNTA)

Intervention Type BIOLOGICAL

Percutaneous tibial nerve stimulation (PTNS)

DEVICE: PTNS involves needle stimulation of the posterior tibial nerve and is typically performed with weekly 30 minute sessions for a 12 week treatment course.

Percutaneous tibial nerve stimulation (PTNS)

Intervention Type PROCEDURE

Interventions

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OnabotulinumtoxinA (BoNTA)

Intervention Type BIOLOGICAL

Percutaneous tibial nerve stimulation (PTNS)

Intervention Type PROCEDURE

Other Intervention Names

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Botox

Eligibility Criteria

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Inclusion Criteria

1. Women with refractory OAB (dry or wet)
2. OAB will be defined by a positive response and bother of "somewhat, quite a bit, a great deal, or a very great deal" to question #3 or #8 on the OAB-q (see appendix B) regarding urinary urgency and urgency incontinence.
3. Refractory will be defined as failure of 2 prior treatments, including behavioral modification, pelvic floor physical therapy, and OAB medication (anticholinergics or mirabegron). Trial of 2 medications that did not improve symptoms after 2 weeks or could not be tolerated due to side effects will constitute 2 treatment failures.
4. Women with mixed urinary incontinence that is urge predominant will also be included.
5. Age ≥ 18 years
6. English speaking
7. Available for 1 year follow-up
8. Able to complete study questionnaires

Exclusion Criteria

1. Neurologic disease known to cause OAB including, but not limited to, Multiple sclerosis, Parkinson's disease, and Spinal Cord Injury.
2. Pregnancy by self-report or pregnancy test
3. Contraindication to PTNS and/or BTX

* PTNS: Pacemaker
* BTX: myasthenia gravis, allergy to BTX, urinary retention (post void residual \>200cc)
4. Planned surgery for pelvic floor disorder during the study period
5. Prior treatment with BTX, PTNS, or sacral nerve stimulation (SNS) for refractory OAB/urinary urge incontinence (UUI)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role collaborator

Methodist Urology Associates, Houston, Texas

UNKNOWN

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role collaborator

University of New Mexico

OTHER

Sponsor Role collaborator

Medstar Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Robert Gutman

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

Columbia University

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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2014-277

Identifier Type: -

Identifier Source: org_study_id