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PTNS vs Botox of Refractory OAB

NCT04451382 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2020-06-30

No results posted yet for this study

Summary

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.

Conditions

  • Overactive Bladder (OAB)

Interventions

BIOLOGICAL

OnabotulinumtoxinA (BoNTA)

PROCEDURE

Percutaneous tibial nerve stimulation (PTNS)

Sponsors & Collaborators

  • University of Michigan

    collaborator OTHER

  • Methodist Urology Associates, Houston, Texas

    collaborator UNKNOWN

  • Columbia University

    collaborator OTHER

  • University of New Mexico

    collaborator OTHER

  • Medstar Health Research Institute

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04451382 on ClinicalTrials.gov