NCT04451382

PTNS vs Botox of Refractory OAB

Treatment of Refractory Overactive Bladder (OAB) With OnabotulinumtoxinA vs. PTNS: TROOP Trial

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Medstar Health Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

• Overactive Bladder (OAB)

Interventions

Type	Name	Description
BIOLOGICAL	OnabotulinumtoxinA (BoNTA)
PROCEDURE	Percutaneous tibial nerve stimulation (PTNS)

Timeline

• Start date: 2015-03-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2020-06-30
• Last updated: 2020-06-30

Locations

2 sites across 1 country: United States