Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04451382
Study type Observational
Source Medstar Health Research Institute
Contact
Status Terminated
Phase
Start date March 2015
Completion date December 2018

See also
  Status Clinical Trial Phase
Completed NCT00507169 - SVT-40776 in Patients Suffering From Overactive Bladder Syndrome Phase 2
Completed NCT02216214 - Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB) Phase 4
Completed NCT02294396 - Postmarketing Study to Evaluate add-on Therapy With Anticholinergics in Patients With Overactive Bladder (OAB) on Mirabegron. Phase 4
Completed NCT01936870 - Drug Use Investigation for Toviaz
Completed NCT03846895 - Vaginal CO2 Laser in Postmenopausal Women With Overactive Bladder Syndrome (OAB) N/A
Completed NCT03903094 - A Study on Anticholinergic Use: Attribution of Overactive Bladder (OAB) Medications to the Anticholinergic Burden
Terminated NCT04641975 - A Study to Evaluate Mirabegron in Pediatric Participants From 5 to Less Than 18 Years of Age With Overactive Bladder (OAB) Phase 3
Completed NCT00366002 - Patient's Perception of Treatment Outcome With Darifenacin by Patients With Overactive Bladder Phase 4
Completed NCT02138747 - A Study to Evaluate Tolerability and Participants Preference Between Mirabegron and Tolterodine Extended Release (ER) in Participants With Overactive Bladder (OAB) Phase 4
Completed NCT03602508 - Treatment Persistence Among Patients With Overactive Bladder: A Retrospective Secondary Data Analysis in Asia Oceania
Completed NCT03572231 - A Registry Study of Patients Initiating a Course of Drug Therapy for Overactive Bladder in Taiwan, Korea and China
Completed NCT05211193 - Open Label Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous URIS I in the Treatment of Overactive Bladder (OAB).
Completed NCT04562090 - A Study With Mirabegron 50 mg and 25 mg in Chinese Participants With Overactive Bladder Phase 4
Completed NCT00282932 - Detrol LA In Men With Overactive Bladder. Phase 4
Completed NCT01639794 - Vesitirimâ„¢ in Men Postmarketing Observational Study N/A
Completed NCT00742833 - A Phase II Study of KUC-7483 in Patients With Overactive Bladder Phase 2
Withdrawn NCT01317810 - A Study Measuring and Tracking Changes in Overactive Bladder (OAB) Medication N/A