Overactive Bladder (OAB)
Conditions
Brief 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.
Interventions
BIOLOGICALOnabotulinumtoxinA (BoNTA)
Sponsors
University of Michigan
Methodist Urology Associates, Houston, Texas
Columbia University
University of New Mexico
Medstar Health Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in patient global impression of improvement score between PTNS and BTX groups | 3 month | The Patient Global Impression of Improvement (PGI-I) is a single question that asks a patient to rate her urinary symptom response to treatment on a 7-point Likert scaleis a validated questionnaire for assessment of the impact of OAB on patient's lives. |
| Change in quality of life between PTNS and BTX groups | 3 month | The minimally important difference (MID) for change in SSS is 10 points. We compare the change in SS score between the PTNS and Botox groups at 3 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in individual question scores on OAB-q questionnaire | 3 | The OAB-q consists of 33 items: an 8-item symptom bother scale (SS) and a 25-item health-related quality of life (HRQL) scale. Higher scores on HRQL scale represent better quality of life and lower scores on SSS is indicative of less bother. |
| Change in urinary symptom severity | 3 | Tools used: Urogenital Distress Inventory short form (UDI-6) is a validated questionnaires used to assess urinary symptoms. We will compare change in scores between the 2 groups |
Countries
United States
Outcome results
None listed