PTNS vs Botox of Refractory OAB

Study Overview
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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.

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

Conditions
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Overactive Bladder (OAB)

Intervention / Treatment
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* Biological: OnabotulinumtoxinA (BoNTA)
* Procedure: Percutaneous tibial nerve stimulation (PTNS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with refractory OAB (dry or wet) 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. 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. Women with mixed urinary incontinence that is urge predominant will also be included. Age ≥ 18 years English speaking Available for 1 year follow-up Able to complete study questionnaires Exclusion Criteria: Neurologic disease known to cause OAB including, but not limited to, Multiple sclerosis, Parkinson's disease, and Spinal Cord Injury. Pregnancy by self-report or pregnancy test Contraindication to PTNS and/or BTX PTNS: Pacemaker BTX: myasthenia gravis, allergy to BTX, urinary retention (post void residual >200cc) Planned surgery for pelvic floor disorder during the study period Prior treatment with BTX, PTNS, or sacral nerve stimulation (SNS) for refractory OAB/urinary urge incontinence (UUI)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OnabotulinumtoxinA (BoNTA)<br>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. | Biological: OnabotulinumtoxinA (BoNTA)<br> <br> * Other names: Botox;|
| Percutaneous tibial nerve stimulation (PTNS)<br>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. | Procedure: Percutaneous tibial nerve stimulation (PTNS)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in patient global impression of improvement score between PTNS and BTX groups | 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. | 3 month | 
| Change in quality of life between PTNS and BTX groups | 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. | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in individual question scores on OAB-q questionnaire | 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. | 3 | 
| Change in urinary symptom severity | 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 | 3 |