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Low recruitment
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| Name | Class |
|---|---|
| University of Michigan | OTHER |
| Methodist Urology Associates, Houston, Texas | UNKNOWN |
| Columbia University | OTHER |
| University of New Mexico |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OnabotulinumtoxinA (BoNTA) | 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. |
| |
| Percutaneous tibial nerve stimulation (PTNS) | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OnabotulinumtoxinA (BoNTA) | Biological |
|
| |
| 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 |
| 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 |
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Inclusion Criteria:
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
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)
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Women with refractory OAB (dry or wet) who have failed 2 prior treatments, including behavioral modification, pelvic floor physical therapy, and/or OAB medication (antimuscarinics or mirabegron), and have chosen either BTX or PTNS as their next treatment.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States | ||
| Columbia University |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| OTHER |
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| Percutaneous tibial nerve stimulation (PTNS) |
| Procedure |
|
| 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 |
| New York |
| New York |
| 10032 |
| United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |