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| Name | Class |
|---|---|
| Medstar Health Research Institute | OTHER |
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Currently, in clinical practice there has been no standardization in the number of injections a single dose of intradetrusor onabotulinumtoxin A is administered in. Given the increasing use of this treatment modality, the aim of this study is to compare outcomes for patients given a 100 unit dose of onabotulinumtoxin A split into 5 as compared to 20 injections for the treatment of overactive bladder or urgency urinary incontinence refractory to medical treatment.
The intradetrusor injection of onabotulinumtoxin A for treatment of idiopathic overactive bladder and urgency urinary incontinence refractory to anticholinergic or β-agonist treatment was approved by the United States Food and Drug Administration (FDA) in 2013. Since then, multiple randomized placebo-controlled trials have demonstrated the effectiveness of the treatment. Currently, Allergan, Inc. and the FDA recommend the intravesical administration of onabotulinumtoxin A with dilution to 100 units/10 mL with preservative-free 0.9% Sodium Chloride Injection, as 20 injections of 0.5 mL each. Currently, in clinical practice there has been no standardization in the number of intravesical injections, with a single dose of onabotulinumtoxin A being administered in as few as 1 injection to as many as 40 injections into the detrusor muscle. Given the increasing use of this treatment modality, the investigators aim to compare patient outcomes for patients given a 100 unit dose of onabotulinumtoxin A split into 5 as compared to the recommended 20 injections for the treatment of idiopathic overactive bladder or urgency urinary incontinence refractory to medical treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 Injections | Experimental | Participant's bladder is backfilled with 50 mL of 1% lidocaine for 15 minutes, then drained prior to procedure start. Dose of 100 units onabotulinumtoxin A with dilution to 100 Units/10 mL with preservative-free 0.9% Sodium Chloride Injection is prepared. Cystoscopy is performed. The 23 gauge Laborie InjeTAK needle is inserted 3 mm into the detrusor. 5 injections of 2 mL each (total volume of 10 mL) in a single procedure is performed 1 cm apart in the bladder body. For the final injection, approximately 1 mL of sterile normal saline should be injected such that the remaining onabotulinumtoxin A in the needle is delivered to the bladder. |
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| 20 Injections | Active Comparator | Participant's bladder is backfilled with 50 mL of 1% lidocaine for 15 minutes, then drained prior to procedure start. Dose of 100 units onabotulinumtoxin A with dilution to 100 Units/10 mL with preservative-free 0.9% Sodium Chloride Injection is prepared. Cystoscopy is performed. The 23 gauge Laborie InjeTAK needle is inserted 3 mm into the detrusor. 20 injections of 0.5 mL each (total volume of 10 mL) in a single procedure is performed 1 cm apart in the bladder body. For the final injection, approximately 1 mL of sterile normal saline should be injected such that the remaining onabotulinumtoxin A in the needle is delivered to the bladder. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OnabotulinumtoxinA 100 UNT | Drug | Intradetrusor onabotulinumtoxin A is administered cystoscopically with 100 unit dose given as either 5 or 20 injections in a single procedure based on the arm the participant is randomized into. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain from procedure: score | Pain score as rated on a 10-point visual analog scale within 5 minutes of procedure completion | Within 5 minutes of procedure completion |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of procedure | Total time of procedure defined as time cystoscope is introduced into the bladder to the time the cystoscope is removed from the bladder after completion of all injections | Procedure time |
| Positive treatment response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eric S Chang, MD | Contact | 813-259-8500 | ericchang@usf.edu | |
| Allison Wyman, MD | Contact | 813-259-8500 | awyman@usf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Eric S Chang, MD | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Washington Hospital Center | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35543540 | Derived | Chang ES, Ringel N, Woodburn KL, Tanner JP, Bassaly R, Greene K, Wyman A, Iglesia C. Postprocedural Pain Associated With 5 Versus 20 Intradetrusor Injections of onabotulinumtoxinA for Treatment of Overactive Bladder: A Multicenter Randomized Clinical Trial. Urogynecology (Phila). 2022 Aug 1;28(8):518-525. doi: 10.1097/SPV.0000000000001199. Epub 2022 May 12. |
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All statistical analyses will be performed at the University of South Florida. The investigators performing review of data and statistical analyses will not require the use of, or have access to any personally identifying patient information from either the primary or secondary site of the study.
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Single-blinded randomized controlled trial
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Participants are randomized into one of two treatment arms (receiving 5 versus 20 injections per treatment with intradetrusor onabotulinumtoxin A) and are not notified of which arm they are participating in.
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The percentage of patients with a positive treatment response based on answering a Global Response Assessment given 6 weeks after completion of procedure
| 6 weeks post-procedure |
| Urinary tract infections | Percentage of patients with culture-proven post-procedure urinary tract infections within 12 weeks of procedure | 12 weeks post-procedure |
| Urinary retention | Percentage of patients with post-procedure urinary retention requiring clean intermittent catheterization within 12 weeks of procedure | 12 weeks post-procedure |
| University of South Florida Health South Tampa Center for Advanced Healthcare | Recruiting | Tampa | Florida | 33606 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 19, 2022 | Mar 18, 2022 | 2 |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D053202 | Urinary Incontinence, Urge |
| D014549 | Urinary Incontinence |
| D053158 | Nocturia |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| 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 |
| D014555 | Urination Disorders |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| 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 |
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