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Early termination due to recruitment and follow-up challenges during the pandemic
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| Name | Class |
|---|---|
| The Allergan Foundation | OTHER |
| Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction | OTHER |
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Injection of OnabotulinumtoxinA (BTX-A) into the bladder is a widely used treatment option for patients with overactive bladder who have failed medical therapy. Urinary tract infection is the most common side effect of this procedure and therefore antibiotics are given around the time of injection in order to prevent these events. While antibiotics are commonly given at the time of injection, the duration of these antibiotic regimens are variable. The investigators propose a study to investigate different antibiotic protocols and their affect on the rate of urinary tract infection after injection.
Intravesical injection of OnabotulinumtoxinA (BTX-A) is a widely practiced third line therapy for non-neurogenic overactive bladder (OAB). However, a paucity of data exists regarding urinary tract infections (UTI), the most common adverse event following injection. The investigators propose a randomized, controlled cross-over trial to investigate the utility of commonly practiced antibiotic protocols and simultaneously derive information regarding risk factors for post-procedural UTIs and their affect on treatment efficacy.
The investigators plan to initiate a prospective, randomized non-inferiority cross-over trial, in which a participant receives peri-procedural antibiotics exclusively at the time of one injection, and then at a subsequent injection, completes a three-day course of antibiotics post-operatively in addition to the peri-procedural dose. Enrollment is planned to achieve a total of 68 participants. Participants will be evaluated at 3 weeks and 3 months following injection to identify adverse events and treatment success. Inter-injection time will be measured and used a surrogate for efficacy over multiple injections.
These results, in addition to filling a void in current literature regarding the increasingly utilized treatment with BTX-A, have the potential to modify clinical practice regarding antibiotic use and decrease rates of adverse events. The means to stratify patients based on their specific risk of UTI may be used to facilitate antibiotic stewardship and improve patient outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Periprocedural Antibiotics Only | Experimental | Patients receive a one-time dose of antibiotics at the time of injection, prior to injection. |
|
| Extended Antibiotics | Experimental | Patients receive a peri-procedural dose of antibiotics and an extended (3-day) course of antibiotics to be taken post-procedurally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Periprocedural Antibiotics | Drug | One the day of injection, after eligibility is determined and consent obtained, research staff will refer to the randomization list to determine to which arm the patient is randomized. Patients randomized to the "Procedural Antibiotics Only" arm will receive a single dose of trimethoprim/sulfamethoxazole (800/160mg) peri-procedurally at the time of the first injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Post Procedural- Urinary Tract Infection | Number of participants with post procedural- urinary tract infection 3 weeks after injections, measured by a urine culture and defined as a urine culture with >10^5 bacterial colonies in the setting of urinary symptoms. | 3 weeks post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Retention | Number of participants with urinary retention > 250 cc post-procedurally as measured by post void residual volume using a bladder scanner in clinic. | 3 weeks post-injection |
| Recurrent Urinary Tract Infection |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Kaufman, MD, PhD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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22 participants were randomized. Data is reported only for the 17 participants who fully completed both injections and all follow-up visits.
Enrollment halted
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| ID | Title | Description |
|---|---|---|
| FG000 | Periprocedural Antibiotics Only, Then Extended Antibiotics | All patients will undergo an intravesical injection of OnabotulinumtoxinA (Botox ®, BTX-A) per a standardized protocol of 1ml injection per site at a concentration of 10 units/ml at Visit 1 and a second injection at Visit 2. Participants will also receive:
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| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 6, 2018 |
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| Extended Antibiotics | Drug | Patients randomized to the "Extended Antibiotics" arm will receive one dose of trimethoprim/sulfamethoxazole peri-procedurally and additionally be prescribed trimethoprim/sulfamethoxazole twice daily for three days. Patients who are allergic will receive amoxicillin/clavulanic acid (875/125mg) twice daily for three days. If allergic to both of the above antibiotics, patients will receive 100mg nitrofurantoin BID for three days. For their second injection, they will receive peri-procedural antibiotics only. |
|
|
| Injection of OnabotulinumtoxinA (BTX-A) | Procedure | Patients will receive injection of OnabotulinumtoxinA (BTX-A) per standard clinic practice protocol. All patients will undergo injection per a standardized protocol of 1ml injection per site at a concentration of 10 units/ml. |
|
Number of participants with 3 or greater post procedural- urinary tract infection after injections, measured by a urine culture and defined as a urine culture with >10^5 bacterial colonies in the setting of urinary symptoms.
| 3 weeks post injection |
| FG001 | Extended Antibiotics, Then Periprocedural Antibiotics Only | All patients will undergo an intravesical injection of OnabotulinumtoxinA (Botox ®, BTX-A) per a standardized protocol of 1ml injection per site at a concentration of 10 units/ml at Visit 1 and a second injection at Visit 2. Participants will also receive:
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| COMPLETED |
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| NOT COMPLETED |
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22 participants were randomized. Data is reported only for the 17 participants who fully completed both injections and all follow-up visits.
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| ID | Title | Description |
|---|---|---|
| BG000 | Periprocedural Antibiotics Only, Then Extended Antibiotics | All patients will undergo an intravesical injection of OnabotulinumtoxinA (Botox ®, BTX-A) per a standardized protocol of 1ml injection per site at a concentration of 10 units/ml at Visit 1 and a second injection at visit 2. Participants will also receive:
|
| BG001 | Extended Antibiotics, Then Periprocedural Antibiotics Only | All patients will undergo an intravesical injection of OnabotulinumtoxinA (Botox ®, BTX-A) per a standardized protocol of 1ml injection per site at a concentration of 10 units/ml at Visit 1 and a second injection at visit 2. Participants will also receive:
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| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post Procedural- Urinary Tract Infection | Number of participants with post procedural- urinary tract infection 3 weeks after injections, measured by a urine culture and defined as a urine culture with >10^5 bacterial colonies in the setting of urinary symptoms. | Data is reported only for the 17 participants who fully completed both injections and all follow-up visits. | Posted | Number | participants | 3 weeks post-injection |
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| Secondary | Urinary Retention | Number of participants with urinary retention > 250 cc post-procedurally as measured by post void residual volume using a bladder scanner in clinic. | Data is reported only for the 17 participants who fully completed both injections and all follow-up visits. | Posted | Number | participants | 3 weeks post-injection |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Recurrent Urinary Tract Infection | Number of participants with 3 or greater post procedural- urinary tract infection after injections, measured by a urine culture and defined as a urine culture with >10^5 bacterial colonies in the setting of urinary symptoms. | Data is reported only for the 17 participants who fully completed both injections and all follow-up visits. | Posted | Number | participants | 3 weeks post injection |
|
3 months following second injection, 6 month total time frame from randomization
Data is reported only for the 17 participants who fully completed both injections and all follow-up visits.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Periprocedural Antibiotics Only | Patients who received a single dose of trimethoprim/sulfamethoxazole (800/160mg) peri-procedurally. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG001 | Extended Antibiotics | Patients who received one dose of trimethoprim/sulfamethoxazole periprocedurally and additionally were prescribed trimethoprim/sulfamethoxazole twice daily for three days. Patients who are allergic received amoxicillin/clavulanic acid (875/125mg) twice daily for three days. If allergic to both of the above antibiotics, patients received 100mg nitrofurantoin BID for three days. | 0 | 17 | 0 | 17 | 0 | 17 |
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Early termination due to recruitment and follow-up challenges during the pandemic resulting in failure to accrue statistically significant sample size.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Kaufman, MD, PhD Professor of Urology | Vanderbilt Medical Center | 615-322-3807 | melissa.kaufman@vumc.org |
| Jul 26, 2023 |
| Prot_SAP_003.pdf |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D014552 | Urinary Tract Infections |
| 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 |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D015662 | Trimethoprim, Sulfamethoxazole Drug Combination |
| ID | Term |
|---|---|
| D013420 | Sulfamethoxazole |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D014295 | Trimethoprim |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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