Trial Outcomes & Findings for Prophylactic Antibiotic Administration for Bladder OnabotulinumtoxinA Injection (NCT NCT05719285)

NCT ID: NCT05719285

Last Updated: 2024-01-02

Results Overview

To assess this aim, the rate of postoperative urinary tract infection (UTI) within 4 weeks following bladder onabotulinumtoxinA injection will be compared between groups. Noninferiority will be declared if the incidence of UTI in the single dose group is not more than UTI incidence in the multiple dose group within statistical variability, by the prespecified noninferiority margin.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

4 weeks

Results posted on

2024-01-02

Participant Flow

Participant milestones

Participant milestones
Measure	1: Single-Dose Antibiotic Prophylaxis Patients will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection. Single-Dose Antibiotic: Allergy, prior urine culture resistance or another contraindication to first line antibiotic will result in the patient being prescribed second line antibiotic and so forth. First line: Arm 1: trimethoprim / sulfamethoxazole 800/160 mg once pre-procedure Second line: Arm 1: cefalexin 500 mg once pre-procedure Third line: Arm 1: nitrofurantoin 100 mg once pre-procedure Fourth line: Arm 1: ciprofloxacin 500 mg once pre-procedure	2: Multi-Dose Antibiotic Prophylaxis Patients will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection. The same antibiotic will be continued for 3 days of total antibiotic administration with additional doses prescribed to the patient's pharmacy. Multi-Dose Antibiotic: Allergy, prior urine culture resistance or another contraindication to first line antibiotic will result in the patient being prescribed second line antibiotic and so forth. First line: Arm 2: trimethoprim / sulfamethoxazole 800/160 mg once pre-procedure plus 800/160 mg every twelve hours for 6 total doses Second line: Arm 2: cefalexin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses Third line: Arm 2: nitrofurantoin 100 mg once pre-procedure plus 100 mg every twelve hours for 6 total doses Fourth line: Arm 2: ciprofloxacin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1: Single-Dose Antibiotic Prophylaxis n=50 Participants Patients will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection. Single-Dose Antibiotic: Allergy, prior urine culture resistance or another contraindication to first line antibiotic will result in the patient being prescribed second line antibiotic and so forth. First line: Arm 1: trimethoprim / sulfamethoxazole 800/160 mg once pre-procedure Second line: Arm 1: cefalexin 500 mg once pre-procedure Third line: Arm 1: nitrofurantoin 100 mg once pre-procedure Fourth line: Arm 1: ciprofloxacin 500 mg once pre-procedure	2: Multi-Dose Antibiotic Prophylaxis n=50 Participants Patients will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection. The same antibiotic will be continued for 3 days of total antibiotic administration with additional doses prescribed to the patient's pharmacy. Multi-Dose Antibiotic: Allergy, prior urine culture resistance or another contraindication to first line antibiotic will result in the patient being prescribed second line antibiotic and so forth. First line: Arm 2: trimethoprim / sulfamethoxazole 800/160 mg once pre-procedure plus 800/160 mg every twelve hours for 6 total doses Second line: Arm 2: cefalexin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses Third line: Arm 2: nitrofurantoin 100 mg once pre-procedure plus 100 mg every twelve hours for 6 total doses Fourth line: Arm 2: ciprofloxacin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses	Total n=100 Participants Total of all reporting groups
Age, Continuous	69.42 years n=50 Participants	64.62 years n=50 Participants	67.02 years n=100 Participants
Sex: Female, Male Female	46 Participants n=50 Participants	50 Participants n=50 Participants	96 Participants n=100 Participants
Sex: Female, Male Male	4 Participants n=50 Participants	0 Participants n=50 Participants	4 Participants n=100 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	50 participants n=50 Participants	50 participants n=50 Participants	100 participants n=100 Participants
Body Mass Index (BMI)	32.26 kg/m^2 n=50 Participants	34.14 kg/m^2 n=50 Participants	33.20 kg/m^2 n=100 Participants
Current Anti-Cholinergic Use	7 participants n=50 Participants	7 participants n=50 Participants	14 participants n=100 Participants
Prior Anti-Cholinergic Use	41 participants n=50 Participants	41 participants n=50 Participants	82 participants n=100 Participants
Current Beta-3 Agonist Use	6 participants n=50 Participants	7 participants n=50 Participants	13 participants n=100 Participants
Prior Beta-3 Agonist Use	24 participants n=50 Participants	22 participants n=50 Participants	46 participants n=100 Participants
Current Posterior Tibial Nerve Stimulation (PTNS) Use	0 participants n=50 Participants	0 participants n=50 Participants	0 participants n=100 Participants
Prior Posterior Tibial Nerve Stimulation (PTNS) Use	3 participants n=50 Participants	1 participants n=50 Participants	4 participants n=100 Participants
Current Sacral Neuromodulation Use	4 participants n=50 Participants	4 participants n=50 Participants	8 participants n=100 Participants
Prior Sacral Neuromodulation Use	4 participants n=50 Participants	5 participants n=50 Participants	9 participants n=100 Participants
Previous Bladder Botox	39 participants n=50 Participants	38 participants n=50 Participants	77 participants n=100 Participants
Neurogenic Bladder	2 participants n=50 Participants	1 participants n=50 Participants	3 participants n=100 Participants
Current Vaginal Estrogen use	4 participants n=46 Participants • Vaginal estrogen status is only assessed in female patients	8 participants n=50 Participants • Vaginal estrogen status is only assessed in female patients	12 participants n=96 Participants • Vaginal estrogen status is only assessed in female patients
Diabetes Mellitus	14 Participants n=50 Participants	13 Participants n=50 Participants	27 Participants n=100 Participants
Current Tobacco Use	6 participants n=50 Participants	4 participants n=50 Participants	10 participants n=100 Participants
Sleep Apnea	22 participants n=50 Participants	10 participants n=50 Participants	32 participants n=100 Participants

PRIMARY outcome

Timeframe: 4 weeks

Outcome measures

Outcome measures
Measure	1: Single-Dose Antibiotic Prophylaxis n=50 Participants Patients will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection. Single-Dose Antibiotic: Allergy, prior urine culture resistance or another contraindication to first line antibiotic will result in the patient being prescribed second line antibiotic and so forth. First line: Arm 1: trimethoprim / sulfamethoxazole 800/160 mg once pre-procedure Second line: Arm 1: cefalexin 500 mg once pre-procedure Third line: Arm 1: nitrofurantoin 100 mg once pre-procedure Fourth line: Arm 1: ciprofloxacin 500 mg once pre-procedure	2: Multi-Dose Antibiotic Prophylaxis n=50 Participants Patients will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection. The same antibiotic will be continued for 3 days of total antibiotic administration with additional doses prescribed to the patient's pharmacy. Multi-Dose Antibiotic: Allergy, prior urine culture resistance or another contraindication to first line antibiotic will result in the patient being prescribed second line antibiotic and so forth. First line: Arm 2: trimethoprim / sulfamethoxazole 800/160 mg once pre-procedure plus 800/160 mg every twelve hours for 6 total doses Second line: Arm 2: cefalexin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses Third line: Arm 2: nitrofurantoin 100 mg once pre-procedure plus 100 mg every twelve hours for 6 total doses Fourth line: Arm 2: ciprofloxacin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses
Establish Noninferiority of the Single Dose Antibiotic Administration to the Multi-dose Antibiotic Administration.	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 4 weeks

Summarize rates of adverse events related to antibiotics in each group.

Outcome measures

Outcome measures
Measure	1: Single-Dose Antibiotic Prophylaxis n=50 Participants Patients will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection. Single-Dose Antibiotic: Allergy, prior urine culture resistance or another contraindication to first line antibiotic will result in the patient being prescribed second line antibiotic and so forth. First line: Arm 1: trimethoprim / sulfamethoxazole 800/160 mg once pre-procedure Second line: Arm 1: cefalexin 500 mg once pre-procedure Third line: Arm 1: nitrofurantoin 100 mg once pre-procedure Fourth line: Arm 1: ciprofloxacin 500 mg once pre-procedure	2: Multi-Dose Antibiotic Prophylaxis n=5 Participants Patients will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection. The same antibiotic will be continued for 3 days of total antibiotic administration with additional doses prescribed to the patient's pharmacy. Multi-Dose Antibiotic: Allergy, prior urine culture resistance or another contraindication to first line antibiotic will result in the patient being prescribed second line antibiotic and so forth. First line: Arm 2: trimethoprim / sulfamethoxazole 800/160 mg once pre-procedure plus 800/160 mg every twelve hours for 6 total doses Second line: Arm 2: cefalexin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses Third line: Arm 2: nitrofurantoin 100 mg once pre-procedure plus 100 mg every twelve hours for 6 total doses Fourth line: Arm 2: ciprofloxacin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses
Antibiotic Adverse Events	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 4 weeks

Estimate the rate of symptomatic urinary retention requiring catheterization among refractory overactive bladder patients who experience a UTI.

Outcome measures

Outcome measures
Measure	1: Single-Dose Antibiotic Prophylaxis n=50 Participants Patients will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection. Single-Dose Antibiotic: Allergy, prior urine culture resistance or another contraindication to first line antibiotic will result in the patient being prescribed second line antibiotic and so forth. First line: Arm 1: trimethoprim / sulfamethoxazole 800/160 mg once pre-procedure Second line: Arm 1: cefalexin 500 mg once pre-procedure Third line: Arm 1: nitrofurantoin 100 mg once pre-procedure Fourth line: Arm 1: ciprofloxacin 500 mg once pre-procedure	2: Multi-Dose Antibiotic Prophylaxis n=50 Participants Patients will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection. The same antibiotic will be continued for 3 days of total antibiotic administration with additional doses prescribed to the patient's pharmacy. Multi-Dose Antibiotic: Allergy, prior urine culture resistance or another contraindication to first line antibiotic will result in the patient being prescribed second line antibiotic and so forth. First line: Arm 2: trimethoprim / sulfamethoxazole 800/160 mg once pre-procedure plus 800/160 mg every twelve hours for 6 total doses Second line: Arm 2: cefalexin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses Third line: Arm 2: nitrofurantoin 100 mg once pre-procedure plus 100 mg every twelve hours for 6 total doses Fourth line: Arm 2: ciprofloxacin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses
Symptomatic Urinary Retention	0 Participants	1 Participants

Adverse Events

1: Single-Dose Antibiotic Prophylaxis

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

2: Multi-Dose Antibiotic Prophylaxis

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	1: Single-Dose Antibiotic Prophylaxis n=50 participants at risk Patients will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection. Single-Dose Antibiotic: Allergy, prior urine culture resistance or another contraindication to first line antibiotic will result in the patient being prescribed second line antibiotic and so forth. First line: Arm 1: trimethoprim / sulfamethoxazole 800/160 mg once pre-procedure Second line: Arm 1: cefalexin 500 mg once pre-procedure Third line: Arm 1: nitrofurantoin 100 mg once pre-procedure Fourth line: Arm 1: ciprofloxacin 500 mg once pre-procedure	2: Multi-Dose Antibiotic Prophylaxis n=50 participants at risk Patients will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection. The same antibiotic will be continued for 3 days of total antibiotic administration with additional doses prescribed to the patient's pharmacy. Multi-Dose Antibiotic: Allergy, prior urine culture resistance or another contraindication to first line antibiotic will result in the patient being prescribed second line antibiotic and so forth. First line: Arm 2: trimethoprim / sulfamethoxazole 800/160 mg once pre-procedure plus 800/160 mg every twelve hours for 6 total doses Second line: Arm 2: cefalexin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses Third line: Arm 2: nitrofurantoin 100 mg once pre-procedure plus 100 mg every twelve hours for 6 total doses Fourth line: Arm 2: ciprofloxacin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses
Infections and infestations Cellulitis	0.00% 0/50 • 6 months Patients will be instructed to report symptomatic UTIs, urinary retention, or any other adverse events related to onabotulinumtoxinA or antibiotic to investigators. At 4 weeks study investigators will contact the patient by phone to evaluate for any UTIs or adverse events not previously reported by the patient during the study period. Chart review will occur in 4 weeks to assess any unreported events.	2.0% 1/50 • Number of events 1 • 6 months Patients will be instructed to report symptomatic UTIs, urinary retention, or any other adverse events related to onabotulinumtoxinA or antibiotic to investigators. At 4 weeks study investigators will contact the patient by phone to evaluate for any UTIs or adverse events not previously reported by the patient during the study period. Chart review will occur in 4 weeks to assess any unreported events.

Other adverse events

Other adverse events
Measure	1: Single-Dose Antibiotic Prophylaxis n=50 participants at risk Patients will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection. Single-Dose Antibiotic: Allergy, prior urine culture resistance or another contraindication to first line antibiotic will result in the patient being prescribed second line antibiotic and so forth. First line: Arm 1: trimethoprim / sulfamethoxazole 800/160 mg once pre-procedure Second line: Arm 1: cefalexin 500 mg once pre-procedure Third line: Arm 1: nitrofurantoin 100 mg once pre-procedure Fourth line: Arm 1: ciprofloxacin 500 mg once pre-procedure	2: Multi-Dose Antibiotic Prophylaxis n=50 participants at risk Patients will receive one dose of antibiotic prior to bladder onabotulinumtoxinA injection. The same antibiotic will be continued for 3 days of total antibiotic administration with additional doses prescribed to the patient's pharmacy. Multi-Dose Antibiotic: Allergy, prior urine culture resistance or another contraindication to first line antibiotic will result in the patient being prescribed second line antibiotic and so forth. First line: Arm 2: trimethoprim / sulfamethoxazole 800/160 mg once pre-procedure plus 800/160 mg every twelve hours for 6 total doses Second line: Arm 2: cefalexin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses Third line: Arm 2: nitrofurantoin 100 mg once pre-procedure plus 100 mg every twelve hours for 6 total doses Fourth line: Arm 2: ciprofloxacin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses
Infections and infestations Bronchial Infection	2.0% 1/50 • Number of events 1 • 6 months Patients will be instructed to report symptomatic UTIs, urinary retention, or any other adverse events related to onabotulinumtoxinA or antibiotic to investigators. At 4 weeks study investigators will contact the patient by phone to evaluate for any UTIs or adverse events not previously reported by the patient during the study period. Chart review will occur in 4 weeks to assess any unreported events.	0.00% 0/50 • 6 months Patients will be instructed to report symptomatic UTIs, urinary retention, or any other adverse events related to onabotulinumtoxinA or antibiotic to investigators. At 4 weeks study investigators will contact the patient by phone to evaluate for any UTIs or adverse events not previously reported by the patient during the study period. Chart review will occur in 4 weeks to assess any unreported events.
Renal and urinary disorders Cystitis noninfective	4.0% 2/50 • Number of events 2 • 6 months Patients will be instructed to report symptomatic UTIs, urinary retention, or any other adverse events related to onabotulinumtoxinA or antibiotic to investigators. At 4 weeks study investigators will contact the patient by phone to evaluate for any UTIs or adverse events not previously reported by the patient during the study period. Chart review will occur in 4 weeks to assess any unreported events.	2.0% 1/50 • Number of events 1 • 6 months Patients will be instructed to report symptomatic UTIs, urinary retention, or any other adverse events related to onabotulinumtoxinA or antibiotic to investigators. At 4 weeks study investigators will contact the patient by phone to evaluate for any UTIs or adverse events not previously reported by the patient during the study period. Chart review will occur in 4 weeks to assess any unreported events.
Renal and urinary disorders Hematuria	0.00% 0/50 • 6 months Patients will be instructed to report symptomatic UTIs, urinary retention, or any other adverse events related to onabotulinumtoxinA or antibiotic to investigators. At 4 weeks study investigators will contact the patient by phone to evaluate for any UTIs or adverse events not previously reported by the patient during the study period. Chart review will occur in 4 weeks to assess any unreported events.	2.0% 1/50 • Number of events 1 • 6 months Patients will be instructed to report symptomatic UTIs, urinary retention, or any other adverse events related to onabotulinumtoxinA or antibiotic to investigators. At 4 weeks study investigators will contact the patient by phone to evaluate for any UTIs or adverse events not previously reported by the patient during the study period. Chart review will occur in 4 weeks to assess any unreported events.
Renal and urinary disorders Urinary Retention	4.0% 2/50 • Number of events 2 • 6 months Patients will be instructed to report symptomatic UTIs, urinary retention, or any other adverse events related to onabotulinumtoxinA or antibiotic to investigators. At 4 weeks study investigators will contact the patient by phone to evaluate for any UTIs or adverse events not previously reported by the patient during the study period. Chart review will occur in 4 weeks to assess any unreported events.	2.0% 1/50 • Number of events 1 • 6 months Patients will be instructed to report symptomatic UTIs, urinary retention, or any other adverse events related to onabotulinumtoxinA or antibiotic to investigators. At 4 weeks study investigators will contact the patient by phone to evaluate for any UTIs or adverse events not previously reported by the patient during the study period. Chart review will occur in 4 weeks to assess any unreported events.
Renal and urinary disorders Urinary Tract Infection	2.0% 1/50 • Number of events 1 • 6 months Patients will be instructed to report symptomatic UTIs, urinary retention, or any other adverse events related to onabotulinumtoxinA or antibiotic to investigators. At 4 weeks study investigators will contact the patient by phone to evaluate for any UTIs or adverse events not previously reported by the patient during the study period. Chart review will occur in 4 weeks to assess any unreported events.	4.0% 2/50 • Number of events 2 • 6 months Patients will be instructed to report symptomatic UTIs, urinary retention, or any other adverse events related to onabotulinumtoxinA or antibiotic to investigators. At 4 weeks study investigators will contact the patient by phone to evaluate for any UTIs or adverse events not previously reported by the patient during the study period. Chart review will occur in 4 weeks to assess any unreported events.
Renal and urinary disorders Urinary Tract Obstruction	0.00% 0/50 • 6 months Patients will be instructed to report symptomatic UTIs, urinary retention, or any other adverse events related to onabotulinumtoxinA or antibiotic to investigators. At 4 weeks study investigators will contact the patient by phone to evaluate for any UTIs or adverse events not previously reported by the patient during the study period. Chart review will occur in 4 weeks to assess any unreported events.	2.0% 1/50 • Number of events 1 • 6 months Patients will be instructed to report symptomatic UTIs, urinary retention, or any other adverse events related to onabotulinumtoxinA or antibiotic to investigators. At 4 weeks study investigators will contact the patient by phone to evaluate for any UTIs or adverse events not previously reported by the patient during the study period. Chart review will occur in 4 weeks to assess any unreported events.
Infections and infestations Vaginal Infection	0.00% 0/46 • 6 months Patients will be instructed to report symptomatic UTIs, urinary retention, or any other adverse events related to onabotulinumtoxinA or antibiotic to investigators. At 4 weeks study investigators will contact the patient by phone to evaluate for any UTIs or adverse events not previously reported by the patient during the study period. Chart review will occur in 4 weeks to assess any unreported events.	2.0% 1/50 • Number of events 1 • 6 months Patients will be instructed to report symptomatic UTIs, urinary retention, or any other adverse events related to onabotulinumtoxinA or antibiotic to investigators. At 4 weeks study investigators will contact the patient by phone to evaluate for any UTIs or adverse events not previously reported by the patient during the study period. Chart review will occur in 4 weeks to assess any unreported events.

Additional Information

Dr. Lauren Gleich

Cleveland Clinic Foundation

Phone: 701-330-1669

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place