Trial Outcomes & Findings for Comparison of Methods for Prevention of Urinary Tract Infection Following Botox Injection (NCT NCT03508921)
NCT ID: NCT03508921
Last Updated: 2023-11-02
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
22 participants
Primary outcome timeframe
3 weeks post-injection
Results posted on
2023-11-02
Participant Flow
Enrollment halted
22 participants were randomized. Data is reported only for the 17 participants who fully completed both injections and all follow-up visits.
Participant milestones
| Measure |
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:
* Periprocedural Antibiotics Only: At Visit 1, patients will receive a single dose of trimethoprim/sulfamethoxazole (800/160mg) peri-procedurally
* Extended antibiotics: At Visit 2, patients will receive one dose of trimethoprim/sulfamethoxazole periprocedurally 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
|
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:
* Extended antibiotics: At Visit 1, patients will receive one dose of trimethoprim/sulfamethoxazole periprocedurally 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
* Periprocedural Antibiotics Only: At Visit 2, patients will receive a single dose of trimethoprim/sulfamethoxazole (800/160mg) peri-procedurally
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
12
|
|
Overall Study
COMPLETED
|
6
|
11
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Methods for Prevention of Urinary Tract Infection Following Botox Injection
Baseline characteristics by cohort
| Measure |
Periprocedural Antibiotics Only, Then Extended Antibiotics
n=6 Participants
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:
* Periprocedural Antibiotics Only: At Visit 1, patients will receive a single dose of trimethoprim/sulfamethoxazole (800/160mg) peri-procedurally
* Extended antibiotics: At Visit 2, patients will receive one dose of trimethoprim/sulfamethoxazole periprocedurally 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
|
Extended Antibiotics, Then Periprocedural Antibiotics Only
n=11 Participants
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:
* Extended antibiotics: At Visit 1, patients will receive one dose of trimethoprim/sulfamethoxazole periprocedurally 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
* Periprocedural Antibiotics Only: At Visit 2, patients will receive a single dose of trimethoprim/sulfamethoxazole (800/160mg) peri-procedurally
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
11 participants
n=7 Participants
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 weeks post-injectionPopulation: Data is reported only for the 17 participants who fully completed both injections and all follow-up visits.
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.
Outcome measures
| Measure |
Periprocedural Antibiotics Only, Then Extended Antibiotics
n=6 Participants
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:
* Periprocedural Antibiotics Only: At Visit 1, patients will receive a single dose of trimethoprim/sulfamethoxazole (800/160mg) peri-procedurally
* Extended antibiotics: At Visit 2, patients will receive one dose of trimethoprim/sulfamethoxazole periprocedurally 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
|
Extended Antibiotics, Then Periprocedural Antibiotics Only
n=11 Participants
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:
* Extended antibiotics: At Visit 1, patients will receive one dose of trimethoprim/sulfamethoxazole periprocedurally 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
* Periprocedural Antibiotics Only: At Visit 2, patients will receive a single dose of trimethoprim/sulfamethoxazole (800/160mg) peri-procedurally
|
|---|---|---|
|
Post Procedural- Urinary Tract Infection
Visit 1: 3 weeks post-injection
|
0 participants
|
1 participants
|
|
Post Procedural- Urinary Tract Infection
Visit 2: 3 weeks post-injection
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 3 weeks post-injectionPopulation: Data is reported only for the 17 participants who fully completed both injections and all follow-up visits.
Number of participants with urinary retention \> 250 cc post-procedurally as measured by post void residual volume using a bladder scanner in clinic.
Outcome measures
| Measure |
Periprocedural Antibiotics Only, Then Extended Antibiotics
n=6 Participants
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:
* Periprocedural Antibiotics Only: At Visit 1, patients will receive a single dose of trimethoprim/sulfamethoxazole (800/160mg) peri-procedurally
* Extended antibiotics: At Visit 2, patients will receive one dose of trimethoprim/sulfamethoxazole periprocedurally 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
|
Extended Antibiotics, Then Periprocedural Antibiotics Only
n=11 Participants
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:
* Extended antibiotics: At Visit 1, patients will receive one dose of trimethoprim/sulfamethoxazole periprocedurally 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
* Periprocedural Antibiotics Only: At Visit 2, patients will receive a single dose of trimethoprim/sulfamethoxazole (800/160mg) peri-procedurally
|
|---|---|---|
|
Urinary Retention
Visit 1: 3 weeks post-injection
|
1 participants
|
3 participants
|
|
Urinary Retention
Visit 2: 3 weeks post-injection
|
0 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 3 weeks post injectionPopulation: Data is reported only for the 17 participants who fully completed both injections and all follow-up visits.
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.
Outcome measures
| Measure |
Periprocedural Antibiotics Only, Then Extended Antibiotics
n=6 Participants
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:
* Periprocedural Antibiotics Only: At Visit 1, patients will receive a single dose of trimethoprim/sulfamethoxazole (800/160mg) peri-procedurally
* Extended antibiotics: At Visit 2, patients will receive one dose of trimethoprim/sulfamethoxazole periprocedurally 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
|
Extended Antibiotics, Then Periprocedural Antibiotics Only
n=11 Participants
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:
* Extended antibiotics: At Visit 1, patients will receive one dose of trimethoprim/sulfamethoxazole periprocedurally 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
* Periprocedural Antibiotics Only: At Visit 2, patients will receive a single dose of trimethoprim/sulfamethoxazole (800/160mg) peri-procedurally
|
|---|---|---|
|
Recurrent Urinary Tract Infection
Visit 1: 3 weeks post-injection
|
0 participants
|
0 participants
|
|
Recurrent Urinary Tract Infection
Visit 2: 3 weeks post-injection
|
0 participants
|
0 participants
|
Adverse Events
Periprocedural Antibiotics Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Extended Antibiotics
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Melissa Kaufman, MD, PhD Professor of Urology
Vanderbilt Medical Center
Phone: 615-322-3807
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place