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Antibiotic Prophylaxis for Bladder Botox

Primary Purpose

Idiopathic Overactive Bladder, Postoperative Urinary Tract Infection

Status

Recruiting

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Ciprofloxacin

Placebo Pill

About this trial

This is an interventional treatment trial for Idiopathic Overactive Bladder focused on measuring prophylaxis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Patients with idiopathic OAB diagnosed clinically who have failed medical management
Female
Age ≥ 18

Exclusion Criteria:

Patients with neurogenic OAB (OAB with potential underlying neurologic cause - multiple sclerosis, spinal cord injury, Parkinson's disease, other)
Contraindication to injection of Botox - hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation, current urinary tract infection, symptomatic urinary retention or PVR > 200 mL, unwillingness or inability to initiate CIC post-treatment if required.
Contraindication to oral Ciprofloxacin - hypersensitivity or allergy to Ciprofloxacin or other fluoroquinolone, concurrently taking Tizanidine or Agomelatine.14
Active antibiotic therapy for any indication at the time of Botox injection - increased risk of adverse reaction with combining antibiotics, reduced risk of UTI with additional antibiotic.
Male
Age < 18
Pregnant and/or breastfeeding

Sites / Locations

Urogynecology Clinic - Royal Alexandra HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment Arm

Placebo Arm

Arm Description

Ciprofloxacin 500 mg PO every 12 hrs for 3 days following the procedure

Placebo pill PO every 12 hrs for 3 days following the procedure

Outcomes

Primary Outcome Measures

Rate of Postoperative Urinary Tract Infection

new or worsening symptoms (dysuria, hematuria, frequency, urgency, suprapubic/flank pain, fever) AND positive urine culture (>10^5 CFU/mL)

Secondary Outcome Measures

Rate of Postoperative Urinary Tract Infection Rate

new or worsening symptoms (dysuria, hematuria, frequency, urgency, suprapubic/flank pain, fever) AND positive urine culture (>10^5 CFU/mL)

Rate of Other Adverse Events

New onset of side effects possibly related to Ciprofloxacin (nausea/vomiting, headache, abdominal pain, constipation, diarrhea, other)

Full Information

NCT ID

NCT04444440

First Posted

June 19, 2020

Last Updated

January 31, 2023

Sponsor

University of Alberta

Collaborators

Women and Children's Health Research Institute, Canada

1. Study Identification

Unique Protocol Identification Number

NCT04444440

Brief Title

Antibiotic Prophylaxis for Bladder Botox

Official Title

Prophylactic Antibiotics During Treatment of Idiopathic Overactive Bladder With Intradetrusor onabotulinumtoxinA for the Reduction of Postoperative UTI: a Randomized Blinded Placebo-controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 6, 2021 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Alberta

Collaborators

Women and Children's Health Research Institute, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Injection of Botox into the bladder is a common treatment for overactive bladder. Postoperative bladder infection is one of the more frequently reported complications of this procedure. Prophylactic antibiotics given at the time of bladder Botox for the reduction of postoperative bladder infection have not been well studied. The main goal of our study is to determine if prophylactic antibiotics at the time of bladder Botox injection for the treatment of overactive bladder in women reduces postoperative bladder infection. The investigators are proposing a study which will randomize participants into two groups - one receiving Ciprofloxacin and the other receiving placebo pills for three days following the procedure. The primary outcome evaluated will be the difference in postoperative bladder infection between the two groups. The investigators will also investigate differences in reported side effects between the two groups possibly related to antibiotic use. Follow-up will be over six weeks following the procedure.

Detailed Description

This study will be a single-centred, double-blinded, randomized, placebo-controlled trial. Recruitment will be undertaken at two Urogynecology/Urology sites associated with the University of Alberta in Edmonton, Alberta. Participants will be randomized to treatment or placebo arm with a 1:1 allocation ratio. Patients and surgeons will be blinded. On the day of the procedure, a urine culture will be collected preoperatively to identify pre-existing bacteriuria. Technique and dose of Botox injection will be at the discretion of the operating physician. Trigone-sparing technique with injection of 100 to 200 units of Botox distributed across 10 to 20 sites is generally used at our centre. Follow-up will occur over a six-week postoperative period. A questionnaire will be used at each follow-up encounter to screen patients for urinary tract infection symptoms, voiding dysfunction, and other adverse events potentially related to the prophylactic antibiotics. Urine cultures will be collected to confirm infection for patients developing postoperative symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Idiopathic Overactive Bladder, Postoperative Urinary Tract Infection

Keywords

prophylaxis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Patients will be randomized at a 1:1 allocation ratio to two parallel treatment arms - intervention versus placebo

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Placebo

Allocation

Randomized

Enrollment

202 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment Arm

Arm Type

Active Comparator

Arm Description

Ciprofloxacin 500 mg PO every 12 hrs for 3 days following the procedure

Arm Title

Placebo Arm

Arm Type

Placebo Comparator

Arm Description

Placebo pill PO every 12 hrs for 3 days following the procedure

Intervention Type

Drug

Intervention Name(s)

Ciprofloxacin

Intervention Description

Fluoroquinolone antibiotic.

Intervention Type

Other

Intervention Name(s)

Placebo Pill

Intervention Description

Placebo Pill

Primary Outcome Measure Information:

Title

Rate of Postoperative Urinary Tract Infection

Description

new or worsening symptoms (dysuria, hematuria, frequency, urgency, suprapubic/flank pain, fever) AND positive urine culture (>10^5 CFU/mL)

Time Frame

2 weeks following the procedure

Secondary Outcome Measure Information:

Title

Rate of Postoperative Urinary Tract Infection Rate

Description

new or worsening symptoms (dysuria, hematuria, frequency, urgency, suprapubic/flank pain, fever) AND positive urine culture (>10^5 CFU/mL)

Time Frame

1 and 6 weeks following the procedure

Title

Rate of Other Adverse Events

Description

New onset of side effects possibly related to Ciprofloxacin (nausea/vomiting, headache, abdominal pain, constipation, diarrhea, other)

Time Frame

1, 2 and 6 weeks following the procedure

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with idiopathic OAB diagnosed clinically who have failed medical management Female Age ≥ 18 Exclusion Criteria: Patients with neurogenic OAB (OAB with potential underlying neurologic cause - multiple sclerosis, spinal cord injury, Parkinson's disease, other) Contraindication to injection of Botox - hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation, current urinary tract infection, symptomatic urinary retention or PVR > 200 mL, unwillingness or inability to initiate CIC post-treatment if required. Contraindication to oral Ciprofloxacin - hypersensitivity or allergy to Ciprofloxacin or other fluoroquinolone, concurrently taking Tizanidine or Agomelatine.14 Active antibiotic therapy for any indication at the time of Botox injection - increased risk of adverse reaction with combining antibiotics, reduced risk of UTI with additional antibiotic. Male Age < 18 Pregnant and/or breastfeeding

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Erin Kelly, MD FRCSC

Phone

780-735-5290

eckelly@ualberta.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Jane Schulz, MR FRCSC

Phone

780-970-4659

schulz@ualberta.ca

Facility Information:

Facility Name

Urogynecology Clinic - Royal Alexandra Hospital

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T5H3V9

Country

Canada

Individual Site Status

Recruiting

Facility Contact: