Neurogenic BladderPhase 2NCT04791579
Antibiotic Prophylaxis for Neurogenic Bladder Botox
A Phase 2 study testing Ciprofloxacin in people with Neurogenic Bladder and Post-operative Urinary Tract Infections, run by University of Alberta at 1 site in Canada.
Trial summary
Injection of Botox into the bladder is a procedure used to treat neurogenic overactive bladder at the Dianne and Irving Kipnes Urology Centre in the Kaye Edmonton Clinic. A common complication following bladder Botox is bladder infection. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Neurogenic Bladder, Post-operative Urinary Tract Infections
- What is being tested?
- Ciprofloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2025to 31 Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with neurogenic OAB, defined as OAB associated with a neurologic condition such as multiple sclerosis, Parkinson's disease, spinal cord injury, previous stroke, or any other neurologic condition the participant may have been told is a cause of their OAB symptoms
- Age ≥ 18
- Participants must be able to read, speak, and write in English
- No contraindication to injection of Botox - hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation, symptomatic urinary retention or PVR > 200 mL, unwillingness or inability to initiate CIC post-treatment if required.
- No contraindication to oral Ciprofloxacin - hypersensitivity or allergy to Ciprofloxacin or other fluoroquinolone, concurrently taking Tizanidine or Agomelatine.
- No active antibiotic therapy for any indication at the time of Botox injection
- Not pregnant and/or breastfeeding - Botox is contraindicated in pregnancy (screen serum pregnancy test 72 hrs prior to the procedure is standard of care).
- No active symptomatic UTI the day of the procedure - wherein the participant presents the day of their Botox procedure with new or worsening urinary frequency, urgency, dysuria, hematuria, suprapubic/flank pain, fevers or chills, will be ground for exclusion from the study - bladder Botox is contraindicated in patients with active symptomatic UTI
Who cannot join
- Participants with idiopathic OAB
- Age < 18
- Patients who cannot read, speak, and write in English
- Any contraindication to injection of Botox - hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation, symptomatic urinary retention or PVR > 200 mL, unwillingness or inability to initiate CIC post-treatment if required.
- Any contraindication to oral Ciprofloxacin - hypersensitivity or allergy to Ciprofloxacin or other fluoroquinolone, concurrently taking Tizanidine or Agomelatine.
- Active antibiotic therapy for any indication at the time of Botox injection
- Pregnant (as indicated by pre-operative serum quantitative B-hCG for patients aged 18 to 51 without previous hysterectomy) and/or breastfeeding
- Active symptomatic UTI the day of the procedure - wherein the participant presents with new or worsening frequency, urgency, dysuria, hematuria, suprapubic/flank pain, fevers or chills, will be ground for exclusion from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Alberta
Edmonton, Alberta, T6G2R3
Joseph LaBossiere, MD FRCSC, 780-407-5958, josephlpmd@gmail.com
About this study
Official title: Prophylactic Antibiotics Following Treatment of Neurogenic Overactive Bladder With Intradetrusor onabotulinumtoxinA for the Reduction of Postoperative UTI: a Randomized Blinded Placebo-controlled Trial
Injection of Botox into the bladder is a procedure used to treat neurogenic overactive bladder at the Dianne and Irving Kipnes Urology Centre in the Kaye Edmonton Clinic. A common complication following bladder Botox is bladder infection. There are no well-studied preventative antibiotics given at the time of bladder Botox for the reduction of post-operative bladder infection. We are proposing a research study that will randomize participants into two groups - one receiving antibiotics and the other receiving placebo pills following bladder Botox. The main goal of our study is to determine if preventative antibiotics at the time of bladder Botox injection reduces post-operative bladder infection. It will provide a valuable learning opportunity for a trainee starting their academic career through working closely with established researchers across two disciplines. We hope the results of our study can ultimately be used to improve outcomes and safety for a common Urologic procedure. In addition, findings from our study could help reduce unnecessary use of antibiotics resulting in cost savings in the health care system and reduction in the risk of antibiotic resistance.
Read the detailed description
This study will be a single-centred, double-blinded, randomized, placebo- controlled trial. Recruitment will be undertaken in the Urology clinic in the Urology Centre at the Kaye Edmonton Clinic in Edmonton, AB. 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 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.
- Being tested
- Ciprofloxacin, Placebo
- Keywords
- prophylaxis, post-operative infection, Botox
- Medical subject headings
- Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofloxacinDrug
Fluoroquinolone antibiotic
PlaceboDrug
Placebo pill
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Active comparator | Ciprofloxacin 500 mg PO every 12 hrs for 3 days following the procedure Receives: Drug: Ciprofloxacin |
| Placebo Arm | Placebo comparator | Placebo pill PO every 12 hrs for 3 days following the procedure Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 weeks following the procedure
Secondary outcomes (2)
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)
Measured: 1 and 6 weeks following the procedure
Rate of Other Adverse Events
New onset of side effects possibly related to Ciprofloxacin (nausea/vomiting, headache, abdominal pain, constipation, diarrhea, other)
Measured: 1, 2 and 6 weeks following the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start1 Feb 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized at a 1:1 allocation ratio to two parallel treatment arms - intervention versus placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791579
- Sponsor's protocol ID
- Pro00108452
- Status last verified
- May 2026
- First submitted
- 8 Mar 2021
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Antibiotics Following Treatment of Neurogenic Overactive Bladder With Intradetrusor onabotulinumtoxinA for the Reduction of Postoperative UTI: a Randomized Blinded Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04791579
- Acronym / sponsor ID
- Pro00108452
- Keywords
- prophylaxis, post-operative infection, Botox
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Injection of Botox into the bladder is a procedure used to treat neurogenic overactive bladder at the Dianne and Irving Kipnes Urology Centre in the Kaye Edmonton Clinic. A common complication following bladder Botox is bladder infection. There are no well-studied preventative antibiotics given at the time of bladder Botox for the reduction of post-operative bladder infection. We are proposing a research study that will randomize participants into two groups - one receiving antibiotics and the other receiving placebo pills following bladder Botox. The main goal of our study is to determine if preventative antibiotics at the time of bladder Botox injection reduces post-operative bladder infection. It will provide a valuable learning opportunity for a trainee starting their academic career through working closely with established researchers across two disciplines. We hope the results of our study can ultimately be used to improve outcomes and safety for a common Urologic procedure. In addition, findings from our study could help reduce unnecessary use of antibiotics resulting in cost savings in the health care system and reduction in the risk of antibiotic resistance.
Detailed description
This study will be a single-centred, double-blinded, randomized, placebo- controlled trial. Recruitment will be undertaken in the Urology clinic in the Urology Centre at the Kaye Edmonton Clinic in Edmonton, AB. 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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized at a 1:1 allocation ratio to two parallel treatment arms - intervention versus placebo
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Active comparator | Drug: CiprofloxacinCiprofloxacin 500 mg PO every 12 hrs for 3 days following the procedure |
| Placebo Arm | Placebo comparator | Drug: PlaceboPlacebo pill PO every 12 hrs for 3 days following the procedure |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants with neurogenic OAB, defined as OAB associated with a neurologic condition such as multiple sclerosis, Parkinson's disease, spinal cord injury, previous stroke, or any other neurologic condition the participant may have been told is a cause of their OAB symptoms
- Age ≥ 18
- Participants must be able to read, speak, and write in English
- No contraindication to injection of Botox - hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation, symptomatic urinary retention or PVR > 200 mL, unwillingness or inability to initiate CIC post-treatment if required.
- No contraindication to oral Ciprofloxacin - hypersensitivity or allergy to Ciprofloxacin or other fluoroquinolone, concurrently taking Tizanidine or Agomelatine.
Key exclusion criteria (8 listed)
- Participants with idiopathic OAB
- Age < 18
- Patients who cannot read, speak, and write in English
- Any contraindication to injection of Botox - hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation, symptomatic urinary retention or PVR > 200 mL, unwillingness or inability to initiate CIC post-treatment if required.
- Any contraindication to oral Ciprofloxacin - hypersensitivity or allergy to Ciprofloxacin or other fluoroquinolone, concurrently taking Tizanidine or Agomelatine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CiprofloxacinFluoroquinolone antibiotic | Drug | Treatment Arm |
| PlaceboPlacebo pill | Drug | Placebo Arm |
Primary outcome
Rate of Postoperative Urinary Tract Infection
Time frame: 2 weeks following the procedure
new or worsening symptoms (dysuria, hematuria, frequency, urgency, suprapubic/flank pain, fever) AND positive urine culture (>10^5 CFU/mL)
2 secondary outcomes
Rate of Postoperative Urinary Tract Infection
Time frame: 1 and 6 weeks following the procedure
Rate of Other Adverse Events
Time frame: 1, 2 and 6 weeks following the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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Pediatric Locomotor Training Bladder Study
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Concomitant Renal and Urinary Bladder Allograft Transplantation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ciprofloxacin in people with Neurogenic Bladder and Post-operative Urinary Tract Infections, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph LaBossiere, MD FRCSC (780-407-5958, josephlpmd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Postoperative Urinary Tract Infection (time frame: 2 weeks following the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.