Ciprofloxacin for Neurogenic Bladder

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Alberta

Must not be taking: Tizanidine, Agomelatine, Antibiotics

Disqualifiers: Idiopathic OAB, Pregnancy, Active UTI, others

Prior Safety Data

Trial Summary

What is the purpose of this 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.

Will I have to stop taking my current medications?

The trial requires that you are not on any active antibiotic therapy at the time of the Botox injection. If you are taking antibiotics, you would need to stop before participating.

What data supports the effectiveness of the drug Ciprofloxacin for treating neurogenic bladder?

Research suggests that using antibiotics like Ciprofloxacin before bladder Botox injections can help prevent urinary tract infections (UTIs) in patients with neurogenic bladder. A study found that a single dose of antibiotics before the procedure was effective in reducing the incidence of UTIs. ^{1 2 3 4 5}

Is ciprofloxacin generally safe for humans?

Ciprofloxacin is generally considered safe for humans, with studies showing it is well tolerated in treating infections, though some rare side effects like neurological issues have been reported. In clinical trials, adverse events were noted in a small percentage of patients, leading to discontinuation in a few cases. ^{6 7 8 9 10}

How does the treatment Bladder Botox Injection differ from other treatments for neurogenic bladder?

Bladder Botox Injection is unique because it involves injecting botulinum toxin directly into the bladder muscle to relax it, which can help reduce urinary incontinence and improve bladder control. This is different from oral medications like ciprofloxacin, which are used to treat infections rather than directly address bladder muscle function. ^{6 9 10 11 12}

Research Team

Eligibility Criteria

Adults over 18 with neurogenic overactive bladder (OAB) due to conditions like multiple sclerosis or spinal cord injury can join. They must speak English and not be pregnant, breastfeeding, or have a current UTI. Participants cannot be allergic to Botox or Ciprofloxacin, nor take certain medications that interact with Ciprofloxacin.

Inclusion Criteria

I am 18 years old or older.

Participants must be able to read, speak, and write in English

My overactive bladder is due to a neurological condition like MS or Parkinson's.

Exclusion Criteria

Participants with idiopathic OAB

I am under 18 years old.

I cannot read, speak, or write in English.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Ciprofloxacin or placebo following bladder Botox injection

3 days

1 visit (in-person) for the procedure

Follow-up

Participants are monitored for urinary tract infection symptoms and other adverse events

6 weeks

Multiple visits (in-person) for follow-up assessments

Treatment Details

Interventions

• Bladder Botox Injection (Procedure)
• Ciprofloxacin (Antibiotic)
• Placebo (Placebo)

Trial Overview The study is testing if taking antibiotics (Ciprofloxacin) after getting Botox injections in the bladder can prevent infections compared to a placebo group. Patients are randomly assigned to one of the two groups to see which method is more effective.

Participant Groups

Group I: Treatment Arm Active Control 1 Intervention

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

Group II: Placebo Arm Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Bill Flanagan

University of Alberta

Chief Executive Officer since 2020

LLB from University of Toronto, LLM from Columbia University

Dr. Verna Yiu

University of Alberta

Chief Medical Officer since 2012

MD from University of Alberta, Fellowship in Pediatric Nephrology at Harvard University

Findings from Research

In a study of 80 patients with neurogenic bladder undergoing urological procedures, only 11.1% developed urinary tract infections (UTIs) within 14 days, indicating a low incidence of post-procedure infections.

The findings suggest that screening and treating asymptomatic bacteriuria may be unnecessary, as 77.8% of UTIs resolved without additional antibiotic therapy, highlighting the potential overuse of antibiotics in this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective evaluation of antibiotic treatment for urological procedure in patients presenting with neurogenic bladder. Weglinski, L., Rouzaud, C., Even, A., et al.[2018]

In a study of 616 procedures involving intravesical botulinum toxin A (BoNTA) injections for detrusor overactivity in patients with spinal cord injury, only 1.8% developed symptomatic urinary tract infections (UTIs), suggesting that the procedure is relatively safe.

The findings indicate that a single dose of antibiotics prior to the BoNTA injection is sufficient to prevent UTIs, challenging the need for prolonged antibiotic prophylaxis, although further randomized clinical trials are needed for confirmation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of different antibiotic protocols for asymptomatic bacteriuria in patients with neurogenic bladder treated with botulinum toxin A. Paradella, AC., Musegante, AF., Brites, C.[2022]

In a study of 93 patients with neurogenic bladder and recurrent urinary tract infections (UTIs), 75% experienced a significant reduction in symptomatic UTIs after receiving intravesical Botox injections.

The improvement in UTI incidence was associated with enhanced bladder function, as indicated by increased bladder capacity and compliance, suggesting that Botox injections may effectively manage bladder overactivity in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In Patients with Neurogenic Detrusor Overactivity and Hinman's Syndrome: Would Intravesical Botox Injections Decrease the Incidence of Symptomatic Urinary Tract Infections. Banakhar, M., Yamani, A.[2022]

In a study of 10 children aged 6 to 17 with nonneurogenic neurogenic bladder, botulinum-A toxin (Botox) injections into the urethral sphincter significantly improved voiding, with 9 out of 10 patients able to void without catheterization immediately after the procedure.

The treatment led to a substantial decrease in post-void residual urine by 89% and a significant increase in maximum urine flow, indicating that Botox injections can effectively reduce urethral resistance and improve bladder function in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botulinum A toxin urethral sphincter injection in children with nonneurogenic neurogenic bladder. Mokhless, I., Gaafar, S., Fouda, K., et al.[2010]

A retrospective study on patients receiving Botox injections in the bladder showed that those who were given antibiotics before and after the procedure had a lower incidence of urinary tract infections (UTIs) compared to those who did not receive antibiotics.

The findings suggest that routine use of antibiotics may be beneficial in reducing the risk of UTIs in patients undergoing intra-vesical Botox treatment for overactive or neurogenic bladder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of prophylactic antibiotics for intra-vesicle Botox® injection. Khan, MH., Baldo, O., Koenig, P., et al.[2018]

In a Phase IV study involving 360 hospitalized patients, intravenous ciprofloxacin demonstrated a high efficacy rate, with 94% of patients showing favorable outcomes for treating lower respiratory tract infections, urinary tract infections, and skin infections after IV therapy.

The treatment was found to be safe, with only 9% of patients experiencing adverse events, and only 3% discontinuing therapy due to these events, indicating that IV ciprofloxacin is a viable option for managing these infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter, phase IV evaluation of intravenous ciprofloxacin as initial therapy in patients with lower respiratory tract, urinary tract, and skin/skin structure infections. Pankey, GA.[2019]

A 12-month study involving 21 patients with spinal cord lesions showed that low-dose ciprofloxacin (100 mg at night) significantly reduced the number of urinary tract infections (UTIs) from 59 during placebo treatment to just 5 during ciprofloxacin treatment (p < 0.00005).

While ciprofloxacin was effective in preventing UTIs without severe side effects, there was a case of supercolonization with ciprofloxacin-resistant bacteria, highlighting the need for monitoring antibiotic resistance in long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ciprofloxacin as prophylaxis for urinary tract infection: prospective, randomized, cross-over, placebo controlled study in patients with spinal cord lesion. Biering-Sørensen, F., Høiby, N., Nordenbo, A., et al.[2022]

Ciprofloxacin is highly effective against nearly all uropathogens causing bacterial urinary tract infections, with low rates of resistance development.

The drug can be administered twice daily and achieves effective concentrations in key areas like blood, urine, kidneys, and prostate, making it suitable even for patients with advanced renal failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ciprofloxacin in management of urinary tract infection. Tolkoff-Rubin, NE., Rubin, RH.[2019]

Ciprofloxacin demonstrated strong effectiveness against 103 strains of enterobacteria from infected urine, maintaining its inhibitory action even at a lower pH of 5.5, which is relevant for treating urinary tract infections.

While some bacteria like Streptococcus spp. and Staphylococcus aureus showed reduced susceptibility, ciprofloxacin concentrations achievable in urine (as low as 2 mg/l) were still effective against most strains, indicating its potential for treating bacterial cystitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibacterial activity of ciprofloxacin in conventional tests and in a model of bacterial cystitis. Greenwood, D., Baxter, S., Cowlishaw, A., et al.[2019]

References

1. France pubmed.ncbi.nlm.nih.gov

Prospective evaluation of antibiotic treatment for urological procedure in patients presenting with neurogenic bladder. [2018]

2. Brazil pubmed.ncbi.nlm.nih.gov

Comparison of different antibiotic protocols for asymptomatic bacteriuria in patients with neurogenic bladder treated with botulinum toxin A. [2022]

3. England pubmed.ncbi.nlm.nih.gov

In Patients with Neurogenic Detrusor Overactivity and Hinman's Syndrome: Would Intravesical Botox Injections Decrease the Incidence of Symptomatic Urinary Tract Infections. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Botulinum A toxin urethral sphincter injection in children with nonneurogenic neurogenic bladder. [2010]

5. United States pubmed.ncbi.nlm.nih.gov

Use of prophylactic antibiotics for intra-vesicle Botox® injection. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Treatment of multi-resistant urinary tract infections in patients with multiple sclerosis. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Multicenter, phase IV evaluation of intravenous ciprofloxacin as initial therapy in patients with lower respiratory tract, urinary tract, and skin/skin structure infections. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A case of hemiballism as a rare side effect of ciprofloxacin in a patient with liver cirrhosis. [2013]

9. England pubmed.ncbi.nlm.nih.gov

Single-dose oral ciprofloxacin compared with cefotaxime and placebo for prophylaxis during transurethral surgery. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

Ciprofloxacin as prophylaxis for urinary tract infection: prospective, randomized, cross-over, placebo controlled study in patients with spinal cord lesion. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Ciprofloxacin in management of urinary tract infection. [2019]

12. Germany pubmed.ncbi.nlm.nih.gov

Antibacterial activity of ciprofloxacin in conventional tests and in a model of bacterial cystitis. [2019]