Ciprofloxacin for Neurogenic Bladder

Overseen By Paul Groves, MR FRCSC

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Alberta

Must not be taking: Tizanidine, Agomelatine, Antibiotics

Disqualifiers: Idiopathic OAB, Pregnancy, Active UTI, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 3 days

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether taking the antibiotic Ciprofloxacin after a bladder Botox injection can prevent bladder infections. Individuals with neurogenic overactive bladder (OAB) due to conditions like multiple sclerosis or spinal cord injury might be suitable candidates. Participants will be divided into two groups: one taking Ciprofloxacin and the other taking a placebo (a pill with no active medicine). The trial aims to determine if the antibiotic reduces infections and enhances the safety of this common procedure. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ciprofloxacin, an antibiotic, is generally safe for individuals with nerve-related bladder issues. In one study involving 360 hospitalized patients, 94% experienced good results with ciprofloxacin. Another review of clinical trials confirmed that ciprofloxacin is safe and effective for treating urinary problems.

While these studies focus on ciprofloxacin's use in various situations, they suggest it is well-tolerated. However, like any medication, it can have side effects. Some individuals might experience mild digestive issues or allergic reactions, but serious side effects are rare. Overall, ciprofloxacin is a common antibiotic known for its safety in treating urinary tract infections.

Prospective trial participants should know that ciprofloxacin has a strong safety record. It is important to discuss any concerns with a doctor regarding its use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for neurogenic bladder, like anticholinergics, focus on relaxing the bladder muscles to reduce involuntary contractions. However, the study drug, ciprofloxacin, is being explored for its potential to prevent infections that often occur after bladder Botox injections, which is a common procedure for managing this condition. Researchers are excited because ciprofloxacin could offer a targeted way to minimize post-procedural infections, potentially enhancing the overall effectiveness and safety of Botox treatments for neurogenic bladder. By addressing a frequent complication, this approach could improve patient outcomes and reduce the need for additional medications.

What evidence suggests that ciprofloxacin might be an effective treatment for preventing bladder infections after bladder Botox?

Research has shown that ciprofloxacin, an antibiotic, can help prevent urinary tract infections (UTIs). In one study, 94% of patients with neurogenic bladder who took ciprofloxacin experienced good results. Another study found it effective in preventing UTIs in people with spinal cord injuries. In this trial, one group of participants will receive ciprofloxacin to evaluate its effectiveness in reducing bladder infections after bladder Botox injections. The evidence supports using ciprofloxacin to prevent infections, making it a promising option for reducing complications after this common urologic procedure. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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

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.

I am not on antibiotics at the time of my Botox injection.

Exclusion Criteria

Participants with idiopathic OAB

I am under 18 years old.

I cannot read, speak, or write in English.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Bladder Botox Injection
• Ciprofloxacin
• 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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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 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]

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]

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]

Ciprofloxacin was administered to 30 patients with multi-resistant urinary tract infections, achieving early bacteriological eradication in 48.3% of cases, but with a high recurrence rate of 50% within 30 days after initial eradication.

The treatment was well tolerated, and most recurring infections were still susceptible to ciprofloxacin, indicating that while the drug is effective, the underlying conditions like vesico-urethral dysfunction and the use of catheters significantly influenced treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of multi-resistant urinary tract infections in patients with multiple sclerosis. van Poppel, H., Baert, L.[2019]

Ciprofloxacin, while generally considered safe for patients with cirrhosis, can lead to rare but serious neurological complications, as demonstrated in a case involving a 59-year-old patient who developed hemiballism and altered mental status after prolonged use.

This case highlights the need for careful dosing and monitoring for neurological side effects in cirrhotic patients taking ciprofloxacin, as symptoms can mimic other conditions like hepatic encephalopathy or stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case of hemiballism as a rare side effect of ciprofloxacin in a patient with liver cirrhosis. Kim, SH., Jeong, SH., Kim, JW., et al.[2013]

In a study of 518 patients undergoing transurethral surgery, a single 500 mg dose of ciprofloxacin was found to be effective in reducing post-operative bacteriuria, with only 3.3% of patients experiencing this complication compared to higher rates in the cefotaxime (4.8%) and placebo (7.0%) groups.

Ciprofloxacin demonstrated a favorable safety profile, with only 3% of patients reporting drug-related adverse events, suggesting it is a suitable prophylactic option for preventing infections after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-dose oral ciprofloxacin compared with cefotaxime and placebo for prophylaxis during transurethral surgery. Klimberg, IW., Malek, GH., Cox, CE., et al.[2013]

Citations

1. withpower.com withpower.com/trial/phase-3-urinary-bladder-neurogenic-8-2021-c4b88

Ciprofloxacin for Neurogenic Bladder In a Phase IV study involving 360 hospitalized patients, intravenous ciprofloxacin demonstrated a high efficacy rate, with 94% of patients showing favorable ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4165668/

A review of prospective Clinical Trials for neurogenic bladder Overall, efficacy rate ranges from 67% to 96%, with no trial showing poor results after therapy. Antimuscarinics are proven to increase bladder capacity, ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022534717348826

Ciprofloxacin as Prophylaxis for Urinary Tract Infection Ciprofloxacin at a dose of 100 mg. at night was efficacious in preventing urinary tract infections during 6 months in patients with spinal cord lesions and ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022534705625694

Once Daily, Extended Release Ciprofloxacin for ... Conclusions. Extended release ciprofloxacin at a dose of 1,000 mg once daily was as safe and effective as conventional treatment with 500 mg ciprofloxacin ...

5. academic.oup.com academic.oup.com/cid/article/39/5/658/362678

Prospective, Randomized Trial of 3 or 14 Days of ... The present double-blind placebo-controlled trial found a significantly improved microbiological outcome associated with a 14-day regimen of ciprofloxacin ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2772973723009244

16 year's experience of a Tertiary Centre in the UK Repeated Botox injections appear to be a safe form of treatment for refractory OAB. Long term complications include recurrent UTIs, which affects 1 in 4 women, ...

7. clinicaltrials.bayer.com clinicaltrials.bayer.com/study/11490

Urinary Tract Infections | Study 11490 The dose of Cipro XR used in this study (1000 mg a day for 7 to 14 days), has been shown to be safe and effective. This study is being done to gather more ...

8. bmcinfectdis.biomedcentral.com bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-016-1484-4

Management of febrile urinary tract infection among spinal ... The only clinical trial to date about UTI in patients with neurogenic bladder revealed that 14 days of ciprofloxacin treatment is associated ...