Antibiotics for Overactive Bladder Post-Botox

Overseen By Jane Schulz, MR FRCSC

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Alberta

Must not be taking: Tizanidine, Agomelatine, others

Disqualifiers: Neurogenic OAB, Male, Pregnant, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 week

202 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if taking antibiotics after a Botox injection in the bladder can reduce the risk of bladder infections. Women with overactive bladder, who have not found relief from other treatments and plan to receive a Botox injection, may be suitable for this study. Participants will be divided into two groups: one will take the antibiotic Ciprofloxacin, and the other will take a placebo (a pill with no active medicine) for three days following the procedure. Researchers will compare bladder infection rates and any side effects between the two groups over a six-week period. As a Phase 4 trial, this study involves an FDA-approved treatment and seeks to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on active antibiotic therapy at the time of the Botox injection.

What is the safety track record for these treatments?

Research has shown that Ciprofloxacin is generally safe for people. In previous studies, 3% to 13% of participants reported mild side effects, mostly related to the stomach, such as nausea or an upset stomach.

Ciprofloxacin is an antibiotic, meaning it treats infections caused by bacteria. This medication already has FDA approval for other uses. Like any drug, it can cause side effects, but for most people, these are minor and resolve on their own.

Overall, while some people might experience mild side effects, Ciprofloxacin is considered well-tolerated. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for overactive bladder, which often focus on managing symptoms with medications like anticholinergics or beta-3 adrenergic agonists, the use of ciprofloxacin after a Botox procedure could offer a new approach. Ciprofloxacin is an antibiotic that may help prevent urinary tract infections, a common complication after Botox treatments in this context. Researchers are excited about this because it could mean fewer infections and better overall outcomes for patients undergoing Botox for overactive bladder management.

What evidence suggests that prophylactic antibiotics might be an effective treatment for reducing postoperative bladder infection in women with overactive bladder?

In this trial, participants will receive either Ciprofloxacin or a placebo to evaluate its effectiveness in preventing infections after Botox treatment for an overactive bladder. Research has shown that Ciprofloxacin, an antibiotic, effectively treats various infections, including urinary tract infections (UTIs). Studies have found that taking a single dose of Ciprofloxacin immediately after a medical procedure can help prevent infections. For those receiving Botox injections to treat an overactive bladder, Ciprofloxacin performs as well as other antibiotics in preventing bladder infections post-procedure. Generally, using antibiotics like Ciprofloxacin lowers the risk of UTIs, which are common after Botox treatment for an overactive bladder. This suggests that using Ciprofloxacin as a preventive measure could help reduce infections following these procedures. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for women over 18 with an overactive bladder (OAB) that hasn't improved with medication. It's not for those under 18, pregnant or breastfeeding, men, anyone allergic to Botox or Ciprofloxacin, currently have a UTI or can't empty their bladder fully.

Inclusion Criteria

I am female.

I have OAB not caused by any known condition and treatments haven't worked.

Exclusion Criteria

I am male.

I am not allergic to Botox, do not have a UTI, can empty my bladder fully, and am willing to follow post-treatment instructions.

I am on antibiotics and understand the risks with Botox injections.

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 for 3 days following the bladder Botox procedure

1 week

1 visit (in-person) for the procedure

Follow-up

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

6 weeks

Multiple visits (in-person) for follow-up and urine cultures

What Are the Treatments Tested in This Trial?

Interventions

• Ciprofloxacin
• Placebo Pill

Trial Overview

The study tests if taking the antibiotic Ciprofloxacin after getting Botox injections in the bladder reduces infections compared to a placebo pill. Women are randomly assigned to one of these two groups and followed up for six weeks.

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+

Women and Children's Health Research Institute, Canada

Collaborator

Trials

18

Recruited

24,800+

Published Research Related to This Trial

In a study of 240 patients with overactive bladder symptoms, 196 received botulinum toxin injections without routine clean intermittent self-catheterization (CISC), and none experienced acute retention or significant voiding issues.

The findings suggest that routinely recommending CISC based solely on a postvoid residual (PVR) volume greater than 200 ml is unnecessary and may discourage patients from seeking botulinum treatment, as CISC should only be used for those with troublesome symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent catheterisation after botulinum toxin injections: the time to reassess our practice. Collins, L., Sathiananthamoorthy, S., Fader, M., et al.[2018]

In a study of 100 patients with overactive bladder (OAB), imidafenacin significantly improved symptoms of urgency and nocturia after 4 weeks of treatment, as measured by the Over Active Bladder Symptom Score (OABSS).

Imidafenacin also showed a notable secondary benefit by significantly reducing sleep disorders, indicating its potential to improve overall quality of life for patients with OAB.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The efficacy of imidafenacin in patients with over active bladder, nocturia, or sleep disorders (Sayama-Iruma-Hannou study)]. Suzuki, T., Uwatoko, N., Watanabe, A., et al.[2015]

In a review of over 6500 patients, the overall incidence of adverse reactions to ciprofloxacin was low, ranging from 3.0% in Europe to 13.4% in the USA, with most reactions being mild and not requiring treatment withdrawal.

The most common side effects were gastrointestinal issues like nausea and diarrhea (2-8% of patients), while serious adverse effects were rare, with only three cases of significant toxicity reported, indicating that ciprofloxacin has an excellent safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ciprofloxacin: an overview of adverse experiences. Ball, P.[2019]

In a study involving 97 patients across six urogynecology centers, OnabotulinumtoxinA (Botox) was primarily used as a second-line treatment for idiopathic overactive bladder after previous therapies like tibial or sacral neuromodulation failed, with 70% of first injections adhering to marketing authorization guidelines.

The study highlighted significant variability in diagnostic and treatment practices among centers, indicating a need for greater standardization in the use of Botox for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Botulinium toxin and idiopathic overactive bladder: Multicentric contempory management in Bourgogne]. Schneider, A., Tourlonias, B., Cormier, L., et al.[2019]

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]

Ciprofloxacin is an effective antibiotic for treating a variety of infections, including osteomyelitis, gonorrhea, and infections of the urinary and gastrointestinal tracts, with data from 2,018 patients showing its broad-spectrum activity against multiple bacteria.

In controlled trials, ciprofloxacin demonstrated comparable or superior safety and efficacy compared to other antibiotics like trimethoprim-sulfamethoxazole and ampicillin, with mild adverse reactions and rare emergence of resistance, making it a reliable treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, safety, and potential economic benefits of oral ciprofloxacin in the treatment of infections. Sanders, WE.[2019]

The synthesized quinolone compounds demonstrated strong antibacterial activity against both gram-positive and gram-negative bacteria, comparable to established antibiotics like ciprofloxacin and ofloxacin.

Among the tested compounds, 3i showed the best pharmacological profile and was significantly less toxic than the reference quinolones, suggesting it could be a safer alternative for treating bacterial infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pyridonecarboxylic acids as antibacterial agents. VIII. Synthesis and structure-activity relationship of 7-(1-aminocyclopropyl)-4-oxo-1,8-naphthyridine-3-carboxylic acids and 7-(1-aminocyclopropyl)-4-oxoquinoline-3-carboxylic acids. Todo, Y., Nitta, J., Miyajima, M., et al.[2019]

Cinoxacin is an effective new treatment for initial and recurrent bacterial urinary tract infections, showing rapid therapeutic concentrations in urine and greater activity against certain bacteria compared to similar drugs.

The drug has a favorable safety profile with infrequent adverse events, and initial studies suggest it may also be beneficial as a preventive treatment for women prone to recurrent urinary tract infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cinoxacin: mechanism of action, spectrum of activity, pharmacokinetics, adverse reactions, and therapeutic indications. Scavone, JM., Gleckman, RA., Fraser, DG.[2019]

In a clinical trial involving 150 patients with lower urinary tract infections, all three quinolone drugs (cinoxacin, ciprofloxacin, and pefloxacin) demonstrated satisfactory therapeutic efficacy.

Cinoxacin was noted for its excellent tolerability, suggesting it may be a preferred option among the three drugs tested.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparison of efficacy and tolerability among 3 quinolones in the treatment of lower urinary tract infections (cinoxacin versus ciprofloxacin and pefloxacin]. Sesia, G., Cauda, F., Alladio, F.[2017]

In a systematic review of 11 randomized controlled trials involving 1008 patients, onabotulinumtoxinA (BOTOX) was found to be significantly more effective than placebo in improving bladder control, symptoms, and quality of life for patients with refractory idiopathic overactive bladder (iOAB).

The treatment was well tolerated, with manageable adverse events such as urinary retention and infections, which did not negatively impact the patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Idiopathic overactive bladder and BOTOX(®): Literature review]. Gamé, X., Karsenty, G., Ruffion, A., et al.[2018]

In a study of 565 women undergoing Botox treatment for overactive bladder, 92.9% received some form of antibiotic prophylaxis, yet this did not significantly reduce the incidence of urinary tract infections (UTIs) post-procedure, with a UTI rate of 30.4%.

No specific route of antibiotic administration (IV, oral, or combination) was found to be more effective than no prophylaxis at preventing UTIs, suggesting that current prophylactic practices may need reevaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibiotic regimen and route of administration do not alter rates of urinary tract infection after intravesical botulinum toxin injection for overactive bladder. Eckhardt, SE., Takashima, Y., Handler, SJ., et al.[2022]

Ciprofloxacin (CIPRO) is associated with a range of serious cutaneous adverse drug reactions (CADRs), including toxic epidermal necrolysis and Stevens-Johnson syndrome, as identified in a systematic review of 39 studies involving doses of 500 to 1,000 mg/day over 7 to 10 days.

To manage CIPRO-induced CADRs, it is crucial to stop the medication immediately and provide supportive care, such as glucocorticoids and moisturizers, highlighting the need for physicians to be cautious when prescribing this antibiotic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ciprofloxacin-induced cutaneous adverse drug events: a systematic review of descriptive studies. Kashyap, A., Sreenivasan, S., Rajan, AK., et al.[2022]

In a review of approximately 30,000 patients, quinolone antibiotics showed an overall adverse reaction rate of 4.0%-8.0%, with gastrointestinal issues being the most common side effects, affecting 1.0%-5.0% of patients.

Most adverse effects were reversible upon stopping the medication and were not dose-dependent, suggesting that quinolones can be safely used when prescribed carefully, although ongoing monitoring for new side effects is recommended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects of the fluoroquinolones. Halkin, H.[2019]

Cinoxacin is an effective urinary antibacterial drug that works well against common Gram-negative pathogens, showing comparable efficacy to nalidixic acid and co-trimoxazole in treating acute or recurrent urinary tract infections.

It is well tolerated with a low likelihood of causing bacterial resistance, making it a promising alternative to related antibiotics like nalidixic and oxolinic acids, although more research is needed on its use for prevention in recurrent infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cinoxacin. A review of its pharmacological properties and therapeutic efficacy in the treatment of urinary tract infections. Sisca, TS., Heel, RC., Romankiewicz, JA.[2018]

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