Antibiotics for Overactive Bladder Post-Botox

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University of Alberta

Must not be taking: Tizanidine, Agomelatine, others

Disqualifiers: Neurogenic OAB, Male, Pregnant, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing if taking antibiotics right after Botox injections in the bladder can prevent infections in women with overactive bladder. The goal is to see if antibiotics reduce the risk of bladder infections after the procedure. Botox A was approved by the U.S. Food and Drug Administration for the treatment of overactive bladder.

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 data supports the effectiveness of the drug ciprofloxacin for treating overactive bladder post-Botox?

Ciprofloxacin has been shown to be effective in treating various infections, including urinary tract infections, due to its broad activity against many bacteria. It has been found to be as effective or superior to other antibiotics in treating these infections, which suggests it may help manage infections that could occur after Botox treatment for overactive bladder. ^{1 2 3 4 5}

Is ciprofloxacin generally safe for humans?

Ciprofloxacin is generally considered safe for humans, with adverse reactions occurring in 3-13% of patients, mostly involving mild gastrointestinal issues like nausea and diarrhea. Serious side effects are rare, and most adverse effects are reversible after stopping the medication. ^{3 6 7 8 9}

How does the antibiotic treatment for overactive bladder post-Botox differ from other treatments?

The use of antibiotics after Botox treatment for overactive bladder is unique because it focuses on preventing urinary tract infections (UTIs) that may occur after the Botox procedure, rather than directly treating the bladder condition itself. This approach is different from other treatments that primarily aim to manage bladder symptoms directly. ^{10 11 12 13 14}

Research Team

Eligibility Criteria

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 am 18 years old or older.

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.

Trial Timeline

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

Treatment Details

Interventions

• Ciprofloxacin (Antibiotic)
• Placebo Pill (Other)

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.

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

Women and Children's Health Research Institute, Canada

Collaborator

Trials

18

Recruited

24,800+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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 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]

References

1. Japan 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. [2019]

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

Cinoxacin: mechanism of action, spectrum of activity, pharmacokinetics, adverse reactions, and therapeutic indications. [2019]

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

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

4. Italy 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]. [2017]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Cinoxacin. A review of its pharmacological properties and therapeutic efficacy in the treatment of urinary tract infections. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Ciprofloxacin: an overview of adverse experiences. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Ciprofloxacin-induced cutaneous adverse drug events: a systematic review of descriptive studies. [2022]

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

Adverse effects of the fluoroquinolones. [2019]

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

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

10. France pubmed.ncbi.nlm.nih.gov

[Idiopathic overactive bladder and BOTOX(®): Literature review]. [2018]

11. England 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. [2022]

12. France pubmed.ncbi.nlm.nih.gov

[Botulinium toxin and idiopathic overactive bladder: Multicentric contempory management in Bourgogne]. [2019]

13. England pubmed.ncbi.nlm.nih.gov

Intermittent catheterisation after botulinum toxin injections: the time to reassess our practice. [2018]

14. Japan pubmed.ncbi.nlm.nih.gov

[The efficacy of imidafenacin in patients with over active bladder, nocturia, or sleep disorders (Sayama-Iruma-Hannou study)]. [2015]