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Antibiotics for Overactive Bladder Post-Botox

Phase 4
Recruiting
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 2 and 6 weeks following the procedure
Awards & highlights

Study Summary

This trial will compare the rate of bladder infection after Botox injection in women who received antibiotics versus those who received a placebo.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include reactions related to antibiotics like stomach upset, rash, and yeast infections. There may also be typical Botox injection issues such as pain at the injection site or difficulty urinating.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 2 and 6 weeks following the procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 2 and 6 weeks following the procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of Postoperative Urinary Tract Infection
Secondary outcome measures
Rate of Other Adverse Events
Rate of Postoperative Urinary Tract Infection Rate

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Treatment ArmActive Control1 Intervention
Ciprofloxacin 500 mg PO every 12 hrs for 3 days following the procedure
Group II: Placebo ArmPlacebo Group1 Intervention
Placebo pill PO every 12 hrs for 3 days following the procedure

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
889 Previous Clinical Trials
384,932 Total Patients Enrolled
Women and Children's Health Research Institute, CanadaOTHER
17 Previous Clinical Trials
24,738 Total Patients Enrolled

Media Library

Treatment Arm Clinical Trial Eligibility Overview. Trial Name: NCT04444440 — Phase 4
Overactive Bladder Research Study Groups: Treatment Arm, Placebo Arm
Overactive Bladder Clinical Trial 2023: Treatment Arm Highlights & Side Effects. Trial Name: NCT04444440 — Phase 4
Treatment Arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT04444440 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Treatment Arm been given official clearance by the FDA?

"Our team has assigned Treatment Arm a score of 3, signifying that it is approved medication as this trial is in its fourth phase."

Answered by AI

How is Treatment Arm typically utilized to benefit patients?

"Treatment Arm is prescribed for urinary tract infections caused by entercococcus faecalis, as well as conditions like abdominal infection and pseudomonas aeruginosa."

Answered by AI

Is the enrolment process for this clinical trial still open?

"Affirmative. According to the details collected on clinicaltrials.gov, this medical research project is still searching for participants and was initially posted on July 6th 2021. 202 individuals need to be enrolled from 1 study site with the last update being made on October 3rd 2022."

Answered by AI

Has Treatment Arm been studied before in any other past experiments?

"At present, 26 scientific investigations of Treatment Arm are in progress. Three of these studies have entered Phase 3 and the majority are based out of Durham, NC with a total of 50 research sites involved."

Answered by AI

How many participants have been recruited for this experiment?

"That is correct. According to the information posted on clinicaltrials.gov, this study was initially announced on July 6th 2021 and has since been updated last October 3rd 2022. 202 participants are being sought after from a single medical site."

Answered by AI
~60 spots leftby Jun 2025