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Fewer Botox Injections for Urinary Incontinence
Study Summary
This trial aims to see if using 5 Botox injection sites instead of 15-20 can provide relief of UUI symptoms. Hypothesis: 5-site protocol is as good as the standard.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am a woman aged 21 or older.You are allergic to botulinum toxin A.I am recommended or planning to have surgery for stress incontinence or pelvic organ prolapse.You have blood in your urine and have not been checked by a doctor.I currently have symptoms of a urinary tract infection that hasn't cleared up.You are allergic to lidocaine.I am willing and able to follow the study's schedule and procedures.I speak English.I can complete all required study tasks and interviews.I am a premenopausal woman without tubal ligation and not on birth control for 3 months.You have experienced five or more episodes of sudden, strong need to urinate and leaking urine on a three-day diary.I stopped taking anticholinergic drugs 3 weeks ago.I am seeking treatment for sudden urges to urinate that I cannot control.I have or had bladder cancer.You have a lot of urine left in your bladder after you pee.I have been diagnosed with interstitial cystitis or chronic pelvic pain.Your kidney test results have shown very high levels of creatinine in the past year.I have had Botox injections in my bladder muscle before.I have a neurological condition that may affect my bladder control.I have been hospitalized at least twice in the last year for medical reasons.You need to use a catheter sometimes to empty your bladder.The doctor thinks that the findings from a cystoscopy test make it unsafe to receive an injection.You have a type of urinary incontinence where you have a strong sudden need to go to the bathroom more than half the time you have accidents.You have had a sacral or tibial neuromodulation device implanted in the past or currently have one implanted.I have had surgery to modify the muscle controlling my bladder.
- Group 1: Experimental
- Group 2: Controls
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any still openings for participants in this research study?
"Affirmative, as evidenced by clinicaltrials.gov's records, this experiment is actively searching for participants to join. The trial was first uploaded on February 23rd 2021 and the most recent update occurred on August 26th 2023. 56 people are needed between 1 medical site."
What is the size of the sample population for this trial?
"Affirmative. According to clinicaltrials.gov, this medical trial is currently recruiting patients; it was initially published on February 23rd 2021 and recently amended on August 26th 2023. 56 participants are needed from 1 centre of care for the study's completion."
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