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Fewer Botox Injections for Urinary Incontinence
N/A
Recruiting
Led By Monique J Vaughan, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Females at least 21 years of age
English speaking
Must not have
Surgical treatment for stress incontinence (sling, Burch or urethral injection) or pelvic organ prolapse recommended or planned at enrollment by study investigator(s)
Current symptomatic urinary tract infection that has not resolved prior to randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
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.
Who is the study for?
This trial is for English-speaking women over 21 with urgency urinary incontinence, who have not had Botox injections for this condition before. They must be willing to possibly use a catheter and follow the study's procedures. Excluded are those with certain medical conditions, previous pelvic surgeries, or untreated UTIs.
What is being tested?
The study aims to see if fewer Botox injection sites (5 instead of the standard 15-20) will be just as effective in reducing episodes of urgency urinary incontinence. Participants will receive an equal amount of Botox but at different numbers of injection sites.
What are the potential side effects?
Potential side effects from Botox may include pain at the injection site, urinary tract infections, difficulty urinating, and possible need for temporary catheterization due to weakened bladder muscles.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman aged 21 or older.
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I speak English.
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I am seeking treatment for sudden urges to urinate that I cannot control.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am recommended or planning to have surgery for stress incontinence or pelvic organ prolapse.
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I currently have symptoms of a urinary tract infection that hasn't cleared up.
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I have or had bladder cancer.
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I have been diagnosed with interstitial cystitis or chronic pelvic pain.
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I have had Botox injections in my bladder muscle before.
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I have been hospitalized at least twice in the last year for medical reasons.
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I have had surgery to modify the muscle controlling my bladder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Reducton of Urgency Urinary Incontinence episodes in standard of care versus modified treatment group
Secondary study objectives
Complications rates in standard of care (15 injections) versus modified treatment (5 injections)
Quality of life improvement in standard of care (15 injections) versus modified treatment (5 injections)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ExperimentalExperimental Treatment1 Intervention
Subjects in this arm will be administered the same amount of Botox in 5 injection sites.
Group II: ControlsActive Control1 Intervention
Subjects in this arm will be administered the standard injection site protocol (15 sites).
Find a Location
Who is running the clinical trial?
University of VirginiaLead Sponsor
781 Previous Clinical Trials
1,315,614 Total Patients Enrolled
1 Trials studying Urinary Incontinence
30 Patients Enrolled for Urinary Incontinence
Monique J Vaughan, MDPrincipal InvestigatorUniversity of Virginia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental
- Group 2: Controls
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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