Standard Injections Versus Reduced Injections for Intravesical onabotulinumtoxinA Treatment of Ov… (NCT04020510) | Clinical Trial Compass
RecruitingPhase 4
Standard Injections Versus Reduced Injections for Intravesical onabotulinumtoxinA Treatment of Overactive Bladder
United States184 participantsStarted 2019-07-01
Plain-language summary
OnabotulinumtoxinA is an effective treatment for both idiopathic and neurogenic overactive bladder and was FDA approved for this indication in 2013. The standard technique for injecting onabotulinumtoxinA into the detrusor is mixing 100 units of onabotulinumtoxinA into 10mL of injectable normal saline and injecting 20 sites with 0.5mL in the posterior wall of hte bladder for idiopathic overactive bladder and mixing 200 units into 30mL and injecting 30 sites with 1mL for neurogenic overactive bladder. The purpose of this study is to compare the efficacy of a technique using a reduced number of injections with the same dosage of onabotulinumtoxinA to the standard technique. The hypothesis is that the reduced technique will not be inferior in terms of efficacy as the standard technique and that there will be a lower incidence of urinary tract infections and urinary retention requiring catheterization post-procedure.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Males or Females ≥ 18 years of age
* Predominant complaint of urinary urgency, urinary frequency or urge incontinence
* Failed at least one medication (inadequate or poorly tolerated response) or behavior modification technique (timed voiding, pelvic floor physical therapy, etc.), or decline such interventions
* Willingness to perform self-catheterization in the event of symptomatic urinary retention
* Ability to follow study instructions and likely to complete all required follow-up
Exclusion Criteria:
* Concurrent use of oral medications for treatment of OAB (anticholinergics or beta 3 agonists).
* Post void residual volume \> 200 ml
* Symptomatic prolapse \> POP-Q (Pelvic Organ Prolapse Quantification) stage 2 or greater that is untreated
* Evidence of active UTI (bladder infection)
* Any previous use of intradetrusor botulinum toxin (onabotulinumtoxinA or abobotulinumtoxinA) within the preceding 6 months
* Use of \>/= 400 units bontulinum toxin in the preceding 3months in other areas of the body
* Procedure performed in the main operating room (not outpatient setting)
* Concurrent diagnosis of interstitial cystitis/painful bladder syndrome
* Females who are pregnant or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
* Any medical condition that may put the subject at incr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean change from baseline in overactive bladder symptom severity and health related quality of life scores on the overactive bladder questionnaire short form
Timeframe: 4-12 weeks post-procedure
2
Mean change from baseline in overactive bladder symptom severity and health related quality of life scores on the overactive bladder questionnaire short form
Timeframe: 6-9 months post-procedure
3
Mean change from baseline in overactive bladder symptoms on the International Consultation on Incontinence Questionnaire short form
Timeframe: 4-12 weeks post-procedure
4
Mean change from baseline in overactive bladder symptoms on the International Consultation on Incontinence Questionnaire short form
Timeframe: 6-9 months post-procedure
5
Mean change from baseline in overactive bladder symptoms assessed with the Patient Global Impression of Severity and Improvement scores
Timeframe: baseline, 4-12 weeks post-procedure and 6-9 months post-procedure
6
Mean change from baseline in overactive bladder symptoms assessed with the Patient Global Impression of Severity and Improvement scores
Trial details
NCT IDNCT04020510
SponsorWalter Reed National Military Medical Center