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Standard vs. Reduced Injections for Overactive Bladder Treatment

This study is investigating a treatment for overactive bladder (OAB), a condition causing sudden urges to urinate, frequent urination, or accidental leakage. The treatment involves injections of onabotulinumtoxinA (onaBoNT-A) into the bladder. Researchers want to see if using a reduced number of injections of onaBoNT-A is as effective as the standard number of injections. You may be able to join if you are 18 or older, have OAB symptoms, and have not found relief from at least one medication or behavior therapy. The study will measure changes in your OAB symptoms and how they affect your quality of life. The current status of this study is unclear, and it plans to enroll 184 participants.

Study design
This interventional study aims to enroll 184 participants to compare two different injection techniques for onabotulinumtoxinA.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for changes in symptoms and quality of life at 4-12 weeks and 6-9 months after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04020510

Standard Injections Versus Reduced Injections for Intravesical onabotulinumtoxinA Treatment of Overactive Bladder

Recruiting
PHASE4Ages 18+InterventionalTreatment
Walter Reed National Military Medical Center
~184 participants
Updated 2020-04-28 on ClinicalTrials.gov
What's tested:onaBoNT-A

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean change from baseline in overactive bladder symptom severity and health related quality of life scores on the overactive bladder questionnaire short form
Measured over 4-12 weeks post-procedure
+6 more outcomes measured

Conditions

Overactive Bladder

Explore related trials

Overactive Bladder

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Angela DiCarlo-Meacham, MD · PRINCIPAL_INVESTIGATOR · Walter Reed National Military Medical Center

Who to contact

Angela DiCarlo-Meacham, MD
[email protected]
636-288-2955
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 increased risk with exposure to botulinum-A toxin, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis/motor neuron disease, neuropathy, renal stones, or any other disorder that might interfere with neuromuscular function
Known allergy or sensitivity to any of the components of onabotulinumtoxinA
Concurrent participation in another investigational drug or device study that could impact the results
Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study

What this trial measures

  • Mean change from baseline in overactive bladder symptom severity and health related quality of life scores on the overactive bladder questionnaire short form4-12 weeks post-procedure

    The overactive bladder questionnaire short form is a validated questionnaire assessing both symptoms and quality of life related to overactive bladder. The survey has two subscales, a health related quality of life scale and a symptom severity scale. Each subscale is scored separately with a range of 0 to 100. For health related quality of life a score of 0 indicates worst quality of life and 100 indicating best quality of life. For symptom severity, the scores also range from 0 to 100 but with higher scores indicating greater symptom severity and lower scores less symptom severity.

  • Mean change from baseline in overactive bladder symptom severity and health related quality of life scores on the overactive bladder questionnaire short form6-9 months post-procedure

    The overactive bladder questionnaire short form is a validated questionnaire assessing both symptoms and quality of life related to overactive bladder. The survey has two subscales, a health related quality of life scale and a symptom severity scale. Each subscale is scored separately with a range of 0 to 100. For health related quality of life a score of 0 indicates worst quality of life and 100 indicating best quality of life. For symptom severity, the scores also range from 0 to 100 but with higher scores indicating greater symptom severity and lower scores less symptom severity.

  • Mean change from baseline in overactive bladder symptoms on the International Consultation on Incontinence Questionnaire short form4-12 weeks post-procedure

    The International Consultation on Incontinence Questionnaire short form is a validated questionnaire assessing symptoms of overactive bladder and effect on quality of life. The scores range from 0 to 21 with higher scores indicating worse symptom severity and effect on quality of life.

  • Mean change from baseline in overactive bladder symptoms on the International Consultation on Incontinence Questionnaire short form6-9 months post-procedure

    The International Consultation on Incontinence Questionnaire short form is a validated questionnaire assessing symptoms of overactive bladder and effect on quality of life. Scores range from 0 to 21 with higher scores indicating greater symptom severity.

  • Mean change from baseline in overactive bladder symptoms assessed with the Patient Global Impression of Severity and Improvement scoresbaseline, 4-12 weeks post-procedure and 6-9 months post-procedure

    The Patient Global Impression of Severity and Patient Global Impression of Improvement scores are validated single question surveys that assess patients' impression of the severity of their illness prior to treatment intervention and the degree of improvement following treatment intervention. The Patient Global Impression of Severity is a 4 point Likert scale ranging from 1 to 4 with 1 being normal and 4 being severe symptoms (mild and moderate completing the range of scores). The Patient Global Impression of Improvement is a 7 point Likert scale with 1 being very much better and 7 being very much worse (much better, a little better, no change, a little worse, and much worse completing the range of scores).

  • Mean change from baseline in overactive bladder symptoms assessed with the Patient Global Impression of Severity and Improvement scores4-12 weeks post-procedure

    The Patient Global Impression of Severity and Patient Global Impression of Improvement scores are validated single question surveys that assess patients' impression of the severity of their illness prior to treatment intervention and the degree of improvement following treatment intervention. The Patient Global Impression of Severity is a 4 point Likert scale ranging from 1 to 4 with 1 being normal and 4 being severe symptoms (mild and moderate completing the range of scores). The Patient Global Impression of Improvement is a 7 point Likert scale with 1 being very much better and 7 being very much worse (much better, a little better, no change, a little worse, and much worse completing the range of scores).

  • Mean change from baseline in overactive bladder symptoms and incontinence episodes using patient reported pad counts and episodes of nocturia6-9 months post-procedure

    Number of pads used for urge incontinence and nocturia episodes are frequent metrics used for assessing efficacy of overactive bladder treatments