Recruiting

OnabotulinumtoxinA

Sponsor:

Walter Reed National Military Medical Center

Code:

NCT04020510

Conditions

Overactive Bladder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

onaBoNT-A

Study Details

Brief 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.

Conditions

Overactive Bladder

Study ID

NCT04020510

Start date

Jul 1, 2019

Status verified date

Apr, 2020

Completion date

Dec 31, 2021

Anticipated

Primary completion date

Jul 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 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

Study Design

Enrollment

184 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard Injections

For idiopathic overactive bladder, 100 units of onabotulinumtoxinA mixed in 10mL of injectable saline injected in 20 sites with 0.5mL per injection along the posterior wall of the bladder above the trigone. For neurogenic overactive bladder, 200 units of onabotulinumtoxinA mixed in 30mL of injectable saline injected in 30 sites with 1mL per injection along the posterior wall of the bladder above the trigone.

experimental: Reduced Injections

For idiopathic overactive bladder, 100 units of onabotulinumtoxinA mixed in 10mL of injectable saline injected in 5 sites with 2mL per injection in an "X" configuration on posterior wall of the bladder above the trigone. For neurogenic overactive bladder, 200 units of onabotulinumtoxinA mixed in 10mL of injectable saline injected in 5 sites with 2mL per injection in an "X" configuration on posterior wall of the bladder above the trigone.

Interventions

onaBoNT-A

Intradetrusor onabotulinumtoxinA in either the standard number of injections or a reduced number of injections

Primary outcome measure

  • Mean change from baseline in overactive bladder symptom severity and health related quality of life scores on the overactive bladder questionnaire short form [ Time Frame: 4-12 weeks post-procedure ]
  • Mean change from baseline in overactive bladder symptom severity and health related quality of life scores on the overactive bladder questionnaire short form [ Time Frame: 6-9 months post-procedure ]
  • Mean change from baseline in overactive bladder symptoms on the International Consultation on Incontinence Questionnaire short form [ Time Frame: 4-12 weeks post-procedure ]
  • Mean change from baseline in overactive bladder symptoms on the International Consultation on Incontinence Questionnaire short form [ Time Frame: 6-9 months post-procedure ]
  • Mean change from baseline in overactive bladder symptoms assessed with the Patient Global Impression of Severity and Improvement scores [ Time Frame: baseline, 4-12 weeks post-procedure and 6-9 months post-procedure ]
  • Mean change from baseline in overactive bladder symptoms assessed with the Patient Global Impression of Severity and Improvement scores [ Time Frame: 4-12 weeks post-procedure ]
  • Mean change from baseline in overactive bladder symptoms and incontinence episodes using patient reported pad counts and episodes of nocturia [ Time Frame: 6-9 months post-procedure ]

Central Contacts and Locations

Central contacts

Angela DiCarlo-Meacham, MD

636-288-2955angeladmmd@gmail.com

Locations

Walter Reed National Military Medical Center

Recruiting

Bethesda, Maryland, United States, 20889

Contacts

Angela M DiCarlo-Meacham, MD

636-288-2955angeladmmd@gmail.com

Christine Vaccaro, DO

301-400-2469christine.m.vaccaro.mil@mail.mil

More Information

Sponsor

Walter Reed National Military Medical Center

Last update posted

Apr 28, 2020

Last verified

Apr, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Walter Reed National Military Medical Center on 2020-04-28.