Summary

Eligibility
for females ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at Long Beach, California
Dates
study started
estimated completion
Principal Investigator
by Carly CrowderFelicia Lane, MD

Description

Summary

Patients with either overactive bladder (OAB) or urgency urinary incontinence (UUI) with be randomized (like a flip of a coin) to receive 100 units of bladder Botox® at either one injection site or ten injection sites. Efficacy and patient satisfaction will be measured by questionnaires.

Official Title

Intradetrusor Botulinum Toxin A: Can Less Injections Maintain Efficacy and Improve Patient Satisfaction?

Details

Intradetrusor (bladder) Botulinum toxin A (BTA or Botox®) is a well-established treatment for urinary urgency incontinence (UUI).[1,2] While this treatment's efficacy in comparison to alternative therapies including anticholinergic medications and sacral neuromodulation for treatment of UUI has been studied, the ideal number of injection sites within the bladder has not been well established. [3,4] Intradetrusor BTA injections are often completed as an office procedure while the patient is awake. Each injection site can cause discomfort for the patient during the procedure. Urinary tract infection and urinary retention are risks associated with this procedure and could potentially be related to number of injection sites. Currently, there is a lack of information in the literature regarding the optimal number of intravesical BTA injection sites. Prior studies evaluated efficacy using 100u BTA spread across 20 injections sites, however current practices at local institutions safely use 10 injections sites based on studies showing similar effect and adverse event profiles between use of 10, 20, and 40 injection sites.[5,6] Research using animal models has shown diffuse distribution of BTA within the entire detrusor muscle after just a single BTA injection at one site.[7] This has been corroborated in human studies.[8] A recently published observational pilot study shows promise for single site intradetrusor Botox® injection as it reported a lower rate of urinary retention and similar durability.[9] Similar clinical efficacy with only one to three intravesical BTA injection[s] has also been reported.[10] In this study, participants will be randomized to receive 100u BTA via intradetrusor injection at one injection site (experimental) versus 10 injection sites (control). Investigators hypothesize that one injection will have similar efficacy to multiple injections and potentially better tolerability and patient satisfaction, due to decreased procedure time and less pain, along with potential for lower adverse event rates, specifically urinary retention and urinary tract infections.

Keywords

Overactive Bladder Urinary Urge Incontinence Overactive Bladder Syndrome Urinary Incontinence, Urge Urge Incontinence Urinary Urgency Urinary Frequency Urinary Incontinence Urinary Bladder, Overactive Botulinum Toxins, Type A abobotulinumtoxinA OnabotulinumtoxinA 100 UNT [Botox]

Eligibility

You can join if…

Open to females ages 18 years and up

You CAN'T join if...

  • Have a diagnosis of neurogenic bladder
  • Received intravesical botox injections within prior 6 months
  • Current treatment with either: SNM, PTNS, or OAB medications - need wash out as below
  • SNM - turn device off for at least 2 weeks prior to procedure, off during 3-month follow up window
  • PTNS - no treatments within 2 weeks of start, none during 3-month post-procedure follow up window
  • OAB meds - 2 week wash out period prior to injection, none during 3-month post-procedure follow up window
  • Currently pregnant or trying to get pregnant
  • Contraindications to Botox® - hypersensitivity to Botox®, inability to self-catheterize/refusal to have indwelling catheter
  • Have a UTI (can enroll after treatment)
  • Have urinary retention (PVR>150cc on two occasions)
  • Do not speak English or Spanish

Location

  • University of California Irvine Medical Center
    Long Beach California 90814 United States

Lead Scientists at UC Irvine

  • Carly Crowder
  • Felicia Lane, MD
    Health Sciences Professor, Obstetrics and Gynecology. Authored (or co-authored) 33 research publications. Research interests: Urinary Incontinence · Fecal Incontinence · Pelvic Organ Prolapse · Reconstructive Pelvic Surgery

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT05308979
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 102 study participants
Last Updated