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Intradetrusor Botulinum Toxin A: Are Less Injections Better?

Sponsor
University of California, Irvine (Other)
Overall Status
Recruiting
CT.gov ID
NCT05308979
Collaborator
Kaiser Permanente (Other), St. Joseph Hospital of Orange (Other)
102
Enrollment
1
Location
2
Arms
20
Anticipated Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: OnabotulinumtoxinA 100 UNT [Botox]
 Phase 4

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
102 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel study with 2 arms, 1:1 randomizationParallel study with 2 arms, 1:1 randomization
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Intradetrusor Botulinum Toxin A: Can Less Injections Maintain Efficacy and Improve Patient Satisfaction?
Actual Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1 Injection Site

100u Botox® injected at one intradetrusor site

Drug: OnabotulinumtoxinA 100 UNT [Botox]
Intradetrusor (Bladder) Botox Injection at 1 vs 10 injection sites
Active Comparator: 10 Injection Sites

100u Botox® injected at 10 intradetrusor sites

Drug: OnabotulinumtoxinA 100 UNT [Botox]
Intradetrusor (Bladder) Botox Injection at 1 vs 10 injection sites

Outcome Measures

Primary Outcome Measures

  1. Change in Overactive Bladder Questionnaire Long Form Score (symptoms severity sub-scale)(OAB-Q LF) [change from baseline OAB-Q score to 3 wk post-procedure score]

    Participants will be asked to Overactive Bladder Questionnaire Long Form prior to receiving the Botox procedure. The OAB-Q LF symptom severity sub-scale score will be compared prior to procedure and again to score at 3 weeks after procedure. The OAB-q Symptom Severity Score will be computed at baseline and 3 weeks (and 3 months) using the standard scoring algorithm. Minimum value of symptom severity subscale is 8, maximum is 48. A higher score means worse symptoms. A lower score means less symptoms.

Secondary Outcome Measures

  1. Change in Overactive Bladder Questionnaire Long Form Score (symptoms severity sub-scale)(OAB-Q LF) [comparison of baseline OAB-Q score to 3 month post-procedure score]

    Participants will be asked to complete Overactive Bladder Questionnaire Long Form prior to receiving the Botox procedure. The OAB-Q LF symptom severity sub-scale score will be compared prior to procedure and again to score at 3 months after procedure. The OAB-q Symptom Severity Score will be computed at baseline and 3 weeks (and 3 months) using the standard scoring algorithm. Minimum value of symptom severity subscale is 8, maximum is 48. A higher score means worse symptoms. A lower score means less symptoms.

  2. Post-void residual (PVR) [PVR collected at 3 wk post-procedure]

    A PVR will be collected via either urethral catheterization or bladder scan (ultrasound in clinic) at 3 weeks post-procedure as a marker of urinary retention. The PVRs will be compared between study and control groups

  3. Number of participants with urinary tract infection (UTI) [anytime after procedure, until at least 3 months post-procedure.]

    Urine culture will be sent for any patient with urinary tract infections symptoms (eg: worsening urgency, frequency, dysuria).

  4. Patient Global Impression - Improvement (PGI-I) [3 months after botox procedure]

    Participants will complete PGI-I Questionnaire at 3 months after procedure. The minimum value is 1 (very much better) and maximum value score is 7 (very much worse). A higher score indicates worse symptoms. A lower score indicates better symptoms or more improvement.

  5. Visual Analogue Scale (VAS) - Pain [immediately after procedure]

    Participants will complete VAS-pain immediately post-procedure as a pain and tolerability assessment

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Female

  • 18 years old or greater

  • Diagnosis of overactive bladder (urinary urgency or frequency, OAB) or urinary urgency incontinence (UUI)

Exclusion Criteria:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California Irvine Medical Center Orange California United States 92868

Sponsors and Collaborators

  • University of California, Irvine
  • Kaiser Permanente
  • St. Joseph Hospital of Orange

Investigators

  • Principal Investigator: Carly Crowder, MD, UC Irvine
  • Study Director: Taylor Brueseke, MD, UC Irvine
  • Study Chair: Felicia Lane, MD, UC Irvine

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Carly Ann Crowder, Fellow Physician, PI, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT05308979
Other Study ID Numbers:
  • 309
First Posted:
Apr 4, 2022
Last Update Posted:
May 23, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Urinary Incontinence
Urinary Bladder, Overactive
Urinary Incontinence, Urge
Botulinum Toxins, Type A
abobotulinumtoxinA

Study Results

No Results Posted as of May 23, 2022