Intradetrusor Botulinum Toxin A for OAB Via 1 Versus 10 Injections: A Randomized Clinical Trial

Phase 4

Completed

Conditions: Overactive Bladder
Urinary Incontinence, Urge
Urinary Urge Incontinence
Urinary Urgency
Overactive Bladder Syndrome
Urge Incontinence
Urinary Frequency

Interventions: Drug: OnabotulinumtoxinA 100 UNT [Botox]

Registration Number: NCT05308979

Lead Sponsor: University of California, Irvine

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 116

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 Injection Site	OnabotulinumtoxinA 100 UNT [Botox]	100u Botox® injected at one intradetrusor site
10 Injection Sites	OnabotulinumtoxinA 100 UNT [Botox]	100u Botox® injected at 10 intradetrusor sites

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
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
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.
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.
Visual Analogue Scale (VAS) - Pain	immediately after procedure	Participants will complete VAS-pain immediately post-procedure as a pain and tolerability assessment