Overactive Bladder, Overactive Bladder Syndrome, Urge Incontinence, Urinary Frequency, Urinary Incontinence, Urge, Urinary Urge Incontinence, Urinary Urgency
Conditions
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.
Interventions
Intradetrusor (Bladder) Botox Injection at 1 vs 10 injection sites
Sponsors
University of California, Irvine
Kaiser Permanente
St. Joseph Hospital of Orange
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Parallel study with 2 arms, 1:1 randomization
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Overactive Bladder Questionnaire Long Form Score (Health Related Quality of Life)(OAB-Q LF HRQL Subscale) | comparison of baseline OAB-Q HRQL 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 HRQL sub-scale score will be compared prior to procedure and again to score at 3 months after procedure. The score range for the OAB-Q LF HRQL score is 0-100. An increased score equates to improvement in quality of life. A positive change equates to improvement in quality of life. A negative change equates to decreased quality of life. |
| 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 |
| 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). |
| Number of Patients With Patient Global Impression - Improvement (PGI-I) Score of 1 | 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. Score on a scale of (0-100) with 0 being no pain and 100 being highest level of pain. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCarly Crowder, MD
UC Irvine
STUDY_DIRECTORTaylor Brueseke, MD
UC Irvine
STUDY_CHAIRFelicia Lane, MD
UC Irvine
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1 Injection Site 100u Botox® injected at one intradetrusor site
OnabotulinumtoxinA 100 UNT \[Botox\]: Intradetrusor (Bladder) Botox Injection at 1 vs 10 injection sites | 58 |
| 10 Injection Sites 100u Botox® injected at 10 intradetrusor sites
OnabotulinumtoxinA 100 UNT \[Botox\]: Intradetrusor (Bladder) Botox Injection at 1 vs 10 injection sites | 58 |
| Total | 116 |
Baseline characteristics
| Characteristic | 10 Injection Sites | Total | 1 Injection Site |
|---|---|---|---|
| Age, Continuous | 68 years STANDARD_DEVIATION 11.34 | 68 years STANDARD_DEVIATION 11 | 67.9 years STANDARD_DEVIATION 10.72 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 18 Participants | 32 Participants | 14 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 35 Participants | 73 Participants | 38 Participants |
| Sex: Female, Male Female | 58 Participants | 116 Participants | 58 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 58 |
| other Total, other adverse events | 0 / 58 | 0 / 58 |
| serious Total, serious adverse events | 0 / 58 | 0 / 58 |
Outcome results
Primary
Change in Overactive Bladder Questionnaire Long Form Score (Symptoms Severity Sub-scale)(OAB-Q LF)
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.
Time frame: change from baseline OAB-Q score to 3 wk post-procedure score
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 Injection Site | Change in Overactive Bladder Questionnaire Long Form Score (Symptoms Severity Sub-scale)(OAB-Q LF) | -31.2 units on a scale | Standard Deviation 26.25 |
| 10 Injection Sites | Change in Overactive Bladder Questionnaire Long Form Score (Symptoms Severity Sub-scale)(OAB-Q LF) | -39.5 units on a scale | Standard Deviation 24.92 |
Secondary
Change in Overactive Bladder Questionnaire Long Form Score (Symptoms Severity Sub-scale)(OAB-Q LF)
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.
Time frame: comparison of baseline OAB-Q score to 3 month post-procedure score
Secondary
Number of Participants With Urinary Tract Infection (UTI)
Urine culture will be sent for any patient with urinary tract infections symptoms (eg: worsening urgency, frequency, dysuria).
Time frame: anytime after procedure, until at least 3 months post-procedure.
Secondary
Patient Global Impression - Improvement (PGI-I)
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.
Time frame: 3 months after botox procedure
Secondary
Post-void Residual (PVR)
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
Time frame: PVR collected at 3 wk post-procedure
Secondary
Visual Analogue Scale (VAS) - Pain
Participants will complete VAS-pain immediately post-procedure as a pain and tolerability assessment
Time frame: immediately after procedure