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| Name | Class |
|---|---|
| Kaiser Permanente | OTHER |
| St. Joseph Hospital of Orange | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Injection Site | Experimental | 100u Botox® injected at one intradetrusor site |
|
| 10 Injection Sites | Active Comparator | 100u Botox® injected at 10 intradetrusor sites |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OnabotulinumtoxinA 100 UNT [Botox] | Drug | Intradetrusor (Bladder) Botox Injection at 1 vs 10 injection sites |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | change from baseline OAB-Q score to 3 wk post-procedure score |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Overactive Bladder Questionnaire Long Form Score (Health Related Quality of Life)(OAB-Q LF HRQL Subscale) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carly Crowder, MD | UC Irvine | Principal Investigator |
| Taylor Brueseke, MD | UC Irvine | Study Director |
| Felicia Lane, MD | UC Irvine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Irvine Medical Center | Orange | California | 92868 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18499184 | Background | Brubaker L, Richter HE, Visco A, Mahajan S, Nygaard I, Braun TM, Barber MD, Menefee S, Schaffer J, Weber AM, Wei J; Pelvic Floor Disorders Network. Refractory idiopathic urge urinary incontinence and botulinum A injection. J Urol. 2008 Jul;180(1):217-22. doi: 10.1016/j.juro.2008.03.028. Epub 2008 May 21. | |
| 23608668 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 Injection Site | 100u Botox® injected at one intradetrusor site OnabotulinumtoxinA 100 UNT [Botox]: Intradetrusor (Bladder) Botox Injection at 1 vs 10 injection sites |
| FG001 | 10 Injection Sites |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 9, 2022 |
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Parallel study with 2 arms, 1:1 randomization
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| comparison of baseline OAB-Q HRQL score to 3 month post-procedure score |
| 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 | PVR collected at 3 wk post-procedure |
| 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). | anytime after procedure, until at least 3 months post-procedure. |
| Number of Patients With Patient Global Impression - Improvement (PGI-I) Score of 1 | 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. | 3 months after botox procedure |
| Visual Analogue Scale (VAS) - Pain | 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. | immediately after procedure |
| Chapple C, Sievert KD, MacDiarmid S, Khullar V, Radziszewski P, Nardo C, Thompson C, Zhou J, Haag-Molkenteller C. OnabotulinumtoxinA 100 U significantly improves all idiopathic overactive bladder symptoms and quality of life in patients with overactive bladder and urinary incontinence: a randomised, double-blind, placebo-controlled trial. Eur Urol. 2013 Aug;64(2):249-56. doi: 10.1016/j.eururo.2013.04.001. Epub 2013 Apr 10. |
| 23036134 | Background | Visco AG, Brubaker L, Richter HE, Nygaard I, Paraiso MF, Menefee SA, Schaffer J, Lowder J, Khandwala S, Sirls L, Spino C, Nolen TL, Wallace D, Meikle SF; Pelvic Floor Disorders Network. Anticholinergic therapy vs. onabotulinumtoxina for urgency urinary incontinence. N Engl J Med. 2012 Nov 8;367(19):1803-13. doi: 10.1056/NEJMoa1208872. Epub 2012 Oct 4. |
| 27701661 | Background | Amundsen CL, Richter HE, Menefee SA, Komesu YM, Arya LA, Gregory WT, Myers DL, Zyczynski HM, Vasavada S, Nolen TL, Wallace D, Meikle SF. OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women: A Randomized Clinical Trial. JAMA. 2016 Oct 4;316(13):1366-1374. doi: 10.1001/jama.2016.14617. |
| 23246476 | Background | Nitti VW, Dmochowski R, Herschorn S, Sand P, Thompson C, Nardo C, Yan X, Haag-Molkenteller C; EMBARK Study Group. OnabotulinumtoxinA for the treatment of patients with overactive bladder and urinary incontinence: results of a phase 3, randomized, placebo controlled trial. J Urol. 2013 Jun;189(6):2186-93. doi: 10.1016/j.juro.2012.12.022. Epub 2012 Dec 14. |
| 25914349 | Background | Liao CH, Chen SF, Kuo HC. Different number of intravesical onabotulinumtoxinA injections for patients with refractory detrusor overactivity do not affect treatment outcome: A prospective randomized comparative study. Neurourol Urodyn. 2016 Aug;35(6):717-23. doi: 10.1002/nau.22780. Epub 2015 Apr 24. |
| 22306320 | Background | Coelho A, Cruz F, Cruz CD, Avelino A. Spread of onabotulinumtoxinA after bladder injection. Experimental study using the distribution of cleaved SNAP-25 as the marker of the toxin action. Eur Urol. 2012 Jun;61(6):1178-84. doi: 10.1016/j.eururo.2012.01.046. Epub 2012 Feb 1. |
| 19145439 | Background | Mehnert U, Boy S, Schmid M, Reitz A, von Hessling A, Hodler J, Schurch B. A morphological evaluation of botulinum neurotoxin A injections into the detrusor muscle using magnetic resonance imaging. World J Urol. 2009 Jun;27(3):397-403. doi: 10.1007/s00345-008-0362-0. Epub 2009 Jan 15. |
| 33742316 | Background | Ton J, Downing P, Versi E, van Uem S, Ephraim S, Murphy M, Lucente V. Outcomes of a single trigone-only vs. 20 trigone-sparing injections of OnabotulinumtoxinA for refractory overactive bladder (OAB). Int Urol Nephrol. 2021 Jun;53(6):1067-1072. doi: 10.1007/s11255-021-02802-0. Epub 2021 Mar 19. |
| 27283922 | Background | Avallone MA, Sack BS, El-Arabi A, Guralnick ML, O'Connor RC. Less is more-A pilot study evaluating one to three intradetrusor sites for injection of OnabotulinumtoxinA for neurogenic and idiopathic detrusor overactivity. Neurourol Urodyn. 2017 Apr;36(4):1104-1107. doi: 10.1002/nau.23052. Epub 2016 Jun 10. |
100u Botox® injected at 10 intradetrusor sites
OnabotulinumtoxinA 100 UNT [Botox]: Intradetrusor (Bladder) Botox Injection at 1 vs 10 injection sites
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 Injection Site | 100u Botox® injected at one intradetrusor site OnabotulinumtoxinA 100 UNT [Botox]: Intradetrusor (Bladder) Botox Injection at 1 vs 10 injection sites |
| BG001 | 10 Injection Sites | 100u Botox® injected at 10 intradetrusor sites OnabotulinumtoxinA 100 UNT [Botox]: Intradetrusor (Bladder) Botox Injection at 1 vs 10 injection sites |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | change from baseline OAB-Q score to 3 wk post-procedure score |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Change in Overactive Bladder Questionnaire Long Form Score (Health Related Quality of Life)(OAB-Q LF HRQL Subscale) | 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. | Posted | Mean | Standard Deviation | score | comparison of baseline OAB-Q HRQL score to 3 month post-procedure score |
|
| ||||||||||||||||||||||||||||||
| 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 | Posted | Mean | Standard Deviation | mL | PVR collected at 3 wk post-procedure |
|
| ||||||||||||||||||||||||||||||
| 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). | Posted | Count of Participants | Participants | anytime after procedure, until at least 3 months post-procedure. |
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Patient Global Impression - Improvement (PGI-I) Score of 1 | 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. | Score of 1 very much better | Posted | Number | participants | 3 months after botox procedure |
|
| ||||||||||||||||||||||||||||||
| Secondary | Visual Analogue Scale (VAS) - Pain | 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. | Posted | Mean | Standard Deviation | score on a scale | immediately after procedure |
|
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1 Injection Site | 100u Botox® injected at one intradetrusor site OnabotulinumtoxinA 100 UNT [Botox]: Intradetrusor (Bladder) Botox Injection at 1 vs 10 injection sites | 0 | 58 | 0 | 58 | 0 | 58 |
| EG001 | 10 Injection Sites | 100u Botox® injected at 10 intradetrusor sites OnabotulinumtoxinA 100 UNT [Botox]: Intradetrusor (Bladder) Botox Injection at 1 vs 10 injection sites | 0 | 58 | 0 | 58 | 0 | 58 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carly Crowder | UC Irvine Medical Center | 7144562911 | crowderc@hs.uci.edu |
| Jan 24, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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