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The purpose of this research study is to help determine if 10 injections of Botox ® 100 units is less painful than 20 injections of Botox ® 100 units based on effectiveness in reducing urge incontinence episodes. Study will also be assessed for the pain of procedure and adverse outcomes of 20 injections versus 10 injections.
This study is a randomized clinical trial to assess whether or not 10 injections of 100 units of intradetrusor Botox® toxin is perceived as less painful compared to 20 injections of 100 units of intradetrusor Botox® toxin for the treatment of refractory overactive bladder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 Botox Injections | Active Comparator | 100 units of Botox® (onabotulinumtoxinA) will be combined with 10 cc of sterile saline for the purpose of 10 injections. The bladder will be instilled with 2% lidocaine solution through a catheter for at least 5 minutes prior to the procedure. Cystoscopy with either a rigid or flexible cystoscope (per surgeon preference) will be performed using sterile technique. The Botox® will be injected in a grid like pattern avoiding the trigone. |
|
| 20 Botox Injections | Active Comparator | 100 units of Botox® (onabotulinumtoxinA) will be combined with 20 cc of sterile saline for the purpose of 20 injections. The bladder will be instilled with 2% lidocaine solution through a catheter for at least 5 minutes prior to the procedure. Cystoscopy with either a rigid or flexible cystoscope (per surgeon preference) will be performed using sterile technique. The Botox® will be injected in a grid like pattern avoiding the trigone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OnabotulinumtoxinA 100 Units | Drug | BOTOX for injection is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: • Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication. |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain Rating Scale (NPRS) | The patients will rate their level of pain from 0 as no pain to 10 as a severe pain immediately following the completion of bladder injections by selecting a whole number from 0 to 10 that represents their level of pain during the procedure. | Post Procedure Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Mean Urge Incontinence Episodes | The mean urge incontinence episodes which will be calculated by averaging the amount of urge urinary incontinence episodes over 3 days as recorded in a bladder diary at week 12 after the procedure | Week 12 after procedure |
| Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Matthews, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology clinic locations at Wake Forest Baptist Medical Center | Greensboro | North Carolina | 27455 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37991564 | Derived | Zdroik A, El Haraki A, Smith W, Badlani G, Parker-Autry C, Matthews C. Injection site number and outcomes of intradetrusor onabotulinumtoxinA for refractory overactive bladder syndrome: a randomized clinical trial. Int Urogynecol J. 2024 Jan;35(1):119-126. doi: 10.1007/s00192-023-05685-0. Epub 2023 Nov 22. |
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154 patients found eligible for study trial participation. 89 of 154 did not meet the inclusion criteria, 14 declined participation, and 10 patients with other reasons did not participate. Total 41 patients participated with 21 in 10 injections arm and 20 in 20 injections arm.21 patients of 10 injections arm and 19 of 20 injection arm were accounted in study analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | 10 Botox Injections | 100 units of Botox® (onabotulinumtoxinA) will be combined with 10 cc of sterile saline for the purpose of 10 injections. The bladder will be instilled with 2% lidocaine solution through a catheter for at least 5 minutes prior to the procedure. Cystoscopy with either a rigid or flexible cystoscope (per surgeon preference) will be performed using sterile technique. The Botox® will be injected in a grid like pattern avoiding the trigone. OnabotulinumtoxinA 100 UNT: BOTOX for injection is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: • Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication. |
| FG001 | 20 Botox Injections | 100 units of Botox® (onabotulinumtoxinA) will be combined with 20 cc of sterile saline for the purpose of 20 injections. The bladder will be instilled with 2% lidocaine solution through a catheter for at least 5 minutes prior to the procedure. Cystoscopy with either a rigid or flexible cystoscope (per surgeon preference) will be performed using sterile technique. The Botox® will be injected in a grid like pattern avoiding the trigone. OnabotulinumtoxinA 100 UNT: BOTOX for injection is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: • Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 10 Botox Injections | 100 units of Botox® (onabotulinumtoxinA) will be combined with 10 cc of sterile saline for the purpose of 10 injections. The bladder will be instilled with 2% lidocaine solution through a catheter for at least 5 minutes prior to the procedure. Cystoscopy with either a rigid or flexible cystoscope (per surgeon preference) will be performed using sterile technique. The Botox® will be injected in a grid like pattern avoiding the trigone. OnabotulinumtoxinA 100 UNT: BOTOX for injection is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: • Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Numeric Pain Rating Scale (NPRS) | The patients will rate their level of pain from 0 as no pain to 10 as a severe pain immediately following the completion of bladder injections by selecting a whole number from 0 to 10 that represents their level of pain during the procedure. | Posted | Mean | Inter-Quartile Range | score on a scale | Post Procedure Day 1 |
|
12 Weeks
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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 | 10 Botox Injections | 100 units of Botox® (onabotulinumtoxinA) will be combined with 10 cc of sterile saline for the purpose of 10 injections. The bladder will be instilled with 2% lidocaine solution through a catheter for at least 5 minutes prior to the procedure. Cystoscopy with either a rigid or flexible cystoscope (per surgeon preference) will be performed using sterile technique. The Botox® will be injected in a grid like pattern avoiding the trigone. OnabotulinumtoxinA 100 UNT: BOTOX for injection is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: • Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Renal and urinary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sachin N. Vyas, Research Manager | Urology Department, Wake Forest University | 336-713-4098 | svyas@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 25, 2022 | Aug 2, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 31, 2023 | Aug 2, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 12, 2022 | Aug 2, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
|
Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 0 - to 100-point scale, with lower scores indicating greater effect, i.e., worse Quality of Life |
| Baseline |
| Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms | Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 0 - to 100-point scale, with lower scores indicating greater effect, i.e., worse Quality of Life | 2 weeks post procedure |
| Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms | Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 0 - to 100-point scale, with lower scores indicating greater effect, i.e., worse Quality of Life | 12 weeks post procedure |
| Over Active Bladder (OAB) Questionnaire Short Form Scores - Health Related Quality of Life | Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 13 items to assess health Related Quality of Life (HRQOL). Total range 0 to 100. A higher score on the HRQOL scale indicates a better HRQO. | Baseline |
| Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life | Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 13 items to assess health Related Quality of Life (HRQOL). Total range 0 to 100. A higher score on the HRQOL scale indicates a better HRQO. | 2 weeks post procedure |
| Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life | Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 13 items to assess health Related Quality of Life (HRQOL). Total range 0 to 100. A higher score on the HRQOL scale indicates a better HRQO. | 12 weeks post procedure |
| Post-Void Residual (PVR) | PVR using bladder scanner evaluates the post void residual in the bladder. | 2 weeks post procedure |
| Post-Void Residual (PVR) | PVR using bladder scanner evaluates the post void residual in the bladder. | 12 weeks post procedure |
| Urology clinic locations at Wake Forest Baptist Medical Center |
| Winston-Salem |
| North Carolina |
| 27157 |
| United States |
| BG001 | 20 Botox Injections | 100 units of Botox® (onabotulinumtoxinA) will be combined with 20 cc of sterile saline for the purpose of 20 injections. The bladder will be instilled with 2% lidocaine solution through a catheter for at least 5 minutes prior to the procedure. Cystoscopy with either a rigid or flexible cystoscope (per surgeon preference) will be performed using sterile technique. The Botox® will be injected in a grid like pattern avoiding the trigone. OnabotulinumtoxinA 100 UNT: BOTOX for injection is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: • Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 20 Botox Injections | 100 units of Botox® (onabotulinumtoxinA) will be combined with 20 cc of sterile saline for the purpose of 20 injections. The bladder will be instilled with 2% lidocaine solution through a catheter for at least 5 minutes prior to the procedure. Cystoscopy with either a rigid or flexible cystoscope (per surgeon preference) will be performed using sterile technique. The Botox® will be injected in a grid like pattern avoiding the trigone. OnabotulinumtoxinA 100 UNT: BOTOX for injection is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: • Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication. |
|
|
| Secondary | Difference in Mean Urge Incontinence Episodes | The mean urge incontinence episodes which will be calculated by averaging the amount of urge urinary incontinence episodes over 3 days as recorded in a bladder diary at week 12 after the procedure | Posted | Mean | Inter-Quartile Range | Number of Urinary Leaks in 24 HRS | Week 12 after procedure |
|
|
|
| Secondary | Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms | Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 0 - to 100-point scale, with lower scores indicating greater effect, i.e., worse Quality of Life | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Secondary | Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms | Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 0 - to 100-point scale, with lower scores indicating greater effect, i.e., worse Quality of Life | Posted | Mean | Standard Deviation | score on a scale | 2 weeks post procedure |
|
|
|
| Secondary | Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms | Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 0 - to 100-point scale, with lower scores indicating greater effect, i.e., worse Quality of Life | Posted | Mean | Standard Deviation | score on a scale | 12 weeks post procedure |
|
|
|
| Secondary | Over Active Bladder (OAB) Questionnaire Short Form Scores - Health Related Quality of Life | Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 13 items to assess health Related Quality of Life (HRQOL). Total range 0 to 100. A higher score on the HRQOL scale indicates a better HRQO. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Secondary | Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life | Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 13 items to assess health Related Quality of Life (HRQOL). Total range 0 to 100. A higher score on the HRQOL scale indicates a better HRQO. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks post procedure |
|
|
|
| Secondary | Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life | Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 13 items to assess health Related Quality of Life (HRQOL). Total range 0 to 100. A higher score on the HRQOL scale indicates a better HRQO. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks post procedure |
|
|
|
| Secondary | Post-Void Residual (PVR) | PVR using bladder scanner evaluates the post void residual in the bladder. | Posted | Mean | Standard Deviation | ml | 2 weeks post procedure |
|
|
|
| Secondary | Post-Void Residual (PVR) | PVR using bladder scanner evaluates the post void residual in the bladder. | Posted | Mean | Inter-Quartile Range | ml | 12 weeks post procedure |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 4 |
| 21 |
| EG001 | 20 Botox Injections | 100 units of Botox® (onabotulinumtoxinA) will be combined with 20 cc of sterile saline for the purpose of 20 injections. The bladder will be instilled with 2% lidocaine solution through a catheter for at least 5 minutes prior to the procedure. Cystoscopy with either a rigid or flexible cystoscope (per surgeon preference) will be performed using sterile technique. The Botox® will be injected in a grid like pattern avoiding the trigone. OnabotulinumtoxinA 100 UNT: BOTOX for injection is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: • Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication. | 0 | 20 | 0 | 20 | 5 | 20 |
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| 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 |
| D009461 | Neurologic Manifestations |
| 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 |