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Injection of intradetrusor OnabotulinumtoxinA (BTX-A) is a highly efficacious therapy with a reliable safety profile and demonstrable improvements in subjective and objective measures for overactive bladder (OAB) symptom control. This procedure can be performed in the office with an evidence-based standard dosing of 100 units for idiopathic OAB. This is a single-blinded, randomized control trial is to evaluate and optimize the technique for performing intradetrusor injections of BTX-A for idiopathic OAB. This trial proposes two different reconstitution and injection schema to study patient-centered outcomes related to procedural discomfort and symptom relief.
This will be a single-blinded, parallel randomized control trial (RCT) utilizing two study arms. This trial will be designed and reported as outlined in the CONSORT guidelines
The primary aim of this study is to evaluate perceived discomfort using the Numeric Pain Scale (NPS) during office injection of intradetrusor BTX-A via two different injection techniques and reconstitution volumes.
The secondary aims of this study are to evaluate treatment effectiveness and patient satisfaction of treatment with BTX-A using validated questionnaires. Investigators will also compare procedure time and post-procedure complication rates between the two study groups.
Study Groups: The patients will be randomized in a 1:1 fashion to one of two groups:
The primary outcome will be measured on the day of the procedure using the NPS scale. Investigators will follow up with patients at 30 days post-procedure to assess treatment effectiveness, overall satisfaction, and post-procedure outcomes using validated questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 mL Group | Active Comparator | 100 units BTX-A reconstituted in 5 mL normal saline, injected into the bladder in 5 separate injections of 1 mL. One injection will be at the trigone. |
|
| 10 mL Group | Active Comparator | 100 units BTX-A reconstituted in 10 mL normal saline, injected into the bladder in 10 separate injections of 1 mL. One injection will be at the trigone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intradetrusor Botox Injections | Biological | 100 units of OnabotuliumtoxinA is injected into the detrusor muscle in 1 mL aliquots using a cystoscope. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant Discomfort Related to BTX-A Injection | Participants will assess their discomfort using the Numeric Pain Scale (NPS), a validated 11-point scale (0-10) where higher scores indicate greater pain, before and immediately after the procedure. Procedural discomfort will be evaluated by comparing the change in NPS scores from pre- to post-procedure between study groups. | Immediately post-procedure (up to 45min after intradetrusor BTX-A injections) |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Efficacy - Overactive Bladder Questionnaire Short-Form (OAB-q SF) | Efficacy will be evaluated using the Overactive Bladder Questionnaire Short-Form (OAB-q SF), a validated instrument designed to measure symptom bother (SB) and the impact of OAB on health-related quality of life (HRQL). This questionnaire is administered on the day of the procedure (baseline) and again 30 days post-procedure. Changes in SB and HRQL scores assess improvement in OAB symptoms following BTX-A treatment. The OAB-q SF includes 19 items divided into two subscales: a 6-item SB scale (Questions 1-6) and a 13-item HRQL scale (Questions 7-19). SB items are scored from 1 ("not at all") to 6 ("a very great deal"), yielding a total SB score range of 6 to 36, with higher scores indicating greater symptom bother. HRQL items are scored from 1 ("none of the time") to 6 ("all of the time"), with total scores ranging from 13 to 78, where higher scores reflect better quality of life. We report here the mean change in SB and HRQL scores from baseline to 30 days post-treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rose Khavari, MD | The Methodist Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38484251 | Derived | Miceli LM, Antosh DD, Nisar T, Stewart J, Rutledge EC, Khavari R. Pain Related to Intradetrusor BotulinumtoxinA: A Randomized Clinical Trial. Urogynecology (Phila). 2024 Mar 1;30(3):337-344. doi: 10.1097/SPV.0000000000001487. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 5 mL Group | 100 units BTX-A reconstituted in 5 mL normal saline, injected into the bladder in 5 separate injections of 1 mL. One injection will be at the trigone. |
| FG001 | 10 mL Group | 100 units BTX-A reconstituted in 10 mL normal saline, injected into the bladder in 10 separate injections of 1 mL. One injection will be at the trigone |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 5 mL Group | 100 units BTX-A reconstituted in 5 mL normal saline, injected into the bladder in 5 separate injections of 1 mL. One injection will be at the trigone. |
| BG001 | 10 mL Group |
| 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 | Participant Discomfort Related to BTX-A Injection | Participants will assess their discomfort using the Numeric Pain Scale (NPS), a validated 11-point scale (0-10) where higher scores indicate greater pain, before and immediately after the procedure. Procedural discomfort will be evaluated by comparing the change in NPS scores from pre- to post-procedure between study groups. | Posted | Mean | Standard Deviation | score on a scale | Immediately post-procedure (up to 45min after intradetrusor BTX-A injections) |
|
1 month post-treatment
Thirty-day AE data were available for 69% (n = 36) of participants in the 5 mL/5 injection arm and 77% (n = 43) of participants in the 10 mL/10 injection arm.
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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 | 5 mL Group | 100 units BTX-A reconstituted in 5 mL normal saline, injected into the bladder in 5 separate injections of 1 mL. One injection will be at the trigone. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
Possible small variations in injection technique were minimized through physician training. Patients were blinded to treatment, but non-naive patients may have biased pain scores based on prior experiences. Loss to follow-up at 30 days limits conclusions on secondary outcomes related to patient experience and procedural efficacy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rose Khavari | Houston Methodist Hospital Department of Urology | 713-441-6455 | rkhavari@houstonmethodist.or |
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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 | Oct 2, 2023 | Mar 25, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Prior to BTX-A injections and 30 days post-procedure |
| Overall Treatment Satisfaction | Overall treatment satisfaction will be assessed at 30-days post-procedure via a "yes or no" response to inquiry about overall satisfaction with the procedure and results of their BTX-A treatment | 30 days post-procedure |
| Impression of Clinical Improvement | Patients impression of clinical improvement after treatment will be assessed at 30-day post-procedure via the Clinical Global Impression - Improvement Scale (CGI-I). The CGI-I is a seven point verbal scale with higher values indicating higher impression of symptomatic improvement related to the treatment. Scale reports values as: Very much improved, Much improved, Minimally improved, No difference. | 30 days post-procedure |
| Procedural Outcomes | We will review the electronic medical record to evaluate instances of symptomatic urinary tract infection, bothersome incomplete bladder emptying requiring catheterization, and instances of bleeding requiring evaluation after the procedure. | 30 days post-procedure |
100 units BTX-A reconstituted in 10 mL normal saline, injected into the bladder in 10 separate injections of 1 mL. One injection will be at the trigone
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Medical Co-Morbidities | Count of Participants | Participants |
|
| Surgical History | Count of Participants | Participants |
|
| First Botox Injection | Count of Participants | Participants | No |
|
100 units BTX-A reconstituted in 10 mL normal saline, injected into the bladder in 10 separate injections of 1 mL. One injection will be at the trigone
|
|
|
| Secondary | Procedural Efficacy - Overactive Bladder Questionnaire Short-Form (OAB-q SF) | Efficacy will be evaluated using the Overactive Bladder Questionnaire Short-Form (OAB-q SF), a validated instrument designed to measure symptom bother (SB) and the impact of OAB on health-related quality of life (HRQL). This questionnaire is administered on the day of the procedure (baseline) and again 30 days post-procedure. Changes in SB and HRQL scores assess improvement in OAB symptoms following BTX-A treatment. The OAB-q SF includes 19 items divided into two subscales: a 6-item SB scale (Questions 1-6) and a 13-item HRQL scale (Questions 7-19). SB items are scored from 1 ("not at all") to 6 ("a very great deal"), yielding a total SB score range of 6 to 36, with higher scores indicating greater symptom bother. HRQL items are scored from 1 ("none of the time") to 6 ("all of the time"), with total scores ranging from 13 to 78, where higher scores reflect better quality of life. We report here the mean change in SB and HRQL scores from baseline to 30 days post-treatment. | Follow-up data 30-days post-treatment was obtained from 69% (n = 36) of participants in the 5 mL/5 injection arm and 77% (n = 43) of participants in the 10 mL/10 injection arm. | Posted | Mean | Full Range | Units on a scale | Prior to BTX-A injections and 30 days post-procedure |
|
|
|
|
| Secondary | Overall Treatment Satisfaction | Overall treatment satisfaction will be assessed at 30-days post-procedure via a "yes or no" response to inquiry about overall satisfaction with the procedure and results of their BTX-A treatment | Thirty-day follow-up data were available for 69% (n = 36) in the 5 mL/5 injection arm and 77% (n = 43) in the 10 mL/10 injection arm. | Posted | Count of Participants | Participants | 30 days post-procedure |
|
|
|
|
| Secondary | Impression of Clinical Improvement | Patients impression of clinical improvement after treatment will be assessed at 30-day post-procedure via the Clinical Global Impression - Improvement Scale (CGI-I). The CGI-I is a seven point verbal scale with higher values indicating higher impression of symptomatic improvement related to the treatment. Scale reports values as: Very much improved, Much improved, Minimally improved, No difference. | Thirty-day follow-up data were available for 69% (n = 36) in the 5 mL/5 injection arm and 77% (n = 43) in the 10 mL/10 injection arm. | Posted | Count of Participants | Participants | 30 days post-procedure |
|
|
|
|
| Secondary | Procedural Outcomes | We will review the electronic medical record to evaluate instances of symptomatic urinary tract infection, bothersome incomplete bladder emptying requiring catheterization, and instances of bleeding requiring evaluation after the procedure. | Post-procedural Adverse Outcomes - Urinary retention, Urinary tract infection, Bleeding requiring evaluation, Hematuria, Bladder pain, and Emergency department evaluation. n=36 and n=43 participants were evaluated for the 5ml and 10ml arms respectively. | Posted | Count of Participants | Participants | 30 days post-procedure |
|
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| 6 |
| 36 |
| EG001 | 10 mL Group | 100 units BTX-A reconstituted in 10 mL normal saline, injected into the bladder in 10 separate injections of 1 mL. One injection will be at the trigone | 0 | 43 | 0 | 43 | 7 | 43 |
| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
|
| Bleeding Requiring Evaluation | Renal and urinary disorders | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Systematic Assessment |
|
| Bladder Pain | Renal and urinary disorders | Systematic Assessment |
|
| Emergency Department Evaluation | Renal and urinary disorders | Systematic Assessment |
|
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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 |
| t-test, 2 sided |
| 0.16 |
Threshold for statistical significance used P-value <0.05 |
| Other |
| Minimally improved |
|
| No difference |
|
| 0.27 |
| Other |
Clinical Global Impression of Improvement scale sores reported by participants as much improved after treatment |
| Chi-squared | 0.14 | Other | Clinical Global Impression of Improvement scale sores reported by participants as minimally improved after treatment |
| Chi-squared | 1.0 | Other | Clinical Global Impression of Improvement scale sores reported by participants as no difference after treatment |
| Bleeding requiring evaluation |
|
| Hematuria |
|
| Bladder pain |
|
| Emergency department evaluation |
|
| Other |
Rates of urinary tract infection observed in participants after BTX-A treatment. |
| Chi-squared | 1.0 | Other | Rates of bleeding requiring evaluation observed in participants after BTX-A treatment. |
| Chi-squared | 0.46 | Other | Rates of hematuria observed in participants after BTX-A treatment. |
| Chi-squared | 1.0 | Other | Rates of bladder pain observed in participants after BTX-A treatment. |
| Chi-squared | 0.5 | Other | Rates of ER department evaluations observed in participants after BTX-A treatment. |