Overactive Bladder
Conditions
Keywords
Overactive bladder, Urinary urgency, Urgency incontinence, Botox
Brief summary
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.
Detailed description
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: * 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 * 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 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.
Interventions
BIOLOGICALIntradetrusor Botox Injections
100 units of OnabotuliumtoxinA is injected into the detrusor muscle in 1 mL aliquots using a cystoscope.
Sponsors
The Methodist Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women scheduled to undergo 100 units intradetrusor BTX-A injections in the office for the diagnosis of idiopathic overactive bladder within the departments of Urology and Urogynecology * 18 years of age or older * Able to give informed consent in English or Spanish * Understand and are willing to undergo follow-up and complete all questionnaires as described in this protocol
Exclusion criteria
* Neurogenic bladder related to prior diagnosis of neurological conditions such as cerebral vascular accident within 6 months prior to treatment, Parkinson's Disease, Multiple Sclerosis, myelomeningocele, traumatic neurologic or spinal injury, or idiopathic diagnosis of neurogenic bladder. * Symptomatic UTI at the time of procedure, defined as positive nitrites or high-volume leukocyte esterase on urine dip in addition to at least one of the following symptoms: dysuria, gross hematuria, suprapubic pain, frequency/urgency above baseline * Diagnosis of a bladder pain syndrome or other chronic pain syndromes including fibromyalgia, chronic pelvic pain, pelvic floor dysfunction, levator myalgia * Known bladder malignancy * Previous history of bladder augmentation or reconstructive surgery not related to prolapse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Discomfort Related to BTX-A Injection | Immediately post-procedure (up to 45min after intradetrusor BTX-A injections) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Efficacy - Overactive Bladder Questionnaire Short-Form (OAB-q SF) | Prior to BTX-A injections and 30 days post-procedure | 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. |
| Overall Treatment Satisfaction | 30 days post-procedure | 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 |
| Impression of Clinical Improvement | 30 days post-procedure | 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. |
| Procedural Outcomes | 30 days post-procedure | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 52 |
| 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 | 56 |
| Total | 108 |
Baseline characteristics
| Characteristic | Total | 5 mL Group | 10 mL Group |
|---|---|---|---|
| Age, Continuous | 67.6 Years STANDARD_DEVIATION 12.8 | 64.6 Years STANDARD_DEVIATION 14.3 | 70.6 Years STANDARD_DEVIATION 10.3 |
| First Botox Injection No | 66 Participants | 30 Participants | 36 Participants |
| First Botox Injection Yes | 42 Participants | 22 Participants | 20 Participants |
| Medical Co-Morbidities Depression | 41 Participants | 23 Participants | 18 Participants |
| Medical Co-Morbidities Diabetes | 17 Participants | 9 Participants | 8 Participants |
| Medical Co-Morbidities Neurologic Diagnosis | 25 Participants | 15 Participants | 10 Participants |
| Medical Co-Morbidities Recurrent Urinary Tract Infection | 17 Participants | 5 Participants | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 91 Participants | 46 Participants | 45 Participants |
| Sex: Female, Male Female | 108 Participants | 52 Participants | 56 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Surgical History Hysterectomy | 58 Participants | 23 Participants | 35 Participants |
| Surgical History Incontinence Procedure | 20 Participants | 14 Participants | 6 Participants |
| Surgical History Prolapse Repair | 26 Participants | 16 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 43 |
| other Total, other adverse events | 6 / 36 | 7 / 43 |
| serious Total, serious adverse events | 0 / 36 | 0 / 43 |
Outcome results
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.
Time frame: Immediately post-procedure (up to 45min after intradetrusor BTX-A injections)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5 mL Group | Participant Discomfort Related to BTX-A Injection | 3.2 score on a scale | Standard Deviation 2.3 |
| 10 mL Group | Participant Discomfort Related to BTX-A Injection | 3.6 score on a scale | Standard Deviation 2.1 |
Comparison: Difference in NPS score pre- and post-procedurep-value: 0.21t-test, 2 sided
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.
Time frame: 30 days post-procedure
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 5 mL Group | Impression of Clinical Improvement | Very much improved | 9 Participants |
| 5 mL Group | Impression of Clinical Improvement | Much improved | 18 Participants |
| 5 mL Group | Impression of Clinical Improvement | Minimally improved | 7 Participants |
| 5 mL Group | Impression of Clinical Improvement | No difference | 2 Participants |
| 10 mL Group | Impression of Clinical Improvement | No difference | 3 Participants |
| 10 mL Group | Impression of Clinical Improvement | Very much improved | 9 Participants |
| 10 mL Group | Impression of Clinical Improvement | Minimally improved | 15 Participants |
| 10 mL Group | Impression of Clinical Improvement | Much improved | 16 Participants |
p-value: 0.79Chi-squared
p-value: 0.27Chi-squared
p-value: 0.14Chi-squared
p-value: 1Chi-squared
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
Time frame: 30 days post-procedure
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 5 mL Group | Overall Treatment Satisfaction | Satisfied | 33 Participants |
| 5 mL Group | Overall Treatment Satisfaction | Not Satisfied | 3 Participants |
| 10 mL Group | Overall Treatment Satisfaction | Satisfied | 34 Participants |
| 10 mL Group | Overall Treatment Satisfaction | Not Satisfied | 9 Participants |
Comparison: Participant rated procedural satisfaction assessed 30-days post-procedure.p-value: 0.21Chi-squared
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.
Time frame: Prior to BTX-A injections and 30 days post-procedure
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| 5 mL Group | Procedural Efficacy - Overactive Bladder Questionnaire Short-Form (OAB-q SF) | OAB-q SF (SB (mean difference)) | -22.4 Units on a scale |
| 5 mL Group | Procedural Efficacy - Overactive Bladder Questionnaire Short-Form (OAB-q SF) | OAB-q SF (HRQL (mean difference)) | 14.59 Units on a scale |
| 10 mL Group | Procedural Efficacy - Overactive Bladder Questionnaire Short-Form (OAB-q SF) | OAB-q SF (SB (mean difference)) | -38.1 Units on a scale |
| 10 mL Group | Procedural Efficacy - Overactive Bladder Questionnaire Short-Form (OAB-q SF) | OAB-q SF (HRQL (mean difference)) | 26.24 Units on a scale |
Comparison: Difference in overactive bladder symptom bother before and after treatmentp-value: 0.07t-test, 2 sided
Comparison: Difference in overactive bladder HRQL mean before and after treatmentp-value: 0.16t-test, 2 sided
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.
Time frame: 30 days post-procedure
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 5 mL Group | Procedural Outcomes | Urinary retention | 0 Participants |
| 5 mL Group | Procedural Outcomes | Urinary tract infection | 5 Participants |
| 5 mL Group | Procedural Outcomes | Bleeding requiring evaluation | 0 Participants |
| 5 mL Group | Procedural Outcomes | Hematuria | 1 Participants |
| 5 mL Group | Procedural Outcomes | Bladder pain | 0 Participants |
| 5 mL Group | Procedural Outcomes | Emergency department evaluation | 0 Participants |
| 10 mL Group | Procedural Outcomes | Bladder pain | 1 Participants |
| 10 mL Group | Procedural Outcomes | Urinary retention | 2 Participants |
| 10 mL Group | Procedural Outcomes | Hematuria | 0 Participants |
| 10 mL Group | Procedural Outcomes | Urinary tract infection | 2 Participants |
| 10 mL Group | Procedural Outcomes | Emergency department evaluation | 2 Participants |
| 10 mL Group | Procedural Outcomes | Bleeding requiring evaluation | 0 Participants |
p-value: 0.5Chi-squared
p-value: 0.24Chi-squared
p-value: 1Chi-squared
p-value: 0.46Chi-squared
p-value: 1Chi-squared
p-value: 0.5Chi-squared