Overactive Bladder
Conditions
Keywords
Overactive Bladder, Botox/OnabotulinumtoxinA, Pain, OAB, Non-neurogenic Overactive bladder
Brief summary
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.
Detailed description
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.
Interventions
DRUGOnabotulinumtoxinA 100 Units
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.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Female gender * At least 18 years of age * Have already decided to undergo intradetrusor Botox® injections for treatment of refractory overactive bladder. * Able and willing to learn clean intermittent catheterization (or care provider is willing and able to perform intermittent catheterization). * Understands and is willing to undergo follow up and complete questionnaires as described in this protocol * Able to give informed consent
Exclusion criteria
* Male gender * Neurological conditions (Examples: Cerebral vascular accident within 6 months prior to treatment, Parkinson's disease, Multiple Sclerosis, and Spina Bifida). * Acute urinary tract infection * Treatment with Botox® toxin for other conditions * Allergy to Botox® toxin * Hematuria that has not been worked up * Known bladder malignancy * Previous history of bladder augmentation * Currently pregnant (with no plans to become pregnant within 6 months of enrollment) or breastfeeding * Currently taking aminoglycoside antibiotics * Post-void residual (PVR) \>150 cc (measured by bladder scan or by catheterization) prior to enrollment * History of chronic pain or pain syndromes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Rating Scale (NPRS) | Post Procedure Day 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Mean Urge Incontinence Episodes | Week 12 after procedure | 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 |
| Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms | Baseline | 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 |
| Over Active Bladder (OAB) Questionnaire Short Form Scores - Health Related Quality of Life | Baseline | 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. |
| Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life | 2 weeks post procedure | 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. |
| Post-Void Residual (PVR) | 2 weeks post procedure | PVR using bladder scanner evaluates the post void residual in the bladder. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| 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. | 20 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 3 |
Baseline characteristics
| Characteristic | 20 Botox Injections | Total | 10 Botox Injections |
|---|---|---|---|
| Age, Continuous | 67.67 years STANDARD_DEVIATION 9.1 | 69.67 years STANDARD_DEVIATION 9.58 | 77.28 years STANDARD_DEVIATION 8.97 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 20 participants | 41 participants | 21 participants |
| Sex: Female, Male Female | 20 Participants | 41 Participants | 21 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 / 21 | 0 / 20 |
| other Total, other adverse events | 4 / 21 | 5 / 20 |
| serious Total, serious adverse events | 0 / 21 | 0 / 20 |
Outcome results
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.
Time frame: Post Procedure Day 1
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 10 Botox Injections | Numeric Pain Rating Scale (NPRS) | 4 score on a scale |
| 20 Botox Injections | Numeric Pain Rating Scale (NPRS) | 3 score on a scale |
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
Time frame: Week 12 after procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 10 Botox Injections | Difference in Mean Urge Incontinence Episodes | 1.64 Number of Urinary Leaks in 24 HRS |
| 20 Botox Injections | Difference in Mean Urge Incontinence Episodes | 1.35 Number of Urinary Leaks in 24 HRS |
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.
Time frame: 12 weeks post procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 10 Botox Injections | Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life | 27.74 score on a scale | Standard Deviation 12.92 |
| 20 Botox Injections | Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life | 27.00 score on a scale | Standard Deviation 11.2 |
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.
Time frame: 2 weeks post procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 10 Botox Injections | Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life | 28.71 score on a scale | Standard Deviation 14.26 |
| 20 Botox Injections | Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life | 23.63 score on a scale | Standard Deviation 14.04 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 10 Botox Injections | Over Active Bladder (OAB) Questionnaire Short Form Scores - Health Related Quality of Life | 56.04 score on a scale | Standard Deviation 13.46 |
| 20 Botox Injections | Over Active Bladder (OAB) Questionnaire Short Form Scores - Health Related Quality of Life | 47.94 score on a scale | Standard Deviation 20.36 |
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
Time frame: 12 weeks post procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 10 Botox Injections | Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms | 15.53 score on a scale | Standard Deviation 6.18 |
| 20 Botox Injections | Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms | 16.41 score on a scale | Standard Deviation 6.48 |
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
Time frame: 2 weeks post procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 10 Botox Injections | Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms | 17.1 score on a scale | Standard Deviation 7.21 |
| 20 Botox Injections | Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms | 17.0 score on a scale | Standard Deviation 17.83 |
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
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 10 Botox Injections | Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms | 29.67 score on a scale | Standard Deviation 5.43 |
| 20 Botox Injections | Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms | 25.89 score on a scale | Standard Deviation 7.45 |
Secondary
Post-Void Residual (PVR)
PVR using bladder scanner evaluates the post void residual in the bladder.
Time frame: 2 weeks post procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 10 Botox Injections | Post-Void Residual (PVR) | 93.87 ml | Standard Deviation 79.37 |
| 20 Botox Injections | Post-Void Residual (PVR) | 71.93 ml | Standard Deviation 89.62 |
Secondary
Post-Void Residual (PVR)
PVR using bladder scanner evaluates the post void residual in the bladder.
Time frame: 12 weeks post procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 10 Botox Injections | Post-Void Residual (PVR) | 17.5 ml |
| 20 Botox Injections | Post-Void Residual (PVR) | 61 ml |