| Primary | Change in Bladder Injection Pain | The primary outcome will be calculated difference in numeric rating scale (NRS) pain score prior to procedure and midway through procedure. Scale is one question and has a range from a score of 0 (no pain) to 10 (worst possible pain). Measure will be reported as the intraoperative pain score minus the preoperative pain score. | | Posted | | Median | Inter-Quartile Range | units on a scale | | Baseline and intraoperative | | | | ID | Title | Description |
|---|
| OG000 | Active B&O Suppository of Belladonna | Receive the B&O suppository (belladonna/morphine) 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia. Onabotulinumtoxin A (BoNT) belladonna: Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg. Morphine: Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg. Active B&O suppository of belladonna: belladonna 16.2mg and morphine 7.5mg | | OG001 | Placebo Suppository | Receive a placebo suppository 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia. Onabotulinumtoxin A (BoNT) Placebo: matching placebo to B&O suppository | | OG002 | Total | |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0005(2 to 6)
- OG0014(3 to 5)
- OG0025(2 to 6)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Kruskal-Wallis | | 0.94 | Two-sided alpha of 0.05 was used to determine statistical significance. | | | | | | | | | | | | | Equivalence | Test for differences in continuous variables. | |
|
| Secondary | Pre-analgesia Pain Score | Measured using NRS. Scale is one question and has a range from a score of 0 (no pain) to 10 (worst possible pain). | | Posted | | Median | Inter-Quartile Range | units on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Active B&O Suppository of Belladonna | Receive the B&O suppository (belladonna/morphine) 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia. Onabotulinumtoxin A (BoNT) belladonna: Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg. Morphine: Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg. Active B&O suppository of belladonna: belladonna 16.2mg and morphine 7.5mg | | OG001 | Placebo Suppository | Receive a placebo suppository 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia. Onabotulinumtoxin A (BoNT) Placebo: matching placebo to B&O suppository | | OG002 | Total | |
| |
| Secondary | Post-operative Pain Score | Measured using NRS. Scale is one question and has a range from a score of 0 (no pain) to 10 (worst possible pain). | | Posted | | Median | Inter-Quartile Range | units on a scale | | Postoperative (within 10 minutes of the end of the BoNT procedure) | | | | ID | Title | Description |
|---|
| OG000 | Active B&O Suppository of Belladonna | Receive the B&O suppository (belladonna/morphine) 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia. Onabotulinumtoxin A (BoNT) belladonna: Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg. Morphine: Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg. Active B&O suppository of belladonna: belladonna 16.2mg and morphine 7.5mg | | OG001 | Placebo Suppository | Receive a placebo suppository 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia. Onabotulinumtoxin A (BoNT) Placebo: matching placebo to B&O suppository | | OG002 | Total | |
| |
| Secondary | Number of Participants Declining to Complete Procedure Due to Pain Intolerance | Number of patients that decline to proceed with entire procedure (20 injections) due to pain or discomfort. | | Posted | | Count of Participants | | Participants | | Intraoperative | | | | ID | Title | Description |
|---|
| OG000 | Active B&O Suppository of Belladonna | Receive the B&O suppository (belladonna/morphine) 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia. Onabotulinumtoxin A (BoNT) belladonna: Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg. Morphine: Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg. Active B&O suppository of belladonna: belladonna 16.2mg and morphine 7.5mg | | OG001 | Placebo Suppository | Receive a placebo suppository 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia. Onabotulinumtoxin A (BoNT) Placebo: matching placebo to B&O suppository | | OG002 | Total | |
| |
| Secondary | Postoperative Voiding Trial Results | Distribution of patients with postoperative volume in ml of post-void residual urine obtained via catheter greater than 200ml. | | Posted | | Count of Participants | | Participants | | Postoperative (before leaving the clinic, within 3 hours of the end of the BoNT procedure) | | | | ID | Title | Description |
|---|
| OG000 | Active B&O Suppository of Belladonna | Receive the B&O suppository (belladonna/morphine) 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia. Onabotulinumtoxin A (BoNT) belladonna: Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg. Morphine: Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg. Active B&O suppository of belladonna: belladonna 16.2mg and morphine 7.5mg | | OG001 | Placebo Suppository | Receive a placebo suppository 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia. Onabotulinumtoxin A (BoNT) Placebo: matching placebo to B&O suppository | | OG002 | Total | |
| |
| Secondary | Post Void Residual (PVR) | Distribution of patients with volume in ml of post-void residual urine obtained via catheter greater than 200 ml at 2-week follow-up appointment. | One patient did not complete 2-week follow-up post-void residual exam. | Posted | | Count of Participants | | Participants | | 2 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Active B&O Suppository of Belladonna | Receive the B&O suppository (belladonna/morphine) 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia. Onabotulinumtoxin A (BoNT) belladonna: Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg. Morphine: Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg. Active B&O suppository of belladonna: belladonna 16.2mg and morphine 7.5mg | | OG001 | Placebo Suppository | Receive a placebo suppository 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia. Onabotulinumtoxin A (BoNT) Placebo: matching placebo to B&O suppository | | OG002 | Total | |
| |
| Secondary | Number of Participants With Evidence of Infection or Positive Urine Culture | Urinalysis results showing evidence of infection or positive urine culture at 2-week follow-up appointment. | One patient did not complete 2-week follow-up appointment. | Posted | | Count of Participants | | Participants | | 2 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Active B&O Suppository of Belladonna | Receive the B&O suppository (belladonna/morphine) 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia. Onabotulinumtoxin A (BoNT) belladonna: Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg. Morphine: Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg. Active B&O suppository of belladonna: belladonna 16.2mg and morphine 7.5mg | | OG001 | Placebo Suppository | Receive a placebo suppository 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia. Onabotulinumtoxin A (BoNT) Placebo: matching placebo to B&O suppository | | OG002 | Total | |
| |
| Secondary | Participant Satisfaction With Pain Control | Measured using one question Likert scale. This will be a 4-level scale ranging from 'not at all satisfied,' 'slightly satisfied,' 'mostly satisfied,' and 'very much satisfied.' | | Posted | | Count of Participants | | Participants | | Postoperative (within 10 minutes of the end of the BoNT procedure) | | | | ID | Title | Description |
|---|
| OG000 | Active B&O Suppository of Belladonna | Receive the B&O suppository (belladonna/morphine) 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia. Onabotulinumtoxin A (BoNT) belladonna: Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg. Morphine: Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg. Active B&O suppository of belladonna: belladonna 16.2mg and morphine 7.5mg | | OG001 | Placebo Suppository | Receive a placebo suppository 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia. Onabotulinumtoxin A (BoNT) Placebo: matching placebo to B&O suppository | | OG002 | Total | |
| |