A Phase 4 interventional study of Onabotulinumtoxin A (BoNT) and belladonna in Overactive Bladder, Urinary Urge Incontinence and Urinary Bladder, Neurogenic, sponsored by Edgar LeClaire, MD. Completed at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-20.
Sponsored by Edgar LeClaire, MD · Phase 4, Interventional, and Prevention
The purpose of this study is to test whether using belladonna \& opiate suppositories (B\&Os) can improve patient discomfort during Onabotulinumtoxin A (BoNT) injection into the bladder for treatment of overactive bladder, neurogenic detrusor overactivity, or interstitial cystitis.
185 studies on the registry are indexed under Urinary Bladder, Neurogenic; 40 are open to participants now.
This study's enrollment of 26 is below the median of 36 across 124 interventional studies indexed under Urinary Bladder, Neurogenic.
Browse Urinary Bladder, Neurogenic studies →This is the only study on the registry with Edgar LeClaire, MD as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Receive the B\&O suppository (belladonna/morphine) 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.
Drug: Onabotulinumtoxin A (BoNT) · Drug: belladonna · Drug: Morphine · Drug: Active B&O suppository of belladonna
Receive a placebo suppository 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.
Drug: Onabotulinumtoxin A (BoNT) · Drug: Placebo
Also known as: Botox, Allergan
Part of dosage of the compounded active B\&O suppository of belladonna 16.2mg and morphine 7.5mg.
Part of dosage of the compounded active B\&O suppository of belladonna 16.2mg and morphine 7.5mg.
matching placebo to B\&O suppository
belladonna 16.2mg and morphine 7.5mg
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.
Time frame: Baseline and intraoperative
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).
Time frame: Baseline
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).
Time frame: Postoperative (within 10 minutes of the end of the BoNT procedure)
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.
Time frame: Intraoperative
Postoperative Voiding Trial Results
Distribution of patients with postoperative volume in ml of post-void residual urine obtained via catheter greater than 200ml.
Time frame: Postoperative (before leaving the clinic, within 3 hours of the end of the BoNT procedure)
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.
Time frame: 2 Weeks
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.
Time frame: 2 Weeks
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.'
Time frame: Postoperative (within 10 minutes of the end of the BoNT procedure)
Recruitment began December 1, 2015 at a private urogynecology clinic. There were 32 patients that were assessed for eligibility. Four patients were excluded: three patients did not meet inclusion criteria (did not proceed with in-office treatment) and one patient declined to participate due to wanting the active suppository.
| Milestone | Active Belladonna & Opiate (B&O) Suppository | Placebo Suppository |
|---|---|---|
| Started | 13 | 13 |
| Allocated to randomization | 13 | 13 |
| Received treatment and suppository | 13 | 13 |
| Completed 2-week follow-up appointment | 13 | 12 |
| Completed | 13 | 13 |
| Not completed | 0 | 0 |
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.
| units on a scale | Active B&O Suppository of Belladonna | Placebo Suppository | Total |
|---|---|---|---|
| Change in Bladder Injection Pain | 5 (2 to 6) | 4 (3 to 5) | 5 (2 to 6) |
Measured using NRS. Scale is one question and has a range from a score of 0 (no pain) to 10 (worst possible pain).
| units on a scale | Active B&O Suppository of Belladonna | Placebo Suppository | Total |
|---|---|---|---|
| Pre-analgesia Pain Score | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
Measured using NRS. Scale is one question and has a range from a score of 0 (no pain) to 10 (worst possible pain).
| units on a scale | Active B&O Suppository of Belladonna | Placebo Suppository | Total |
|---|---|---|---|
| Post-operative Pain Score | 2 (0 to 5) | 3 (1 to 7) | 2 (1 to 5) |
Number of patients that decline to proceed with entire procedure (20 injections) due to pain or discomfort.
| Participants | Active B&O Suppository of Belladonna | Placebo Suppository | Total |
|---|---|---|---|
| Number of Participants Declining to Complete Procedure Due to Pain Intolerance | 0 | 0 | 0 |
Distribution of patients with postoperative volume in ml of post-void residual urine obtained via catheter greater than 200ml.
| Participants | Active B&O Suppository of Belladonna | Placebo Suppository | Total |
|---|---|---|---|
| Postoperative Voiding Trial Results | 3 | 5 | 8 |
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.
| Participants | Active B&O Suppository of Belladonna | Placebo Suppository | Total |
|---|---|---|---|
| Post Void Residual (PVR) | 2 | 3 | 5 |
Urinalysis results showing evidence of infection or positive urine culture at 2-week follow-up appointment.
| Participants | Active B&O Suppository of Belladonna | Placebo Suppository | Total |
|---|---|---|---|
| Number of Participants With Evidence of Infection or Positive Urine Culture | 2 | 4 | 6 |
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.'
| Participants | Active B&O Suppository of Belladonna | Placebo Suppository | Total |
|---|---|---|---|
| Not at all satisfied | 0 | 1 | 1 |
| Slightly satisfied | 2 | 1 | 3 |
| Mostly satisfied | 2 | 5 | 7 |
| Very much satisfied | 9 | 6 | 15 |
Collected over Two-weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active B&O Suppository of Belladonna | 0/13 (0%) | 0/13 (0%) | 2/13 (15.4%) |
| Placebo Suppository | 0/12 (0%) | 0/12 (0%) | 4/12 (33.3%) |
| Total | 0/25 (0%) | 0/25 (0%) | 6/25 (24%) |
| Event | Active B&O Suppository of Belladonna | Placebo Suppository | Total |
|---|---|---|---|
| Urinary Tract Infection Two Weeks Post-operativeInfections and infestations | 2/13 | 4/12 | 6/25 |
| Age, Continuous(years) | Active B&O Suppository of Belladonna | Placebo Suppository | Total |
|---|---|---|---|
| Mean | 73.62 ± 10.25 | 65.54 ± 10.22 | 69.58 ± 10.84 |
| Sex: Female, Male(Participants) | Active B&O Suppository of Belladonna | Placebo Suppository | Total |
|---|---|---|---|
| Female | 13 | 13 | 26 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Active B&O Suppository of Belladonna | Placebo Suppository | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 13 | 13 | 26 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Body mass index(kg/m^2) | Active B&O Suppository of Belladonna | Placebo Suppository | Total |
|---|---|---|---|
| Mean | 35.45 ± 11.34 | 34.19 ± 6.33 | 34.82 ± 9.02 |
| Vaginal parity(pregnancies) | Active B&O Suppository of Belladonna | Placebo Suppository | Total |
|---|---|---|---|
| Median | 2 (2 to 3) | 3 (1 to 3) | 2 (2 to 3) |
| Current smoker(Participants) | Active B&O Suppository of Belladonna | Placebo Suppository | Total |
|---|---|---|---|
| Count of participants | 1 | 1 | 2 |
| Menopausal(Participants) | Active B&O Suppository of Belladonna | Placebo Suppository | Total |
|---|---|---|---|
| Count of participants | 13 | 12 | 25 |
| Estrogen use(Participants) | Active B&O Suppository of Belladonna | Placebo Suppository | Total |
|---|---|---|---|
| Vaginal estrogen | 4 | 7 | 11 |
| Oral estrogen | 2 | 1 | 3 |
4 further baseline measures are reported on the registry.
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