Reduction of Bladder Injection Pain With Belladonna Opiate Suppository (ROBIN)
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ClinicalTrials.gov Identifier: NCT02600715 |
Recruitment Status :
Completed
First Posted : November 9, 2015
Results First Posted : September 20, 2018
Last Update Posted : September 20, 2018
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention |
Conditions |
Overactive Bladder Urinary Urge Incontinence Urinary Bladder, Neurogenic Painful Bladder Syndrome |
Interventions |
Drug: Onabotulinumtoxin A (BoNT) Drug: belladonna Drug: Morphine Drug: Placebo Drug: Active B&O suppository of belladonna |
Enrollment | 26 |
Recruitment Details | 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. |
Pre-assignment Details |
28 patients consented to participate in the study. Two patients withdrew consent to participate and did not end up participating: one patient's medication resumed efficacy, and one patient withdrew regarding possible use of narcotics and concern due to a a previous narcotic addition. Thus, only 26 patients are considered enrolled in this study. |
Arm/Group Title | Active Belladonna & Opiate (B&O) Suppository | Placebo Suppository |
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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 |
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 |
Period Title: Overall Study | ||
Started | 13 | 13 |
Allocated to Randomization | 13 | 13 |
Received Treatment and Suppository | 13 | 13 |
Completed 2-week Follow-up Appointment | 13 | 12 |
Completed [1] | 13 | 13 |
Not Completed | 0 | 0 |
[1]
Included in final analysis
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Arm/Group Title | Active B&O Suppository of Belladonna | Placebo Suppository | Total | |
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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 |
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 |
Total of all reporting groups | |
Overall Number of Baseline Participants | 13 | 13 | 26 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 13 participants | 13 participants | 26 participants | |
73.62 (10.25) | 65.54 (10.22) | 69.58 (10.84) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 13 participants | 13 participants | 26 participants | |
Female |
13 100.0%
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13 100.0%
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26 100.0%
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Male |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 13 participants | 13 participants | 26 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
0 0.0%
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0 0.0%
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0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
0 0.0%
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0 0.0%
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0 0.0%
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White |
13 100.0%
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13 100.0%
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26 100.0%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Body mass index
Mean (Standard Deviation) Unit of measure: Kg/m^2 |
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Number Analyzed | 13 participants | 13 participants | 26 participants | |
35.45 (11.34) | 34.19 (6.33) | 34.82 (9.02) | ||
Vaginal parity
[1] Median (Inter-Quartile Range) Unit of measure: Pregnancies |
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Number Analyzed | 13 participants | 13 participants | 26 participants | |
2
(2 to 3)
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3
(1 to 3)
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2
(2 to 3)
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[1]
Measure Description:
Vaginal parity is the number of pregnancies that the patient had, that was carried to greater 20 weeks. Zero indicates that the patient did not have any pregnancies beyond 20 weeks (nulliparous). |
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Current smoker
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 13 participants | 13 participants | 26 participants | |
1 7.7%
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1 7.7%
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2 7.7%
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Menopausal
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 13 participants | 13 participants | 26 participants | |
13 100.0%
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12 92.3%
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25 96.2%
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Estrogen use
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 13 participants | 13 participants | 26 participants |
Vaginal estrogen |
4 30.8%
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7 53.8%
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11 42.3%
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Oral estrogen |
2 15.4%
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1 7.7%
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3 11.5%
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Gynecologic disorders/diagnoses
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 13 participants | 13 participants | 26 participants |
Vulvovaginal atrophy |
7 53.8%
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7 53.8%
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14 53.8%
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Constipation |
1 7.7%
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2 15.4%
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3 11.5%
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Chronic cystitis |
3 23.1%
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2 15.4%
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5 19.2%
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Cystocele |
0 0.0%
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3 23.1%
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3 11.5%
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Vaginal vault prolapse |
1 7.7%
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2 15.4%
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3 11.5%
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Uterine prolapse |
0 0.0%
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0 0.0%
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0 0.0%
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Rectocele |
0 0.0%
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1 7.7%
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1 3.8%
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Medication use
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 13 participants | 13 participants | 26 participants |
Steroid medication |
1 7.7%
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0 0.0%
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1 3.8%
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Narcotic medication |
1 7.7%
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1 7.7%
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2 7.7%
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Diuretic medication |
1 7.7%
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4 30.8%
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5 19.2%
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Surgical history
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 13 participants | 13 participants | 26 participants |
Hysterectomy |
10 76.9%
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10 76.9%
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20 76.9%
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Bilateral salpingo-oophorectomy (BSO) |
6 46.2%
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7 53.8%
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13 50.0%
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Prolapse surgery with mesh |
0 0.0%
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1 7.7%
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1 3.8%
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Prolapse surgery without mesh |
2 15.4%
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3 23.1%
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5 19.2%
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Previous sling procedure |
3 23.1%
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3 23.1%
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6 23.1%
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Laparotomy |
5 38.5%
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5 38.5%
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10 38.5%
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Back or spinal surgery |
3 23.1%
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2 15.4%
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5 19.2%
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Medication use in Last 24 Hours
[1] Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 13 participants | 13 participants | 26 participants |
Selective serotonin reuptake inhibitors (SSRIs) |
7 53.8%
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0 0.0%
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7 26.9%
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Nonsteroidal anti-inflammatory drugs (NSAIDs) |
5 38.5%
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6 46.2%
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11 42.3%
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Sedative medication |
1 7.7%
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5 38.5%
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6 23.1%
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Neuromodulator medication |
1 7.7%
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1 7.7%
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2 7.7%
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Opioid medication |
2 15.4%
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1 7.7%
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3 11.5%
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[1]
Measure Description: Participant medication use in last 24 hours prior to intravesical onabotulinum toxin A injection
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Name/Title: | Jennifer Duong, MPH, Research Associate |
Organization: | University of Kansas School of Medicine-Wichita |
Phone: | 316-962-3126 |
EMail: | jduong@kumc.edu |
Responsible Party: | Edgar LeClaire, MD, University of Kansas Medical Center |
ClinicalTrials.gov Identifier: | NCT02600715 |
Other Study ID Numbers: |
STUDY00003056 15-051 ( Other Identifier: Wichita Medical Research and Education Foundation IRB ) |
First Submitted: | October 29, 2015 |
First Posted: | November 9, 2015 |
Results First Submitted: | June 26, 2018 |
Results First Posted: | September 20, 2018 |
Last Update Posted: | September 20, 2018 |