Trial Outcomes & Findings for Reduction of Bladder Injection Pain With Belladonna Opiate Suppository (NCT NCT02600715)
NCT ID: NCT02600715
Last Updated: 2018-09-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
26 participants
Primary outcome timeframe
Baseline and intraoperative
Results posted on
2018-09-20
Participant Flow
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.
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.
Participant milestones
| Measure |
Active Belladonna & Opiate (B&O) Suppository
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
Allocated to Randomization
|
13
|
13
|
|
Overall Study
Received Treatment and Suppository
|
13
|
13
|
|
Overall Study
Completed 2-week Follow-up Appointment
|
13
|
12
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reduction of Bladder Injection Pain With Belladonna Opiate Suppository
Baseline characteristics by cohort
| Measure |
Active B&O Suppository of Belladonna
n=13 Participants
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
|
Placebo Suppository
n=13 Participants
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
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.62 years
STANDARD_DEVIATION 10.25 • n=5 Participants
|
65.54 years
STANDARD_DEVIATION 10.22 • n=7 Participants
|
69.58 years
STANDARD_DEVIATION 10.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Body mass index
|
35.45 kg/m^2
STANDARD_DEVIATION 11.34 • n=5 Participants
|
34.19 kg/m^2
STANDARD_DEVIATION 6.33 • n=7 Participants
|
34.82 kg/m^2
STANDARD_DEVIATION 9.02 • n=5 Participants
|
|
Vaginal parity
|
2 pregnancies
n=5 Participants
|
3 pregnancies
n=7 Participants
|
2 pregnancies
n=5 Participants
|
|
Current smoker
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Menopausal
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Estrogen use
Vaginal estrogen
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Estrogen use
Oral estrogen
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Gynecologic disorders/diagnoses
Vulvovaginal atrophy
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Gynecologic disorders/diagnoses
Constipation
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Gynecologic disorders/diagnoses
Chronic cystitis
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Gynecologic disorders/diagnoses
Cystocele
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Gynecologic disorders/diagnoses
Vaginal vault prolapse
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Gynecologic disorders/diagnoses
Uterine prolapse
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Gynecologic disorders/diagnoses
Rectocele
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Medication use
Steroid medication
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Medication use
Narcotic medication
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Medication use
Diuretic medication
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Surgical history
Hysterectomy
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Surgical history
Bilateral salpingo-oophorectomy (BSO)
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Surgical history
Prolapse surgery with mesh
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Surgical history
Prolapse surgery without mesh
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Surgical history
Previous sling procedure
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Surgical history
Laparotomy
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Surgical history
Back or spinal surgery
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Medication use in Last 24 Hours
Selective serotonin reuptake inhibitors (SSRIs)
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Medication use in Last 24 Hours
Nonsteroidal anti-inflammatory drugs (NSAIDs)
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Medication use in Last 24 Hours
Sedative medication
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Medication use in Last 24 Hours
Neuromodulator medication
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Medication use in Last 24 Hours
Opioid medication
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and intraoperativeThe 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.
Outcome measures
| Measure |
Active B&O Suppository of Belladonna
n=13 Participants
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
|
Placebo Suppository
n=13 Participants
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
n=26 Participants
26 participants
|
|---|---|---|---|
|
Change in Bladder Injection Pain
|
5 units on a scale
Interval 2.0 to 6.0
|
4 units on a scale
Interval 3.0 to 5.0
|
5 units on a scale
Interval 2.0 to 6.0
|
SECONDARY outcome
Timeframe: BaselineMeasured using NRS. Scale is one question and has a range from a score of 0 (no pain) to 10 (worst possible pain).
Outcome measures
| Measure |
Active B&O Suppository of Belladonna
n=13 Participants
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
|
Placebo Suppository
n=13 Participants
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
n=26 Participants
26 participants
|
|---|---|---|---|
|
Pre-analgesia Pain Score
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Postoperative (within 10 minutes of the end of the BoNT procedure)Measured using NRS. Scale is one question and has a range from a score of 0 (no pain) to 10 (worst possible pain).
Outcome measures
| Measure |
Active B&O Suppository of Belladonna
n=13 Participants
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
|
Placebo Suppository
n=13 Participants
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
n=26 Participants
26 participants
|
|---|---|---|---|
|
Post-operative Pain Score
|
2 units on a scale
Interval 0.0 to 5.0
|
3 units on a scale
Interval 1.0 to 7.0
|
2 units on a scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: IntraoperativeNumber of patients that decline to proceed with entire procedure (20 injections) due to pain or discomfort.
Outcome measures
| Measure |
Active B&O Suppository of Belladonna
n=13 Participants
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
|
Placebo Suppository
n=13 Participants
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
n=26 Participants
26 participants
|
|---|---|---|---|
|
Number of Participants Declining to Complete Procedure Due to Pain Intolerance
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Postoperative (before leaving the clinic, within 3 hours of the end of the BoNT procedure)Distribution of patients with postoperative volume in ml of post-void residual urine obtained via catheter greater than 200ml.
Outcome measures
| Measure |
Active B&O Suppository of Belladonna
n=13 Participants
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
|
Placebo Suppository
n=13 Participants
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
n=26 Participants
26 participants
|
|---|---|---|---|
|
Postoperative Voiding Trial Results
|
3 Participants
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 2 WeeksPopulation: One patient did not complete 2-week follow-up post-void residual exam.
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.
Outcome measures
| Measure |
Active B&O Suppository of Belladonna
n=13 Participants
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
|
Placebo Suppository
n=12 Participants
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
n=25 Participants
26 participants
|
|---|---|---|---|
|
Post Void Residual (PVR)
|
2 Participants
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 2 WeeksPopulation: One patient did not complete 2-week follow-up appointment.
Urinalysis results showing evidence of infection or positive urine culture at 2-week follow-up appointment.
Outcome measures
| Measure |
Active B&O Suppository of Belladonna
n=13 Participants
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
|
Placebo Suppository
n=12 Participants
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
n=25 Participants
26 participants
|
|---|---|---|---|
|
Number of Participants With Evidence of Infection or Positive Urine Culture
|
2 Participants
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Postoperative (within 10 minutes of the end of the BoNT procedure)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.'
Outcome measures
| Measure |
Active B&O Suppository of Belladonna
n=13 Participants
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
|
Placebo Suppository
n=13 Participants
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
n=26 Participants
26 participants
|
|---|---|---|---|
|
Participant Satisfaction With Pain Control
Not at all satisfied
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Participant Satisfaction With Pain Control
Slightly satisfied
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Participant Satisfaction With Pain Control
Mostly satisfied
|
2 Participants
|
5 Participants
|
7 Participants
|
|
Participant Satisfaction With Pain Control
Very much satisfied
|
9 Participants
|
6 Participants
|
15 Participants
|
Adverse Events
Active B&O Suppository of Belladonna
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Suppository
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Total
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active B&O Suppository of Belladonna
n=13 participants at risk
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
|
Placebo Suppository
n=12 participants at risk
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
n=25 participants at risk
25 participants completed the two-week follow-up visit
|
|---|---|---|---|
|
Infections and infestations
Urinary Tract Infection Two Weeks Post-operative
|
15.4%
2/13 • Number of events 13 • Two-weeks
Adverse event reporting is applicable to only participants that completed the two week follow-up visit post-operative. Thus, only 25 participants are included.
|
33.3%
4/12 • Number of events 12 • Two-weeks
Adverse event reporting is applicable to only participants that completed the two week follow-up visit post-operative. Thus, only 25 participants are included.
|
24.0%
6/25 • Number of events 25 • Two-weeks
Adverse event reporting is applicable to only participants that completed the two week follow-up visit post-operative. Thus, only 25 participants are included.
|
Additional Information
Jennifer Duong, MPH, Research Associate
University of Kansas School of Medicine-Wichita
Phone: 316-962-3126
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place