ROBIN: Reduction of Bladder Injection Pain With Belladonna Opiate Suppository

• Sponsor: Edgar LeClaire, MD (Other)
• Overall Status: Completed
• CT.gov ID: NCT02600715
• Collaborator: (none)
• Enrollment: 26
• Locations: 2
• Arms: 2
• Duration (Months): 19.8
• Patients Per Site: 13
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder; Urinary Urge Incontinence; Urinary Bladder, Neurogenic; Painful Bladder Syndrome	Drug: Onabotulinumtoxin A (BoNT); Drug: belladonna; Drug: Morphine; Drug: Placebo; Drug: Active B&O suppository of belladonna	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Reduction of Bladder Injection Pain With Belladonna Opiate Suppository: A Randomized, Double-Blind, Placebo-Controlled Trial (ROBIN Trial)
• Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: Jun 26, 2017
• Actual Study Completion Date: Jun 26, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Onabotulinumtoxin A (BoNT); Other Names: Botox Allergan ; Drug: belladonna; Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg.; Drug: Morphine; Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg.; Drug: Active B&O suppository of belladonna; belladonna 16.2mg and morphine 7.5mg
Placebo Comparator: Placebo suppository Receive a placebo suppository 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia.	Drug: Onabotulinumtoxin A (BoNT); Other Names: Botox Allergan ; Drug: Placebo; matching placebo to B&O suppository

Outcome Measures

Primary Outcome Measures

1. Change in Bladder Injection Pain [Baseline and intraoperative]

   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.

Secondary Outcome Measures

1. Pre-analgesia Pain Score [Baseline]

   Measured using NRS. Scale is one question and has a range from a score of 0 (no pain) to 10 (worst possible pain).

2. Post-operative Pain Score [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).

3. Number of Participants Declining to Complete Procedure Due to Pain Intolerance [Intraoperative]

   Number of patients that decline to proceed with entire procedure (20 injections) due to pain or discomfort.

4. Postoperative Voiding Trial Results [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.

5. Post Void Residual (PVR) [2 Weeks]

   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.

6. Number of Participants With Evidence of Infection or Positive Urine Culture [2 Weeks]

   Urinalysis results showing evidence of infection or positive urine culture at 2-week follow-up appointment.

7. Participant Satisfaction With Pain Control [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.'

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Met clinical criteria under outside care or during the Principal Investigator's routine standard of care for BoNT injection therapy

• No contraindication to BoNT therapy as outlined by drug manufacturer guidelines

• Participants have elected to have the BoNT injection therapy prior to being offered enrollment into the study for either overactive bladder (OAB), neurogenic detrusor overactivity (NDO), or refractory interstitial cystitis (IC)

Exclusion Criteria:

• Currently pregnant

• Currently nursing a baby

• Anticipated geographic relocation within the first 3 months following treatment

• Allergy to morphine, belladonna, or opiates

• Patients will be excluded if participating in another research study

• Individuals unable to provide informed consent or to complete two-week follow-up bladder testing (post-void residual) or data collection will also be excluded

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wichita Women's Pelvic Surgery Center at Associates in Women's Health	Wichita	Kansas	United States	67208
2	University of Kansas School of Medicine - Wichita	Wichita	Kansas	United States	67214

Sponsors and Collaborators

• Edgar LeClaire, MD

Investigators

• Principal Investigator: Edgar LeClaire, MD, FACOG, University of Kansas Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 5, 2015
• Informed Consent Form - Nov 23, 2015

More Information

Publications

None provided.

• Responsible Party: Edgar LeClaire, MD, Clinical Instructor, University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT02600715
• Other Study ID Numbers: STUDY00003056; 15-051
• First Posted: Nov 9, 2015
• Last Update Posted: Sep 20, 2018
• Last Verified: Jun 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Urinary Bladder, Neurogenic; Urinary Bladder, Overactive; Urinary Incontinence, Urge; Cystitis, Interstitial; Morphine; Botulinum Toxins, Type A; abobotulinumtoxinA

Study Results

Participant Flow

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 Detail	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
Arm/Group Description	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	13	13
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Active B&O Suppository of Belladonna	Placebo Suppository	Total
Arm/Group Description	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 Participants	13	13	26
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	73.62 (10.25)	65.54 (10.22)	69.58 (10.84)
Sex: Female, Male (Count of Participants)
Female	13 100%	13 100%	26 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	13 100%	13 100%	26 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Body mass index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	35.45 (11.34)	34.19 (6.33)	34.82 (9.02)
Vaginal parity (pregnancies) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [pregnancies]	2	3	2
Current smoker (Count of Participants)
Count of Participants [Participants]	1 7.7%	1 7.7%	2 7.7%
Menopausal (Count of Participants)
Count of Participants [Participants]	13 100%	12 92.3%	25 96.2%
Estrogen use (Count of Participants)
Vaginal estrogen	4 30.8%	7 53.8%	11 42.3%
Oral estrogen	2 15.4%	1 7.7%	3 11.5%
Gynecologic disorders/diagnoses (Count of Participants)
Vulvovaginal atrophy	7 53.8%	7 53.8%	14 53.8%
Constipation	1 7.7%	2 15.4%	3 11.5%
Chronic cystitis	3 23.1%	2 15.4%	5 19.2%
Cystocele	0 0%	3 23.1%	3 11.5%
Vaginal vault prolapse	1 7.7%	2 15.4%	3 11.5%
Uterine prolapse	0 0%	0 0%	0 0%
Rectocele	0 0%	1 7.7%	1 3.8%
Medication use (Count of Participants)
Steroid medication	1 7.7%	0 0%	1 3.8%
Narcotic medication	1 7.7%	1 7.7%	2 7.7%
Diuretic medication	1 7.7%	4 30.8%	5 19.2%
Surgical history (Count of Participants)
Hysterectomy	10 76.9%	10 76.9%	20 76.9%
Bilateral salpingo-oophorectomy (BSO)	6 46.2%	7 53.8%	13 50%
Prolapse surgery with mesh	0 0%	1 7.7%	1 3.8%
Prolapse surgery without mesh	2 15.4%	3 23.1%	5 19.2%
Previous sling procedure	3 23.1%	3 23.1%	6 23.1%
Laparotomy	5 38.5%	5 38.5%	10 38.5%
Back or spinal surgery	3 23.1%	2 15.4%	5 19.2%
Medication use in Last 24 Hours (Count of Participants)
Selective serotonin reuptake inhibitors (SSRIs)	7 53.8%	0 0%	7 26.9%
Nonsteroidal anti-inflammatory drugs (NSAIDs)	5 38.5%	6 46.2%	11 42.3%
Sedative medication	1 7.7%	5 38.5%	6 23.1%
Neuromodulator medication	1 7.7%	1 7.7%	2 7.7%
Opioid medication	2 15.4%	1 7.7%	3 11.5%

Outcome Measures

1. Primary Outcome

Title	Change in Bladder Injection Pain
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active B&O Suppository of Belladonna	Placebo Suppository	Total
Arm/Group Description	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	26 participants
Measure Participants	13	13	26
Median (Inter-Quartile Range) [units on a scale]	5	4	5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Active B&O Suppository of Belladonna, Placebo Suppository
	Comments
	Type of Statistical Test	Equivalence
	Comments	Test for differences in continuous variables.
Statistical Test of Hypothesis	p-Value	0.94
	Comments	Two-sided alpha of 0.05 was used to determine statistical significance.
	Method	Kruskal-Wallis
	Comments

2. Secondary Outcome

Title	Pre-analgesia Pain Score
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active B&O Suppository of Belladonna	Placebo Suppository	Total
Arm/Group Description	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	26 participants
Measure Participants	13	13	26
Median (Inter-Quartile Range) [units on a scale]	0	0	0

3. Secondary Outcome

Title	Post-operative Pain Score
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active B&O Suppository of Belladonna	Placebo Suppository	Total
Arm/Group Description	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	26 participants
Measure Participants	13	13	26
Median (Inter-Quartile Range) [units on a scale]	2	3	2

4. Secondary Outcome

Title	Number of Participants Declining to Complete Procedure Due to Pain Intolerance
Description	Number of patients that decline to proceed with entire procedure (20 injections) due to pain or discomfort.
Time Frame	Intraoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active B&O Suppository of Belladonna	Placebo Suppository	Total
Arm/Group Description	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	26 participants
Measure Participants	13	13	26
Count of Participants [Participants]	0 0%	0 0%	0 0%

5. Secondary Outcome

Title	Postoperative Voiding Trial Results
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active B&O Suppository of Belladonna	Placebo Suppository	Total
Arm/Group Description	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	26 participants
Measure Participants	13	13	26
Count of Participants [Participants]	3 23.1%	5 38.5%	8 30.8%

6. Secondary Outcome

Title	Post Void Residual (PVR)
Description	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

Outcome Measure Data

Analysis Population Description

One patient did not complete 2-week follow-up post-void residual exam.

Arm/Group Title	Active B&O Suppository of Belladonna	Placebo Suppository	Total
Arm/Group Description	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	25 participants
Measure Participants	13	12	25
Count of Participants [Participants]	2 15.4%	3 23.1%	5 19.2%

7. Secondary Outcome

Title	Number of Participants With Evidence of Infection or Positive Urine Culture
Description	Urinalysis results showing evidence of infection or positive urine culture at 2-week follow-up appointment.
Time Frame	2 Weeks

Outcome Measure Data

Analysis Population Description

One patient did not complete 2-week follow-up appointment.

Arm/Group Title	Active B&O Suppository of Belladonna	Placebo Suppository	Total
Arm/Group Description	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	25 participants
Measure Participants	13	12	25
Count of Participants [Participants]	2 15.4%	4 30.8%	6 23.1%

8. Secondary Outcome

Title	Participant Satisfaction With Pain Control
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Active B&O Suppository of Belladonna	Placebo Suppository	Total
Arm/Group Description	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	26 participants
Measure Participants	13	13	26
Not at all satisfied	0 0%	1 7.7%	1 3.8%
Slightly satisfied	2 15.4%	1 7.7%	3 11.5%
Mostly satisfied	2 15.4%	5 38.5%	7 26.9%
Very much satisfied	9 69.2%	6 46.2%	15 57.7%

Adverse Events

Time Frame	Two-weeks
Adverse Event Reporting Description	Adverse event reporting is applicable to only participants that completed the two week follow-up visit post-operative. Thus, only 25 participants are included.
Arm/Group Title	Active B&O Suppository of Belladonna		Placebo Suppository		Total
Arm/Group Description	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		25 participants completed the two-week follow-up visit
All Cause Mortality
	Active B&O Suppository of Belladonna		Placebo Suppository		Total
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/12 (0%)		0/25 (0%)
Serious Adverse Events
	Active B&O Suppository of Belladonna		Placebo Suppository		Total
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/12 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Active B&O Suppository of Belladonna		Placebo Suppository		Total
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/13 (15.4%)		4/12 (33.3%)		6/25 (24%)
Infections and infestations
Urinary Tract Infection Two Weeks Post-operative	2/13 (15.4%)	13	4/12 (33.3%)	12	6/25 (24%)	25

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.