Safety and Efficacy Study of Botulinum Toxin Type A to Treat Lower Urinary Symptoms Due to Benign Prostatic Hyperplasia

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00284518
• Collaborator: (none)
• Enrollment: 380
• Locations: 11
• Arms: 4
• Duration (Months): 53
• Patients Per Site: 34.5
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The purpose of this study was to determine the safety and effectiveness of different doses of botulinum toxin Type A in treating lower urinary tract symptoms due to benign prostatic hyperplasia.

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia	Biological: botulinum toxin Type A; Drug: normal saline	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 380 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Dec 1, 2005
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: botulinum toxin Type A 300 U Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.	Biological: botulinum toxin Type A; Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.; Other Names: BOTOX®
Experimental: botulinum toxin Type A 200 U Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.	Biological: botulinum toxin Type A; Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.; Other Names: BOTOX®
Experimental: botulinum toxin Type A 100 U Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.	Biological: botulinum toxin Type A; Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.; Other Names: BOTOX®
Placebo Comparator: Placebo (Normal Saline) Placebo (Normal Saline) transperineal or transrectal injection on Day 1.	Drug: normal saline; Normal Saline (Placebo) transperineal or transrectal injection on Day 1.

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12 [Baseline, Week 12]

   The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.

Secondary Outcome Measures

1. Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72 [Baseline, Week 72]

   The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.

2. Change From Baseline in Peak Urine Flow Rate [Baseline, Week 12, Week 72]

   Urinary flow was determined by uroflowmetry at baseline and various time-points during the study. An increase from baseline indicates improvement.

3. Change From Baseline in Total Prostate Volume [Baseline, Week 12, Week 72]

   Measurement of the prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement.

4. Change From Baseline in Transitional Zone Prostate Volume [Baseline, Week 12, Week 72]

   Measurement of the transitional zone prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement.

5. Change From Baseline in Post-Void Residual [Baseline, Week 2, Week 12, Week 72]

   Post-void residual urine volume was assessed by bladder scan or ultrasound on all participants at baseline and various time-points during the study. After voiding, any residual urine volume in the bladder was measured. A negative change from baseline indicates improvement.

Other Outcome Measures

1. Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain [Baseline, Week 12, Week 72]

   The IIEF is a 15-item questionnaire filled out by the patient to assess erectile function over the past 4 weeks that contains five domains. The score for the erectile function domain is the sum of scores for Questions 1, 2, 3, 4, 5 and 15 for a total possible score of 1 to 30. A higher score indicates a better outcome. A positive change from baseline indicates improvement.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Lower urinary tract symptoms due to benign prostatic hyperplasia

• Enlarged prostate volume by rectal ultrasound

Exclusion Criteria:

• Previous prostate surgery

• Previous or current diagnosis of prostate cancer

• Use of other medications for the treatment of prostatic hyperplasia

• Urinary tract infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Murdoch		Australia
2		Vienna		Austria
3		Victoria	British Columbia	Canada
4		Olomouc		Czech Republic
5		Paris Cedex 13		France
6		Braunschweig		Germany
7		Perugia		Italy
8		Seoul		Korea, Republic of
9		Martin		Slovakia
10		Taipei		Taiwan
11		London		United Kingdom

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT00284518
• Other Study ID Numbers: 191622-517
• First Posted: Feb 1, 2006
• Last Update Posted: Dec 17, 2012
• Last Verified: Nov 1, 2012

• Additional relevant MeSH terms: Prostatic Hyperplasia; Hyperplasia; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA

Study Results

Participant Flow

Arm/Group Title	Botulinum Toxin Type A 300 U	Botulinum Toxin Type A 200 U	Botulinum Toxin Type A 100 U	Placebo (Normal Saline)
Arm/Group Description	Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.	Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.	Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.	Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
Period Title: Overall Study
STARTED	97	94	95	94
COMPLETED	71	66	67	61
NOT COMPLETED	26	28	28	33

Baseline Characteristics

Arm/Group Title	Botulinum Toxin Type A 300 U	Botulinum Toxin Type A 200 U	Botulinum Toxin Type A 100 U	Placebo (Normal Saline)	Total
Arm/Group Description	Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.	Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.	Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.	Placebo (Normal Saline) transperineal or transrectal injection on Day 1.	Total of all reporting groups
Overall Participants	97	94	95	94	380
Age, Customized (Number) [Number]
45 to 65 Years	48 49.5%	46 48.9%	56 58.9%	44 46.8%	194 51.1%
>65 Years	49 50.5%	48 51.1%	39 41.1%	50 53.2%	186 48.9%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%	0 0%
Male	97 100%	94 100%	95 100%	94 100%	380 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12
Description	The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.

Arm/Group Title	Botulinum Toxin Type A 300 U	Botulinum Toxin Type A 200 U	Botulinum Toxin Type A 100 U	Placebo (Normal Saline)
Arm/Group Description	Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.	Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.	Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.	Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
Measure Participants	89	91	94	92
Baseline	21.3 (6.03)	20.2 (5.80)	21.5 (5.42)	20.7 (5.44)
Change from baseline at Week 12 (N=86,89,93,90)	-5.6 (7.73)	-6.3 (7.13)	-6.6 (6.87)	-5.5 (6.33)

2. Secondary Outcome

Title	Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72
Description	The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.
Time Frame	Baseline, Week 72

Outcome Measure Data

Analysis Population Description

Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.

Arm/Group Title	Botulinum Toxin Type A 300 U	Botulinum Toxin Type A 200 U	Botulinum Toxin Type A 100 U	Placebo (Normal Saline)
Arm/Group Description	Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.	Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.	Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.	Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
Measure Participants	89	91	94	92
Baseline	21.3 (6.03)	20.2 (5.80)	21.5 (5.42)	20.7 (5.44)
Change from baseline at Week 72 (N=64,61,66,58)	-5.0 (6.50)	-4.1 (6.40)	-4.7 (7.15)	-4.3 (7.15)

3. Secondary Outcome

Title	Change From Baseline in Peak Urine Flow Rate
Description	Urinary flow was determined by uroflowmetry at baseline and various time-points during the study. An increase from baseline indicates improvement.
Time Frame	Baseline, Week 12, Week 72

Outcome Measure Data

Analysis Population Description

Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.

Arm/Group Title	Botulinum Toxin Type A 300 U	Botulinum Toxin Type A 200 U	Botulinum Toxin Type A 100 U	Placebo (Normal Saline)
Arm/Group Description	Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.	Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.	Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.	Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
Measure Participants	95	89	93	91
Baseline	10.4 (2.70)	10.6 (2.83)	9.6 (2.57)	10.1 (2.82)
Change from baseline to Week 12 (N=81,80,86,77)	1.8 (4.65)	2.0 (4.98)	2.7 (5.21)	2.8 (4.74)
Change from baseline to Week 72 (N=59,56,64,53)	2.0 (4.67)	2.4 (5.18)	2.0 (4.07)	2.3 (4.31)

4. Secondary Outcome

Title	Change From Baseline in Total Prostate Volume
Description	Measurement of the prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement.
Time Frame	Baseline, Week 12, Week 72

Outcome Measure Data

Analysis Population Description

Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.

Arm/Group Title	Botulinum Toxin Type A 300 U	Botulinum Toxin Type A 200 U	Botulinum Toxin Type A 100 U	Placebo (Normal Saline)
Arm/Group Description	Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.	Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.	Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.	Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
Measure Participants	96	91	92	91
Baseline	48.78 (16.800)	48.40 (16.325)	47.54 (16.917)	47.23 (14.867)
Change from baseline at Week 12 (N=86,84,88,82)	-3.40 (10.046)	-3.65 (9.255)	-3.54 (9.823)	-4.59 (8.392)
Change from baseline at Week 72 (N=65,60,67,57)	-3.58 (9.773)	-2.82 (11.194)	-1.77 (10.714)	-2.69 (10.875)

5. Secondary Outcome

Title	Change From Baseline in Transitional Zone Prostate Volume
Description	Measurement of the transitional zone prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement.
Time Frame	Baseline, Week 12, Week 72

Outcome Measure Data

Analysis Population Description

Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.

Arm/Group Title	Botulinum Toxin Type A 300 U	Botulinum Toxin Type A 200 U	Botulinum Toxin Type A 100 U	Placebo (Normal Saline)
Arm/Group Description	Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.	Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.	Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.	Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
Measure Participants	94	89	90	87
Baseline	20.78 (14.657)	21.75 (12.931)	21.00 (14.188)	20.73 (13.210)
Change from baseline at Week 12 (N=83,82,86,79)	-0.23 (6.516)	-0.76 (8.085)	-0.02 (8.445)	-0.27 (6.551)
Change from baseline at Week 72 (N=64,59,65,55)	0.19 (7.655)	-0.94 (8.119)	-0.35 (8.808)	-1.35 (6.801)

6. Secondary Outcome

Title	Change From Baseline in Post-Void Residual
Description	Post-void residual urine volume was assessed by bladder scan or ultrasound on all participants at baseline and various time-points during the study. After voiding, any residual urine volume in the bladder was measured. A negative change from baseline indicates improvement.
Time Frame	Baseline, Week 2, Week 12, Week 72

Outcome Measure Data

Analysis Population Description

Participants from the safety population (includes all randomized and treated participants) with data available for analyses at the given time-point.

Arm/Group Title	Botulinum Toxin Type A 300 U	Botulinum Toxin Type A 200 U	Botulinum Toxin Type A 100 U	Placebo (Normal Saline)
Arm/Group Description	Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.	Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.	Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.	Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
Measure Participants	92	89	89	91
Baseline	73.0 (57.07)	69.7 (54.93)	66.1 (55.59)	64.3 (51.89)
Change from baseline at Week 2 (N=76,82,80,78)	5.4 (64.06)	10.9 (88.62)	-1.4 (65.01)	1.6 (61.03)
Change from baseline at Week 12 (N=88,84,89,82)	7.5 (78.18)	9.0 (81.23)	-1.4 (62.82)	3.2 (57.92)
Change from baseline at Week 72 (N=66,60,65,60)	10.9 (73.27)	-12.4 (54.31)	14.0 (75.97)	6.0 (69.79)

7. Other Pre-specified Outcome

Title	Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain
Description	The IIEF is a 15-item questionnaire filled out by the patient to assess erectile function over the past 4 weeks that contains five domains. The score for the erectile function domain is the sum of scores for Questions 1, 2, 3, 4, 5 and 15 for a total possible score of 1 to 30. A higher score indicates a better outcome. A positive change from baseline indicates improvement.
Time Frame	Baseline, Week 12, Week 72

Outcome Measure Data

Analysis Population Description

Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.

Arm/Group Title	Botulinum Toxin Type A 300 U	Botulinum Toxin Type A 200 U	Botulinum Toxin Type A 100 U	Placebo (Normal Saline)
Arm/Group Description	Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.	Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.	Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.	Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
Measure Participants	86	79	84	87
Baseline	15.4 (10.20)	14.6 (10.7)	17.2 (10.19)	16.7 (10.29)
Change from baseline at Week 12 (N=80,72,83,79)	0.1 (6.66)	-0.2 (5.54)	-0.9 (6.93)	1.3 (7.86)
Change from baseline at Week 72 (N=61,54,61,58)	0.8 (7.17)	0.5 (4.56)	-1.5 (7.34)	-0.9 (7.95)

8. Post-Hoc Outcome

Title	Change From Baseline in IPSS at Week 12 in Patients Previously Treated With Alpha-blockers
Description	The International Prostate Symptom Score (IPSS) is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Participants from the Intent-to-treat population previously treated with alpha-blockers with data available for analyses.

Arm/Group Title	Botulinum Toxin Type A 300 U	Botulinum Toxin Type A 200 U	Botulinum Toxin Type A 100 U	Placebo (Normal Saline)
Arm/Group Description	Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.	Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.	Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.	Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
Measure Participants	44	35	52	43
Baseline	21.3 (6.20)	19.6 (6.15)	21.9 (5.65)	20.4 (5.32)
Change from baseline at Week 12 (N=44,35,52,42)	-5.1 (7.76)	-6.6 (5.91)	-5.4 (5.17)	-3.5 (6.12)

Adverse Events

Adverse Event Reporting Description	Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
Arm/Group Title	Botulinum Toxin Type A 300 U		Botulinum Toxin Type A 200 U		Botulinum Toxin Type A 100 U		Placebo (Normal Saline)
Arm/Group Description	Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.		Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.		Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.		Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
All Cause Mortality
	Botulinum Toxin Type A 300 U		Botulinum Toxin Type A 200 U		Botulinum Toxin Type A 100 U		Placebo (Normal Saline)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Botulinum Toxin Type A 300 U		Botulinum Toxin Type A 200 U		Botulinum Toxin Type A 100 U		Placebo (Normal Saline)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/94 (9.6%)		16/93 (17.2%)		10/94 (10.6%)		11/92 (12%)
Cardiac disorders
Angina pectoris	0/94 (0%)		2/93 (2.2%)		0/94 (0%)		0/92 (0%)
Angina unstable	0/94 (0%)		1/93 (1.1%)		0/94 (0%)		0/92 (0%)
Myocardial infarction	0/94 (0%)		1/93 (1.1%)		0/94 (0%)		0/92 (0%)
Acute coronary syndrome	0/94 (0%)		0/93 (0%)		2/94 (2.1%)		0/92 (0%)
Eye disorders
Blindness unilateral	0/94 (0%)		0/93 (0%)		1/94 (1.1%)		0/92 (0%)
Retinal artery thrombosis	0/94 (0%)		0/93 (0%)		1/94 (1.1%)		0/92 (0%)
Corneal degeneration	0/94 (0%)		0/93 (0%)		0/94 (0%)		1/92 (1.1%)
Gastrointestinal disorders
Gastritis	0/94 (0%)		1/93 (1.1%)		0/94 (0%)		0/92 (0%)
Intestinal obstruction	0/94 (0%)		1/93 (1.1%)		0/94 (0%)		0/92 (0%)
Inguinal hernia	0/94 (0%)		0/93 (0%)		1/94 (1.1%)		0/92 (0%)
General disorders
Accidental death	0/94 (0%)		2/93 (2.2%)		0/94 (0%)		0/92 (0%)
Non-cardiac chest pain	0/94 (0%)		0/93 (0%)		1/94 (1.1%)		0/92 (0%)
Hepatobiliary disorders
Cholecystitis acute	0/94 (0%)		1/93 (1.1%)		0/94 (0%)		0/92 (0%)
Cholelithiasis	0/94 (0%)		1/93 (1.1%)		0/94 (0%)		0/92 (0%)
Infections and infestations
Herpes zoster	0/94 (0%)		1/93 (1.1%)		0/94 (0%)		0/92 (0%)
Bacterial prostatitis	0/94 (0%)		0/93 (0%)		0/94 (0%)		1/92 (1.1%)
Cellulitis	0/94 (0%)		0/93 (0%)		0/94 (0%)		1/92 (1.1%)
Injury, poisoning and procedural complications
Femur fracture	1/94 (1.1%)		0/93 (0%)		0/94 (0%)		0/92 (0%)
Investigations
Prostatic specific antigen increased	1/94 (1.1%)		0/93 (0%)		0/94 (0%)		0/92 (0%)
Musculoskeletal and connective tissue disorders
Arthritis	1/94 (1.1%)		0/93 (0%)		0/94 (0%)		0/92 (0%)
Intervertebral disc protrusion	1/94 (1.1%)		0/93 (0%)		0/94 (0%)		0/92 (0%)
Osteoarthritis	0/94 (0%)		0/93 (0%)		1/94 (1.1%)		2/92 (2.2%)
Arthralgia	0/94 (0%)		0/93 (0%)		0/94 (0%)		1/92 (1.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer	1/94 (1.1%)		0/93 (0%)		0/94 (0%)		0/92 (0%)
Renal cell carcinoma	0/94 (0%)		1/93 (1.1%)		0/94 (0%)		1/92 (1.1%)
Renal cancer	0/94 (0%)		1/93 (1.1%)		0/94 (0%)		0/92 (0%)
Metastatic neoplasm	0/94 (0%)		0/93 (0%)		1/94 (1.1%)		0/92 (0%)
Basal cell carcinoma	0/94 (0%)		0/93 (0%)		0/94 (0%)		1/92 (1.1%)
Gastric adenoma	0/94 (0%)		0/93 (0%)		0/94 (0%)		1/92 (1.1%)
Gastric cancer	0/94 (0%)		0/93 (0%)		0/94 (0%)		1/92 (1.1%)
Nervous system disorders
Hypoaesthesia	1/94 (1.1%)		0/93 (0%)		0/94 (0%)		0/92 (0%)
Carotid artery stenosis	0/94 (0%)		0/93 (0%)		0/94 (0%)		1/92 (1.1%)
Psychiatric disorders
Alcoholism	0/94 (0%)		1/93 (1.1%)		0/94 (0%)		0/92 (0%)
Anxiety	0/94 (0%)		0/93 (0%)		1/94 (1.1%)		0/92 (0%)
Renal and urinary disorders
Calculus bladder	2/94 (2.1%)		0/93 (0%)		0/94 (0%)		0/92 (0%)
Urinary retention	1/94 (1.1%)		0/93 (0%)		1/94 (1.1%)		0/92 (0%)
Nephrolithiasis	1/94 (1.1%)		0/93 (0%)		0/94 (0%)		0/92 (0%)
Calculus ureteric	0/94 (0%)		0/93 (0%)		1/94 (1.1%)		0/92 (0%)
Hydronephrosis	0/94 (0%)		0/93 (0%)		1/94 (1.1%)		0/92 (0%)
Reproductive system and breast disorders
Prostatitis	1/94 (1.1%)		2/93 (2.2%)		1/94 (1.1%)		0/92 (0%)
Benign prostatic hyperplasia	0/94 (0%)		1/93 (1.1%)		0/94 (0%)		1/92 (1.1%)
Respiratory, thoracic and mediastinal disorders
Pleural effusion	0/94 (0%)		0/93 (0%)		1/94 (1.1%)		0/92 (0%)
Vascular disorders
Hypertensive crisis	0/94 (0%)		1/93 (1.1%)		0/94 (0%)		0/92 (0%)
Other (Not Including Serious) Adverse Events
	Botulinum Toxin Type A 300 U		Botulinum Toxin Type A 200 U		Botulinum Toxin Type A 100 U		Placebo (Normal Saline)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	41/94 (43.6%)		46/93 (49.5%)		53/94 (56.4%)		55/92 (59.8%)
Infections and infestations
Urinary tract infection	6/94 (6.4%)		1/93 (1.1%)		4/94 (4.3%)		3/92 (3.3%)
Nasopharyngitis	5/94 (5.3%)		6/93 (6.5%)		5/94 (5.3%)		5/92 (5.4%)
Investigations
Prostatic specific antigen increase	5/94 (5.3%)		5/93 (5.4%)		3/94 (3.2%)		5/92 (5.4%)
Musculoskeletal and connective tissue disorders
Back pain	1/94 (1.1%)		5/93 (5.4%)		2/94 (2.1%)		3/92 (3.3%)
Renal and urinary disorders
Renal cyst	7/94 (7.4%)		2/93 (2.2%)		7/94 (7.4%)		3/92 (3.3%)
Haematuria	4/94 (4.3%)		7/93 (7.5%)		8/94 (8.5%)		8/92 (8.7%)
Urinary retention	2/94 (2.1%)		2/93 (2.2%)		5/94 (5.3%)		3/92 (3.3%)
Dysuria	2/94 (2.1%)		5/93 (5.4%)		4/94 (4.3%)		3/92 (3.3%)
Micturition urgency	1/94 (1.1%)		3/93 (3.2%)		5/94 (5.3%)		6/92 (6.5%)
Pollakiuria	1/94 (1.1%)		2/93 (2.2%)		2/94 (2.1%)		5/92 (5.4%)
Reproductive system and breast disorders
Haematospermia	2/94 (2.1%)		6/93 (6.5%)		5/94 (5.3%)		7/92 (7.6%)
Vascular disorders
Hypertension	5/94 (5.3%)		2/93 (2.2%)		3/94 (3.2%)		4/92 (4.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.