Trial · NCT00284518

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

NCT00284518, Phase 2, Completed, Allergan; results first posted 2012-12-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy Study of Botulinum Toxin Type A to Treat Lower Urinary Symptoms Due to Benign Prostatic Hyperplasia. Trials, record NCT00284518. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00284518

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy Study of Botulinum Toxin Type A to Treat Lower Urinary Symptoms Due to Benign Prostatic Hyperplasia
NCT number: NCT00284518
Status: Completed
Phases: Phase 2
Enrollment: 380 participants, actual
Lead sponsor: Allergan
Conditions: Benign Prostatic Hyperplasia
Interventions: botulinum toxin Type A, normal saline
First posted: 2006-02-01
Last updated: 2012-12-17
Results first posted: 2012-12-17

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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	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.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12	Baseline, Week 12	Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.	Score on a scale	MEAN
SECONDARY	Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72	Baseline, Week 72	Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.	Score on a scale	MEAN
SECONDARY	Change From Baseline in Peak Urine Flow Rate	Baseline, Week 12, Week 72	Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.	milliliters (mL)/second	MEAN
SECONDARY	Change From Baseline in Total Prostate Volume	Baseline, Week 12, Week 72	Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.	milliliter (mL)	MEAN
SECONDARY	Change From Baseline in Transitional Zone Prostate Volume	Baseline, Week 12, Week 72	Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.	milliliters (mL)	MEAN
SECONDARY	Change From Baseline in Post-Void Residual	Baseline, Week 2, Week 12, Week 72	Participants from the safety population (includes all randomized and treated participants) with data available for analyses at the given time-point.	milliliters (mL)	MEAN
OTHER_PRE_SPECIFIED	Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain	Baseline, Week 12, Week 72	Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.	Score on a scale	MEAN
POST_HOC	Change From Baseline in IPSS at Week 12 in Patients Previously Treated With Alpha-blockers	Baseline, Week 12	Participants from the Intent-to-treat population previously treated with alpha-blockers with data available for analyses.	Score on a scale	MEAN

Source ClinicalTrials.gov

Results by group88

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12	Botulinum Toxin Type A 300 U	Baseline	21.3	Standard Deviation 6.03	Score on a scale
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12	Botulinum Toxin Type A 200 U	Baseline	20.2	Standard Deviation 5.80	Score on a scale
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12	Botulinum Toxin Type A 100 U	Baseline	21.5	Standard Deviation 5.42	Score on a scale
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12	Placebo (Normal Saline)	Baseline	20.7	Standard Deviation 5.44	Score on a scale
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12	Botulinum Toxin Type A 300 U	Change from baseline at Week 12 (N=86,89,93,90)	-5.6	Standard Deviation 7.73	Score on a scale
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12	Botulinum Toxin Type A 200 U	Change from baseline at Week 12 (N=86,89,93,90)	-6.3	Standard Deviation 7.13	Score on a scale
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12	Botulinum Toxin Type A 100 U	Change from baseline at Week 12 (N=86,89,93,90)	-6.6	Standard Deviation 6.87	Score on a scale
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12	Placebo (Normal Saline)	Change from baseline at Week 12 (N=86,89,93,90)	-5.5	Standard Deviation 6.33	Score on a scale
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72	Botulinum Toxin Type A 300 U	Baseline	21.3	Standard Deviation 6.03	Score on a scale
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72	Botulinum Toxin Type A 200 U	Baseline	20.2	Standard Deviation 5.80	Score on a scale

1 to 10 of 88Source ClinicalTrials.gov

See all 88 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Botulinum Toxin Type A 300 U	97
Overall Study	STARTED	Botulinum Toxin Type A 200 U	94
Overall Study	STARTED	Botulinum Toxin Type A 100 U	95
Overall Study	STARTED	Placebo (Normal Saline)	94
Overall Study	COMPLETED	Botulinum Toxin Type A 300 U	71
Overall Study	COMPLETED	Botulinum Toxin Type A 200 U	66
Overall Study	COMPLETED	Botulinum Toxin Type A 100 U	67
Overall Study	COMPLETED	Placebo (Normal Saline)	61
Overall Study	NOT COMPLETED	Botulinum Toxin Type A 300 U	26
Overall Study	NOT COMPLETED	Botulinum Toxin Type A 200 U	28

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events220

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Urinary tract infection	Infections and infestations	Botulinum Toxin Type A 300 U	6	94
other	Urinary tract infection	Infections and infestations	Botulinum Toxin Type A 200 U	1	93
other	Urinary tract infection	Infections and infestations	Botulinum Toxin Type A 100 U	4	94
other	Urinary tract infection	Infections and infestations	Placebo (Normal Saline)	3	92
other	Nasopharyngitis	Infections and infestations	Botulinum Toxin Type A 300 U	5	94
other	Nasopharyngitis	Infections and infestations	Botulinum Toxin Type A 200 U	6	93
other	Nasopharyngitis	Infections and infestations	Botulinum Toxin Type A 100 U	5	94
other	Nasopharyngitis	Infections and infestations	Placebo (Normal Saline)	5	92
other	Prostatic specific antigen increase	Investigations	Botulinum Toxin Type A 300 U	5	94
other	Prostatic specific antigen increase	Investigations	Botulinum Toxin Type A 200 U	5	93

1 to 10 of 220Source ClinicalTrials.gov

See all 220 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Botulinum Toxin Type A 300 U
Total, all-cause mortality	Botulinum Toxin Type A 200 U
Total, all-cause mortality	Botulinum Toxin Type A 100 U
Total, all-cause mortality	Placebo (Normal Saline)
Total, other adverse events	Botulinum Toxin Type A 300 U	41	94
Total, other adverse events	Botulinum Toxin Type A 200 U	46	93
Total, other adverse events	Botulinum Toxin Type A 100 U	53	94
Total, other adverse events	Placebo (Normal Saline)	55	92
Total, serious adverse events	Botulinum Toxin Type A 300 U	9	94
Total, serious adverse events	Botulinum Toxin Type A 200 U	16	93

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23098762	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00284518

GET https://conductscience.org/api/trials/v1/NCT00284518/results?page=2

API reference For AI assistants