Trial Outcomes & Findings for Safety and Efficacy of Botulinum Toxin Type A to Treat Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (NCT NCT01107392)

Last Updated: 2019-05-03

Results Overview

IPSS is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consisted of seven items. The patient evaluated their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score ranged from 0 (no symptoms) to 35 (most severe symptoms). A negative change from Baseline indicated improvement.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

315 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2019-05-03

Participant Flow

Participant milestones

Participant milestones
Measure	Botulinum Toxin Type A botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.	Placebo (Normal Saline) Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
Overall Study STARTED	158	157
Overall Study COMPLETED	153	154
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Botulinum Toxin Type A botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.	Placebo (Normal Saline) Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
Overall Study Adverse Event	2	0
Overall Study Personal Reasons	2	3
Overall Study Administrative decision	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Botulinum Toxin Type A n=158 Participants botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.	Placebo (Normal Saline) n=157 Participants Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.	Total n=315 Participants Total of all reporting groups
Age, Customized ≤ 65 Years	89 Participants 8.19 • n=5 Participants	79 Participants 8.12 • n=7 Participants	168 Participants n=5 Participants
Age, Customized > 65 Years	69 Participants n=5 Participants	78 Participants n=7 Participants	147 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	158 Participants n=5 Participants	157 Participants n=7 Participants	315 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Modified Intent-to-treat population included all randomized and treated participants with at least one post-baseline IPSS measurement.

Outcome measures

Outcome measures
Measure	Botulinum Toxin Type A n=156 Participants botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.	Placebo (Normal Saline) n=157 Participants Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Week 12 Baseline	21.8 Score on a scale Standard Deviation 4.90	21.5 Score on a scale Standard Deviation 4.56
Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Week 12 Change from Baseline at Week 12	-6.3 Score on a scale Standard Deviation 6.61	-5.6 Score on a scale Standard Deviation 5.86

SECONDARY outcome

Timeframe: Baseline, Week 6, Week 24

Population: Modified Intent-to-treat population included all randomized and treated participants with at least one post-baseline IPSS measurement.

Outcome measures

Outcome measures
Measure	Botulinum Toxin Type A n=156 Participants botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.	Placebo (Normal Saline) n=157 Participants Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
Change From Baseline in the Total International Prostate Symptom Score (IPSS) Change from Baseline at Week 6 (n=156,156)	-5.4 Score on a scale Standard Deviation 5.84	-5.3 Score on a scale Standard Deviation 5.27
Change From Baseline in the Total International Prostate Symptom Score (IPSS) Baseline	21.8 Score on a scale Standard Deviation 4.90	21.5 Score on a scale Standard Deviation 4.56
Change From Baseline in the Total International Prostate Symptom Score (IPSS) Change from Baseline at Week 24 (n=152,154)	-6.3 Score on a scale Standard Deviation 6.43	-6.0 Score on a scale Standard Deviation 5.79

SECONDARY outcome

Timeframe: Baseline, Weeks 6, 12 and 24

Population: Modified Intent-to-treat population included all randomized and treated participants with at least one post-baseline IPSS measurement with data available for this outcome measure.

Urinary flow was determined by uroflowmetry measured in milliliters/second (mL/sec). An increase from Baseline indicated improvement.

Outcome measures

Outcome measures
Measure	Botulinum Toxin Type A n=154 Participants botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.	Placebo (Normal Saline) n=156 Participants Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
Change From Baseline in Peak Urine Flow Rate Baseline	8.0 mL/sec Standard Deviation 2.52	8.0 mL/sec Standard Deviation 2.86
Change From Baseline in Peak Urine Flow Rate Change from Baseline at Week 6 (n=138,136)	2.5 mL/sec Standard Deviation 4.97	1.2 mL/sec Standard Deviation 3.40
Change From Baseline in Peak Urine Flow Rate Change from Baseline at Week 12 (n=143,147)	2.5 mL/sec Standard Deviation 5.24	1.7 mL/sec Standard Deviation 4.38
Change From Baseline in Peak Urine Flow Rate Change from Baseline at Week 24 (n=140,149)	2.5 mL/sec Standard Deviation 4.97	1.9 mL/sec Standard Deviation 4.32

SECONDARY outcome

Timeframe: 24 Weeks

Population: Modified Intent-to-treat population included all randomized and treated patients with at least one post-baseline IPSS measurement. Only patients with at least a 4-point reduction from Baseline in total IPSS were included in the analysis.

Duration of effect was calculated from the time of the first follow-up visit with a ≥ 4-point reduction from Baseline in IPSS to the next visit when the IPSS change from Baseline was \< 4-points.

Outcome measures

Outcome measures
Measure	Botulinum Toxin Type A n=123 Participants botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.	Placebo (Normal Saline) n=120 Participants Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
Duration of Effect	20.9 Weeks Interval 18.6 to 20.9	20.6 Weeks Interval 20.1 to Not estimable.

Adverse Events

Botulinum Toxin Type A

Serious events: 5 serious events

Other events: 42 other events

Deaths: 0 deaths

Placebo (Normal Saline)

Serious events: 8 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Botulinum Toxin Type A n=158 participants at risk botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.	Placebo (Normal Saline) n=157 participants at risk Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
Eye disorders Retinal detachment	0.63% 1/158	0.00% 0/157
Gastrointestinal disorders Inguinal hernia	0.63% 1/158	0.00% 0/157
Hepatobiliary disorders Cholelithiasis	0.00% 0/158	0.64% 1/157
Infections and infestations Cellulitis	0.63% 1/158	0.00% 0/157
Infections and infestations Localised infection	0.63% 1/158	0.00% 0/157
Infections and infestations Urosepsis	0.00% 0/158	0.64% 1/157
Metabolism and nutrition disorders Hypoglycaemia	0.63% 1/158	0.00% 0/157
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/158	0.64% 1/157
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.63% 1/158	0.00% 0/157
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/158	0.64% 1/157
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.00% 0/158	0.64% 1/157
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.00% 0/158	0.64% 1/157
Nervous system disorders Carotid artery stenosis	0.00% 0/158	0.64% 1/157
Skin and subcutaneous tissue disorders Leukoplakia	0.00% 0/158	0.64% 1/157

Other adverse events

Other adverse events
Measure	Botulinum Toxin Type A n=158 participants at risk botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.	Placebo (Normal Saline) n=157 participants at risk Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
Investigations Prostatic specific antigen increased	3.8% 6/158	6.4% 10/157
Renal and urinary disorders Haematuria	14.6% 23/158	11.5% 18/157
Reproductive system and breast disorders Haematospermia	8.2% 13/158	10.2% 16/157

Additional Information

Therapeutic Area Head,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER