NCT01107392

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

Completed Phase 2 Results posted Last updated 3 May 2019

What this trial tests

Phase 2 trial testing botulinum toxin Type A in Benign Prostatic Hyperplasia in 315 participants. Completed in 8 June 2012.

Timeline

1 August 2010

Primary endpoint
16 March 2012

8 June 2012

Quick facts

Lead sponsor	Allergan
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	315
Start date	1 August 2010
Primary completion	16 March 2012
Estimated completion	8 June 2012
Sites	8 locations across France, Germany, Poland, South Korea, Philippines, Canada, United States, Czechia

Drugs / interventions tested

• botulinum toxin Type A (BOTULINUM TOXIN TYPE A) — full drug profile →
• Normal saline

Conditions studied

• Benign Prostatic Hyperplasia — all drugs for Benign Prostatic Hyperplasia →

Sponsor

Allergan — full company profile →

Who can join

45 and older, male only, with Benign Prostatic Hyperplasia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Week 12 Primary · Baseline, Week 12

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.

Baseline

Group	Value	95% CI
Botulinum Toxin Type A	21.8	± 4.90
Placebo (Normal Saline)	21.5	± 4.56

Change from Baseline at Week 12

Group	Value	95% CI
Botulinum Toxin Type A	-6.3	± 6.61
Placebo (Normal Saline)	-5.6	± 5.86

Change From Baseline in the Total International Prostate Symptom Score (IPSS) Secondary · Baseline, Week 6, Week 24

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.

Baseline

Group	Value	95% CI
Botulinum Toxin Type A	21.8	± 4.90
Placebo (Normal Saline)	21.5	± 4.56

Change from Baseline at Week 6 (n=156,156)

Group	Value	95% CI
Botulinum Toxin Type A	-5.4	± 5.84
Placebo (Normal Saline)	-5.3	± 5.27

Change from Baseline at Week 24 (n=152,154)

Group	Value	95% CI
Botulinum Toxin Type A	-6.3	± 6.43
Placebo (Normal Saline)	-6.0	± 5.79

Change From Baseline in Peak Urine Flow Rate Secondary · Baseline, Weeks 6, 12 and 24

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

Baseline

Group	Value	95% CI
Botulinum Toxin Type A	8.0	± 2.52
Placebo (Normal Saline)	8.0	± 2.86

Change from Baseline at Week 6 (n=138,136)

Group	Value	95% CI
Botulinum Toxin Type A	2.5	± 4.97
Placebo (Normal Saline)	1.2	± 3.40

Change from Baseline at Week 12 (n=143,147)

Group	Value	95% CI
Botulinum Toxin Type A	2.5	± 5.24
Placebo (Normal Saline)	1.7	± 4.38

Change from Baseline at Week 24 (n=140,149)

Group	Value	95% CI
Botulinum Toxin Type A	2.5	± 4.97
Placebo (Normal Saline)	1.9	± 4.32

Duration of Effect Secondary · 24 Weeks

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.

Group	Value	95% CI
Botulinum Toxin Type A	20.9	18.6 – 20.9
Placebo (Normal Saline)	20.6	20.1 – NA

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Botulinum Toxin Type A

Serious: 5/158 (3%)

Deaths: —

Placebo (Normal Saline)

Serious: 8/157 (5%)

Deaths: —

Serious adverse events (14 terms)

Reaction	System	Botulinum Toxin Type A	Placebo (Normal Saline)
Retinal detachment	Eye disorders	—	—
Inguinal hernia	Gastrointestinal disorders	—	—
Cholelithiasis	Hepatobiliary disorders	—	—
Cellulitis	Infections and infestations	—	—
Localised infection	Infections and infestations	—	—
Urosepsis	Infections and infestations	—	—
Hypoglycaemia	Metabolism and nutrition disorders	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Carotid artery stenosis	Nervous system disorders	—	—
Leukoplakia	Skin and subcutaneous tissue disorders	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	Botulinum Toxin Type A	Placebo (Normal Saline)
Haematuria	Renal and urinary disorders	—	—
Haematospermia	Reproductive system and breast disorders	—	—
Prostatic specific antigen increased	Investigations	—	—

Most-reported serious reactions: Retinal detachment, Inguinal hernia, Cholelithiasis, Cellulitis, Localised infection, Urosepsis, Hypoglycaemia, Osteoarthritis.

Data from ClinicalTrials.gov NCT01107392 adverse events section.

Sponsor's own description

This study will evaluate the safety and efficacy of intraprostatic administration of botulinum toxin Type A (BOTOX®) compared with placebo to treat urinary tract symptoms due to benign prostatic hyperplasia.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.