A multicenter, double blind, randomized, placebo-controlled, dose-response study to evaluate the safety and efficacy of a single treatment of Botox (Botulinum Toxin Type A) purified neurotoxin complex injected into the prostate for the treatment of lower urinary tract symptoms in patients due to benign prostatic hyperplasia

• Conditions: Patients with lower urinary tract symptoms due to benign prostatic hyperplasia.; MedDRA version: 14.1Level: PTClassification code 10062225Term: Urinary tract painSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2005-004281-17-IT
• Lead Sponsor: ALLERGA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-12
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 300

Inclusion Criteria

1. Male, aged 50 years and older 2. Weight at least 50 kg 3. Lower urinary tract symptoms in patients due to benign prostatic hyperplasia based on medical history and digital rectal exam; respectively. Lower urinary tract symptoms (except incontinence) for at least 3 months by patient report. These symptoms may include any or all of the following obstructive or irritative symptoms: weak urinary stream, prolonged voiding, abdominal straining, hesitancy, intermittency, incomplete bladder emptying, dribbling, frequency, nocturia, urgency, bladder pain, and dysuria. 5. International Prostate Symptom Score (IPSS) greater than or equal to 13 at the screening (day -14) and baseline visit (day 5 to 1). 6. Total prostate volume by transrectal ultrasound of at least 30 mL but not greater than 100 mL determined at the screening visit (day -14). 7. Peak urinary flow rate of at least 5 mL/sec, but not greater than 15 mL/sec with a voided urine volume of at least 125 mL at the screening (day -14) and baseline(day 5 to 1) visit. 8. Post-void residual urine volume less than 250 mL measured by ultrasound or bladder scan at the screening visit (day -14). 9. If engaging in sexual activities, all patients must use a male condom for a minimum of 3 months post-treatment irrespective of other contraceptive methods (e.g., vasectomy). 10. Patients with a partner of child-bearing potential must also use a spermicide gel or cream with the male condom, if patient has not had a vasectomy or the female partner is not using an oral, patch, injectable contraceptive or intrauterine device (if she has not had a tubal ligation or hysterectomy). 11. Written informed consent obtained including information regarding the collection, use, disclosure and protection of their personal information (Canadian sites only) or Data Protection Consent (European sites only). 12. Patient is registered in the French social security system and fulfils necessary requirements as required by local law (French sites only). 13.Able and willing to comply with study instructions and visit schedule.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Previous or planned prostate surgery, including minimally invasive procedures(e.g., transurethral needle ablation, transurethral microwave therapy). 2. Any prostate biopsy within 6 weeks of the screening visit (day -14). Patients will be allowed to be re-screened a minimum of 6 weeks after a negative biopsy result is documented. All other protocol inclusion and exclusion criteria must be met. 3. Prominent medial lobe at the screening visit (day -14,)as determined by investigator s opinion (e.g., transrectal ultrasound or previous cystoscopy). 4. Previous or current diagnosis of prostate cancer. Investigators are required to rule out prostate cancer to their satisfaction at the screening visit (day -14). In addition, patients with a total PSA greater than 10 ng/mL will require a biopsy to rule out prostate cancer, unless a biopsy has been performed on the patient within the last 12 months. 5. Alpha-adrenergic antagonists within 15 days prior to the screening visit (day -14) and patient is unwilling to remain off the medication for the duration of the study. 6. Medications in the following classes within 15 days of the screening visit (day -14) or patient is unwilling or unable to remain off chronic use of these medications for the duration of the study. (Intermittent use of these drugs is acceptable but must not be taken at least 5 days prior to any study visit.) Alpha-adrenergic agonists Drugs with anticholinergic activity Antispasmodics Parasympathomimetics and cholinomimetics 7. Medication in the following classes within 90 days of the screening visit (day -14) and throughout the duration of the study. 5-alpha-reductase inhibitors Androgens Drugs with anti-androgenic activity (e.g., spironolactone) Phytotherapy 8. Medication with anti-platelet or anti-coagulant effect, except low doses of acetylsalicylic acid (75 mg to 125 mg), within 10 days of the treatment visit(day 1). 9. Symptomatic prostatitis (acute or chronic) within 24 months of the screening visit (day -14), as determined by patient history. 10. History or evidence of any urologic abnormalities, bladder surgery, or disease (other than BPH) that may impact bladder function.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified