A Study Evaluating the Effect of Botulinum Toxin Type A on Semen Quality in Patients With Benign Prostatic Hyperplasia

Study Overview
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Brief Summary
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This is a 24 week study evaluating the effects of botulinum toxin Type A on semen quality in patients with signs and symptoms of Benign Prostatic Hyperplasia (BPH).

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Biological: Botulinum Toxin Type A
* Drug: Placebo (saline)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptoms due to an enlarged prostate Able to provide semen samples at required visits. Exclusion Criteria: Previous use of any botulinum toxin for the treatment of any urological condition History of vasectomy History of undescended testicles or testicular trauma Subject who has not ejaculated for greater than 1 year History of prostate infection or any sexually transmitted disease, such as gonorrhea, within the previous 12 months History of bladder stones History of cancer in the prostate, testicles, or bladder Previous use of chemotherapy for cancer treatment History of urinary incontinence Previous prostate surgery

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum Toxin Type A<br>OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1. | Biological: Botulinum Toxin Type A<br>* OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.<br>* Other names: BOTOX®;|
| Placebo Comparator: Placebo (saline)<br>Placebo (saline) injected into the prostate on Day 1. | Drug: Placebo (saline)<br>* Saline injected into the prostate on Day 1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Total Sperm Count Per Ejaculate | Sperm count per ejaculate was calculated based on the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Ejaculatory volume and sperm concentration were used to determine the total sperm count per ejaculate. A positive percent change from Baseline indicated improvement. | Baseline, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Log Transformed Sperm Concentration | Sperm concentration was calculated based on the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Collected sperm samples were assessed using a CELL-VU® count chamber. The total number of sperm per 100 boxes on the chamber grid were counted. Sperm Concentration = total number of sperm counted in 100 boxes × dilution factor / 1 × 10^6 and is reported in millions per milliliter. Log transformation of the sperm concentration was used for analysis . The log transformed sperm concentration data has no units. A negative change from Baseline indicated a lower sperm concentration (worsening). | Baseline, Week 12 | 
| Change From Baseline in Ejaculatory Volume | Ejaculatory volume was calculated using the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Ejaculatory volume was measured using a standard pipette (measuring device). A negative change from Baseline indicated worsening. | Baseline, Week 12 | 
| Change From Baseline in Total Sperm Motility | Sperm motility was calculated using the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Sperm motility was assessed using the CELL-VU chamber and was scored according to the World Health Organization criteria for sperm progression and motility. A total of at least 200 motile and immotile sperm were counted. A percent was determined by the calculation of motile sperm/total sperm count. A negative change from Baseline indicated a worsening. | Baseline, Week 12 | 
| Change From Baseline in Normal Sperm Morphology | Sperm Morphology was evaluated using the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Normal sperm morphology was assessed from slide smears sent to a central reading facility. A positive change from Baseline indicated improvement. | Baseline, Week 12 |