Intraprostatic Injection of Botulinum Toxin A Versus Ethanol for Treatment of Patients With Benign Prostatic Hyperplasia Refractory to Medical Treatment
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Male
- Sponsor
- Cairo University
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- International prostate symptom score (IPSS)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
To compare safely and efficacy of intraprostatic injection of botulinum toxin A versus ethanol for treatment of benign prostatic hyperplasia (BPH).
Detailed Description
To compare safely and efficacy of transrectal intraprostatic injection of botulinum toxin A versus ethanol for treatment of symptomatic benign prostatic hyperplasia (BPH) refractory to medical treatment.
Investigators
Mohammed Said ElSheemy
Associate Professor of Urology
Cairo University
Eligibility Criteria
Inclusion Criteria
- •international prostate symptoms score (IPSS) \> 7
- •Qmax \< 15
- •Patients with refractory symptomatic BPH to medications
- •patients high risk for surgery or unwilling to do surgery
Exclusion Criteria
- •bladder stones
- •acute or chronic urinary retention
- •urethral stricture
- •bladder or prostatic carcinoma.
- •Neurogenic bladder dysfunctions
Outcomes
Primary Outcomes
International prostate symptom score (IPSS)
Time Frame: 1, 3, 6 months and one year
7 items Questionnaire with a score range from 0 - 35 (5 points for each item) A score of 35 is considered the worst The score is calculated during each period of follow-up The difference in the score in each group will be compared versus each other to detect any significant difference between both groups
Secondary Outcomes
- Maximum flow rate (Qmax)(1, 3, 6 months and one year)
- Prostate volume(1, 3, 6 months and one year)
- quality of life (QoL)(1, 3, 6 months and one year)