Botulinum Toxins, Type A, Injection; Complications, Infection, Male, Prostatic Hyperplasia, Ultrasonography
Conditions
Keywords
ethanol ablation of the prostate, Benign prostatic hyperplasia (BPH), Prostate, Ethanol, Transrectal, BPH, onaBoNT-A, Botox, Lower urinary tract symptoms, Botulinum toxin, OnabotulinumtoxinA, Quality of life, IPSS, Randomised controlled study
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.
Interventions
PROCEDUREBotulinum toxin A
PROCEDUREEthanol
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Only the surgeon during injection knows the active material
Eligibility
Sex/Gender
MALE
Age
50 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International prostate symptom score (IPSS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Maximum flow rate (Qmax) | 1, 3, 6 months and one year | The peak flow rate measured during flowmetry (mL/Sec) Increase in the flow rate is considered improvement The Qmax is calculated during each period of follow-up by flowmetry The difference in the Qmax in each group will be compared versus each other to detect any significant difference between both groups |
| Prostate volume | 1, 3, 6 months and one year | Prostate volume (PV) will be measured by transrectal US (Cubic cm) Decrease in size is considered improvement The PV is calculated during each period of follow-up The difference in the PV in each group will be compared versus each other to detect any significant difference between both groups |
| quality of life (QoL) | 1, 3, 6 months and one year | one items Questionnaire It is the QoL portion of the International prostate symptom score (IPSS) The score range from 0 - 6 A score of 6 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| retention of urine | 1, 3, 6 months and one year | Significant difference between the rate (%) of development of retention of urine in both groups during follow-up |
| Other lines of treatment including TURP | 1, 3, 6 months and one year | Significant difference between the rate (%) of required TURP and other lines of treatment in both groups (due to failure of studied intervention to improve symptoms of the patient ) |
Countries
Egypt
Outcome results
None listed