Prostate Hyperplasia
Conditions
Keywords
Rezum, tamsulosin
Brief summary
the investigators aimed to compare the efficacy and safety of Rezūm therapy for the management of benign prostatic hyperplasia (BPH) with Tamsulosin.
Detailed description
So far, data from available studies point towards good clinical outcomes with a short-term risk of self-limiting minor complications. Its application has demonstrated clinical effectiveness and possesses specific benefits that distinguish it among other treatments. It is applicable to outpatient setting, is effective in preserving sexual function and is versatile in its ability to treat a variety of prostate gland morphology.
Interventions
DEVICERezum
Rezum procedure in Rezum group
DRUGTamsulosin
Tamsulosin were given to Tamsulosin group
Sponsors
khaled Abdelsattar Gad Ibrahim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. with prostate volumes of 30- 80 mL, 2. mild to mod LUTS 3. (maximum urinary flow rate \[Q max\] of \<15 mL/s 4. International Prostate Symptom Score \[IPSS\] of \>13) 5. PVR urine \< 250 ml
Exclusion criteria
1. prostate cancer, 2. neurogenic bladder 3. urethral stricture, 4. urinary bladder stone 5. previous prostatic surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The International Prostate Symptom score (IPSS) | Time Frame: for each case in both groups the investigator assess IPSS at 3, 6, 12 after procedures through study completion, an average of 1 year | Measurement of The International Prostate Symptom score (IPSS) in both groups After 3, 6, 12 months of operation, the questioner is performed. Minimum :0 / Maximum : 35 Total score: 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic |
| The Maximum Urinary flow rate (Qmax) | Time Frame: for each case in both groups the investigator assess Qmax at 3, 6, 12 months after procedures through study completion, an average of 1year | Measurement of The Maximum Urinary flow rate (Qmax) in both groups After 3, 6, 12 months of operation, the procedure is performed. Qmax is measured by (ml/sec) Normal values are described as a Qmax above 15 ml/sec and below 10 ml/sec is considered abnormal |
| The Quality of Life (QoL) | [Time Frame: for each case in both groups the investigator assess QoL at 3, 6, 12 months after procedures through study completion, an average of 1 year | Measurement of The Quality of Life (QoL) in both groups After 3, 6, 12 months of operation, the questioner is performed. Minimum :0 means delighted / Maximum : 5 means unhappy |
| The Prostate size | Time Frame: for each case in both groups the investigator assess prostate size at 3, 6, 12 months after procedures through study completion, an average of 1 year. | the prostate size was measured by grams by Trans-rectal ultra sound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of complications | through 1 year | For each case in both groups the investigator assess the safety using incidence of complications by The Clavien-Dindo system. It uses a 5-grade scale (I-V), to classify complications from minor issues not requiring intervention (Grade I) to death (Grade V). |
Countries
Egypt
Outcome results
None listed