BPH (Benign Prostatic Hyperplasia)
Conditions
Brief summary
Convective RF water vapor energy was introduced as a minimally invasive, radio-frequency thermal energy-based treatment, designed to convectively deliver sterile water vapor, or steam for targeted ablation limited to the transition and central zones in men with clinical BPH. Thus. the aim of the study is to compare Convective RF water vapor energy (Rezum) with trans-urethral enucleation of the prostate (TUEP) regarding efficacy in terms of lower urinary tract symptoms (LUTS) improvement, international prostatic symptoms score (IPSS), improving of the maximum flow rate (Qmax), worsening of erectile and ejaculatory function, and safety regarding post operative complications & hospital stay.
Interventions
Sponsors
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male aged \> 50 yrs. * International Prostate Symptom Score (IPSS) \>12 * Maximum flow rate ( Qmax ) \< 15 ml/s for 125ml voided volume * Post-void residual volume \<350 ml * Prostate volume 80-120 g
Exclusion criteria
* Active urinary tract infection at time of treatment. * Prostate-specific antigen (PSA) more than 10 ng/l. * history of prostate or bladder cancer. * Anticoagulants within 3d of the index procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Prostate Symptom Score (IPSS) | 1, 6, 12 months | The total score ranges from 0 to 35, where 0 indicates no symptoms and 35 indicates the most severe symptoms. Higher scores represent worse urinary symptoms and poorer clinical status. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International Index of Erectile Function (IIEF-EF) | 1, 6, 12 months | The erectile function domain score ranges from 1 to 30, where lower scores indicate more severe erectile dysfunction and higher scores indicate better erectile function. Higher scores represent better clinical outcomes. |
| four-item version of Male Sexual Health Questionnaire (MSHQ-EjD Short Form) | 1, 6, 12 months | The total score ranges from 1 to 15 for the ejaculatory function domain, with higher scores indicating better ejaculatory function. In the bother item, scores range from 0 to 5, where higher scores indicate greater bother or distress related to ejaculatory dysfunction. |
| Qmax maximum urinary flow rate | 1, 6, 12 months | Maximum urinary flow rate (Qmax) will be assessed using uroflowmetry, a non-invasive urodynamic test that measures the maximum flow rate of urine during voiding. Qmax is reported in milliliters per second (mL/s). Higher values indicate better urinary flow and improved urinary function. |
| Post Void Residual volume (PVR) | 1, 6, 12 months | Post-Void Residual urine volume (PVR) will be assessed using bladder ultrasound immediately after voiding to determine the amount of urine remaining in the bladder. PVR is reported in milliliters (mL). Higher values indicate worse bladder emptying and poorer urinary function. |
Countries
Egypt
Outcome results
None listed