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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Convective RF water vapor energy (Rezum) | Active Comparator |
| |
| Transurethral enucleation of prostate (TUEP) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rezum | Procedure | Convective RF water vapor energy (Rezum) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| International Prostate Symptom Score (IPSS) | 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. | 1, 6, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| International Index of Erectile Function (IIEF-EF) | 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. | 1, 6, 12 months |
| four-item version of Male Sexual Health Questionnaire (MSHQ-EjD Short Form) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of medicine Beni Suef University | Banī Suwayf | Egypt |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2025 | May 8, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| TUEP |
| Procedure |
transurethral enucleation of prostate (TUEP) |
|
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. |
| 1, 6, 12 months |
| Qmax maximum urinary flow rate | 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. | 1, 6, 12 months |
| Post Void Residual volume (PVR) | 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. | 1, 6, 12 months |
| D052801 |
| Male Urogenital Diseases |