Urological and Genital Diseases
Conditions
Interventions
Sponsors
Tanta University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male patients aged =45 years 2. Clinical diagnosis of BPH with moderate to severe LUTS (IPSS =13) 3. Scheduled for Rezum water vapor thermal therapy as definitive treatment for BPH 4. Prostate volume 30–80 cc (measured by transabdominal ultrasound or transrectal ultrasound within 90 days) 5. Willing and able to provide written informed consent 6. Ability to complete follow-up assessments (including questionnaires in native language or with validated translation) 7. Life expectancy =12 months
Exclusion criteria
Exclusion criteria: 1. Active urinary tract infection (positive urine culture or symptomatic UTI) 2. Urinary retention requiring chronic catheterization (>30 days indwelling catheter or clean intermittent catheterization) 3. Previous prostate surgery (TURP, open prostatectomy, laser enucleation) or minimally invasive procedures (UroLift, TUNA, TIND, previous Rezum) 4. Histologically confirmed or suspected prostate or bladder cancer 5. Neurogenic bladder dysfunction (multiple sclerosis, Parkinson's disease, spinal cord injury, diabetic cystopathy) 6. Bladder stones or bladder diverticulum requiring concurrent treatment 7. Urethral stricture disease (urethral calibration <16 Fr) or prior urethral surgery 8. Bleeding disorders or anticoagulation that cannot be held per protocol: - Warfarin: Hold 5 days, INR <1.5 required - Direct oral anticoagulants (apixaban, rivaroxaban, dabigatran, edoxaban): Hold per manufacturer guidelines (typically 48–72 hours) - Antiplatelet agents: Aspirin may be continued; clopidogrel held 5–7 days if medically appropriate 9. Severe comorbidities precluding outpatient procedure (ASA Class IV–V) 10. Inability to complete questionnaires due to cognitive impairment (Mini-Mental State Examination <24) or language barrier 11. Participation in another interventional clinical trial within 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether pre-treatment IPP grade predicts treatment success following Rezum therapy in BPH patients, defined as =50% reduction in International Prostate Symptom Score (IPSS) from baseline at 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To correlate IPP grades with absolute and percentage improvement in IPSS at 1, 3, 6, and 12 months post-procedure 2. To assess the relationship between IPP grade and post-procedure urinary retention rates and time to catheter removal 3. To evaluate IPP correlation with quality of life (QoL) improvements and BPH Impact Index (BPHII) changes 4. To determine optimal IPP cut-off values for predicting treatment success using receiver operating characteristic (ROC) curve analysis 5. To evaluate inter-observer and intra-observer reliability of IPP measurement 6. To assess change in IPP at 12 months and correlation with sustained clinical outcomes 7. To evaluate retreatment rates at 12 months stratified by IPP grade 8. To assess patient satisfaction and treatment recommendation rates by IPP grade | — |
Countries
Egypt
Contacts
Public ContactMohamed Elkhashab
Lecturer of Urology
Outcome results
None listed