Benign Prostate Hyperplasia
Conditions
Keywords
Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Intravenous Sedation, Local Anesthesia, Prostate Enlargement, Urinary Retention, Minimally Invasive Therapy, Water Vapor Thermal Therapy, Rezum, LUTS, BPH
Brief summary
This single-center retrospective study evaluates the safety, feasibility, and short-term clinical outcomes of Rezūm water vapor thermal therapy (WVTT) for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) in patients treated under local anesthesia with intravenous sedation. The study was conducted at Royal Hospital, Sulaymaniyah, Kurdistan Region of Iraq, and includes 129 consecutive patients aged 45 to 96 years with prostate volumes ranging from 30 to 120 grams. Outcomes assessed include symptom improvement, urinary flow, post-void residual volume, quality of life, erectile function, prostate volume reduction, catheter-related outcomes, perioperative complications, and retreatment rates. This study aims to provide real-world evidence regarding the use of Rezūm therapy in a high-comorbidity population and in a Middle Eastern clinical setting.
Detailed description
Benign prostatic hyperplasia (BPH) is a common condition in aging men and is a major cause of lower urinary tract symptoms (LUTS), including urinary frequency, urgency, nocturia, weak urinary stream, intermittency, hesitancy, and incomplete bladder emptying. Although transurethral resection of the prostate (TURP) has historically been considered the standard surgical treatment, it may be associated with bleeding, retrograde ejaculation, erectile dysfunction, incontinence, and the need for spinal or general anesthesia. Minimally invasive surgical therapies such as Rezūm water vapor thermal therapy (WVTT) have emerged as alternatives for selected patients. This retrospective observational study was conducted at the Department of Urology, Royal Hospital, Sulaymaniyah, Kurdistan Region of Iraq, between September 3, 2025, and March 12, 2026. The study includes 129 consecutive male patients aged 45 years or older with moderate-to-severe LUTS secondary to BPH, including patients with prostate volumes between 30 and 120 grams, those who failed or were intolerant to medical therapy, and selected patients with catheter-dependent urinary retention related to BPH. All patients underwent preoperative evaluation including medical history, physical examination, digital rectal examination, International Prostate Symptom Score (IPSS), quality of life assessment, International Index of Erectile Function (IIEF), prostate-specific antigen testing, renal function tests, urinalysis, urine culture, uroflowmetry, post-void residual measurement, prostate imaging, and cystoscopic assessment. Selected patients with possible neurogenic bladder dysfunction underwent urodynamic testing when indicated. All procedures were performed using the Rezūm System under local anesthesia with intravenous sedation. Treatment details, including number and location of injections, were determined according to prostate anatomy and size. Postoperatively, all patients received urethral catheterization for a duration based on prostate size, antibiotic prophylaxis, and alpha-blocker therapy. Primary outcome measures include changes in IPSS, maximum urinary flow rate (Qmax), post-void residual volume (PVR), quality of life score, erectile function, and prostate volume reduction at follow-up. Secondary outcome measures include intraoperative and postoperative complications, catheter duration, discharge time, urinary retention after catheter removal, urinary tract infection, hematuria, sexual side effects, and need for retreatment or alternative surgical intervention. The purpose of this study is to assess the safety, feasibility, and short-term effectiveness of Rezūm therapy performed under local anesthesia with intravenous sedation in a real-world clinical setting, including patients with significant comorbidities and larger prostate volumes.
Interventions
Transurethral convective water vapor thermal therapy used for the treatment of benign prostatic hyperplasia.
Sponsors
ALI KAMAL M. SAMI
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
45 Years to 96 Years
Healthy volunteers
No
Inclusion criteria
1. Male patients aged 45 years or older. 2. Moderate-to-severe lower urinary tract symptoms secondary to benign prostatic hyperplasia (IPSS ≥8). 3. Maximum urinary flow rate (Qmax) less than 15 mL/s on uroflowmetry. 4. Prostate volume 30 to 120 g on transrectal or transabdominal ultrasonography. 5. Failure of medical therapy or intolerance to medical therapy. 6. Catheter-dependent urinary retention secondary to benign prostatic hyperplasia in patients who were not candidates for or declined conventional surgical intervention. 7. Consecutive patients who underwent Rezūm water vapor thermal therapy during the study period.
Exclusion criteria
1. Pre-existing erectile dysfunction not attributable to benign prostatic hyperplasia medication side effects. 2. Retrograde ejaculation not caused by alpha-blocker therapy. 3. Lower urinary tract symptoms attributable to causes other than benign prostatic hyperplasia, including neurogenic bladder or bladder overactivity unrelated to benign prostatic hyperplasia. 4. History of previous bladder surgery, prostate surgery, or urethral stricture surgery. 5. Presence of vesical calculi. 6. Confirmed neurogenic bladder. 7. Suspected or confirmed prostate malignancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in International Prostate Symptom Score (IPSS) | Baseline, 1 month, and 3 months | Change in IPSS from baseline to follow-up after Rezūm water vapor thermal therapy. |
| Change in Maximum Urinary Flow Rate (Qmax) | Baseline, 1 month, and 3 months | Change in maximum urinary flow rate from baseline to follow-up after treatment. |
| Change in Post-Void Residual Volume (PVR) | Baseline, 1 month, and 3 months | Change in post-void residual urine volume from baseline to follow-up after treatment. |
| Change in Quality of Life (QoL) Score | Baseline, 1 month, and 3 months | Change in disease-specific quality of life score from baseline to follow-up after treatment. |
| Change in International Index of Erectile Function (IIEF) | Baseline, 1 month, and 3 months | Change in erectile function as assessed by IIEF from baseline to follow-up after treatment. |
| Change in Prostate Volume | Baseline, 1 month, and 3 months | Change in prostate volume from baseline to follow-up after treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative and Postoperative Complications | From procedure date to 3 months | Assessment of complications including hematuria, urinary tract infection, urinary retention, urgency, frequency, nocturia, urge incontinence, and other treatment-related adverse events. |
| Catheterization Duration | From procedure date until catheter removal, up to 12 days | Duration of postoperative urethral catheterization following Rezūm treatment. |
| Hospital Discharge Time | Day of procedure to next day | Time from completion of the procedure to discharge from hospital. |
| Retreatment or Conversion to Alternative Surgery | Up to 3 months | Need for repeat Rezūm treatment or conversion to alternative surgical procedures such as laser ablation or bipolar transurethral resection of the prostate. |
| Incidence of Retrograde Ejaculation | From procedure date to 3 months | Number of patients reporting retrograde ejaculation after Rezūm treatment. |
| Incidence of De Novo Erectile Dysfunction | From procedure date to 3 months | Number of patients with new-onset erectile dysfunction after treatment. |
Countries
Iraq
Contacts
PRINCIPAL_INVESTIGATORAli K M.Sami, M.B.Ch.B., F.I.B.M.S.( PhD)
College of Medicine, University of Sulaimani
Outcome results
None listed