Benign Prostate HyperplasiaNCT07507591
Safety, Efficacy, and Short-Term Outcomes of Rezūm Water Vapor Thermal Therapy for Benign Prostatic Hyperplasia Under Local Anesthesia With Intravenous Sedation: A Single-Center Retrospective Study of 129 Patients in the Kurdistan Region of Iraq
An observational study of Benign Prostate Hyperplasia, run by ALI KAMAL M. SAMI at 1 site in Iraq.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 96 years, men only
- Conditions the study is for
- Benign Prostate Hyperplasia
- What is being tested?
- Rezum Water Vapor Thermal Therapy
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 129 participants
- Where
- 1 siteIraq
- Study dates
- 3 Sep 2025to 12 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 96 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male patients with moderate-to-severe lower urinary tract symptoms secondary to benign prostatic hyperplasia who underwent Rezūm water vapor thermal therapy at Royal Hospital, Sulaymaniyah, Kurdistan Region of Iraq.
Who may be able to join
- Male patients aged 45 years or older.
- Moderate-to-severe lower urinary tract symptoms secondary to benign prostatic hyperplasia (IPSS ≥8).
- Maximum urinary flow rate (Qmax) less than 15 mL/s on uroflowmetry.
- Prostate volume 30 to 120 g on transrectal or transabdominal ultrasonography.
- Failure of medical therapy or intolerance to medical therapy.
- Catheter-dependent urinary retention secondary to benign prostatic hyperplasia in patients who were not candidates for or declined conventional surgical intervention.
- Consecutive patients who underwent Rezūm water vapor thermal therapy during the study period.
Who cannot join
- Pre-existing erectile dysfunction not attributable to benign prostatic hyperplasia medication side effects.
- Retrograde ejaculation not caused by alpha-blocker therapy.
- Lower urinary tract symptoms attributable to causes other than benign prostatic hyperplasia, including neurogenic bladder or bladder overactivity unrelated to benign prostatic hyperplasia.
- History of previous bladder surgery, prostate surgery, or urethral stricture surgery.
- Presence of vesical calculi.
- Confirmed neurogenic bladder.
- Suspected or confirmed prostate malignancy.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Benign Prostate Hyperplasia
- Being tested
- Rezum Water Vapor Thermal Therapy
- 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
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rezum Water Vapor Thermal TherapyDevice
Transurethral convective water vapor thermal therapy used for the treatment of benign prostatic hyperplasia.
| Study group | Role | What they receive |
|---|---|---|
| Patients with BPH treated with Rezum | Consecutive patients with benign prostatic hyperplasia who underwent Rezūm water vapor thermal therapy at a single center under local anesthesia with intravenous sedation. Receives: Device: Rezum Water Vapor Thermal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in International Prostate Symptom Score (IPSS)
Change in IPSS from baseline to follow-up after Rezūm water vapor thermal therapy.
Measured: Baseline, 1 month, and 3 months
Change in Maximum Urinary Flow Rate (Qmax)
Change in maximum urinary flow rate from baseline to follow-up after treatment.
Measured: Baseline, 1 month, and 3 months
Change in Post-Void Residual Volume (PVR)
Change in post-void residual urine volume from baseline to follow-up after treatment.
Measured: Baseline, 1 month, and 3 months
Change in Quality of Life (QoL) Score
Change in disease-specific quality of life score from baseline to follow-up after treatment.
Measured: Baseline, 1 month, and 3 months
Change in International Index of Erectile Function (IIEF)
Change in erectile function as assessed by IIEF from baseline to follow-up after treatment.
Measured: Baseline, 1 month, and 3 months
Change in Prostate Volume
Change in prostate volume from baseline to follow-up after treatment.
Measured: Baseline, 1 month, and 3 months
Secondary outcomes (6)
Perioperative and Postoperative Complications
Assessment of complications including hematuria, urinary tract infection, urinary retention, urgency, frequency, nocturia, urge incontinence, and other treatment-related adverse events.
Measured: From procedure date to 3 months
Catheterization Duration
Duration of postoperative urethral catheterization following Rezūm treatment.
Measured: From procedure date until catheter removal, up to 12 days
Hospital Discharge Time
Time from completion of the procedure to discharge from hospital.
Measured: Day of procedure to next day
Retreatment or Conversion to Alternative Surgery
Need for repeat Rezūm treatment or conversion to alternative surgical procedures such as laser ablation or bipolar transurethral resection of the prostate.
Measured: Up to 3 months
Incidence of Retrograde Ejaculation
Number of patients reporting retrograde ejaculation after Rezūm treatment.
Measured: From procedure date to 3 months
Incidence of De Novo Erectile Dysfunction
Number of patients with new-onset erectile dysfunction after treatment.
Measured: From procedure date to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start3 Sep 2025
- Primary completion12 Mar 2026
- Study completion12 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostate HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALI KAMAL M. SAMI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ALI KAMAL M. SAMI, University of Sulaimani
- Investigators
- Ali K M.Sami, M.B.Ch.B., F.I.B.M.S.( PhD), Principal investigator, College of Medicine, University of Sulaimani
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507591
- Sponsor's protocol ID
- 21022023
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data will not be made available
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Efficacy, and Short-Term Outcomes of Rezūm Water Vapor Thermal Therapy for Benign Prostatic Hyperplasia Under Local Anesthesia With Intravenous Sedation: A Single-Center Retrospective Study of 129 Patients in the Kurdistan Region of Iraq
- ClinicalTrials.gov ID
- NCT07507591
- Acronym / sponsor ID
- 21022023
- Conditions
- Benign Prostate Hyperplasia
- Keywords
- Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Intravenous Sedation, Local Anesthesia, Prostate Enlargement, Urinary Retention, Minimally Invasive Therapy, Water Vapor Thermal Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- ALI KAMAL M. SAMIUniversity, hospital or other
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- 12 Mar 2026 (actual)
- Study completion
- 12 Mar 2026 (actual)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with BPH treated with Rezum | – | Device: Rezum Water Vapor Thermal TherapyConsecutive patients with benign prostatic hyperplasia who underwent Rezūm water vapor thermal therapy at a single center under local anesthesia with intravenous sedation. |
Who may qualify
- Ages
- 45 to 96 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients with moderate-to-severe lower urinary tract symptoms secondary to benign prostatic hyperplasia who underwent Rezūm water vapor thermal therapy at Royal Hospital, Sulaymaniyah, Kurdistan Region of Iraq.
Key inclusion criteria (7 listed)
- Male patients aged 45 years or older.
- Moderate-to-severe lower urinary tract symptoms secondary to benign prostatic hyperplasia (IPSS ≥8).
- Maximum urinary flow rate (Qmax) less than 15 mL/s on uroflowmetry.
- Prostate volume 30 to 120 g on transrectal or transabdominal ultrasonography.
- Failure of medical therapy or intolerance to medical therapy.
Key exclusion criteria (7 listed)
- Pre-existing erectile dysfunction not attributable to benign prostatic hyperplasia medication side effects.
- Retrograde ejaculation not caused by alpha-blocker therapy.
- Lower urinary tract symptoms attributable to causes other than benign prostatic hyperplasia, including neurogenic bladder or bladder overactivity unrelated to benign prostatic hyperplasia.
- History of previous bladder surgery, prostate surgery, or urethral stricture surgery.
- Presence of vesical calculi.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rezum Water Vapor Thermal TherapyTransurethral convective water vapor thermal therapy used for the treatment of benign prostatic hyperplasia. | Device | Patients with BPH treated with Rezum |
Primary outcome
Change in International Prostate Symptom Score (IPSS)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: Baseline, 1 month, and 3 months
Change in prostate volume from baseline to follow-up after treatment.
6 secondary outcomes
Perioperative and Postoperative Complications
Time frame: From procedure date to 3 months
Catheterization Duration
Time frame: From procedure date until catheter removal, up to 12 days
Hospital Discharge Time
Time frame: Day of procedure to next day
Retreatment or Conversion to Alternative Surgery
Time frame: Up to 3 months
Incidence of Retrograde Ejaculation
Time frame: From procedure date to 3 months
Incidence of De Novo Erectile Dysfunction
Time frame: From procedure date to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No. individual participant data will not be made available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali K M.Sami, M.B.Ch.B., F.I.B.M.S.( PhD) principal investigator
College of Medicine, University of Sulaimani
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostate Hyperplasia, run by ALI KAMAL M. SAMI at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in International Prostate Symptom Score (IPSS) (time frame: Baseline, 1 month, and 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.