Study on Water Vapor Thermal Therapy
ConditionBenign Prostatic Hyperplasia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age50+
SponsorSaint Vincent's Hospital, Korea
About this trial
The goal of this observational study is to learn about the efficacy of Rezum water vapor thermal therapy in benign prostatic hyperplasia patients. The main question it aims to answer is:
* Is Rezum an effective treatment? * Is Rezum safe?
Participants will be followed up for at least three months after the treatment to evaluate efficacy and safety.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 50 or older
Prostate size between 30cc and 80cc as measured by transrectal ultrasound
Patients scheduled for Rezum surgery for BPH
Disqualifiers
Suspected prostate cancer
Suspected urinary tract infection
Inability to complete follow-up
Patients who do not consent to participate in the study
Trial population
The study subjects are patients requiring surgery for benign prostatic hyperplasia (BPH).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Rezum (water vapor thermal therapy)
Procedure/SurgeryRezum or water vapor thermal therapy is a procedure that involves injecting steam at 103°C into the prostate tissue to induce necrosis and reduce the size of the enlarged prostate.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Rezum Group1 intervention
Trial outcomes
Primary outcomes
1
International Prostate Symptom Score (IPSS)
International Prostate Symptom Score (IPSS) is a validated, reproducible scoring system to assess disease severity and response to therapy for BPH. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Time frame
From enrollment to three months after treatment2
Qmax
Maximal urine flow rate in uroflowmetry exam
Time frame
From enrollment to three months after treatmentSecondary outcomes
1
Complications
Complications evaluated using the Clavien-Dindo classification
Time frame
Three months after treatmentSponsors and contacts
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Source ClinicalTrials.gov