Clinical trial NCT06177821: Rezum for 30-80ml Patients With Moderate-severe LUTS to Study Surgical Principles for Median Lobe Enlargement
Official title: Feasibility of Water Vaporization (Rezum®) for Patients With ≥ 30 and < 80 ml With Moderate-severe LUTS to Establish the Surgical Principles for Prominent or Non-prominent Median Lobe Enlargement: A Single-center, Prospective, Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostatic Hyperplasia of the Medial Lobe
Keywords: median lobe enlargement
lower urinary tract symptoms
International Prostate Symptoms Score
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-12-20
Enrollment: 44
Sex: MALE
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was created to determine the safety and efficacy of treating prostatic hyperplasia with or without prominent median lobe enlargement with the REZUM technique. The systematic implementation of decisions for the location, vapor time, and the number of injections contributes to the Rezum procedure configuration for the median lobe treatment being safer and standardizer.


Eligibility criteria: Inclusion Criteria:

* Patients aged 50 to 85 years who have been diagnosed with benign prostatic hyperplasia at Seoul National University Hospital and are scheduled to undergo endoscopic surgery.
* benign prostatic hyperplasia ≥ 30 and \< 80 ml
* Patients who have given written informed consent to participate in the study according to their age
* A urinary symptom score (International ProstateSymptom Score \[IPSS\] moderated (8-19 points) to severe (20-35 points)
* Measured Postvoiding Residual (PVR) \<250 mL

Exclusion Criteria:

* History of prostate or bladder cancer, neurogenic bladder, bladder calculus, or clinically significant bladder diverticulum
* Active infection, treatment for chronic prostatitis
* Diagnosis of urethral stricture, meatal stenosis or bladder neck contracture, damaged external urinary sphincter, stress urinary incontinence, post-void residual \>300 mL or urinary retention, or prior prostate surgery
* Men taking anticoagulants or on bladder anticholinergics or with severe cardiovascular disease
* PSA greater than 4.0 ng/ml (unless prostate cancer was ruled out by biopsy)
* Allergy to device materials, immune suppressants or corticosteroids use, and serious medical or mental illness.

Primary outcomes:
measure: age
timeFrame: prior to procedure
measure: Gender
timeFrame: prior to procedure
measure: height
timeFrame: prior to procedure
measure: weight
timeFrame: prior to procedure
measure: Medical history
timeFrame: prior to procedure
measure: Surgical history
timeFrame: prior to procedure
measure: Date of consent
timeFrame: prior to procedure
measure: Eastern Cooperative Oncology Group
timeFrame: prior to procedure
measure: complications
timeFrame: prior to procedure
measure: medications used at the time of pre-consent
timeFrame: prior to procedure
measure: drug allergies
timeFrame: prior to procedure
measure: prostate specific antigen
timeFrame: prior to procedure, 3 month after surgery
measure: Protein
timeFrame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
measure: pH
timeFrame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
measure: occult blood
timeFrame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
measure: white blood cell : Urinalysis
timeFrame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
measure: glucose
timeFrame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
measure: red blood cell
timeFrame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
measure: Bacteria
timeFrame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
measure: Sodium
timeFrame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
measure: Chloride
timeFrame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
measure: calcium
timeFrame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
measure: Phosphorus
timeFrame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
measure: uric acid
timeFrame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
measure: blood urea nitrogen
timeFrame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
measure: creatinine
timeFrame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
measure: C-reactive protein
timeFrame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
measure: White blood cell : Blood tests
timeFrame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
measure: Hemoglobin
timeFrame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
measure: Platelet
timeFrame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
measure: Prostate specific antigen
timeFrame: prior to procedure, 1-2 weeks after injection, 3 month after surgery
measure: Prostate Ultrasound
timeFrame: prior to procedure, 3 month after surgery
measure: Uroflowmetry
timeFrame: prior to procedure, 3 month after surgery
measure: International Prostate Symptom Score
timeFrame: prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
measure: Incontinence Severity Index
timeFrame: prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
measure: Overactive Bladder Symptom Score
timeFrame: prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
measure: Male Sexual Health for assessing ejaculatory dysfunction
timeFrame: prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
measure: International Index of Erectile Function
timeFrame: prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
measure: McGill Pain Questionnaire
timeFrame: prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
measure: Brief Pain Inventory
timeFrame: prior to procedure, admission, 1-2 weeks after injection, 3 month after surgery
measure: Treatment Satisfaction-Visual Analogue Scale
timeFrame: 1-2 weeks after injection, 3 month after surgery
measure: Patient Global Impression of Improvement
timeFrame: 1-2 weeks after injection, 3 month after surgery
measure: transrectal sonography of the prostate
timeFrame: prior to procedure, 3 month after surgery
measure: transrectal ultrasound
timeFrame: prior to procedure
measure: Postvoiding Residual
timeFrame: prior to procedure, 3 month after surgery
measure: Post-surgery complications
timeFrame: 1-2 weeks after injection, 3 month after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: