Status:
NOT_YET_RECRUITING
Modified Water Vapor Thermal Therapy in Management of Patients With Large-volume Benign Prostatic Hyperplasia
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
45-85 years
Phase:
NA
Brief Summary
Water vapor thermal therapy (Rezum) is a minimally invasive treatment for benign prostatic hyperplasia (BPH) that uses injections of sterile water vapor directly into the prostate for tissue ablation....
Detailed Description
For prostates larger than 80ml, open or transurethral anatomical enucleation is recommended. Open prostatectomy has a higher risk of bleeding and slower postoperative recovery, with a higher probabili...
Eligibility Criteria
Inclusion
- Male subjects ≥ 45 years of age who have obstructive symptoms secondary to BPH requiring invasive intervention.
- IPSS score of ≥ 13.
- Qmax: Peak flow rate ≤ 15 ml/sec.
- Post-void residual (PVR) \< 300 ml.
- Prostate volume between 80 to 120 ml.
- Subject able to complete the study protocol in the opinion of the Principal Investigator.
Exclusion
- History of any illness or surgery that in the opinion of the Principal Investigator may confound the results of the study.
- Any prior minimally invasive intervention or surgical intervention for the symptoms of BPH.
- Currently enrolled in another clinical trial.
- Confirmed or suspected malignancy of prostate or bladder.
- Documented active urinary tract infection by culture or bacterial prostatitis.
- Neurogenic bladder or sphincter abnormalities.
- Urethral strictures, bladder neck contracture or muscle spasms.
- Bleeding disorder (note that use of anti-platelet medication is not an exclusion criterion).
- Subjects who are interested in maintaining fertility.
- Significant urge incontinence.
- Unable or unwilling to sign the Informed Consent Form.
- Any cognitive disorder that interferes with or precludes a subject from directly and accurately communicating with the Principal Investigator regarding the study.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT06596590
Start Date
September 1 2024
End Date
September 1 2027
Last Update
September 19 2024
Active Locations (1)
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1
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China