Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06596590
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-04-27
Brief Title:
Modified Water Vapor Thermal Therapy in Management of Patients With Large-volume Benign Prostatic Hyperplasia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Modified Water Vapor Thermal Therapy REZUM in Management of Patients With Large-volume Benign Prostatic Hyperplasia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Although Rezum is currently indicated for use in men with prostate sizes 30 and 80 ml the guidelines offer no recommendation with regards to Rezum therapy for those with large-volume glands
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 probability of requiring blood transfusion The incidence of urinary incontinence after transurethral enucleation ranges from 333 to 20 possibly due to excessive traction and compression on the external urethral sphincter leading to partial muscle fiber rupture The rate of erectile dysfunction after enucleation is 882 while retrograde ejaculation occurs in 637 of cases especially for patients with larger prostates Once these complications occur they are often difficult to recover from and severely impact the patients quality of life In our center the technique of Rezum has been further improved by incorporating ultrasound and MRI imaging guidance The investigators design a reasonable and comprehensive ablation plan that ensures accurate positioning of enlarged prostate glands for complete and thorough ablation while ensuring efficacy and safety
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None