Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-29 @ 8:24 PM
Study NCT ID:
NCT05148156
Status:
SUSPENDED
Last Update Posted:
2024-09-19
First Post:
2021-11-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Urolift Pre-SBRT for Reduced Urinary Toxicity in Patients With BPH and Prostate Cancer.
Sponsor:
Northwell Health
Organization:
Study Overview
Official Title:
Reduction of Urinary Toxicity of Stereotactic Body Radiation Therapy (SBRT) With Prostatic Urethral Lift (Urolift)
Status:
SUSPENDED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Principal Investigator changing locations.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Many patients may face long-term urinary side effects following stereotactic body radiation therapy (SBRT), including increased urinary frequency, dysuria, and nocturia. The investigator hypothesizes that Urolift, which represents a novel minimally invasive therapy, may reduce acute and long-term urinary toxicity and side effects of radiation therapy (SBRT).
Detailed Description:
Urolift is a standard of care treatment for BPH. It involves the placement of a stainless-steel urethral end piece tethered to a capsular tab to the left and right side of the prostatic urethra approximately 1.5cm distal to the bladder neck. It pulls and maintains the opening of a continuous channel through the prostatic urethra. A previous study examined the effect of Urolift on urinary symptoms and urinary medications at six months post-procedure.Urolift was associated with significant urinary improvements measured by IPSS and quality of life questionnaires and a reduction in the use of total medication as well as alpha-blockers and beta-3 agonists.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: