Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06452927
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-23
Brief Title:
EEP in Patients With Urodynamically Proven DUDA
Sponsor:
EEPiDuDa Study Group
Organization:
EEPiDuDa Study Group
Study Overview
Official Title:
Endoscopic Enucleation of the Prostate in Patients With Urodynamically Proven Detrusor UnderactivityAcontractility
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this project is to create und evaluate a multicentral retro-prospective database for patients with urodynamically proven detrusor underactivity DU or acontractility DA secondary to a non-neurogenic aetiology who undergo endoscopic anatomic enucleation of the prostate EEP
Detailed Description:
Background
As one of the most common urological diseases benign prostatic hyperplasia BPH affects about ¾ of men in the seventh decade and is associated with major impact on quality of life QoL of patients as well as with substantial costs for the health care For many patients suffering from lower urinary tract symptoms LUTS medical therapy such as the use of α1-blockers is initially successful but surgical therapy becomes necessary when medical therapy fails and results function remain unsatisfactory Dependent on prostate volume PV different surgical techniques are available for treatment For substantially enlarged glands open prostatectomy OP dominated as the oldest surgical procedure for many years However OP is associated with significant complications and is currently recommended by the European Association of Urology EAU only in the absence of laser-assisted endoscopic enucleation options
Among these patients the presence of detrusor underactivity DU and detrusor acontractility DA represents a particularly challenging condition since no medical treatment is available Due to this efforts were focused on maximal surgical reduction of bladder outlet resistance to ensure efficient bladder emptying The limited data on this topic showed promising outcomes for patients receiving holmium laser enucleation of the prostate HoLEP Therefore the aim of this project is to evaluate the efficacy of EEP as a surgical approach for patients with DUDA regardless of PV or enucleation devicemethod
Projekt objectives
Creating a multicentral retro-prospective database for patients with urodynamically proven detrusor underactivity DU or acontractility DA secondary to a non-neurogenic aetiology who undergo EEP
Phase 1 retrospective patients with urodynamically proven meeting inclusion criteria and postoperative outcome according to material and methods from existing patient chart
Phase 2 prospective capture of patients data according to material and methods
Estimated cohort-size based on available data set
Powering of phase 2 based on the retrospective cohort
Evaluating EEP as a surgical approach for patients with DUDA regardless of PV or energy source for endoscopic EEP
Enhancing importance of preoperative urodynamics as a tool for precision medicine in LUTS
As one of the most common urological diseases benign prostatic hyperplasia BPH affects about ¾ of men in the seventh decade and is associated with major impact on quality of life QoL of patients as well as with substantial costs for the health care For many patients suffering from lower urinary tract symptoms LUTS medical therapy such as the use of α1-blockers is initially successful but surgical therapy becomes necessary when medical therapy fails and results function remain unsatisfactory Dependent on prostate volume PV different surgical techniques are available for treatment For substantially enlarged glands open prostatectomy OP dominated as the oldest surgical procedure for many years However OP is associated with significant complications and is currently recommended by the European Association of Urology EAU only in the absence of laser-assisted endoscopic enucleation options
Among these patients the presence of detrusor underactivity DU and detrusor acontractility DA represents a particularly challenging condition since no medical treatment is available Due to this efforts were focused on maximal surgical reduction of bladder outlet resistance to ensure efficient bladder emptying The limited data on this topic showed promising outcomes for patients receiving holmium laser enucleation of the prostate HoLEP Therefore the aim of this project is to evaluate the efficacy of EEP as a surgical approach for patients with DUDA regardless of PV or enucleation devicemethod
Projekt objectives
Creating a multicentral retro-prospective database for patients with urodynamically proven detrusor underactivity DU or acontractility DA secondary to a non-neurogenic aetiology who undergo EEP
Phase 1 retrospective patients with urodynamically proven meeting inclusion criteria and postoperative outcome according to material and methods from existing patient chart
Phase 2 prospective capture of patients data according to material and methods
Estimated cohort-size based on available data set
Powering of phase 2 based on the retrospective cohort
Evaluating EEP as a surgical approach for patients with DUDA regardless of PV or energy source for endoscopic EEP
Enhancing importance of preoperative urodynamics as a tool for precision medicine in LUTS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None