Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06179654
Status:
RECRUITING
Last Update Posted:
2023-12-22
First Post:
2023-11-29
Brief Title:
Preoperative Pelvic Floor Physical Therapy to Minimize Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Preoperative Pelvic Floor Physical Therapy to Minimize Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate
Status:
RECRUITING
Status Verified Date:
2023-12
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 purpose of this study is to allow us to assess the effectiveness or success of starting pelvic floor physical therapy ie exercises for your pelvic muscles prior to HoLEP holmium laser enucleation of the prostate surgery for enlarged prostates in order to manage or prevent urinary incontinence ie leaking after surgery ie post-operatively Your pelvic floor refers to the muscles under your bladder along your pelvic bones that prevent you from leaking urine or stool Traditionally pelvic floor physical therapy is started after surgery and continued until urinary continence ie no leaking of urine is regained We want to assess if beginning pelvic floor physical therapy prior to surgery and continuing afterwards reduces the time required to regain urinary continence following HoLEP
Detailed Description:
The incidence of benign prostatic hyperplasia BPH in men significantly increases with age and is estimated to impact over 80 of men 70 to 80 years of age HoLEP is one of many treatments for BPH and associated lower urinary tract symptoms Compared to other minimally invasive surgical techniques for treatment of BPH HoLEP has been found to have superior outcomes and is a prostate size-independent procedure with excellent durability high efficacy and low complications rates However transient stress urinary incontinence SUI following HoLEP may last for several months after surgery and can lead to diminished patient quality of life during the recovery period Measures to prevent or reduce post-operative SUI following HoLEP including PFPT may improve patient outcomes
SUI is also commonly documented after radical prostatectomy RP for prostate cancer The mechanism for incontinence in both RP and HoLEP is thought to at least partially be related to temporary weakness of the external urinary sphincter which is part of the pelvic floor musculature While it is unclear if post-operative PFPT alone reduces SUI for patients who have undergone RP there is evidence that PFPT started pre-operatively and continued post-operatively can decrease SUI following RP
The utilization of pre-operative PFPT for patients undergoing HoLEP to reduce post-operative SUI is currently not well documented To date only one study has demonstrated evidence that PFPT prior to HoLEP may improve continence at 3 months However the study included patients with a BMI significantly lower than average in the United States utilized an unclear PFPT program and had a relatively small median prostate size 60 mL which is important as studies have shown that prostate size can affect post-operative incontinence
We propose a prospective randomized trial to investigate the efficacy of standardized pre-operative PFPT in reducing SUI and improving patient QoL following HoLEP This study will help determine the role of pre-operative PFPT in the management of HoLEP associated SUI
SUI is also commonly documented after radical prostatectomy RP for prostate cancer The mechanism for incontinence in both RP and HoLEP is thought to at least partially be related to temporary weakness of the external urinary sphincter which is part of the pelvic floor musculature While it is unclear if post-operative PFPT alone reduces SUI for patients who have undergone RP there is evidence that PFPT started pre-operatively and continued post-operatively can decrease SUI following RP
The utilization of pre-operative PFPT for patients undergoing HoLEP to reduce post-operative SUI is currently not well documented To date only one study has demonstrated evidence that PFPT prior to HoLEP may improve continence at 3 months However the study included patients with a BMI significantly lower than average in the United States utilized an unclear PFPT program and had a relatively small median prostate size 60 mL which is important as studies have shown that prostate size can affect post-operative incontinence
We propose a prospective randomized trial to investigate the efficacy of standardized pre-operative PFPT in reducing SUI and improving patient QoL following HoLEP This study will help determine the role of pre-operative PFPT in the management of HoLEP associated SUI
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