Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05910983
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2023-06-11
Brief Title:
Prostate Enucleation With Intravesical Botox Injections in Treating BPH and Bladder Overactivity
Sponsor:
Menoufia University
Organization:
Menoufia University
Study Overview
Official Title:
Prostate Enucleation With Intravesical Botox Injections in Treating Benign Prostatic Hyperplasia and Bladder Overactivity A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
BPH Botox
Brief Summary:
The aim of this study is to evaluate the effect of intravesical Botox injections on lower urinary tract symptoms LUTS when administered during Bipolar prostate enucleation surgery in patients with bladder outlet obstruction BOO and overactive bladder symptoms OAB
Detailed Description:
Benign prostatic hyperplasia BPH is the most common benign neoplasm in men Almost 90 of men in their 70s report lower urinary tract symptoms related to BPH These symptoms carry a significant negative impact on the patients quality of life
Despite the wide availability of surgical offerings to relieve bladder outlet obstruction such as transurethral resection of the prostate TURP Thulium Laser Enucleation of the Prostate ThuLEP and prostatectomy many patients still suffer from persistent LUTS after undergoing these
A study describing postoperative outcomes following HoLEP revealed that patients with severe lower urinary tract symptoms storage-positive sub-score and high maximum urinary flow rate before the surgery were affected by a rebound of mainly storage symptoms 6-8 weeks after HoLEP and prolonged recovery from LUTS with 74 of them presenting for persistent urge complaints
Optimizing the management approach for these patients has been limited by lack of high level evidence-based recommendations and expert consensus Intravesical botox injections are well-established therapeutic options for several urinary disorders The current practice offers intravesical botox injections to patients who suffer from persistent urinary symptoms few months after their BPH procedure This study aims to evaluate if giving botox injections at the time of the HoLEP surgery would yield a better outcome than performing the two procedures separately at different times few months apart
The concomitant use of botox injection during bladder de-obstructing procedures has been previously studied in TURP and have showed a significant reduction of incontinence episodes and OAB symptoms in the group that were treated with botox injections after 36 weeks post TURP This data may suggest promising potential of this intervention in managing persistent OAB symptoms in patients with BOO However the efficacy of combining HoLEP and bladder Botox injections has not been systematically studied and evaluated
The aim of this study is to evaluate the effect of intravesical Botox injections on lower urinary tract symptoms LUTS when administered during Bipolar prostate enucleation BipolEP surgery in patients with bladder outlet obstruction BOO and overactive bladder symptoms OAB
The investigators are interested in comparing the postoperative outcome in terms of recovery and symptom relief in patients who performed HoLEP surgery with bladder Botox injections versus those who performed HoLEP surgery only at 2 weeks1 month 3 months and 6 months postoperatively
The investigators hypothesize that administering bladder botox injections during BipolEP surgery is a combination treatment that will result in faster and more potent symptom relief compared to patients who received only a BipolEP surgery for their obstructive and irritative symptoms
Despite the wide availability of surgical offerings to relieve bladder outlet obstruction such as transurethral resection of the prostate TURP Thulium Laser Enucleation of the Prostate ThuLEP and prostatectomy many patients still suffer from persistent LUTS after undergoing these
A study describing postoperative outcomes following HoLEP revealed that patients with severe lower urinary tract symptoms storage-positive sub-score and high maximum urinary flow rate before the surgery were affected by a rebound of mainly storage symptoms 6-8 weeks after HoLEP and prolonged recovery from LUTS with 74 of them presenting for persistent urge complaints
Optimizing the management approach for these patients has been limited by lack of high level evidence-based recommendations and expert consensus Intravesical botox injections are well-established therapeutic options for several urinary disorders The current practice offers intravesical botox injections to patients who suffer from persistent urinary symptoms few months after their BPH procedure This study aims to evaluate if giving botox injections at the time of the HoLEP surgery would yield a better outcome than performing the two procedures separately at different times few months apart
The concomitant use of botox injection during bladder de-obstructing procedures has been previously studied in TURP and have showed a significant reduction of incontinence episodes and OAB symptoms in the group that were treated with botox injections after 36 weeks post TURP This data may suggest promising potential of this intervention in managing persistent OAB symptoms in patients with BOO However the efficacy of combining HoLEP and bladder Botox injections has not been systematically studied and evaluated
The aim of this study is to evaluate the effect of intravesical Botox injections on lower urinary tract symptoms LUTS when administered during Bipolar prostate enucleation BipolEP surgery in patients with bladder outlet obstruction BOO and overactive bladder symptoms OAB
The investigators are interested in comparing the postoperative outcome in terms of recovery and symptom relief in patients who performed HoLEP surgery with bladder Botox injections versus those who performed HoLEP surgery only at 2 weeks1 month 3 months and 6 months postoperatively
The investigators hypothesize that administering bladder botox injections during BipolEP surgery is a combination treatment that will result in faster and more potent symptom relief compared to patients who received only a BipolEP surgery for their obstructive and irritative symptoms
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