Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00252941
Status:
COMPLETED
Last Update Posted:
2010-12-21
First Post:
2005-11-14
Brief Title:
Prophylactic Urethral Stenting With Memokath After Prostate Implantation for Prostate Adenocarcinoma
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
The Role Of Prophylactic Urethral Stenting With Memokath 028SW in Patients Undergoing Prostate 125I Seed Implants For Prostate Carcinoma A Phase III Study
Status:
COMPLETED
Status Verified Date:
2010-12
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:
The purpose of this study is to determine the feasibility safety and efficacy of the Memokath 028SW stent to prevent urinary obstructive symptoms difficulty urinating when used after prostate seed implantation for the treatment of localized prostate cancer
Detailed Description:
Image-guided transperineal permanent prostate brachytherapy PI is an accepted curative treatment option for patients with early stage prostate cancer Multiple reports have defined its efficacy and shown it to be superior to antecedent trans-abdominal techniques In addition the efficacy of PI has been shown to be similar to radical retropubic prostatectomy RRP and external beam radiotherapy EBRT These positive results however are gained at the expense of toxicity The most notable toxicity is associated with the urinary system The most severe side effect of PI is urinary retention requiring intermittent self-catheterization ISC
The reported rate of severe urinary retention following PI is 10 Most of these patients can be managed with ISC and alpha-blockers for a few weeks Although this is generally a temporary phenomenon a small percentage will eventually require surgical intervention to permit urinary flow This is a major concern for patients undergoing PI but should not be a reason to avoid this form of curative treatment
The use of implantable stents has been successful in BPH The Memokath device has been shown to decrease the International Prostate Symptom Score from a mean of 203 to 82 in the first 3 months after stent placement in patients with bladder outlet obstruction unable to undergo TURP Few experience side-effects with pain in 3 hematuria in 3 incontinence in 6 and infection in 6 A multicenter randomized control trial is currently underway assessing the use of this device in patients with recurrent urethral strictures
Urethral stents have been used with some success in patients with post-brachytherapy bladder outlet obstruction Five patients who could not tolerate alpha-blockers or clean intermittent catheterization received UroLume urethral stents following one or more episodes of urinary retention All patients were able to void immediately after stent placement No patients developed incontinence after the stent placement The main complaints following UroLume stent placement were urethral bleeding referred pain at the head of the penis and dysuria These symptoms required stent removal in 2 out of the 5 patients In another study five patients received SpannerTM urethral stents following significant urinary symptoms after prostate brachytherapy All patients were able to void spontaneously with no post-void residual volume of urine Flow rates increased and the International Prostate Symptom Score decreased from a mean of 252 to 10 p003 However two patients experienced pain which required removal of the stent
Given that few patients have experienced side effects with the Memokath urethral stent in bladder outlet obstruction we wish to assess the toxicity associated with this stent in a post-brachytherapy setting In addition we would like to assess its efficacy when used prophylactically in reducing bladder outlet obstruction following prostate brachytherapy and its impact on the AUA score
The reported rate of severe urinary retention following PI is 10 Most of these patients can be managed with ISC and alpha-blockers for a few weeks Although this is generally a temporary phenomenon a small percentage will eventually require surgical intervention to permit urinary flow This is a major concern for patients undergoing PI but should not be a reason to avoid this form of curative treatment
The use of implantable stents has been successful in BPH The Memokath device has been shown to decrease the International Prostate Symptom Score from a mean of 203 to 82 in the first 3 months after stent placement in patients with bladder outlet obstruction unable to undergo TURP Few experience side-effects with pain in 3 hematuria in 3 incontinence in 6 and infection in 6 A multicenter randomized control trial is currently underway assessing the use of this device in patients with recurrent urethral strictures
Urethral stents have been used with some success in patients with post-brachytherapy bladder outlet obstruction Five patients who could not tolerate alpha-blockers or clean intermittent catheterization received UroLume urethral stents following one or more episodes of urinary retention All patients were able to void immediately after stent placement No patients developed incontinence after the stent placement The main complaints following UroLume stent placement were urethral bleeding referred pain at the head of the penis and dysuria These symptoms required stent removal in 2 out of the 5 patients In another study five patients received SpannerTM urethral stents following significant urinary symptoms after prostate brachytherapy All patients were able to void spontaneously with no post-void residual volume of urine Flow rates increased and the International Prostate Symptom Score decreased from a mean of 252 to 10 p003 However two patients experienced pain which required removal of the stent
Given that few patients have experienced side effects with the Memokath urethral stent in bladder outlet obstruction we wish to assess the toxicity associated with this stent in a post-brachytherapy setting In addition we would like to assess its efficacy when used prophylactically in reducing bladder outlet obstruction following prostate brachytherapy and its impact on the AUA score
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CASE16804 | None | None | None |