Prophylactic Urethral Stenting With Memokath After Prostate Implantation for Prostate Adenocarcinoma

This study has been completed.
Sponsor:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00252941
First received: November 14, 2005
Last updated: December 20, 2010
Last verified: December 2010

November 14, 2005
December 20, 2010
November 2005
April 2006   (final data collection date for primary outcome measure)
  • Morbidities assessed on RTOG Morbidity Scale weekly for 12 weeks after PI then biweekly for next 12 weeks
  • Clinic visits at 2 weeks, 3 months and 6 months; physical exam to include urine flow rate, post-void residual and urinalysis
  • CT at 1 month post-brachytherapy
  • Device removal at 6 months (earlier if adverse event or patient wishes to discontinue trial)
  • Cystoscopy to assess urethra after stent removal
Same as current
Complete list of historical versions of study NCT00252941 on ClinicalTrials.gov Archive Site
AUA score to assess severity of urinary symptoms
Same as current
Not Provided
Not Provided
 
Prophylactic Urethral Stenting With Memokath After Prostate Implantation for Prostate Adenocarcinoma
The Role Of Prophylactic Urethral Stenting With Memokath® 028SW in Patients Undergoing Prostate 125I Seed Implants For Prostate Carcinoma: A Phase I/II Study

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.

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 20.3 to 8.2 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 25.2 to 10 (p=0.03). 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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Prostate Cancer
  • Post-Brachytherapy Bladder Outlet Obstruction
Device: Memokath 028SW Urethral Stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
November 2006
April 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • eligible for prostate seed implant
  • 50 years of age or older
  • able to give informed consent

Exclusion Criteria:

  • presence of any other urologic implant, including stents,penile prosthesis or artificial sphincter
  • history of transurethral resection of prostate (TURP)procedure
  • presence of urethral diverticuli
  • presence of urethral strictures
  • presence of bladder calculi or tumors
  • prostatic urethra is less than 2.5 cm or greater than 6.5 cm
  • inability to participate in study activities due to physical or mental limitations
  • inability or unwillingness to return for all the required follow-up visits
Male
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00252941
IRB 8488, CASE16804
Not Provided
Not Provided
The Cleveland Clinic
Not Provided
Principal Investigator: Jay P Ciezki, MD The Cleveland Clinic
The Cleveland Clinic
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP