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
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Post-Brachytherapy Bladder Outlet Obstruction
Device: Memokath 028SW Urethral Stent
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Role Of Prophylactic Urethral Stenting With Memokath® 028SW in Patients Undergoing Prostate 125I Seed Implants For Prostate Carcinoma: A Phase I/II Study

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • AUA score to assess severity of urinary symptoms

Estimated Enrollment: 20
Study Start Date: November 2005
Study Completion Date: November 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
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 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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00252941

Locations
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Jay P Ciezki, MD The Cleveland Clinic
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00252941     History of Changes
Other Study ID Numbers: IRB 8488, CASE16804
Study First Received: November 14, 2005
Last Updated: December 20, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by The Cleveland Clinic:
prostate cancer
brachytherapy
urethral stenting

Additional relevant MeSH terms:
Urinary Bladder Neck Obstruction
Prostatic Neoplasms
Urethral Obstruction
Urethral Diseases
Urologic Diseases
Urinary Bladder Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 23, 2014