A Study of Intra-operative Autologous Retropubic Urethral Sling on Urinary Control After Robot Assisted Radical Prostatectomy
Condition: Men With Prostate Cancer Undergoing Robot Assisted Radical Prostatectomy
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      Placement of an autologous retropubic urethral sling at the time of robot assisted radical
      prostatectomy will improve the recovery of continence after radical prostatectomy
    

Detailed description: 
      This is a phase 2 single blinded study of patients undergoing robot assisted radical
      prostatectomy who are randomized to placement of an autologous retropubic urethral sling or
      not. Placement of a retropubic urethral sling will involve dissection and harvesting of the
      right and left vas deferens, which will be taken out of the body by the bed side assistant
      who will suture the two vas deferens together in a side to side fashion with the smaller of
      the two vas deferens placed in the middle of the larger one. A single 3-0 V-lock suture on a
      CV23 needle will be placed through one end of the vas sling and then passed into the body by
      the bed side assistant. The sling will then be placed on the rectum below the site of the
      vesicourethral anastamosis and the anastamosis will be completed. The sling will then be
      placed around the vesicourethral anastomosis, suspended to the pubic symphysis and tensioned
      to allow elevation of the vesicourethral anastomosis. There are four surgeons working at both
      trial sites who will be involved in performing the radical prostatectomy and sling placement
      on trial patients. All surgeons have had significant experience in performing radical
      prostatectomy (> 100 cases each). To ensure sufficient experience in the placement of
      urethral slings, each surgeon (other than the principle investigator, who has placed over 200
      slings) will undergo a training period of 5 patients with sling placement under the
      proctoring of the principal investigator prior to accrual of the first trial patient from the
      individual surgeon. All patients will be characterized with respect to age, ethnicity, BMI,
      prostate size, amount of nerve sparing, preoperative urinary function, surgeon, serum PSA,
      and tumor characteristics. Prostate size and tumor characteristics will be attained at
      histological assessment of the prostate specimen by the pathology department. Preoperative
      urinary function will be assessed by EPIC and IPSS questionnaires at baseline. The amount of
      nerve sparing will be assessed by the surgeon performing the radical prostatectomy after the
      prostate dissection is complete. Each side will be assessed separately as complete, partial
      or no nerve sparing. Stratification will be based upon age at enrollment (<65 years vs. >65
      years). For each of the 2 strata patients will be randomized to placement of a sling or not,
      serving as the control group, on a one to one basis with the assignment determined using a
      computer software program. Randomization assignment of the planned procedure will be balanced
      using a fixed block design. Consecutively identified patients undergoing RARP and meeting
      eligibility criteria for the trial will be approached for involvement in this trial. Patients
      and study personnel will be blinded as to which patients received slings. Surgeons performing
      the individual procedures cannot be blinded to the procedure, but will not know the
      randomization assignment until the prostate dissection is completed and the procedure reaches
      the stage of sling placement. A sealed envelope containing the randomization assignment of
      the patient to the sling or non-sling group will be placed at the operating room front desk
      by the research coordinator prior to the start of surgery. This envelope will not be opened
      until the prostate is removed. A unique identifying number, that has no association with
      randomization allocation, will be assigned to each trial patient. These numbers will be
      placed on envelopes to match them to patients to avoid any confusion on days where multiple
      trial patients may be undergoing radical prostatectomy. Furthermore, surgeons will not be
      involved in attaining any outcome data from patients and therefore should not cause any bias
      to the study outcomes. Investigators expect accrual of 5 patients every week; therefore,
      investigators estimate that it will take approximately 37 weeks to complete the study accrual
      of 182 evaluable patients.
    

Intervention name(s): Placement of sling
Intervention type(s): Procedure
Intervention description(s): Placement of a retropubic urethral sling will involve dissection and harvesting of the right and left vas deferens, which we will be taken out of the body by the bed side assistant who will suture the two vas deferens together in a side to side fashion with the smaller of the two vas deferens placed in the middle of the larger one. A single 3-0 V-lock suture on a CV23 needle will be placed through one end of the vas sling and then passed into the body by the bed side assistant. The sling will then be placed on the rectum below the site of the vesicourethral anastamosis and the anastamosis will be completed. The sling will then be placed around the vesicourethral anastomosis, suspended to the pubic symphysis and tensioned to allow elevation of the vesicourethral anastomosis.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: prostate cancer, robotic surgery, urethral sling,