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CompletedNCT00937833Updated Dec 29, 2014Results posted

Return of Continence Following Robot-Assisted Radical Prostatectomy With or Without a Urethrovesical Sling

An interventional study of Prostatectomy and Surgisis Male Sling in Urinary Incontinence and Prostate Cancer, sponsored by Cook Group Incorporated. Completed at 2 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-29.

Sponsored by Cook Group Incorporated · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study summary

The purpose of this study is to determine the impact of an absorbable urethrovesical sling on the post-operative return of urinary continence after robot-assisted radical prostatectomy.

02

Conditions studied

  • Urinary Incontinence
  • Prostate Cancer

Keywords

  • prostate cancer
  • prostatectomy
  • incontinence
03

In context

Urinary Incontinence

1,375 studies on the registry are indexed under Urinary Incontinence; 224 are open to participants now.

This study's enrollment of 150 is above the median of 66 across 1,021 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Cook Group Incorporated is the lead sponsor of 74 studies on the registry; none are open to participants now.

Browse Cook Group Incorporated studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients must have organ confined prostate cancer.
  • Patients must have PSA\< 15.
  • Patients must have clinical stage prostate cancer \< cT3.
  • Patients must be scheduled for robot assisted transperitoneal laparoscopic radical prostatectomy.
  • Patients must be able to provide written informed consent and HIPAA authorization for release of personal health information.
  • Patients must be at least 18 years of age.

Exclusion criteria

Exclusion Criteria:

  • Patients must not have previously undergone transurethral resection, laser therapy, microwave therapy, radiofrequency ablation, or other surgery of the prostate.
  • Patients must not have previously undergone incision of urethral stricture or incision of bladder neck contracture.
  • Patients must not have previously been diagnosed with urethral stricture, bladder neck contracture or urinary incontinence.
  • Patients must not have previously been diagnosed with atonic bladder or neurogenic bladder.
  • Patients must not have significant pre-operative voiding symptoms as defined by an American Urologic Association symptom score of greater than 19.
  • Patients must not have a prior history of radiation to the pelvis.
  • Patients must not have persistent bacteriuria that cannot be cleared, as demonstrated by a negative urinalysis or urine culture, within 1 month of surgery.
  • Patients must not have allergies to pig tissue or pig products or have religious or cultural objection to the use of pig tissue.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    Urethrovesical Sling

    Surgisis Male Sling placed at the time of prostatectomy

    Procedure: Prostatectomy · Device: Surgisis Male Sling

  • Active comparator
    Control

    Prostatectomy

    Procedure: Prostatectomy

Interventions

  • ProcedureProstatectomy
  • DeviceSurgisis Male Sling
06

What researchers measure

Primary outcomes

  1. Number of Continent Patients Post Prostatectomy

    Time frame: 1 Month

07

Results

Posted Nov 13, 2014

Participant flow

Participant flow — Overall Study
MilestoneUrethrovesical SlingControl
Started7377
Completed5860
Not completed1517
Withdrew: Protocol violation12
Withdrew: Procedure delayed; enrollment closed01
Withdrew: Lost to follow-up108
Withdrew: Withdrawal by subject46

Outcome measures

PrimaryNumber of Continent Patients Post Prostatectomy
Time frame:
1 Month
Reported as:
Number · participants
Number of Continent Patients Post Prostatectomy
participantsUrethrovesical SlingControl
Number of Continent Patients Post Prostatectomy3732

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Urethrovesical Sling—2/73 (2.7%)0/73 (0%)
Control—0/74 (0%)0/74 (0%)
Most frequent serious events
Most frequent serious events
EventUrethrovesical SlingControl
HospitalizationRenal and urinary disorders2/730/74
HospitalizationInfections and infestations1/730/74
Intervention to prevent impairmentRenal and urinary disorders1/730/74

Baseline characteristics

147 patients were treated with the study procedure.

Age, Continuous
Age, Continuous(years)Urethrovesical SlingControlTotal
Mean60.9 ± 6.160.6 ± 7.160.8 ± 6.6
Sex: Female, Male
Sex: Female, Male(Participants)Urethrovesical SlingControlTotal
Female000
Male7374147
08

Study locations

2 sites
  • Indiana University School of Medicine
    Indianapolis, Indiana 46202, United States
  • Urology of San Antonio Research
    San Antonio, Texas 78229, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00937833
Lead sponsor
Cook Group Incorporated
Responsible party
Sponsor
First posted
Jul 13, 2009
Start date
Nov 2009
Primary completion
Oct 2013
Completion
Nov 2014
Results posted
Nov 13, 2014
Last update
Dec 29, 2014

Study contacts

Chandru Sundaram, MD
principal investigator · Indiana Cancer Pavilion
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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