NCT00937833

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 13, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
12 days until next milestone

Results Posted

Study results publicly available

November 13, 2014

Completed
Last Updated

December 29, 2014

Status Verified

December 1, 2014

Enrollment Period

3.9 years

First QC Date

July 10, 2009

Results QC Date

October 1, 2014

Last Update Submit

December 23, 2014

Conditions

Urinary IncontinenceProstate Cancer

Keywords

prostate cancerprostatectomyincontinence

Outcome Measures

Primary Outcomes (1)

  • Number of Continent Patients Post Prostatectomy

    1 Month

Study Arms (2)

Urethrovesical Sling

EXPERIMENTAL

Surgisis Male Sling placed at the time of prostatectomy

Procedure: ProstatectomyDevice: Surgisis Male Sling

Control

ACTIVE COMPARATOR

Prostatectomy

Procedure: Prostatectomy

Interventions

ProstatectomyPROCEDURE
ControlUrethrovesical Sling
Surgisis Male SlingDEVICE
Urethrovesical Sling

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Urology of San Antonio Research

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Urinary IncontinenceProstatic Neoplasms

Interventions

Prostatectomy

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesProstatic Diseases

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Results Point of Contact

Title
Jason Hodde, Clinical Affairs Manager
Organization
Cook Biotech Incorporated
jhodde@CookBiotech.com
765-497-3355

Study Officials

  • Chandru Sundaram, MD

    Indiana Cancer Pavilion

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2009

First Posted

July 13, 2009

Study Start

November 1, 2009

Primary Completion

October 1, 2013

Study Completion

November 1, 2014

Last Updated

December 29, 2014

Results First Posted

November 13, 2014

Record last verified: 2014-12

Locations

US(2)