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OpenTrials
Completed

NCT Number: NCT00937833

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

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.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Urination Disorders Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University School of Medicine, Indianapolis, Indiana, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Prostatectomy

Procedure

Surgisis Male Sling

Device

Primary outcomes

  1. Number of Continent Patients Post Prostatectomy

    Time frame: 1 Month

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Official study title

Randomized Controlled Trial Examining the Return of Urinary Continence After Robot-assisted Radical Prostatectomy With or Without a Urethrovesical Sling

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Jul 13, 2009
Registry last updated
Dec 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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