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N/A
21 Years
N/A
Open (Enrolling)
Male
Prostate Cancer, Post Prostatectomy Incontinence

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Trial Information


Inclusion Criteria:



- Only men will be included since this is a study of post prostatectomy incontinence.
Cases will be comprised of men who are post radical retropubic or laparoscopic
(robotic) prostatectomy who have stress urinary incontinence based on history and a
minimum of 50 grams of urine loss on 24 hour pad weights. Controls will be comprised
of men who are post radical retropubic or laparoscopic (robotic) prostatectomy who do
not have any kind or amount of incontinence based on history. Cases and controls will
be matched for both age and race these have been shown to alter anatomical appearance
of structures and lower urinary tract function.

Exclusion Criteria:

- Criteria for both groups include urge incontinence, urinary retention, neurologic
disease, insulin dependent diabetes, high dose steroid use, pre-surgical abnormal
voiding function or incontinence, prior pelvic radiation or urologic surgery, any
prior incontinence surgery, current medical therapy for incontinence or a perineal
route of radical prostatectomy since this had been shown to give a distinctly
different appearance on MRI compared to the laparoscopic or retropubic approach. Any
patient with pelvic or systemic recurrence of their prostate cancer will also be
excluded. Any man with relative or absolute contraindications to MRI such as implants
or claustrophobia will be excluded.

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Thickness and length of both the smooth muscle and striated muscle external urethral sphincter

Outcome Description:

Structural assessment

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Anne Pelletier-Cameron, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan

Authority:

United States: Institutional Review Board

Study ID:

HUM00035833

NCT ID:

NCT01832831

Start Date:

May 2010

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Post Prostatectomy Incontinence
  • Prostatic Neoplasms

Name

Location

University of MichiganAnn Arbor, Michigan  48109-0624
VA Ann Arbor Healthcare SystemAnn Arbor, Michigan  48113