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Spots Global Cancer Trial Database for Anatomical and Functional Differences Between Continent and Incontinent Men Post Radical Prostatectomy

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Trial Identification

Brief Title: Anatomical and Functional Differences Between Continent and Incontinent Men Post Radical Prostatectomy

Official Title:

Study ID: NCT01832831

Interventions

Study Description

Brief Summary: One out of every six men will be diagnosed with prostate cancer and post prostatectomy up to 75% report urinary incontinence. There are many hypotheses about the exact cause of post prostatectomy stress incontinence (PPI). Existing studies have focused on surgical or cadaveric dissections to define structures responsible for PPI. Contemporary 3T MRI now allows three dimensional, sub-millimeter resolution of the human pelvis and clearly demonstrates pelvic anatomy without the distortion of dissection. It is our overarching hypothesis that PPI is multifactorial and occurs because of a combination of specific anatomical and functional impairments. We propose conducting a case control study with matching for age and race to compare the MRI anatomy and urinary tract function on urodynamics between 20 men with PPI (cases) and 20 men who are continent post prostatectomy (controls) who are all a minimum of 12 months post surgery. We will use static and dynamic MRI at 3 Tesla to make objective measurements of the bladder neck, external urethral sphincter, pelvic floor, urethral anastomotic fibrosis, and urethral hypermobility- all believed to play a large part in continence. Multi-channel urodynamic studies will also be performed to assess the leak point and maximum urethral closure pressure. All cases and controls will complete standardized questionnaires - the AUA symptom index and the Incontinence Severity Index as a quality of life measure. This study is needed to provide critical information about causes of male PPI, a quality of life altering voiding dysfunction, and will assist with the advancement of pharmacological and surgical treatment of this disease.

Detailed Description:

Keywords

Eligibility

Minimum Age: 21 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: Yes

Locations

VA Ann Arbor Healthcare System, Ann Arbor, Michigan, United States

University of Michigan, Ann Arbor, Michigan, United States

Contact Details

Name: Anne Pelletier-Cameron, MD

Affiliation: University of Michigan

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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