Anatomical and Functional Differences Between Continent and Incontinent Men Post Radical Prostatectomy

April 20, 2016 updated by: Anne Pelletier-Cameron, University of Michigan
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Ann Arbor, Michigan, United States, 48105
        • VA Ann Arbor Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

primary care clinic

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Continent Men
Incontinent Men

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Thickness and length of both the smooth muscle and striated muscle external urethral sphincter
Time Frame: 2 years
Structural assessment
2 years
Posterior urethral length from the bladder neck to the perineal membrane.
Time Frame: 2 years
Structural assessment
2 years
Levator ani thickness
Time Frame: 3 years
Structural assessment
3 years
Thickness and length of anastomotic fibrosis in both sagittal and axial planes
Time Frame: 3 years
Structural assessment
3 years
Maximal urethral closure pressure
Time Frame: 3 years
Functional assessment
3 years
Increase in urethral pressure during maximal muscle contraction
Time Frame: 3 years
Functional assessment
3 years
Urethral hypermobility on MRI
Time Frame: 3 years
Functional assessment
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HUM00035833

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