Prostate CancerNCT01832831
Anatomical and Functional Differences Between Continent and Incontinent Men Post Radical Prostatectomy
An observational study of Prostate Cancer and Post Prostatectomy Incontinence, run by University of Michigan at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Post Prostatectomy Incontinence
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2010to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48105
University of Michigan
Ann Arbor, Michigan, 48109
About this study
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.
- Conditions
- Prostate Cancer, Post Prostatectomy Incontinence
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Continent Men | Not described | |
| Incontinent Men | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thickness and length of both the smooth muscle and striated muscle external urethral sphincter
Structural assessment
Measured: 2 years
Posterior urethral length from the bladder neck to the perineal membrane.
Structural assessment
Measured: 2 years
Levator ani thickness
Structural assessment
Measured: 3 years
Thickness and length of anastomotic fibrosis in both sagittal and axial planes
Structural assessment
Measured: 3 years
Maximal urethral closure pressure
Functional assessment
Measured: 3 years
Increase in urethral pressure during maximal muscle contraction
Functional assessment
Measured: 3 years
Urethral hypermobility on MRI
Functional assessment
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startMay 2010
- Primary completionFeb 2013
- Study completionDec 2014
Why it stopped: The study was completed as planned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Pelletier-Cameron, University of Michigan
- Investigators
- Anne Pelletier-Cameron, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832831
- Sponsor's protocol ID
- HUM00035833
- Status last verified
- Apr 2016
- First submitted
- 10 Apr 2013
- Last updated
- 21 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical and Functional Differences Between Continent and Incontinent Men Post Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT01832831
- Acronym / sponsor ID
- HUM00035833
- Conditions
- Prostate Cancer, Post Prostatectomy Incontinence
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was completed as planned
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 16 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continent Men | – | – |
| Incontinent Men | – | – |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Thickness and length of both the smooth muscle and striated muscle external urethral sphincter
Time frame: 2 years
Structural assessment
Posterior urethral length from the bladder neck to the perineal membrane.
Time frame: 2 years
Structural assessment
Levator ani thickness
Time frame: 3 years
Structural assessment
Thickness and length of anastomotic fibrosis in both sagittal and axial planes
Time frame: 3 years
Structural assessment
Maximal urethral closure pressure
Time frame: 3 years
Functional assessment
Increase in urethral pressure during maximal muscle contraction
Time frame: 3 years
Functional assessment
Urethral hypermobility on MRI
Time frame: 3 years
Functional assessment
Results and safety
The study was stopped early (reason given: The study was completed as planned). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Pelletier-Cameron, MD principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Post Prostatectomy Incontinence, run by University of Michigan at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was completed as planned). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thickness and length of both the smooth muscle and striated muscle external urethral sphincter (time frame: 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2016.