Prostate CancerNCT01379378
Male Stress Urinary Incontinence and Sexual Health
An observational study of Prostate Cancer, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study if to demonstrate if post-prostatectomy incontinence is a barrier to sexual satisfaction/frequency/desire and if surgical correction of incontinence will improve these aspects of sexual health. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Artificial urinary sphincter, InVance Sling and AdVance Sling
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Dec 2011
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Post-prostatectomy patients at least 6 months after either open radical retropubic prostatectomy or robot assisted laparoscopic prostatectomy with bothersome stress urinary incontinence will be initially screened with urodynamics, a 24 hour pad test, and a self questionnaire to assess how bothersome their incontinence is.
Who may be able to join
- Adult men age 18-80 who have had an open or laparoscopic radical prostatectomy more than 6 months ago who have bothersome urinary incontinence.
Who cannot join
- Any significant cardiac or pulmonary co-morbidities that would preclude the patient from another surgical procedure as they would be too high risk for general anesthesia.
- They will also be excluded if based on their anatomy or urodynamics, they will most likely not benefit from a surgical incontinence procedure (e.g. poor bladder contractility, bladder neck contracture, etc).
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
The purpose of this study if to demonstrate if post-prostatectomy incontinence is a barrier to sexual satisfaction/frequency/desire and if surgical correction of incontinence will improve these aspects of sexual health.
- Conditions
- Prostate Cancer
- Being tested
- Artificial urinary sphincter, InVance Sling, AdVance Sling, Virtue Sling, Contigen
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial urinary sphincterDevice
Also called urethral sphincter, American Medical Systems
Standard of care
InVance SlingDevice
Also called Urithrary sling, American Medical Systems
Standard of care
AdVance SlingDevice
Also called Urithrary sling
Standard of care
Virtue SlingDevice
Also called Coloplast
Standard of care
ContigenDrug
Also called Bard
2.5-10 cc
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether stress urinary incontinence is a barrier to sexual satisfaction/frequency/desire
Measured: 1 year
Whether surgical correction of stress urinary incontinence will improve these aspects of sexual health
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2011
- Study completionDec 2011
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 Stanford UniversityThe 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
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Craig Vance Comiter, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379378
- Sponsor's protocol ID
- PROS0035
- Other IDs
- SU-06152011-7928
- Status last verified
- Jul 2016
- First submitted
- 21 Jun 2011
- Last updated
- 22 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Male Stress Urinary Incontinence and Sexual Health
- ClinicalTrials.gov ID
- NCT01379378
- Acronym / sponsor ID
- PROS0035
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 23 Jun 2011 (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.
The purpose of this study if to demonstrate if post-prostatectomy incontinence is a barrier to sexual satisfaction/frequency/desire and if surgical correction of incontinence will improve these aspects of sexual health.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Post-prostatectomy patients at least 6 months after either open radical retropubic prostatectomy or robot assisted laparoscopic prostatectomy with bothersome stress urinary incontinence will be initially screened with urodynamics, a 24 hour pad test, and a self questionnaire to assess how bothersome their incontinence is.
Key inclusion criteria (1 listed)
- Adult men age 18-80 who have had an open or laparoscopic radical prostatectomy more than 6 months ago who have bothersome urinary incontinence.
Key exclusion criteria (2 listed)
- Any significant cardiac or pulmonary co-morbidities that would preclude the patient from another surgical procedure as they would be too high risk for general anesthesia.
- They will also be excluded if based on their anatomy or urodynamics, they will most likely not benefit from a surgical incontinence procedure (e.g. poor bladder contractility, bladder neck contracture, etc).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial urinary sphincterAlso: urethral sphincter, American Medical SystemsStandard of care | Device | – |
| InVance SlingAlso: Urithrary sling, American Medical SystemsStandard of care | Device | – |
| AdVance SlingAlso: Urithrary slingStandard of care | Device | – |
| Virtue SlingAlso: ColoplastStandard of care | Device | – |
| ContigenAlso: Bard2.5-10 cc | Drug | – |
Primary outcome
Whether stress urinary incontinence is a barrier to sexual satisfaction/frequency/desire
Time frame: 1 year
Whether surgical correction of stress urinary incontinence will improve these aspects of sexual health
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 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.
Craig Vance Comiter principal investigator
Stanford University
1 site 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, run by Stanford University at 1 site 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 2 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: withdrawn, as of the sponsor's last update on 22 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 withdrawn before enrolling participants, so there are no results.
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?
Whether stress urinary incontinence is a barrier to sexual satisfaction/frequency/desire (time frame: 1 year). The study lists 2 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 22 Jul 2016.