Urinary IncontinenceNCT00937833
Return of Continence Following Robot-Assisted Radical Prostatectomy With or Without a Urethrovesical Sling
A study testing Prostatectomy and Surgisis Male Sling in people with Urinary Incontinence and Prostate Cancer, run by Cook Group Incorporated at 2 sites in United States.
Trial summary
The purpose of this study is to determine the impact of an absorbable urethrovesical sling on the post-operative return of urinary continence after robot-assisted radical prostatectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Incontinence, Prostate Cancer
- What is being tested?
- Prostatectomy and Surgisis Male Sling
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2009to Nov 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Patients must have organ confined prostate cancer.
- Patients must have PSA< 15.
- Patients must have clinical stage prostate cancer < cT3.
- Patients must be scheduled for robot assisted transperitoneal laparoscopic radical prostatectomy.
- Patients must be able to provide written informed consent and HIPAA authorization for release of personal health information.
- Patients must be at least 18 years of age.
Who cannot join
- Patients must not have previously undergone transurethral resection, laser therapy, microwave therapy, radiofrequency ablation, or other surgery of the prostate.
- Patients must not have previously undergone incision of urethral stricture or incision of bladder neck contracture.
- Patients must not have previously been diagnosed with urethral stricture, bladder neck contracture or urinary incontinence.
- Patients must not have previously been diagnosed with atonic bladder or neurogenic bladder.
- Patients must not have significant pre-operative voiding symptoms as defined by an American Urologic Association symptom score of greater than 19.
- Patients must not have a prior history of radiation to the pelvis.
- Patients must not have persistent bacteriuria that cannot be cleared, as demonstrated by a negative urinalysis or urine culture, within 1 month of surgery.
- Patients must not have allergies to pig tissue or pig products or have religious or cultural objection to the use of pig tissue.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Urology of San Antonio Research
San Antonio, Texas, 78229
About this study
Official title: Randomized Controlled Trial Examining the Return of Urinary Continence After Robot-assisted Radical Prostatectomy With or Without a Urethrovesical Sling
The purpose of this study is to determine the impact of an absorbable urethrovesical sling on the post-operative return of urinary continence after robot-assisted radical prostatectomy.
- Conditions
- Urinary Incontinence, Prostate Cancer
- Being tested
- Prostatectomy, Surgisis Male Sling
- Keywords
- prostate cancer, prostatectomy, incontinence
- Medical subject headings
- Urinary Incontinence, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProstatectomyProcedure or surgery
Surgisis Male SlingDevice
| Study group | Role | What they receive |
|---|---|---|
| Urethrovesical Sling | Experimental | Surgisis Male Sling placed at the time of prostatectomy Receives: Procedure: Prostatectomy; Device: Surgisis Male Sling |
| Control | Active comparator | Prostatectomy Receives: Procedure: Prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Continent Patients Post Prostatectomy
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study startNov 2009
- Primary completionOct 2013
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chandru Sundaram, MD, Principal investigator, Indiana Cancer Pavilion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00937833
- Sponsor's protocol ID
- 08-015
- Other IDs
- 350017
- Status last verified
- Dec 2014
- First submitted
- 10 Jul 2009
- Last updated
- 29 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Examining the Return of Urinary Continence After Robot-assisted Radical Prostatectomy With or Without a Urethrovesical Sling
- ClinicalTrials.gov ID
- NCT00937833
- Acronym / sponsor ID
- 08-015
- Conditions
- Urinary Incontinence, Prostate Cancer
- Keywords
- prostate cancer, prostatectomy, incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 13 Jul 2009 (estimated)
- Results
- Posted 13 Nov 2014
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 is to determine the impact of an absorbable urethrovesical sling on the post-operative return of urinary continence after robot-assisted radical prostatectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urethrovesical Sling | Experimental | Procedure: Prostatectomy, Device: Surgisis Male SlingSurgisis Male Sling placed at the time of prostatectomy |
| Control | Active comparator | Procedure: ProstatectomyProstatectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must have organ confined prostate cancer.
- Patients must have PSA< 15.
- Patients must have clinical stage prostate cancer < cT3.
- Patients must be scheduled for robot assisted transperitoneal laparoscopic radical prostatectomy.
- Patients must be able to provide written informed consent and HIPAA authorization for release of personal health information.
Key exclusion criteria (8 listed)
- Patients must not have previously undergone transurethral resection, laser therapy, microwave therapy, radiofrequency ablation, or other surgery of the prostate.
- Patients must not have previously undergone incision of urethral stricture or incision of bladder neck contracture.
- Patients must not have previously been diagnosed with urethral stricture, bladder neck contracture or urinary incontinence.
- Patients must not have previously been diagnosed with atonic bladder or neurogenic bladder.
- Patients must not have significant pre-operative voiding symptoms as defined by an American Urologic Association symptom score of greater than 19.
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 |
|---|---|---|
| Prostatectomy | Procedure or surgery | Control, Urethrovesical Sling |
| Surgisis Male Sling | Device | Urethrovesical Sling |
Primary outcome
Number of Continent Patients Post Prostatectomy
Time frame: 1 Month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Chandru Sundaram, MD principal investigator
Indiana Cancer Pavilion
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prostatectomy and Surgisis Male Sling in people with Urinary Incontinence and Prostate Cancer, run by Cook Group Incorporated 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 29 Dec 2014. 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?
Yes. Results are posted in the registry (first posted 13 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Continent Patients Post Prostatectomy (time frame: 1 Month). 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 29 Dec 2014.