IncontinenceNCT00376298
Urology Database to Evaluate Clinical Information and Improve Patient Care.
An observational study of Incontinence and Prostate Cancer, run by Kenneth Peters, MD at 1 site in United States.
Trial summary
The purpose of initiating the Urology Database is to evaluate the outcomes of urology procedures and medical management to enhance the care and treatment of urology patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incontinence, Prostate Cancer, Interstitial Cystitis
- How many people
- 215 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Dec 2015
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men and Women with conditions including radical prostatectomy, pelvic organ prolapse and neurostimulator implantation at William Beaumont Hospital
Who may be able to join
- All patients undergoing radical prostatectomy, pelvic organ prolapse repair and neurostimulator (Interstim) implantation at William Beaumont Hospital beginning January 1, 1998, as well as other urology patients as research questions are identified. Only patients who have accepted William Beaumont Hospital's Privacy Notices will be included in the database.
Who cannot join
- Patients not acknowledging acceptance of William Beaumont Hospital's Privacy Notices.
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: Urology Database for Outcomes Research
The purpose of initiating the Urology Database is to evaluate the outcomes of urology procedures and medical management to enhance the care and treatment of urology patients.
Read the detailed description
The current study population will include all patients having had a radical prostatectomy for the treatment of prostate cancer, surgical prolapse repair as well as patients having had InterStim sacral nerve stimulator implantation. The database will house data extracted from the medical records. Patient demographics, and preoperative, intra-operative, postoperative, and follow-up clinical data will be collected.
- Conditions
- Incontinence, Prostate Cancer, Interstitial Cystitis, Urinary Retention, Pelvic Organ Prolapse
- Keywords
- incontinence, prostate cancer, interstitial cystitis
- Medical subject headings
- Prostatic Neoplasms, Cystitis, Interstitial, Urinary Retention, Pelvic Organ Prolapse
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2006 (estimated)
- Study startFeb 2004
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kenneth Peters, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Corewell Health East
- Responsible party
- Sponsor-investigator, Kenneth Peters, MD, Corewell Health East
- Investigators
- Kenneth Peters, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00376298
- Sponsor's protocol ID
- 2004-050
- Status last verified
- Dec 2015
- First submitted
- 13 Sep 2006
- Last updated
- 24 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urology Database for Outcomes Research
- ClinicalTrials.gov ID
- NCT00376298
- Acronym / sponsor ID
- 2004-050
- Conditions
- Incontinence, Prostate Cancer, Interstitial Cystitis, Urinary Retention, Pelvic Organ Prolapse
- Keywords
- incontinence, prostate cancer, interstitial cystitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Kenneth Peters, MDUniversity, hospital or other
- Collaborators
- Corewell Health East
- Study start
- Feb 2004
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 14 Sep 2006 (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 initiating the Urology Database is to evaluate the outcomes of urology procedures and medical management to enhance the care and treatment of urology patients.
Detailed description
The current study population will include all patients having had a radical prostatectomy for the treatment of prostate cancer, surgical prolapse repair as well as patients having had InterStim sacral nerve stimulator implantation. The database will house data extracted from the medical records. Patient demographics, and preoperative, intra-operative, postoperative, and follow-up clinical data will be collected.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and Women with conditions including radical prostatectomy, pelvic organ prolapse and neurostimulator implantation at William Beaumont Hospital
Key inclusion criteria (1 listed)
- All patients undergoing radical prostatectomy, pelvic organ prolapse repair and neurostimulator (Interstim) implantation at William Beaumont Hospital beginning January 1, 1998, as well as other urology patients as research questions are identified. Only patients who have accepted William Beaumont Hospital's Privacy Notices will be included in the database.
Key exclusion criteria (1 listed)
- Patients not acknowledging acceptance of William Beaumont Hospital's Privacy Notices.
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2015.
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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.
Kenneth Peters, MD principal investigator
Corewell Health East
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 Incontinence and Prostate Cancer, run by Kenneth Peters, MD 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 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: finished, as of the sponsor's last update on 24 Dec 2015. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 24 Dec 2015.