Prostate CancerNCT00444730
Urology Database for Outcomes Research
An observational study of Prostate Cancer and Pelvic Pain, run by Kenneth Peters, MD at 1 site in United States.
Trial summary
The purpose of initiating the urology database is to collect relevant retrospective data via chart review related to patients undergoing radical prostatectomy via the retropubic, perineal, laparoscopic, and robotic assisted laparoscopic approaches and InterStim implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Pelvic Pain, Incontinence
- What is being tested?
- Radical Prostatectomy, InterStim Implantation and Pelvic organ prolapse repair
- Type of treatment
- Surgery or procedure
- How many people
- 860 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing radical prostatectomy or InterStim implantation at William Beaumont Hospital.
Who may be able to join
- All patients undergoing radical prostatectomy or InterStim implantation at William Beaumont Hospital.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
The purpose of initiating the urology database is to collect relevant retrospective data via chart review related to patients undergoing radical prostatectomy via the retropubic, perineal, laparoscopic, and robotic assisted laparoscopic approaches and InterStim implantation. This data will be utilized to evaluate the health benefits and outcomes of each of these procedures to enhance care and treatment.
Read the detailed description
The objective of this study is to initiate and maintain a patient information database that will be used to study the impact of each surgical procedure on patients' overall health, quality of life, and bowel/bladder/sexual function.
The study coordinator will, on an ongoing basis, abstract needed medical information from inpatient hospital and physician office records for inclusion into the database.
- Conditions
- Prostate Cancer, Pelvic Pain, Incontinence
- Being tested
- Radical Prostatectomy, InterStim Implantation, Pelvic organ prolapse repair
- Keywords
- Prostate Cancer, Prostatectomy, Pelvic pain, urgency, incontinence, frequency
- Medical subject headings
- Prostatic Neoplasms, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical ProstatectomyProcedure or surgery
Surgical procedure for prostate cancer.
InterStim ImplantationProcedure or surgery
Also called interstim
surgical placement of the interstim
Pelvic organ prolapse repairProcedure or surgery
Also called prolapse repair
Surgical pelvic organ prolapse repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2007 (estimated)
- Study startJan 2007
- Primary completionAug 2014
- Study completionAug 2014
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.
- 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
- 860 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, M.D., Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444730
- Sponsor's protocol ID
- 2007-031
- Status last verified
- Aug 2014
- First submitted
- 6 Mar 2007
- Last updated
- 28 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urology Database for Outcomes Research
- ClinicalTrials.gov ID
- NCT00444730
- Acronym / sponsor ID
- 2007-031
- Conditions
- Prostate Cancer, Pelvic Pain, Incontinence
- Keywords
- Prostate Cancer, Prostatectomy, Pelvic pain, urgency, incontinence, frequency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 860 participants (actual)
- Lead sponsor
- Kenneth Peters, MDUniversity, hospital or other
- Collaborators
- Corewell Health East
- Study start
- Jan 2007
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 8 Mar 2007 (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 collect relevant retrospective data via chart review related to patients undergoing radical prostatectomy via the retropubic, perineal, laparoscopic, and robotic assisted laparoscopic approaches and InterStim implantation. This data will be utilized to evaluate the health benefits and outcomes of each of these procedures to enhance care and treatment.
Detailed description
The objective of this study is to initiate and maintain a patient information database that will be used to study the impact of each surgical procedure on patients' overall health, quality of life, and bowel/bladder/sexual function.
The study coordinator will, on an ongoing basis, abstract needed medical information from inpatient hospital and physician office records for inclusion into the database.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing radical prostatectomy or InterStim implantation at William Beaumont Hospital.
Key inclusion criteria (1 listed)
- All patients undergoing radical prostatectomy or InterStim implantation at William Beaumont Hospital.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Radical ProstatectomySurgical procedure for prostate cancer. | Procedure or surgery | – |
| InterStim ImplantationAlso: interstimsurgical placement of the interstim | Procedure or surgery | – |
| Pelvic organ prolapse repairAlso: prolapse repairSurgical pelvic organ prolapse repair | Procedure or surgery | – |
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 28 Aug 2014.
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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, M.D. 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 Prostate Cancer and Pelvic Pain, 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 28 Aug 2014. 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 28 Aug 2014; AzTrials last refreshed its copy on 27 Oct 2026.