Pelvic Organ ProlapseNCT01611285
Uphold Versus Robotic Surgery for Pelvic Prolapse Repair: A Decision Analytic Approach
An observational study of Pelvic Organ Prolapse, run by Atlantic Health System at 1 site in United States.
Trial summary
Within the general objective of investigating optimal medical techniques for pelvic prolapse repair, this study proposes to: (1) test the hypothesis that the UPHOLD procedure is more cost effective than robotic surgery for pelvic prolapse repair (2)using formal decision analysis as the comparative strategy Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Aug 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 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 20 patients who underwent either robotic surgery or the UPHOLD procedure to treat pelvic organ prolapse from 2009-2010
Who may be able to join
- Female
- Underwent either UPHOLD procedure or Robotic Surgery for Pelvic Organ prolapse
Who cannot join
- Other vaginal procedure to correct prolapse
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlantic Health System Department of Urogynecology
Morristown, New Jersey, 07960
About this study
Within the general objective of investigating optimal medical techniques for pelvic prolapse repair, this study proposes to: (1) test the hypothesis that the UPHOLD procedure is more cost effective than robotic surgery for pelvic prolapse repair (2)using formal decision analysis as the comparative strategy
Read the detailed description
The cumulative incidence of pelvic organ prolapse was approximately 2% in 2001. Given the aging demographics in the U.S., the incidence of prolapse is projected to increase to 30% or more for women aged 60 years and older and become of greater concern to both patients and physicians. The demand for gynecologic services is predicted to increase by more than 45% in the next ten years. Prolapse is related to childbirth, aging, defects in collagen, and smooth muscle structure and strength. Etiology includes intra-abdominal pressure from obesity, with obesity becoming an ever increasing factor in the US.
Treatment Choice of Patients:
Patients choose between pessary, surgery, and expectant management based on: age, prior prolapse surgery, preoperative pelvic pain scores, and pelvic organ prolapse severity. These are difficult decisions for patients.
When it comes to choosing between destinctive interventions with subtle advantages and disadvantages, patients typically want to hear their physician's views of the scientific merits of each procedure. Informed consent becomes extremely difficult when issues of cost-effectiveness are at hand. Thus, the proposed project.
- Conditions
- Pelvic Organ Prolapse
- Keywords
- UPHOLD, robotic surgery, decision analysis, FDA, decision node, outcome node
- Medical subject headings
- Pelvic Organ Prolapse
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 |
|---|---|---|
| Robotic Sacrocolpopexy patients | Patients who underwent Robotic Sacrocolpopexy to treat pelvic organ prolapse between 2009 and 2010 | |
| UPHOLD patients | Patients who underwent the UPHOLD procedure to treat pelvic organ prolapse from 2009-2010. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical cure versus failure of prolapse repair
Incidence of recurrance of pelvic organ prolapse within 12 months of either robotic sacrocolpopexy or the UPHOLD procedure
Measured: within 12 months of patients surgery
Secondary outcomes (1)
Financial costs of outcomes
Financial costs that will incur to produce the primary outcomes- success or failure. When the two outcomes are considered together, we have "cost effectiveness"
Measured: within 12 months of patients surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study startNov 2010
- Primary completionJul 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Patrick Culligan, MD FACOG FACS, Principal investigator, Atlantic Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611285
- Sponsor's protocol ID
- R10-04-002
- Status last verified
- Jun 2017
- First submitted
- 30 May 2012
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uphold Versus Robotic Surgery for Pelvic Prolapse Repair: A Decision Analytic Approach
- ClinicalTrials.gov ID
- NCT01611285
- Acronym / sponsor ID
- R10-04-002
- Conditions
- Pelvic Organ Prolapse
- Keywords
- UPHOLD, robotic surgery, decision analysis, FDA, decision node, outcome node
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Nov 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 4 Jun 2012 (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.
Within the general objective of investigating optimal medical techniques for pelvic prolapse repair, this study proposes to: (1) test the hypothesis that the UPHOLD procedure is more cost effective than robotic surgery for pelvic prolapse repair (2)using formal decision analysis as the comparative strategy
Detailed description
The cumulative incidence of pelvic organ prolapse was approximately 2% in 2001. Given the aging demographics in the U.S., the incidence of prolapse is projected to increase to 30% or more for women aged 60 years and older and become of greater concern to both patients and physicians. The demand for gynecologic services is predicted to increase by more than 45% in the next ten years. Prolapse is related to childbirth, aging, defects in collagen, and smooth muscle structure and strength. Etiology includes intra-abdominal pressure from obesity, with obesity becoming an ever increasing factor in the US.
Treatment Choice of Patients:
Patients choose between pessary, surgery, and expectant management based on: age, prior prolapse surgery, preoperative pelvic pain scores, and pelvic organ prolapse severity. These are difficult decisions for patients.
When it comes to choosing between destinctive interventions with subtle advantages and disadvantages, patients typically want to hear their physician's views of the scientific merits of each procedure. Informed consent becomes extremely difficult when issues of cost-effectiveness are at hand. Thus, the proposed project.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic Sacrocolpopexy patients | – | –Patients who underwent Robotic Sacrocolpopexy to treat pelvic organ prolapse between 2009 and 2010 |
| UPHOLD patients | – | –Patients who underwent the UPHOLD procedure to treat pelvic organ prolapse from 2009-2010. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 20 patients who underwent either robotic surgery or the UPHOLD procedure to treat pelvic organ prolapse from 2009-2010
Key inclusion criteria (2 listed)
- Female
- Underwent either UPHOLD procedure or Robotic Surgery for Pelvic Organ prolapse
Key exclusion criteria (1 listed)
- Other vaginal procedure to correct prolapse
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
Surgical cure versus failure of prolapse repair
Time frame: within 12 months of patients surgery
Incidence of recurrance of pelvic organ prolapse within 12 months of either robotic sacrocolpopexy or the UPHOLD procedure
1 secondary outcome
Financial costs of outcomes
Time frame: within 12 months of patients surgery
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 9 Jun 2017.
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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.
Patrick Culligan, MD FACOG FACS principal investigator
Atlantic Health System
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 Pelvic Organ Prolapse, run by Atlantic Health System 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 2 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 9 Jun 2017. 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.
What does the primary outcome measure?
Surgical cure versus failure of prolapse repair (time frame: within 12 months of patients surgery). 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 9 Jun 2017.