Genital ProlapseNCT00784602
Observing Pelvic Organ Prolapse Symptoms And Treatment Outcomes
An observational study of Genital Prolapse, run by Melissa Fischer, MD at 1 site in United States.
Trial summary
To prospectively observe the outcomes of surgical prolapse treatment in terms of urinary, bowel, and sexual function, quality of life, patient satisfaction, cost, and achieving patient determined treatment goals. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Genital Prolapse
- How many people
- 301 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2008to 29 Aug 2016
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with genital prolapse.
Who may be able to join
- Female
- Pelvic Organ Prolapse
- Able to provide informed consent
- Able to complete study assessments, per clinician judgment
Who cannot join
- Age < 21 years
- Currently pregnant or < 6 months post-partum
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
To prospectively observe the outcomes of surgical prolapse treatment in terms of urinary, bowel, and sexual function, quality of life, patient satisfaction, cost, and achieving patient determined treatment goals.
Read the detailed description
Patients meeting the inclusion/exclusion criteria will be identified by reviewing the hospital's surgical boarding list and contacted by phone to obtain informed consent. Once informed consent is obtained, chart review will be conducted here at William Beaumont Hospital and at the physician's office to collect patient information related to their prolapse condition. Prior to surgery, questionnaires will be mailed and completed by the participant and then again at 6 and 12 months after surgery, and then yearly. Questionnaires will assess urinary, bowel, and sexual function, and patient treatment goals, treatment satisfaction, and general health and wellbeing. Completion of the questionnaires will be voluntary, and participants will be followed in this manner until voluntary withdrawal, exclusionary criteria emerge, or death.
- Conditions
- Genital Prolapse
- Keywords
- prolapse, pelvic organ prolapse
- Medical subject headings
- Prolapse, Pelvic Organ Prolapse
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in urinary, bowel, and sexual function as measured on the PFDI, PFIQ, and PISQ validated questionnaires
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2008 (estimated)
- Study start29 Oct 2008
- Primary completion29 Aug 2016
- Study completion29 Aug 2016
Why it stopped: Shift in department's research interests
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genital 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
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melissa Fischer, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Corewell Health East
- Responsible party
- Sponsor-investigator, Melissa Fischer, MD, Corewell Health East
- Investigators
- Melissa Fischer, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00784602
- Sponsor's protocol ID
- 2008-242
- Status last verified
- Dec 2017
- First submitted
- 3 Nov 2008
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observing Pelvic Organ Prolapse Symptoms And Treatment Outcomes
- ClinicalTrials.gov ID
- NCT00784602
- Acronym / sponsor ID
- 2008-242
- Conditions
- Genital Prolapse
- Keywords
- prolapse, pelvic organ prolapse
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Shift in department's research interests
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Melissa Fischer, MDUniversity, hospital or other
- Collaborators
- Corewell Health East
- Study start
- 29 Oct 2008 (actual)
- Primary completion
- 29 Aug 2016 (actual)
- Study completion
- 29 Aug 2016 (actual)
- First posted
- 4 Nov 2008 (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.
To prospectively observe the outcomes of surgical prolapse treatment in terms of urinary, bowel, and sexual function, quality of life, patient satisfaction, cost, and achieving patient determined treatment goals.
Detailed description
Patients meeting the inclusion/exclusion criteria will be identified by reviewing the hospital's surgical boarding list and contacted by phone to obtain informed consent. Once informed consent is obtained, chart review will be conducted here at William Beaumont Hospital and at the physician's office to collect patient information related to their prolapse condition. Prior to surgery, questionnaires will be mailed and completed by the participant and then again at 6 and 12 months after surgery, and then yearly. Questionnaires will assess urinary, bowel, and sexual function, and patient treatment goals, treatment satisfaction, and general health and wellbeing. Completion of the questionnaires will be voluntary, and participants will be followed in this manner until voluntary withdrawal, exclusionary criteria emerge, or death.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with genital prolapse.
Key inclusion criteria (4 listed)
- Female
- Pelvic Organ Prolapse
- Able to provide informed consent
- Able to complete study assessments, per clinician judgment
Key exclusion criteria (2 listed)
- Age < 21 years
- Currently pregnant or < 6 months post-partum
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
Changes in urinary, bowel, and sexual function as measured on the PFDI, PFIQ, and PISQ validated questionnaires
Time frame: Ongoing
Results and safety
The study was stopped early (reason given: Shift in department's research interests). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Genital Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
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Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
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Active, not recruiting
Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse
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Functional Links Between the Temporomandibular Joint and the Pelvis in Gynecology
Prolapse; Female, Endometriosis-related Pain
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.
Melissa Fischer, 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 Genital Prolapse, run by Melissa Fischer, 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 4 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: stopped early, as of the sponsor's last update on 3 Jan 2018. 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 stopped early (reason given: Shift in department's research interests). Results are not available in the source record.
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?
Changes in urinary, bowel, and sexual function as measured on the PFDI, PFIQ, and PISQ validated questionnaires (time frame: Ongoing). 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 3 Jan 2018.