- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02085746
Defining Sexual Activity
May 10, 2019 updated by: Kristie Greene, University of South Florida
Defining Sexual Activity: How Demographics May Impact Our Definition
This will be a descriptive study using patients from the Urogynecology and Urology University of South Florida Clinics and Urology clinic at Tampa General Hospital Healthpark on 30th Street to analyze the impact of demographics on the definition of being sexually active.
It is believed one's demographics influence their definition of being sexually active.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Tampa, Florida, United States
- Tampa General Hospital HealthPark/30th Street
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Tampa, Florida, United States
- University of South Florida Urogynecology clinic
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Tampa, Florida, United States
- University South Florida Urology Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Male or female patient over 18 years of age seeking urogynecological/urological treatment at one of the participating clinical sites.
Description
Inclusion Criteria:
- Men and Women >18 who seek urogynecological/urological treatment
- English speaking
- Willing and able to provide written and informed consent
Exclusion Criteria:
- Men and Women <18
- Not a patient at the appropriate Urogynecological and Urology clinics
- Non-English speaking
- Unable or unwilling to provide written and informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Definition of Sexual Activity
Time Frame: 6 months
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Based on questionnaire answers, the goal is to define sexual activity.
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kristie Greene, M.D., University of South Florida
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Rogers RG, Rockwood TH, Constantine ML, Thakar R, Kammerer-Doak DN, Pauls RN, Parekh M, Ridgeway B, Jha S, Pitkin J, Reid F, Sutherland SE, Lukacz ES, Domoney C, Sand P, Davila GW, Espuna Pons ME. A new measure of sexual function in women with pelvic floor disorders (PFD): the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR). Int Urogynecol J. 2013 Jul;24(7):1091-103. doi: 10.1007/s00192-012-2020-8. Epub 2013 Apr 30.
- Dalpiaz O, Kerschbaumer A, Mitterberger M, Pinggera GM, Colleselli D, Bartsch G, Strasser H. Female sexual dysfunction: a new urogynaecological research field. BJU Int. 2008 Mar;101(6):717-21. doi: 10.1111/j.1464-410X.2007.07442.x. Epub 2008 Jan 10.
- Fashokun TB, Harvie HS, Schimpf MO, Olivera CK, Epstein LB, Jean-Michel M, Rooney KE, Balgobin S, Ibeanu OA, Gala RB, Rogers RG; Society of Gynecologic Surgeons' Fellows' Pelvic Research Network. Sexual activity and function in women with and without pelvic floor disorders. Int Urogynecol J. 2013 Jan;24(1):91-7. doi: 10.1007/s00192-012-1848-2. Epub 2012 Jun 29.
- Tok EC, Yasa O, Ertunc D, Savas A, Durukan H, Kanik A. The effect of pelvic organ prolapse on sexual function in a general cohort of women. J Sex Med. 2010 Dec;7(12):3957-62. doi: 10.1111/j.1743-6109.2010.01940.x.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
March 10, 2014
First Submitted That Met QC Criteria
March 12, 2014
First Posted (Estimate)
March 13, 2014
Study Record Updates
Last Update Posted (Actual)
May 14, 2019
Last Update Submitted That Met QC Criteria
May 10, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- Pro00015065
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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