Demographics Effecting One's Definition of Being Sexually ActiveNCT02085746
Defining Sexual Activity
An observational study of Demographics Effecting One's Definition of Being Sexually Active, run by University of South Florida at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Demographics Effecting One's Definition of Being Sexually Active
- What is being tested?
- Defining Sexual Activity Questionnaire
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2014to Jul 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male or female patient over 18 years of age seeking urogynecological/urological treatment at one of the participating clinical sites.
Who may be able to join
- Men and Women >18 who seek urogynecological/urological treatment
- English speaking
- Willing and able to provide written and informed consent
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Tampa General Hospital HealthPark/30th Street
Tampa, Florida
University of South Florida Urogynecology Clinic
Tampa, Florida
University South Florida Urology Clinic
Tampa, Florida
About this study
Official title: 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.
- Being tested
- Defining Sexual Activity Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Defining Sexual Activity QuestionnaireOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Definition of Sexual Activity
Based on questionnaire answers, the goal is to define sexual activity.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Demographics Effecting One's Definition of Being Sexually ActiveStudies 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
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristie Greene, University of South Florida
- Investigators
- Kristie Greene, M.D., Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085746
- Sponsor's protocol ID
- Pro00015065
- Status last verified
- May 2019
- First submitted
- 10 Mar 2014
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18190620Fashokun 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.
PubMed 22744621Rogers 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.
PubMed 23632798Tok 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.
PubMed 20646180
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Sexual Activity: How Demographics May Impact Our Definition
- ClinicalTrials.gov ID
- NCT02085746
- Acronym / sponsor ID
- Pro00015065
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 13 Mar 2014 (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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female patient over 18 years of age seeking urogynecological/urological treatment at one of the participating clinical sites.
Key inclusion criteria (3 listed)
- Men and Women >18 who seek urogynecological/urological treatment
- English speaking
- Willing and able to provide written and informed consent
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Defining Sexual Activity Questionnaire | Other | – |
Primary outcome
Definition of Sexual Activity
Time frame: 6 months
Based on questionnaire answers, the goal is to define sexual activity.
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 14 May 2019.
- Background: PubMed 18190620Dalpiaz 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.
- Background: PubMed 22744621Fashokun 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.
- Background: PubMed 23632798Rogers 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.
- Background: PubMed 20646180Tok 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.
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.
Kristie Greene, M.D. principal investigator
University of South Florida
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Demographics Effecting One's Definition of Being Sexually Active, run by University of South Florida at 3 sites 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 3 inclusion and 4 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 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Definition of Sexual Activity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02085746, which also lists 4 linked publications.
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 14 May 2019.