Male Sexual Experience and Its Impact on Quality of Life Before and After Their Sexual Partners Undergo Polypropylene Mesh Augmented Pelvic Floor Reconstruction (SEXQ)
| Tracking Information | |
|---|---|
| First Received Date ICMJE | March 21, 2011 |
| Last Updated Date | August 2, 2012 |
| Start Date ICMJE | September 2009 |
| Primary Completion Date | September 2011 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | Complete list of historical versions of study NCT01320631 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Male Sexual Experience and Its Impact on Quality of Life Before and After Their Sexual Partners Undergo Polypropylene Mesh Augmented Pelvic Floor Reconstruction |
| Official Title ICMJE | Not Provided |
| Brief Summary | The correction of the pelvic organ protrusion is aimed at restoring the pelvic floor functional status and ultimately improving the patient's quality of life. There are a few studies that have explored the effect of pelvic reconstructive surgery on female sexual function (1,2) but no studies have evaluated the male partner's sexual experience. The investigators intend to use a newly psychometrically validated questionnaire to capture this aspect. The sexual experience questionnaire (SEX-Q) is the first questionnaire to solely and exclusively combine functional and quality of life concepts (erection, individual satisfaction, and couple satisfaction domains) in a brief questionnaire, which allows a more focused and less burdensome evaluation of the sexual experience in men (3). Another issue is the density of the mesh material and if it can be felt vaginally even if it is not eroded and to what degree this might bother the male partner during intercourse. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Non-Probability Sample |
| Study Population | Male sexual partners of women who are sexually active and are scheduled to undergo a mesh augmented repair for pelvic organ prolapse referred to the Division of Urogynecology and Reconstructive Pelvic Surgery |
| Condition ICMJE |
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| Intervention ICMJE | Not Provided |
| Study Group/Cohort (s) | Not Provided |
| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 80 |
| Completion Date | September 2011 |
| Primary Completion Date | September 2011 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT Number ICMJE | NCT01320631 |
| Other Study ID Numbers ICMJE | R09-08-008 |
| Has Data Monitoring Committee | No |
| Responsible Party | Jodie Komar, Atlantic Health System |
| Study Sponsor ICMJE | Atlantic Health System |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Atlantic Health System |
| Verification Date | July 2012 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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