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Male Sexual Experience and Its Impact on Quality of Life Before and After Their Sexual Partners Undergo Polypropylene Mesh Augmented Pelvic Floor Reconstruction (SEXQ)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jodie Komar, Atlantic Health System
ClinicalTrials.gov Identifier:
NCT01320631
First received: March 21, 2011
Last updated: August 2, 2012
Last verified: July 2012

March 21, 2011
August 2, 2012
September 2009
September 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01320631 on ClinicalTrials.gov Archive Site
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Male Sexual Experience and Its Impact on Quality of Life Before and After Their Sexual Partners Undergo Polypropylene Mesh Augmented Pelvic Floor Reconstruction
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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.

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Observational
Time Perspective: Prospective
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Non-Probability Sample

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

  • Sacral Colpopexy
  • Pelvic Organ Prolapse
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Sexually active couple at the time of pre-operative visit
  2. Female partner scheduled to undergo a mesh augmented repair

Exclusion Criteria:

  1. Not sexually active
  2. Use of other graft material than polypropylene mesh
  3. Contraindications to surgery based on existing medical conditions
  4. Pregnancy
  5. Desire for pregnancy in the future
Male
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01320631
R09-08-008
No
Jodie Komar, Atlantic Health System
Atlantic Health System
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Atlantic Health System
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP