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

Sponsor
Atlantic Health System (Other)
Overall Status
Completed
CT.gov ID
NCT01320631
Collaborator
(none)
80
Enrollment
1
Location
24
Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    80 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Study Start Date :
    Sep 1, 2009
    Actual Primary Completion Date :
    Sep 1, 2011
    Actual Study Completion Date :
    Sep 1, 2011

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      Male
      Accepts Healthy Volunteers:
      Yes
      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

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Atlantic Health System Morristown New Jersey United States 07960

      Sponsors and Collaborators

      • Atlantic Health System

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Atlantic Health System
      ClinicalTrials.gov Identifier:
      NCT01320631
      Other Study ID Numbers:
      • R09-08-008
      First Posted:
      Mar 22, 2011
      Last Update Posted:
      Jun 9, 2017
      Last Verified:
      Jun 1, 2017
      Keywords provided by Atlantic Health System
      uterine prolapse
      vaginal prolapse
      Additional relevant MeSH terms:
      Prolapse
      Pelvic Organ Prolapse

      Study Results

      No Results Posted as of Jun 9, 2017