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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
History of Changes
  Purpose

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
Sacral Colpopexy
Pelvic Organ Prolapse

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Atlantic Health System:

Enrollment: 80
Study Start Date: September 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01320631

Locations
United States, New Jersey
Atlantic Health System
Morristown, New Jersey, United States, 07960
Sponsors and Collaborators
Atlantic Health System
  More Information

No publications provided

Responsible Party: Jodie Komar, PI, Atlantic Health System
ClinicalTrials.gov Identifier: NCT01320631     History of Changes
Other Study ID Numbers: R09-08-008
Study First Received: March 21, 2011
Last Updated: August 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Atlantic Health System:
uterine prolapse
vaginal prolapse

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 19, 2013