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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)

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ClinicalTrials.gov Identifier: NCT01320631
Recruitment Status : Completed
First Posted : March 22, 2011
Last Update Posted : June 9, 2017
Sponsor:
Information provided by (Responsible Party):
Atlantic Health System

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
Sacral Colpopexy Pelvic Organ Prolapse

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01320631


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

Responsible Party: Atlantic Health System
ClinicalTrials.gov Identifier: NCT01320631     History of Changes
Other Study ID Numbers: R09-08-008
First Posted: March 22, 2011    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: June 2017

Keywords provided by Atlantic Health System:
uterine prolapse
vaginal prolapse

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