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

Pelvic Organ Prolapse Clinical Trial

— SEXQ  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01320631
• Other study ID #: R09-08-008
• Status: Completed
• Phase: N/A
• First received: March 21, 2011
• Last updated: June 8, 2017
• Start date: September 2009
• Est. completion date: September 2011

Study information

• Verified date: June 2017
• Source: Atlantic Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse
• Sacral Colpopexy

Locations

Country	Name	City	State
United States	Atlantic Health System	Morristown	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Atlantic Health System

Country where clinical trial is conducted

United States,