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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01320631
Other study ID # R09-08-008
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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, 

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