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

NCT ID: NCT01320631

Last Updated: 2017-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Sacral Colpopexy Pelvic Organ Prolapse

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Atlantic Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Atlantic Health System

Morristown, New Jersey, United States

Site Status

Countries

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United States

References

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Culligan PJ, Haughey S, Lewis C, Priestley J, Salamon C. Sexual Satisfaction Changes Reported by Men After Their Partners' Robotic-Assisted Laparoscopic Sacrocolpopexies. Female Pelvic Med Reconstr Surg. 2019 Sep/Oct;25(5):365-368. doi: 10.1097/SPV.0000000000000574.

Reference Type DERIVED
PMID: 29494351 (View on PubMed)

Other Identifiers

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R09-08-008

Identifier Type: -

Identifier Source: org_study_id

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