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NCT01320631 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Atlantic Health System.

Completed
Registry status
80
Enrollment target

NCT01320631: Completed study, sponsored by Atlantic Health System.

NCT01320631 is a clinical trial that has completed, run by Atlantic Health System. The registered enrollment target is 80 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01320631 has completed, sponsored by Atlantic Health System.

COMPLETED
Registry status
80 participants
Enrollment target

Study 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.

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2009-09
Est. Completion 2011-09
Atlantic Health System

43 total trials

What the finished NCT01320631 record still lists

NCT01320631 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 80 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT01320631 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01320631 about?

NCT01320631 is a clinical study titled "Male Sexual Experience and Its Impact on Quality of Life Before and After Their Sexual Partners Undergo Polypropylene Mesh Augmented Pelvic Floor Reconstruction". 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 ev...

What is the current status of trial NCT01320631?

This trial is currently completed. The enrollment target is 80 participants. The study started on 2009-09. Estimated completion is 2011-09.

Who is sponsoring clinical trial NCT01320631?

This trial is sponsored by Atlantic Health System, which has 43 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01320631, the US trial registry maintained by the National Library of Medicine. NCT01320631 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.