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NCT02111642 · ClinicalTrials.gov registry record · NA

Effect of a Risk Calculator on Patient Satisfaction With the Decision for Midurethral Sling During Prolapse Surgery

A NA study, sponsored by Medstar Health Research Institute.

Completed
Registry status
NA
Development phase
42
Enrollment target

NCT02111642 is a NA study that has completed, run by Medstar Health Research Institute. The registered enrollment target is 42 participants.

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The verdict

NCT02111642, a NA study, has completed, sponsored by Medstar Health Research Institute.

COMPLETED
Registry status
NA
Development phase
42 participants
Enrollment target

Study Summary

Pelvic organ prolapse occurs with descent of one or more pelvic structures: the uterus and/or cervix, bowel, bladder, or rectum. Although options for treatment include expectant management, pelvic floor physical therapy, and pessary (intravaginal device) use, surgery is the only option which potentially offers a cure. It is well known that women with pelvic organ prolapse are at risk of developing new stress urinary incontinence symptoms after prolapse surgery. Stress urinary incontinence is defined as involuntary loss of urine with an increase in intra-abdominal pressure, such as sneezing, coughing, or laughing. Previous studies have demonstrated that the addition of a prophylactic anti-incontinence procedure at the time of prolapse surgery reduces this risk. One example of such a procedure is a mesh sling placed underneath the urethra (midurethral sling). Nevertheless, the decision to place a midurethral sling to prevent stress urinary incontinence after prolapse surgery remains controversial. A new risk calculator tool has been developed to provide patients' with their individualized risk of developing de novo stress urinary incontinence after prolapse surgery. The primary objective of this study is to determine whether use of this new personalized online risk calculator tool increases patient satisfaction with the decision whether or not to have a midurethral sling placed at the time of prolapse surgery to prevent development of stress urinary incontinence. The investigators hypothesize that use of this tool will increase patient satisfaction with their decision regarding midurethral sling placement.

Interventions

  • OTHER Online risk calculator

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2014-06
Est. Completion 2015-06
Phase NA

Sponsor

Medstar Health Research Institute

115 total trials

What the Registry Record Tells You About NCT02111642

The ClinicalTrials.gov registry entry for NCT02111642 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medstar Health Research Institute, which has 115 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Online risk calculator is the first listed.

NCT02111642 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02111642 about?

NCT02111642 is a clinical study titled "Effect of a Risk Calculator on Patient Satisfaction With the Decision for Midurethral Sling During Prolapse Surgery". Pelvic organ prolapse occurs with descent of one or more pelvic structures: the uterus and/or cervix, bowel, bladder, or rectum. Although options for treatment include expectant management, pelvic floor physical therapy, and pessary (intravaginal device) use, surgery is the only option which potenti...

What is the current status of trial NCT02111642?

This trial is currently completed. It is a NA study. The enrollment target is 42 participants. The study started on 2014-06. Estimated completion is 2015-06.

What interventions are being tested in trial NCT02111642?

The interventions under investigation include: Online risk calculator (OTHER).

Who is sponsoring clinical trial NCT02111642?

This trial is sponsored by Medstar Health Research Institute, which has 115 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.