Overview

This trial is active, not recruiting.

Conditions pelvic organ prolapse, stress urinary incontinence, satisfaction
Treatment online risk calculator
Sponsor Medstar Research Institute
Start date June 2014
End date June 2015
Trial size 42 participants
Trial identifier NCT02111642, MHRI 2014-073

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Arm
(Experimental)
Online risk calculator tool for the development of postoperative de novo stress urinary incontinence used during preoperative counseling session.
online risk calculator
A new online risk calculator tool has been developed to predict a woman's individual risk of developing de novo stress urinary incontinence after prolapse surgery. This validated tool has been shown to outperform preoperative prolapse reduction stress testing results and expert predictions when providing risk assessment of de novo stress urinary incontinence after vaginal prolapse surgery. After inputting individual patient characteristics, including patient age, body mass index, number of vaginal deliveries, presence or absence of urgency urinary incontinence and diabetes, and prolapse reduction stress testing results if available, this tool calculates the theoretical risk of postoperative de novo stress urinary incontinence both with and without an anti-incontinence procedure.
(Placebo Comparator)
Online risk calculator tool for the development of postoperative de novo stress urinary incontinence not used during preoperative counseling session.

Primary Outcomes

Measure
Satisfaction with Decision Scale for Pelvic Floor Disorders
time frame: 3 months postoperative

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - ≥ Stage 2 pelvic organ prolapse according to the Pelvic Organ Prolapse Quantification system (POP-Q) - Desire for prolapse surgery - No symptoms of stress urinary incontinence preoperatively - Age ≥ 18 - English-speaking Exclusion Criteria: - Symptoms of stress urinary incontinence preoperatively - History of previous prolapse or anti-incontinence surgery - Pregnancy - Dementia or other cognitive impairment - Unable or unwilling to complete post-operative questionnaires

Additional Information

Official title Effect of a New Risk Calculator on Patient Satisfaction With the Decision for Concomitant Midurethral Sling During Prolapse Surgery
Principal investigator Jeannine M. Miranne, MD, MS
Description The investigators plan to conduct a randomized, controlled clinical trial involving women with pelvic organ prolapse planning to have prolapse surgery with 1 of 4 fellowship-trained Urogynecologists at the National Center for Advanced Pelvic Surgery at MedStar Washington Hospital Center in Washington, DC. Women will be recruited prior to their preoperative counseling sessions during routine office visits and/or by telephone. After obtaining informed consent, women who agree to participate will be randomized to preoperative counseling sessions where an online risk calculator tool for the development of postoperative de novo stress urinary incontinence is or is not used. This tool is accessible at no cost from the following website: http://www.r-calc.com/ExistingFormulas.aspx?filter=CCQHS. At the time of these sessions, participants will decide whether to have a midurethral sling placed at the time of their prolapse repair to prevent development of stress urinary incontinence after surgery. After making this decision, all participants will complete the validated Satisfaction with Decision Scale to assess their satisfaction with their decision regarding midurethral sling placement. This validated 6-item self-administered questionnaire with a 5 point response scale takes approximately 3 minutes to complete. Participants will complete the Satisfaction with Decision Scale a second time at the time of their 2 week postoperative visit. Three months after surgery, participants will complete the Satisfaction with Decision Scale a third time, along with other validated quality of life questionnaires.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Medstar Research Institute.