Effect of a Risk Calculator on Patient Satisfaction With the Decision for Midurethral Sling During Prolapse Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies, Urology, Urology |
| Therapuetic Areas: | Nephrology / Urology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/13/2015 |
| Start Date: | June 2014 |
| Contact: | Jeannine M. Miranne, MD |
| Email: | Jeannine.M.Miranne@medstar.net |
| Phone: | 202-877-6526 |
Effect of a New Risk Calculator on Patient Satisfaction With the Decision for Concomitant 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 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.
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.
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.
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.
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
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