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

NCT ID: NCT02111642

Last Updated: 2022-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-06-30

Brief 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.

Detailed 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.

Conditions

Pelvic Organ Prolapse; Stress Urinary Incontinence; Satisfaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Online risk calculator used

Online risk calculator tool for the development of postoperative de novo stress urinary incontinence used during preoperative counseling session.

Group Type: EXPERIMENTAL

Online risk calculator

Intervention Type: OTHER

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.

Online risk calculator not used

Online risk calculator tool for the development of postoperative de novo stress urinary incontinence not used during preoperative counseling session.

Group Type: PLACEBO_COMPARATOR

Online risk calculator

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medstar Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Jeannine Miranne

MD, MS, Fellow, Female Pelvic Medicine and Reconstructive Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeannine M. Miranne, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Locations

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Countries

United States

References

Jelovsek JE, Chagin K, Brubaker L, Rogers RG, Richter HE, Arya L, Barber MD, Shepherd JP, Nolen TL, Norton P, Sung V, Menefee S, Siddiqui N, Meikle SF, Kattan MW; Pelvic Floor Disorders Network. A model for predicting the risk of de novo stress urinary incontinence in women undergoing pelvic organ prolapse surgery. Obstet Gynecol. 2014 Feb;123(2 Pt 1):279-287. doi: 10.1097/AOG.0000000000000094.

Reference Type: BACKGROUND

PMID: 24402598 (View on PubMed)

Other Identifiers

MHRI 2014-073

Identifier Type: -

Identifier Source: org_study_id