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

NCT02111642 | Completed

• 1 other identifier: MHRI 2014-073
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse; Stress Urinary Incontinence; Satisfaction

Keywords

Pelvic organ prolapse; Stress urinary incontinence; Midurethral sling; Patient satisfaction

Outcome Measures

Primary Outcomes (1)

• Satisfaction with Decision Scale for Pelvic Floor Disorders

  The primary outcome will be patient satisfaction with the decision for concomitant midurethral sling placement at 3 months postoperative in the intervention (risk calculator tool) group versus the control group, assessed using the Satisfaction with Decision Scale for Pelvic Floor Disorders.

  3 months postoperative

Study Arms (2)

Online risk calculator used

EXPERIMENTAL

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

Other: Online risk calculator

Online risk calculator not used

PLACEBO COMPARATOR

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

Other: Online risk calculator

Interventions

Online risk calculator 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 used

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (1)

• 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.

  PMID: 24402598 BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse; Urinary Incontinence, Stress; Personal Satisfaction; Patient Satisfaction

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Behavior; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Jeannine M. Miranne, MD, MS

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MS, Fellow, Female Pelvic Medicine and Reconstructive Surgery

Study Record Dates

• First Submitted: April 9, 2014
• First Posted: April 11, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 20, 2022

Record last verified: 2022-01

Locations

US (1)