N/A
N=66
Impact of Decision Aids in Urogynecology
Pelvic Organ Prolapse · Stress Urinary Incontinence · Overactive Bladder
Bottom Line
View on ClinicalTrials.gov: NCT04369404 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Patient Knowledge — 60; 72 percentage of questions answered correct — p=0.06
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pelvic organ prolapse decision aid (Behavioral); Stress urinary incontinence decision aid (Behavioral); Overactive bladder decision aid (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Knowledge |
60; 72 | 0.06 |
| PRIMARY Patient Treatment Preference |
22; 28; 11; 5 | 0.085 |
| PRIMARY Physician Visit Satisfaction |
0; 0; 5; 9; 23; 19 | 0.47 |
| SECONDARY SURE Scale |
24; 30 | — |
| SECONDARY CollaboRATE |
17; 25 | — |
| SECONDARY SDM Process Scale |
3.18; 3.17 | — |
| SECONDARY MD Perceptions of Length of Visit |
25; 23 | — |
Summary
To evaluate how patient knowledge and confidence in decision making can be impacted by shared decision making in common urogynecology conditions.
Eligibility Criteria
Inclusion Criteria
- Adults 18-95 years only
- English speaking
- Pelvic organ prolapse defined by noticeable (to the patient) vaginal bulging
- Symptoms of stress urinary incontinence (cough, sneeze, laugh, exercise)
- Presenting for initial consultation for either of the above symptoms
Exclusion Criteria
- Primary complaint is not vaginal bulging or stress urinary incontinence
- Prior surgery for pelvic organ prolapse or any incontinence procedure
Data sourced from ClinicalTrials.gov (NCT04369404). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.