About this trial
This study aims to understand if using a vibrator affects urgency related urinary incontinence. Insights from this study may open new recommendations for treating urinary urgency and incontinence.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Assigned female at birth.
Age ≥18 years.
Able to read and speak English.
Diagnosis of urgency urinary incontinence or mixed urinary incontinence (based on clinical assessment and UDI-6 urgency questions).
Disqualifiers
Pelvic organ prolapse beyond the hymen
Neurogenic bladder, multiple sclerosis, or other neurologic causes of incontinence.
Recurrent urinary tract infection (>3 UTIs in the past year or >2 in the past 6 months).
Active urinary tract infection at the time of enrollment.
Trial design
Parallel
Treatments tested in this trial
Vibrator
DeviceScheduled vibrator use
Behavioral modification
BehavioralGuideline based standard lifestyle and behavioral modifications for urgency urinary incontinence
Treatment groups
Trial outcomes
Primary outcomes
Change in score on UDI-6 from baseline to follow-up in 8 weeks.
Submitted
Secondary outcomes
Female Sexual Function Index (FSFI)
The Female Sexual Function Index is a 19-item questionnaire assessing domains of sexual function including desire, arousal, lubrication, orgasm, satisfaction, and pain. Scores range from 2 to 36, with higher scores indicating better sexual function and lower likelihood of dysfunction.
Brief Pittsburgh Sleep Quality Index (B-PSQI)
The Brief Pittsburgh Sleep Quality Index is a shortened version of the Pittsburgh Sleep Quality Index that evaluates sleep quality and disturbances over a recent time period. Scores typically range from 0 to 15 (depending on version), with higher scores indicating worse sleep quality.
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)
The PISQ-IR assesses sexual function in women with pelvic floor disorders and includes separate scoring for sexually active and non-sexually active individuals. Scores vary by domain, but are generally transformed to a 0-100 scale, with higher scores indicating better sexual function and condition-specific quality of life.
Patient Global Impression of Improvement (PGI-I)
The Patient Global Impression of Improvement is a single-item scale that asks patients to rate their condition after treatment compared to baseline. It ranges from 1 (very much better) to 7 (very much worse), with lower scores indicating better outcomes/improvement.
Locations
Sponsors and contacts
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