Effect of Vibrator Use on Symptoms of Urgency Urinary Incontinence, Sexual Function, and Sleep (BLISS)
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Details and patient eligibility
About
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.
Full description
This is a randomized superiority trial designed to evaluate the efficacy of scheduled vibrator use as an adjunct to standard lifestyle and behavioral modifications for urgency urinary incontinence (UUI) or urgency-predominant mixed urinary incontinence (MUI). UUI is defined as involuntary urine leakage preceded by a sudden, compelling urge to void. This will be identified and confirmed by patient report and screening with urgency-related items on the Urogenital Distress Inventory-6 (UDI-6), with participants required to report urgency-related leakage at least once per week.
Eligible participants will be recruited from the Albany Medical Center Urogynecology clinic during routine outpatient visits. After informed consent and baseline assessment, participants will be randomized 1:1 to either (1) lifestyle and bladder training counseling alone (control arm) or (2) lifestyle and bladder training counseling plus scheduled vibrator use (intervention arm). Participants in the intervention group will be instructed to use a provided FDA-registered Class II wellness vibrator for 5-10 minutes at least three times per week over an eight-week period, while all participants will receive standardized bladder retraining education materials. The primary outcome measure will be change in UDI-6 score, Female Sexual Function Index (FSFI), and Brief Pittsburgh Sleep Quality Index (B-PSQI) from baseline to eight weeks. Secondary outcomes will include validated assessments of quality of life and distress, including the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), Patient Global Impression of Improvement (PGI-I), Patient Health Questionnaire-4 (PHQ-4).
The study will be conducted at Albany Medical Center, Department of Obstetrics and Gynecology, Division of Urogynecology and Pelvic Reconstructive Surgery, following approval by the Institutional Review Board (IRB).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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).
- Leaks urine at least once per week due to urgency.
- Postvoid residual volume <100 mL or a third of the voided volume
Exclusion criteria
- 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.
- Interstitial cystitis/bladder pain syndrome.
- Current use of sacral neuromodulation or percutaneous tibial nerve stimulation (PTNS).
- Bladder Botox injection within the past 6 months.
- Vibrator use within the past 3 months.
- Patients uncomfortable with vibrator use
- Pregnancy or plans for pregnancy during the study period.
Trial design
Primary purpose
Allocation
Interventional model
Masking
116 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Vinita Gottipati, MD
Data sourced from clinicaltrials.gov
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