Effect of Vibrator Use on Symptoms of Urgency Urinary Incontinence, Sexual Function, and Sleep (BLISS)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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).
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Vinita Gottipati, MD
- Telefoonnummer: 518-262-5013
- E-mail: gottipv@amc.edu
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: Lifestyle and behavioral modifications
|
Guideline based standard lifestyle and behavioral modifications for urgency urinary incontinence
|
|
Experimenteel: Scheduled vibrator use
Standard behavioral modifications and vibrator use
|
Guideline based standard lifestyle and behavioral modifications for urgency urinary incontinence
Scheduled vibrator use
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in score on UDI-6 from baseline to follow-up in 8 weeks.
Tijdsspanne: 12 weeks
|
Submitted
|
12 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Female Sexual Function Index (FSFI)
Tijdsspanne: 12 weeks
|
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.
|
12 weeks
|
|
Brief Pittsburgh Sleep Quality Index (B-PSQI)
Tijdsspanne: 12 weeks
|
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.
|
12 weeks
|
|
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)
Tijdsspanne: 12 weeks
|
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.
|
12 weeks
|
|
Patient Global Impression of Improvement (PGI-I)
Tijdsspanne: 12 weeks
|
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.
|
12 weeks
|
|
Patient Health Questionnaire-4 (PHQ-4)
Tijdsspanne: 12 weeks
|
The Patient Health Questionnaire-4 is an ultra-brief screening tool combining 2 items for anxiety and 2 for depression.
Scores range from 0 to 12, with higher scores indicating greater psychological distress.
|
12 weeks
|
|
International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
Tijdsspanne: 12 weeks
|
The International Consultation on Incontinence Questionnaire-Short Form evaluates the frequency, severity, and impact of urinary incontinence on quality of life.
Scores range from 0 to 21, with higher scores indicating more severe symptoms and worse quality of life impact.
|
12 weeks
|
Medewerkers en onderzoekers
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Meer informatie
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Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 7438
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