Effect of Vibrator Use on Symptoms of Urgency Urinary Incontinence, Sexual Function, and Sleep (BLISS)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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).
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Vinita Gottipati, MD
- Numéro de téléphone: 518-262-5013
- E-mail: gottipv@amc.edu
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Lifestyle and behavioral modifications
|
Guideline based standard lifestyle and behavioral modifications for urgency urinary incontinence
|
|
Expérimental: Scheduled vibrator use
Standard behavioral modifications and vibrator use
|
Guideline based standard lifestyle and behavioral modifications for urgency urinary incontinence
Scheduled vibrator use
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in score on UDI-6 from baseline to follow-up in 8 weeks.
Délai: 12 weeks
|
Submitted
|
12 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Female Sexual Function Index (FSFI)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 7438
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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