Effect of Vibrator Use on Symptoms of Urgency Urinary Incontinence, Sexual Function, and Sleep (BLISS)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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).
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Vinita Gottipati, MD
- Numero di telefono: 518-262-5013
- Email: gottipv@amc.edu
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Lifestyle and behavioral modifications
|
Guideline based standard lifestyle and behavioral modifications for urgency urinary incontinence
|
|
Sperimentale: Scheduled vibrator use
Standard behavioral modifications and vibrator use
|
Guideline based standard lifestyle and behavioral modifications for urgency urinary incontinence
Scheduled vibrator use
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in score on UDI-6 from baseline to follow-up in 8 weeks.
Lasso di tempo: 12 weeks
|
Submitted
|
12 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Female Sexual Function Index (FSFI)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
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Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 7438
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