Effect of Vibrator Use on Symptoms of Urgency Urinary Incontinence, Sexual Function, and Sleep
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Vibrator, Behavioral modification.
- Кому может быть актуально
- Состояния в реестре: Urgency Urinary Symptoms. Базовые параметры: от 18 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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).
Вмешательства
- Устройство Vibrator
Scheduled vibrator use - Поведенческое Behavioral modification
Guideline based standard lifestyle and behavioral modifications for urgency urinary incontinence
Первичные конечные точки
- Change in score on UDI-6 from baseline to follow-up in 8 weeks. [Срок оценки: 12 weeks]
Вторичные конечные точки (6)
- Female Sexual Function Index (FSFI) [Срок оценки: 12 weeks]
- Brief Pittsburgh Sleep Quality Index (B-PSQI) [Срок оценки: 12 weeks]
- Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) [Срок оценки: 12 weeks]
- Patient Global Impression of Improvement (PGI-I) [Срок оценки: 12 weeks]
- Patient Health Questionnaire-4 (PHQ-4) [Срок оценки: 12 weeks]
- International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) [Срок оценки: 12 weeks]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07569822 · 7438