Evaluation of Hyivy Floora in Managing Interstitial Cystitis/Bladder Pain Syndrome/High-tone Pelvic Floor Dysfunction

Официальное название

Evaluation of the Hyivy Floora Pelvic Rehabilitation Vaginal Dilator in Managing Interstitial Cystitis/ Bladder Pain Syndrome and High-tone Pelvic Floor Dysfunction

Обзор

The purpose of this study is to test the safety and effectiveness of the Floora Pelvic Rehabilitation Vaginal Dilator in females with Interstitial Cystitis/ Bladder pain Syndrome (IC/BPS) and High-tome Pelvic Floor Dysfunction (HTPFD). After enrollment, participants will be given a Floora device and will be instructed to use the device at least three times per week for 12-weeks in the comfort of their home. Each session consists of 10 minutes of heat and 10 minutes of dilation. All participants will be required to attend 3 in-person clinic visits and there will be two follow-up phone-calls throughout the 16-week trial period.

Подробное описание

The expansion of Interstitial Cystitis (IC) to include Bladder Pain Syndrome (BPS) started in 2002 by the International Continence Society and was further expanded in 2008 to focus on the inclusion of chronic pelvic pain, pressure, and discomfort perceived to be related to the bladder. These symptoms must occur for more than 6 weeks in the absence of infection or other identifiable cause . There has been further distinction between patients who have erosive bladder lesions (Hunner lesions) and those who do not. The Floora allows women suffering from HTPFD and IC/BPS to manage their physical therapy treatment privately and comfortably in their own space, fostering a sense of control to take an active role in their healing. This self-controlled option can reduce anxiety, improve mental well-being, and increasing adherence to dilator therapy, ultimately leading to better outcomes in managing pain, thus improving quality of life for these patients.

Вмешательства

• Устройство Floora Pelvic Rehabilitation Vaginal Dilator
  The Floora Pelvic Rehabilitation Vaginal Dilator, created by Hyivy Health Inc, is a multi-therapy hand held ergonomic intravaginal wand device that is designed to be used in the comfort of the user's home. The Floora has two main therapeutic functions, controllable dilation and thermal therapy. It is the first vaginal dilator that performs auto-dilation using one or two air chambers inflated from the device surface by an internal pump, eliminating the need for reinsertion. The device is equipped

Первичные конечные точки

• Pelvic Pain Score [Срок оценки: Baseline]
• Pelvic Pain Score [Срок оценки: Week 6]
• Pelvic Pain Score [Срок оценки: Week 12]
• Pelvic Pain Score [Срок оценки: Week 16]

Вторичные конечные точки (5)

• O'Leary-Sant Interstitial cystitis (IC) Symptom Score [Срок оценки: Baseline, 6-weeks, 12-weeks and 16-weeks]
• Pelvic Pain, Urgency and Frequency (PUF) Questionnaire Score [Срок оценки: Baseline, 6-weeks, 12-weeks and 16-weeks]
• Pelvic Floor Impact Questionnaire- Short Form 7 (PFIQ-7) [Срок оценки: Baseline, 6-weeks, 12-weeks and 16-weeks]
• The Female Sexual Functioning Index (FSFI) [Срок оценки: Baseline, 6-weeks, 12-weeks and 16-weeks.]
• The Global Response Assessment (GRA) [Срок оценки: 12-weeks]

Критерии участия

Критерии включения

• Biological Female
• Previously established clinical diagnosis of Interstitial Cystitis/ Bladder Pain Syndrome (IC/BPS)
• Diagnosed with High-tone Pelvic Floor Dysfunction (HTPFD)
• Current pelvic pain score of 5 or greater on an 11-point Likert Scale
• Must be willing and able to insert intravaginal device
• No cognitive deficits
• Agrees not to commence any new treatments for HTPFD or IC/BPS (medical or physical therapy) during the 12-week intervention period

Критерии исключения

• History of a spinal cord injury
• Currently pregnant or lactating
• Allergy to device materials
• Active vaginal infection (e.g. vulvovaginal candidiasis, trichomonas, vaginitis, bacterial vaginosis, STIs, etc.)
• Have open wounds, cuts, or open sores present in the vaginal or pelvic area
• Recent pelvic or abdominal surgery within the last 3 months
• Currently under the care of a pelvic floor physical therapist or pelvic floor physiotherapist
• History of Neurogenic bladder
• History of bladder, uterine, ovarian or vaginal cancer
• History of radiation cystitis
• Any pelvic floor/bladder Botox use within 6 months of enrollment and no future plans for Botox injections during the study period.
• Any other medical condition or clinical finding giving reasonable suspicion of a disease or condition that contraindicates the use of the Floora, at the discretion of the Investigator

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Atrium Health Wake Forest Baptist Urology — Winston-Salem

Идентификаторы

NCT: NCT07038512 · IRB00130697

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗