UCon Treatment of Overactive Bladder (OAB) in Males

Официальное название

Safety and Performance of UCon for Management of Non-Neurogenic OAB in Males - An Early Feasibility Study

Обзор

UCon is a medical device for treatment of the symptoms of OAB and fecal incontinence (FI). It electrically stimulates the DGN through the skin to obtain modulated behaviour of the bladder musculature e.g., suppress undesired bladder activity to relieve the symptoms of the patient. This clinical investigation is a randomized, cross-over, single-site, prospective, early feasibility study, which is used to evaluate Ucon with respect to its initial clinical safety and device performance in a small number of males with OAB.

Подробное описание

The purpose of the current investigation is to obtain information about the type of stimulation that Ucon provide (time limited vs. urge stimulation), would be the most effective and feasible for the treatment of non-neurogenic OAB symptoms in males.

Вмешательства

• Устройство Urge stimulation
  Participants will receive stimulation for 60 seconds, when they feel an urgency.
• Устройство Time limited stimulation
  Participant will receive the stimulation as provided in time limited sessions (Range: 15 min - continuous), whenever it suits the participant during the day.

Первичные конечные точки

• PRIMARY SAFETY: To evaluate adverse events [initial safety] of UCon for treatment of OAB symptoms in a home setting. [Срок оценки: After 44 days (end of study)]
• PRIMARY PERFORMANCE: To evaluate the ratio of treatment change [performance] of OAB symptoms using UCon in a home setting [Срок оценки: Change from baseline at 14 days, 30 days and 44 days (study end)]

Вторичные конечные точки (5)

• SECONDARY SAFETY: To identify the number of subjects experiencing adverse events associated with the use of UCon during the investigational period. [Срок оценки: After 44 days (end of study)]
• SECONDARY SAFETY: To evaluate the severity of adverse events associated with the use of UCon during the investigational period. [Срок оценки: After 44 days (study end)]
• SECONDARY PERFORMANCE: To evaluate whether subjects using UCon experience a change in their quality of life. [Срок оценки: Change from baseline at 14 days and 44 days (end of study)]
• SECONDARY PERFORMANCE: To evaluate whether subjects using UCon experience a change in their treatment outcome (i.e. symptoms) after therapy. [Срок оценки: Change from baseline at 14 days and 44 days (end of study)]
• SECONDARY PERFORMANCE: To evaluate the device and treatment acceptability of UCon. [Срок оценки: After 44 days (study end)]

Критерии участия

Критерии включения

• Subject is ≥ 18 years of age.
• Subject is male.
• Subject is diagnosed with OAB
• Subject is able to communicate, provide feedback, understand and follow instructions during the course of the investigation.

Критерии исключения

• Subject is medically unstable (acute illness or complications of a chronic condition that might affect the subject's participation in the investigation).
• Subject has a Post Void Residual (PVR) of more than 100 ml or a Bladder Voiding Efficiency (BVE) of less than 75% (measured by uroflowmetry as the ratio of voided volume (VV) and total bladder capacity (VV+PVR)).
• Subject has an active infection in the genital area incl. skin infections and urinary tract infection.
• Subject has had botulinum toxin (BOTOX) treatment in the pelvic region within 6 months.
• Subject has used antimuscarinics or β3 agonists within 14 days weeks\*.
• Subject has an implanted pacemaker, implantable drug pump or other active medical device (any medical device that uses electrical energy or other source of power to make it function).
• Subject is enrolled or planning to enrol in another clinical investigation or was enrolled in an investigational drug study or medical device investigation within four weeks to enrolment.
• Subject has neuropathy to a degree that is presumed to diminish the effect of the electrical stimulation.
• Subject has a history of cancer in the pelvic region, are currently receiving cancer treatment, or has radiation-induced damage to the pelvic region.
• Subject has addictive behaviour defined as abuse of alcohol, cannabis, opioids, or other intoxicating drugs.
• Subject does not speak and understand Dutch.

• If a subject is currently being treated with antimuscarinics or β3 agonists, he is allowed to be included in the investigation, however, a washout period of 14 days is required before baseline can be established.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• Maastricht University Medical Center+ — Maastricht

Идентификаторы

NCT: NCT05874375 · NL_FEAS_01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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