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Идёт набор NCT01953263

Muscle Fiber Fragment Treatment for Urinary Incontinence

Фаза I / Фаза II С лечением Urinary Incontinence

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: Autologous Muscle Fiber Fragments.
Кому может быть актуально
Состояния в реестре: Urinary Incontinence. Базовые параметры: 18 лет — 75 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
США
Следующий шаг
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Официальное название

A Phase 1 Study of Human Muscle Fiber Fragment (MFF) Treatment for Urinary Incontinence

Обзор

This study is designed to evaluate the safety of autologous muscle fiber fragments for the treatment of urinary incontinence due to incompetent outlet (bladder neck/urethra).

Подробное описание

Eligible subjects with a diagnosis of urinary incontinence who give consent to take part will undergo a biopsy of the muscle from the inner thigh under anesthesia. During the same procedure, muscle fiber fragments will be obtained from the sample and then immediately delivered via target injected into the bladder neck sphincter region using an endoscopic needle via cystoscope or under ultrasound guidance. All subjects will be followed at 1 week, 6 weeks, 3 months, 6 months and 12 months post-treatment injection.

Вмешательства

  • Другое Autologous Muscle Fiber Fragments
    Autologous muscle fiber fragments administered via a single direct injection into the bladder neck sphincter region

Первичные конечные точки

  • Incidence of treatment-related serious adverse events [Срок оценки: 12 months]
Вторичные конечные точки (1)
  • Change in Incontinence Assessment by Pad Test [Срок оценки: baseline, 3, 6, and 12 months post-treatment]

Критерии участия

Критерии включения

  • Adult female patients who are not pregnant or lactating/breast-feeding and must be either not sexually active, surgically sterilized, or must be practicing an effective method of birth control as determined by the investigator
  • Patients between the ages of 18 and 75 years
  • Patients with positive diagnosis of urinary incontinence due to sphincter insufficiency caused by acquired (e.g., stress urinary incontinence) and/or congenital conditions.
  • Patients with cystometric capacity of bladder > 100 ml
  • Patients with normal renal function
  • Patients with a history of primary incontinence

Критерии исключения

  • Patients with a history of hypercontractile bladder, non-compliant bladder, hydronephrosis or neurogenic bladder
  • Patients with an active urinary tract infection as evidenced by positive urine culture
  • Patients who are taking medication that affect urination such as prescription drugs, over-the-counter drugs, or dietary supplements, including herbal supplements and those taken with teas
  • Patients requiring concomitant use of or treatment with immunosuppressive agents
  • Patients with a history of systemic conditions, including but not limited to HIV, diabetes and chronic liver disease (including Hepatitis B or C), that the Investigator believes may jeopardize the safety of the patient to participate in the study
  • Patients with evidence or diagnosis of any primary muscle disease or coagulation disorder (including concomitant anti-coagulation therapy)
  • Patients who have been treated with any other investigational drug or participated in any investigational study within 30 days prior to enrollment in this study
  • Patients who have been treated with any cellular therapy within 12 months prior to enrollment in this study
  • Patients with urinary incontinence other than the categories being investigated
  • Patients with significant (>grade 2) pelvic organ prolapse
  • Patients with vaginal prolapse beyond introitus
  • Patients with neurological disorders
  • Patients with abnormal bladder capacity (i.e., less than 100 cc)
  • Patients with abnormal urologic conditions, including post-void residual, urethral stricture and bladder neck contracture, spastic bladder, vesicoureteral reflux, bladder stones, bladder tumors, hydronephrosis, other renal impairment

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
Лечение

Центры проведения

США · 1 центр
  • Wake Forest Urology Clinic — Winston-Salem

Идентификаторы

NCT: NCT01953263 · IRB00025341

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗