Botox for Chronic Pelvic Pain

Официальное название

High-Density Surface Electromyography Guided Precision Botulinum Neurotoxin Injections to Manage Chronic Pelvic Floor Pain

Обзор

The purpose of this research study is to find out if precise, targeted injection of botulinum neurotoxin (commonly known as Botox) provides better relief of pelvic floor hypertonicity and pain than the standard method being used. The researchers want to better understand the effects (good and bad) of targeted botulinum neurotoxin injections in women with pelvic floor disorders.

Вмешательства

• Препарат Botulinum neurotoxin
  Botulinum neurotoxin will be injected into the pelvic floor muscles following either a standard template (standard injection arm), or guided using high-density surface EMG (guided arm). Participants will receive this drug twice throughout the duration of the study. Approximately 200 units of botulinum neurotoxin will be administered per injection.
• Устройство High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device
  A personalized, precision botulinum neurotoxin injection guidance medical device, utilizing an intra-vaginal high-density surface EMG system to optimize the treatment outcomes in chronic pelvic pain (CPP) management. The device will be used five times during the study. Each use will last approximately ten minutes.

Первичные конечные точки

• Hypertonic index of the pelvic muscles as measured by high-density surface-EMG (HD-sEMG) [Срок оценки: 1 month post-injection]

Вторичные конечные точки (3)

• Change in Self-Report Pelvic Pain as measured by Global Response Assessment (GRA) [Срок оценки: Baseline, 1 month post-injection]
• Change in Self-Report Pelvic Symptoms as measured by Global Response Assessment (GRA) [Срок оценки: Baseline, 1 month post-injection]
• Change in Self-Report Pelvic Pain as measured by the Female Genitourinary Index [Срок оценки: Baseline, 1 month post-injection]

Критерии участия

Критерии включения

• Females between 18 and 75 years of age
• Clinical diagnosis of chronic pelvic pain
• Complaints of pain, pressure, or discomfort in the bladder and/or pelvic area for the past 6 months or more, associated with lower urinary tract symptoms (such as frequency of urination), in the absence of other explanation of the symptoms (e.g., UTI) \*
• Myofascial pain diagnosed with palpable bands or nodules of contracted muscle fibers
• Pelvic muscle tenderness by assessment of pelvic floor muscles on digital pelvic examination
• No botulinum neurotoxin pelvic floor muscle injection treatment within 6 months prior to recruitment
• Able to provide informed consent

Критерии исключения

• Males
• Women < 18 and > 76 years of age
• History of pelvic malignancy and sexual transmitted diseases that is currently not in remission
• Bleeding disorder such as coagulopathy
• Hypersensitivity to botulinum neurotoxin
• Received botulinum neurotoxin pelvic floor muscle injection within 6 months prior to recruitment
• History of neurological disorders, such as spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis or myasthenia gravis
• Pregnancy, breast feeding or planning to get pregnant within one year after the last botulinum neurotoxin injection.

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

США · 1 центр

• University of Miami — Miami

Идентификаторы

NCT: NCT06796985 · 20240022 · 7R01DK133800-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗