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临床试验/NCT02357784
NCT02357784终止不适用

Sacral Neuromodulation in Dual Incontinence: Ultrasound and Afferent Nerve Sensation Assessment

Northwestern University2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
1
试验地点
2
主要终点
Change From Baseline in Urethral and Anal Afferent Nerve Innervation at 3 Months Post Sacral Neuromodulation Device Implantation

研究概览

简要总结

Women with Dual Incontinence (DI) (both Urinary Incontinence (UI) and Fecal Incontinence (FI)) often have more bothersome symptoms, quality of life impact, and sexual dysfunction than those with just UI or FI. In many situations, DI is the result of a failure of communication between the brain and the sacral nerve, which controls the bladder, bowel, and pelvic floor. The only currently available treatment with level 1 effectiveness data for the treatment of BOTH UI and FI is called Sacral Neuromodulation (SNM). Sacral Neuromodulation is a standard of care treatment that involves surgically implanting a device in to a patient's body to target communication issues between their brain and bladder/bowel. Because the exact mechanism of action of SNM remains unclear, this study aims to better understand how SNM affects the nerves of patients with DI. Patients who are already planning on undergoing SNM device implantation will be recruited to this study. Study participants will undergo Current Perception Threshold (CPT) Testing and fill out questionnaires before SNM and 3 months after their SNM treatment. CPT Testing uses mild electrical stimulation in the urethra and rectum to measure and quantify the amount of physical stimuli required for the nerves in the pelvic floor to sense a stimulus. By learning more about nerve function in patients with DI, the investigators hope to find a way to screen patients before treatment with SNM to make sure the treatment will be effective for that individual.

详细描述

One in four women reports bothersome symptoms of a pelvic floor disorder with 16% reporting urinary incontinence (UI), otherwise known as leakage. Likewise, 1 in 5 women with UI reports fecal incontinence (FI). Women with dual incontinence (UI/FI) often have more bothersome symptoms, quality of life impact, and sexual dysfunction than those with just UI or FI. In many situations, bladder and/or bowel control problems are the result of a failure of communication between the brain and the sacral nerve. The sacral nerve controls the bladder, bowel, and pelvic floor and the muscles related to their function. If the brain and sacral nerve do not communicate correctly, the bladder and/or bowel cannot function properly, which often leads to incontinence, or leakage. The only currently available treatment with level 1 effectiveness data for the treatment of BOTH UI and FI is called Sacral Neuromodulation. Sacral Neuromodulation (SNM) is a standard of care procedure used to treat men and women that have symptoms of Urinary and Fecal Incontinence and involves surgically implanting a device in to the patient's body to target this communication problem by stimulating the nerves that control bladder and bowel function with mild electrical pulses. This helps the brain and nerves to communicate so the bladder and bowel can function properly. It is known that changes in nerve stimulation and muscular function are important factors in the cause and onset of UI and FI and in how a patient will respond to various treatments, however, the precise mechanism of action of SNM on UI and FI remains unclear.

This study therefore aims to obtain a better understanding of nerve and muscle function in patients with dual incontinence and to quantify how SNM affects the nerves of patients with dual incontinence. We hope to do so by using Current Perception Threshold (CPT) Testing, which is a way to quantify the function of different populations of afferent nerves. We will recruit patients who already plan on undergoing Sacral Neuromodulation implantation for the treatment of their dual incontinence, and as part of the research study we will use CPT testing to measure the amount of stimulation required to activate the participant's sacral nerve before SNM and will also measure the current perception threshold of the participant's sacral nerve after SNM treatment. We expect to see a difference in the amount of stimulation required to activate different pelvic floor nerves before and after the device implantation. By learning more about nerve function in patients with DI, we hope to find a way to screen patients before treatment with SNM to make sure the treatment will work for them. We also hope to learn how urethral and anal sphincter anatomy in patients with dual incontinence changes after treatment with SNM. Lastly, we will study the quality of sexual relationships in women with dual incontinence and their male partners and attempt to identify specific areas of dysfunction that are common in patients with DI.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Subject is a female over the age of 18 years old
  • Subject is diagnosed with idiopathic dual incontinence
  • Subject is planning to undergo placement of a sacral nerve modulator
  • Subject has at least 5 UUI episodes on a 3-day diary
  • Subject has 2 FI episodes on a 7-day diary
  • Subject has given signed, informed consent prior to registration on study

排除标准

  • Subject has a neurologic disease
  • Subject has a disease that may impair sphincter tone or sensation
  • Subject is pregnant
  • Subject has > Stage II pelvic organ prolapse
  • Subject underwent rectal surgery in the past year
  • Subject has chronic inflammatory bowel disease
  • Subject has diathermy
  • Subject has QTc prolongation
  • Subject has cardiac arrhythmia

结局指标

主要结局

Change From Baseline in Urethral and Anal Afferent Nerve Innervation at 3 Months Post Sacral Neuromodulation Device Implantation

时间窗: Baseline and 3 months Post-Treatment

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Margaret Mueller

Assistant Professor of Obstetrics and Gynecology

Northwestern University

研究点 (2)

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