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临床试验/NCT01780636
NCT01780636终止2 期

Ultrasound and EMG Guided Botox Injection for the Treatment of Non-Relaxing Puborectalis Syndrome

Karen Noblett1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2013年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
发起方
Karen Noblett
入组人数
7
试验地点
1
主要终点
PAC-SYM and Wexner Scores

研究概览

简要总结

Our study aims to determine the efficacy of ultrasound and EMG guided Botox injections into the puborectalis muscle in women with non-relaxing puborectalis syndrome. With use of this technique, we believe we will find that Botox injections decrease symptom severity and improve quality of life (QOL) in patients with NRPS. All enrolled patients will receive ultrasound and EMG guided Botox injections at three points along the puborectalis muscle. Post-injection data will be obtained with a defecation diary and questionnaire data at the 2-week, 3-month, and 6-month intervals.

详细描述

Non-relaxing puborectalis syndrome (NRPS) is an obstructive defecatory disorder that presents with chronic constipation, anismus, or a sensation of incomplete rectal emptying. The specific etiology of this syndrome is unknown. The true incidence of NRPS is unknown, but it is estimated that 4% of patients with defecatory disorders have NRPS. Previous therapies for non-relaxing PRS have included biofeedback, pelvic floor physical therapy, dietary changes, laxatives, enemas, and surgical division of the puborectalis muscle. Unfortunately, responses to these treatments have been variable at best. Direct injection of botulinum toxin (Botox) into the puborectalis muscle is an alternative approach for treating NRPS and has recently been reported in a limited number of studies. Botox blocks cholinergic nerve endings in the autonomic nervous system and has been used to weaken the puborectalis muscle in constipated patients.

Our study aims to determine the efficacy of ultrasound and EMG guided Botox injections into the puborectalis muscle in women with NRPS. With use of this technique, we believe we will find that Botox injections decrease symptom severity and improve quality of life (QOL) in patients with NRPS.

We plan to compare patient reported symptoms, symptom severity, and QOL prior to Botox injections with symptoms and QOL at 2-week, 3-month, and 6-month intervals after Botox injection into the puborectalis muscle in patients with NRPS.

All enrolled patients will receive ultrasound and EMG guided Botox injections at three points along the puborectalis muscle. Post-injection data will be obtained with a defecation diary and questionnaire data at the 2-week, 3-month, and 6-month intervals. Additional injections will be offered to patients who fail the initial treatment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • 18 years of age or older
  • Diagnosis of non-relaxing puborectalis syndrome

排除标准

  • Allergy or sensitivity to botulinum toxin
  • Pregnancy or plan to become pregnant in the subsequent 6 months after injection
  • Undiagnosed ano-rectal mass, lesion, or infection
  • Stage II or greater rectocele

研究组 & 干预措施

Botulinum toxin (Botox) injection

Experimental

All patients will be given the active Botox injection and thus this study will remain open-label and non-randomized as this is a pilot study to determine initial efficacy.

干预措施: botulinum toxin (Drug)

结局指标

主要结局

PAC-SYM and Wexner Scores

时间窗: Baseline to 6 months

Scores on a scale The baseline scores were compared to scores at 6 months to evaluate the degree of improvement

Change in Symptoms Based on Scores Using the PAC-SYM and Wexner Constipation Questionnaires.

时间窗: Baseline to 6 months post-injection

To assess whether Botox injections into the puborectalis muscle will improve patient's symptoms based on scores using the PAC-SYM and Wexner Constipation validated questionnaires from baseline to 6 months post-Botox injection to determine severity of symptoms. The PAC-SYM questionnaire unabbreviated title is Patient Assessment of Constipation-Symptoms and the total score is summed ranging from 0 to 44. The Wexner Constipation questionnaire total score is summed ranging from 0 to 30. Both questionnaires have higher values representing a worse outcome.

次要结局

  • Change in Pressures on Anal Manometry(Baseline to 6 months post-injection)

研究者

发起方
Karen Noblett
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Karen Noblett

Professor of Obstetrics & Gynecology

University of California, Irvine

研究点 (1)

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