Varma Madhulika G, Matthews Catherine A, Muir Tristi, Takase-Sanchez Michelle M, Hale Douglass S, Van Drie Douglas, Richter Holly E
1 Section of Colorectal Surgery, Department of Surgery, University of California, San Francisco, San Francisco, California 2 Division of Urogynecology and Reconstructive Surgery, University of North Carolina, Chapel Hill, North Carolina 3 Departments of Obstetrics and Gynecology and Urology, University of Texas Medical Branch, Galveston, Texas 4 Division of Urogynecology, Indiana University Health, Indianapolis, Indiana 5 Female Pelvic Medicine and Reconstructive Surgery, Indiana University Health System, Indiana University Health, Indianapolis, Indiana 6 Female Pelvic Medicine & Urogynecology Institute of Michigan, a division of Grand Rapids Women's Health, Grand Rapids, Michigan 7 Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama.
Dis Colon Rectum. 2016 Feb;59(2):127-31. doi: 10.1097/DCR.0000000000000517.
Bowel dysfunction, including frequency, fecal urgency, stool consistency, and evacuation symptoms, contributes to fecal incontinence.
The purpose of this study was to examine the impact of a vaginal bowel control system on parameters of bowel function, including frequency, urgency, stool consistency, and evacuation.
This was a secondary analysis of a multicenter, prospective clinical trial.
This study was conducted at 6 sites in the United States, including university hospitals and private practices in urogynecology and colorectal surgery.
A total of 56 evaluable female subjects aged 19 to 75 years with 4 or more fecal incontinence episodes on a 2-week bowel diary were included.
The study intervention was composed of the vaginal bowel control system, consisting of a vaginal insert and pressure-regulated pump.
Subjects completed a 2-week baseline diary of bowel function before and after treatment completed at 1 month. Fecal urgency, consistency of stool (Bristol score), and completeness of evacuation were recorded for all bowel movements.
Use of the insert was associated with an improvement in bowel function across all 4 categories. Two thirds (8/12) of subjects with a high frequency of daily stools (more than 2 per day) shifted to a normal or low frequency of stools. Analysis of Bristol stool scale scores demonstrated a significant reduction in the proportion of all bowel movements reported as liquid (Bristol 6 or 7), from 36% to 21% (p = 0.0001). On average, 54% of stools were associated with urgency at baseline compared with 26% at 1 month (p < 0.0001). Incomplete evacuations with all bowel movements were reduced from 39% to 26% of subjects at 1 month (p = 0.0034).
The study follow-up period was 1 month (with an optional additional 2 months).
The vaginal bowel control system was associated with an improvement in bowel symptoms and function, including reduced bowel movement frequency, less fecal urgency, increased solid consistency, and improved evacuation in patients with significant fecal incontinence.
肠道功能障碍，包括排便频率、便急、粪便稠度及排空症状，会导致大便失禁。
本研究旨在探讨阴道肠道控制系统对肠道功能参数的影响，包括排便频率、便急、粪便稠度及排空情况。
这是一项对多中心前瞻性临床试验的二次分析。
本研究在美国的6个地点进行，包括大学医院以及泌尿妇科和结直肠外科的私人诊所。
纳入了56名年龄在19至75岁之间、在为期2周的肠道日记中有4次或更多次大便失禁发作的可评估女性受试者。
研究干预措施由阴道肠道控制系统组成，该系统包括一个阴道插入物和压力调节泵。
受试者在1个月治疗前后完成了一份为期2周的肠道功能基线日记。记录所有排便的便急情况、粪便稠度（布里斯托评分）及排空完整性。
使用该插入物与所有4个类别中的肠道功能改善相关。三分之二（8/12）每天排便频率高（每天超过2次）的受试者排便频率转变为正常或较低。对布里斯托粪便量表评分的分析表明，报告为液体状（布里斯托6级或7级）的所有排便比例从36%显著降至21%（p = 0.0001）。平均而言，基线时54%的排便伴有便急，而在1个月时为26%（p < 0.0001）。1个月时，所有排便存在排空不完全情况的受试者比例从39%降至26%（p = 0.0034）。
研究随访期为1个月（可选择额外延长2个月）。
阴道肠道控制系统与肠道症状和功能的改善相关，包括排便频率降低、便急减轻、粪便稠度增加以及大便失禁严重患者的排空改善。
