跳至主要内容
临床试验/NCT03842410
NCT03842410Unknown不适用

Solyx Single-Incision SlingDynamic Intraoperative Standing Sling Technique (DISST) as an Office-based Procedure

Michigan Institution of Women's Health PC2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年5月31日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
2
主要终点
Subject tolerability of the Solyx SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISST)

研究概览

简要总结

This study will assess the feasibility and success of performing the SolyxTM SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISSTTM). Study endpoints will be feasibility, composite success, complications, and patient and physician acceptance.

详细描述

The single-incision midurethral sling (SIMUS) is a procedure where there are no exit incisions. There is a 15 mm suburethral incision with the sling being attached with anchors to the obturator muscle on each side. This procedure has potentially lesser side-effects compared to the longer slings however, the literature has not found the SIMUS to be as effective as the long slings. In our recently published study, the DISSTTM technique has significantly improved the success of the SIMUS procedure as the sling can be tested for proper application in vivo.

As we have performed several of these procedures in the operating room entirely under local anesthesia, we have decided to perform this procedure in an office setting using the same safety precautions as in a hospital operating room.

Performing this procedure in the office has significant benefits for the patient, the healthcare industry, and the economy overall. Moving away from a hospital setting has significant psychological benefits. This will increase patient acceptance and therefore will become appealing to many more women who may be shying away from treatment.

It would also eliminate the risk of nosocomial infections for the patient and family members, improve efficiency as the wait time would be negligible, and would reduce the expense of the entire treatment as hospital costs would not feature in the equation.

This study will assess the feasibility and success of performing the SolyxTM SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISSTTM). Study endpoints will be feasibility, composite success, complications, and patient and physician acceptance.

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 89 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • SUI with hypermobility of the urethrovesical (UV) junction
  • American Society of Anesthesiologists (ASA) classes I or II
  • Ages ranging 21-89 years
  • Have the ability to stand for CST during the procedure
  • Have failed behavioral therapy
  • Completed childbearing

排除标准

  • ASA classes III or IV
  • Need for concomitant surgery
  • Poor compliance for office-based approach
  • Demonstrate concomitant urgency incontinence on urodynamic testing

结局指标

主要结局

Subject tolerability of the Solyx SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISST)

时间窗: intraoperative

Subject tolerability will be assessed using a 10-cm Visual Analogue Scale rating tolerability of the procedure. The Visual Analog Scale measures discomfort of the procedure with 0 being no discomfort and 10 being severe discomfort.

Surgeon difficulty of performing the Solyx SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISST)

时间窗: intraoperative

Surgeon difficulty will be determined by a 5-point Likert scale ranging from 1 (very easy) to 5 (very difficult).

Ability to achieve DISST SUCCESS

时间窗: intraoperative

Defined as a negative intraoperative standing cough stress test (CST) at bladder fullness.

Complications of performing the Solyx SIMUS in the office using the Dynamic Interactive Standing Sling Technique (DISST)

时间窗: intraoperative

Any intraoperative complications will be documented

次要结局

  • Improvement in patient quality of life as it relates to urinary symptoms(3, 6,12, 24 and 60 months post operative)
  • Improvement in overall urinary incontinence (stress and urge incontinence)(3, 6, 12, 24 and 60 months post operative)
  • Post operative complications(post procedure to 12, 24 and 60 months)
  • Sexual function(3, 6,12, 24 and 60 months post operative)
  • Subject satisfaction with overall improvement from sling procedure(3, 6, 12, 24 and 60 months post operative)
  • Post operative pain(pre-procedure to 7 days after procedure)
  • Return to pre-surgical activities(Pre-procedure to return to 60 months)

研究者

发起方
Michigan Institution of Women's Health PC
申办方类型
Other
责任方
Principal Investigator
主要研究者

Salil Khandwala

Director

Michigan Institution of Women's Health PC

研究点 (2)

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