PACTR201808641266843招募中1 期
Prospective study to evaluate use of TephaFLEX sling implanted via aretropubic mid-urethral sling procedure for treatment of women withstress urinary incontinence
Pelvic Floor Foundation of South Africa0 个研究点目标入组 25 人开始时间: 2018年8月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- Female
入选标准
- •To be eligible for enrollment, the subject must:
- •1. Be female, = 18 years of age
- •2. Female symptomatic (moderate or severe) SUI resulting
- •from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).
- •3. Patients who have planned to undergo surgical
- •correction of symptomatic SUI after consultation with their physician
- •about the risks and benefits of such a procedure, and a
- •determination by the physician that surgical treatment is the most
- •appropriate treatment option for the patient.
- •4. Understand and be willing to follow all aspects of the
- •study protocol and have signed and dated the EC-approved Informed
- •Consent prior to any study-related procedures being performed
排除标准
- •1. Subjects who have mixed or urge incontinence
- •2. Subjects who have stage 2 or more genital prolapse,
- •according to the ICS classification
- •3. Subjects with previous surgery for SUI
- •4. Subjects who undergo concomitant surgical procedures
- •5. Subjects who are pregnant or want to become pregnant
- •in the next 24 months
- •6. Subjects who are not capable of giving informed
- •7. Subjects with a BMI = 35 kg/m2
- •8. Subjects diagnosed with a current urinary tract infection
- •or chronic urinary tract infections (defined as 4 or more UTI in the
- •9. Subjects with known sensitivity to tetracycline or
研究者
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