NL-OMON43407已完成不适用
The use of a Polycaprolactone Based Bulking Agent for the Treatment of Female Stress Urinary Incontinence, a Pivotal Trial - A polycaprolactone treatment for SUI
AQLANE Medical BV0 个研究点目标入组 35 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
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
- 18 至 99（—）
入选标准
- •1. Subjects 18 years of age or older
- •2. Subjects with predominant SUI as determined by the Questionnaire for Urinary Incontinence Diagnosis (QUID); Total Stress score (Sum Q1-3) of >= 4 and Total Urge score (Sum Q4-6) of < 6.
- •3. Subjects who attempted or failed prior noninvasive pelvic muscle rehabilitation treatment while incontinent.
- •4. Subjects with mild to moderate SUI as confirmed by SGS 1 or 2
- •5. Subjects willing and able to comply with study follow-up procedures and schedule
- •6. Subjects willing to provide written informed consent for their participation in the trial
排除标准
- •1. Subjects who have received previous bulking agent implantation in the submucosa of the urethra or had any form of surgery to treat SUI
- •2. Subjects with any form of urinary incontinence other than predominant SUI
- •3. Subjects with urinary retention (postvoid residual volume >=100ml)
- •4. Subjects with morbid obesity (body mass index (BMI) >=40 kg/m2)
- •5. Subjects with known allergies to antibiotics
- •6. Subjects with a neurogenic bladder
- •7. Subjects who were treated with chemotherapy agents or systemic corticosteroids within 3 months prior to enrollment
- •8. Subjects with a history of autoimmune disorder
- •9. Subjects with known allergies to topical, injectable, or general anesthetics
- •10. Subjects with severe allergies manifested by a history of anaphylaxis or those with severe, chronic allergies (e.g. asthma)
- •11. Subjects with a known bleeding disorder
- •12. Subjects with an active infection of any kind at the time of enrollment
- •13. Subjects with known connective tissue disease
- •14. Subjects who do not agree to use contraceptives throughout the initial 12 months of the trial
- •15. Subjects who are pregnant (or within 12 months postpartum) or lactating
- •16. Subjects who are unwilling and/or unable to comply trial follow-up procedures and schedules
- •17. Subjects enrolled in another investigational clinical trial
- •18. Subjects with co-morbidities
- •19. Subjects with non-viable tissue, e.g. history of significant pelvic irradiation, multiple pelvic surgeries, etc. (scar tissue and significantly compromised tissue will not coapt appropriately)
- •20. Subjects with urethral or bladder neck strictures (use of bulking agents in patients with strictures may cause injury and/or urethral obstruction)
- •21. Subjects with peripheral vascular disease and/or prior pelvic surgery may be at increased risk for tissue erosion
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