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临床试验/NCT05741580
NCT05741580已完成不适用

Evolution of Symptoms After Peri-urethral Bulk Agent Injection of Bulkamid® for Urinary Incontinence

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年10月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Evolution of symptoms

研究概览

简要总结

There are currently different treatment options in the management of stress urinary incontinence according to the latest recommendations. Suburethral slings are currently considered the first surgical option due to an excellent cure rate of around 90%. Nevertheless, due to a risk of prosthetic complications and numerous current controversies over the placement of synthetic tissue, other therapeutic alternatives must be offered to patients.

Peri-urethral bulk agent injections have been used since 2006 in urinary incontinence and should be integrated into the therapeutic arsenal. This is a minimally invasive technique performed under local anesthesia on an outpatient basis. The mechanism of action is explained by better coaptation of the urethra and increased resistance to urine flow during the bladder filling phase. It also increases the strength of the striated sphincter thanks to a better arrangement of muscle fibers.

According to the European Association of Urology (EAU), the use of bulk agents is recommended for the management of urinary incontinence in elderly and/or frail patients whose comorbidities contraindicate surgical management. These peri-urethral injections can also be offered to patients with incontinence due to sphincter deficiency but also to young women with stress urinary incontinence who are ready to accept a partial improvement in their incontinence. The personal choice of the patient is currently a decisive factor for the implementation of a treatment for functional disorders and in particular for urinary incontinence.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Evolution of symptoms

时间窗: at 7 days after surgery

percentage of patients with improvement in their symptoms on the PGI-I scale (score 1, 2, or 3)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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