Optimizing the Management of Patients With Mixed Urinary Incontinence.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 156
- 主要终点
- The Overactive Bladder Symptom Score (OABSS) questionnaire
研究概览
简要总结
The aim of this clinical study is to optimize treatment outcomes in patients with mixed forms of urinary incontinence by implanting an adjustable suburethral sling and to determine factors influencing treatment effectiveness. The main questions it aims to answer are:
- What is the effectiveness of an adjustable suburethral sling in patients with mixed urinary incontinence?
- How do preoperative medications and other factors affect the effectiveness of adjustable suburethral sling implantation?
- How does quality of life change in these patients after surgery? Participants will undergo implantation of an adjustable suburethral sling. Postoperatively, the effectiveness of the sling for mixed urinary incontinence will be assessed. Predictors of treatment effectiveness will also be identified.
Patients will be examined 24 hours after surgery, 2 months later, and 1 year later.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women over 18 years of age.
- •Mixed urinary incontinence (stress and urgency components, with the stress component being predominant or equal) of moderate to severe severity, confirmed by questionnaire data.
- •Signed informed consent to participate in the study.
排除标准
- •Isolated stress or urge urinary incontinence.
- •Contraindications to diagnosis and treatment.
- •Obstructive urination, large residual urine volume.
- •Chronic pelvic pain syndrome.
- •Pelvic organ prolapse (grade 2 or higher according to POP-Q).
- •History of any suburethral sling implantation.
- •History of surgical treatment for pelvic organ prolapse.
- •Pregnancy.
研究组 & 干预措施
Patients with mixed urinary incontinence
Patients with mixed urinary incontinence, who were or were not prescribed drug therapy before the start of the study, planned for surgical treatment - implantation of a suburethral adjustable sling.
干预措施: implantation of an adjustable suburethral sling (Procedure)
结局指标
主要结局
The Overactive Bladder Symptom Score (OABSS) questionnaire
时间窗: At 24 hours postoperatively compared
Changes in scores on the Overactive Bladder Symptom Score (OABSS) questionnaire at 24 hours postoperatively compared to pre-treatment values.
次要结局
未报告次要终点
研究者
Brednikhina Irina
Urologist
Saint Petersburg State University, Russia