Urine Incontinence Occurrence and Sexual Hormones in Women With Chronic Spinal Cord Injury/Disease - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Incontinence event(s)
研究概览
简要总结
There is a knowledge gap about the influence of the menstrual cycle on bladder function in women with spinal cord injury. So far, studies regarding urinary incontinence have primarily focused on women after menopause. It has become clear that a lack of the sex hormone estrogen, which occurs after menopause, can lead to urinary incontinence. During the course of the menstrual cycle, women also experience fluctuations in their sex hormones, particularly estrogen. The estrogen level is highest before ovulation and decreases afterwards. The investigators aim to explore whether this drop in hormone levels could lead to more frequent urinary incontinence during this phase. In order to offer the patients optimal treatment for urinary incontinence, it is important to understand the potential causes behind it. Participants will document their menstrual cycles and episodes of urinary incontinences over three menstrual cycles using a diary, and urine tests. This research project is a pilot study and is being conducted by Swiss Paraplegic Research at the Swiss Paraplegic Centre. The investigators are recruiting 12 participants who experience incontinence at least once a month and 12 participants who experience incontinence less frequently or not at all.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •age ≥ 18 years
- •chronic neurogenic bladder dysfunction due to acquired spinal cord injury
- •regular menstrual cycle (26-30 days/cycle)
- •written consent given
- •UI group only: UI at least once per month
排除标准
- •Detrusor overactivity in storage phase above 15cmH20
- •Oligomenorrhea or amenorrhea (infrequent or absent menstrual periods)
- •Hormonal intake/contraception
- •Intake of androgens
- •Intake of drugs which interfere with female sex hormones significantly
- •Individuals who underwent sex reassignment surgery
- •Pregnant or breastfeeding women
- •Women who are trying to conceive
- •Gynaecological carcinoma
- •Endometriosis
- •Ovariectomy
- •Current pelvic floor physiotherapy
- •Reconstructive surgery of bladder
- •Local irritation of the bladder, such as bladder tumour, bladder stones, acute urinary tract infection at study start
- •Inability to follow study procedures (cognitive or language barriers)
研究组 & 干预措施
Premenopausal women with spinal cord injury and urinary incontinence
Premenopausal women with spinal cord injury without urinary incontinence
结局指标
主要结局
Incontinence event(s)
时间窗: through study completion, an average of 3 months
Daily patient-reported events of urinary incontinence
次要结局
- Ovulation(through study completion, an average of 3 months)
- Recruitment rate(at study completion, an average of 2 years)
- Positive screening rate(at study completion, an average of 2 years)
- Retention rate(at study completion, an average of 2 years)
- Assessment completion rate(at study completion, an average of 2 years)
- Type of urinary incontinence event(through study completion, an average of 3 months)
- Symptoms of urinary tract infection(through study completion, an average of 3 months)
- Retention rate(at study completion, an average of 2 years)
- Assessment completion rate(at study completion, an average of 2 years)
- Type of urinary incontinence event(through study completion, an average of 3 months)
- Ovulation(through study completion, an average of 3 months)
- Recruitment rate(at study completion, an average of 2 years)
- Positive screening rate(at study completion, an average of 2 years)
- Symptoms of urinary tract infection(through study completion, an average of 3 months)