Synergistic Effects of Traditional Chinese Medicine Practices and Pelvic Floor Muscle Training on Postpartum Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Incontinence Episode Frequency
研究概览
简要总结
This study was conducted within a randomized controlled trial framework using a double-blind design. Participants were assigned to one of three intervention groups: the Pelvic Floor Muscle Training group (PFMT), the Pelvic Floor Muscle Training combined with the Qigong group (PFMTQG), and the Qigong Practice group (QG). Randomization was performed using a random number table. Professional trainers implemented the intervention programs. Researchers conducted a 12-week intervention study, with training sessions held thrice weekly. During the trial, participants agreed not to engage in other forms of physical exercise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 20-35 years.
- •Within 12 months postpartum.
- •Diagnosed with mild to moderate SUI.
- •Physically capable of participating in mild to moderate exercise.
- •Provided written informed consent.
排除标准
- •Severe pelvic floor dysfunction.
- •Systemic health conditions that contraindicate physical activity.
- •Pregnant at the time of recruitment or planning pregnancy during the study
- •Prior structured training in Qigong or PFMT.
- •Ongoing physiotherapy for pelvic floor health.
- •Participation in other urinary incontinence research.
- •Inability to provide informed consent due to cognitive or language barriers.
研究组 & 干预措施
Pelvic floor muscle training
干预措施: PFMT (Behavioral)
Qigong with pelvic floor muscle training
干预措施: QGPFMT (Behavioral)
Qigong
干预措施: Qigong (Behavioral)
结局指标
主要结局
Incontinence Episode Frequency
时间窗: Month 3
Incontinence Episode Frequency (IEF) will be measured using a 72-hour bladder diary maintained by participants. Participants will be provided with a structured bladder diary template, which includes columns for recording each instance of urine leakage, the associated activity (e.g., coughing, sneezing, physical exertion), and the approximate volume of leakage (if subjectively estimable). The frequency of urine leakage episodes will be calculated by averaging the total number of incidents recorded over the three days at each assessment point. The 72-hour urinary incontinence episode values will represent the total number of leakage incidents observed across the three days and will be used to evaluate changes in IEF over time.
1-hour Pad Test
时间窗: Month 3
Urine leakage will be objectively quantified using the 1-hour pad test, conducted at the same time points as the bladder diary assessments. Participants will be provided with pre-weighed absorbent pads and instructed to wear them for a continuous 1-hour period. During this time, participants will be asked to drink 500 ml of plain water over 15 minutes and perform normal activities, including simple walking for the next 30 minutes. In the last 15 minutes, participants will be instructed to perform the standard ICS provocation exercises in a private area. If a participant is found to have vaginal bleeding or excessive vaginal discharge, the test will be postponed and rescheduled for a later date. After the 1-hour period, participants will seal the pads in provided plastic bags and return them to the study site. Trained assessors will measure the weight difference between the pre- and post-use pads using a precision digital scale .
次要结局
- Pelvic Floor Muscle Assessment(Month 3)
- Incontinence Impact Questionnaire-7(Month 3)
- Urinary Distress Inventory-6(Month 3)
- Psychological Well-being Assessment(Month 3)