Effects of Pelvic Floor Muscle Training Combined With Bladder Training on Urinary Frequency, Pelvic Floor Function, and Post-Void Residual Volume in Men With Urinary Frequency: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Pelvic floor muscle strength as assessed by ultrasound
研究概览
简要总结
This prospective, single-center, parallel-group, assessor-blinded randomized controlled trial will include 120 voluntary male participants who have had complaints of urinary frequency for at least 3 months and meet the inclusion criteria. Participants will be randomly allocated into two groups (Group 1: Bladder Training + Pelvic Floor Muscle Training; Group 2: Bladder Training Alone). Assessments will be repeated at baseline, at week 4, and at week 8. The primary outcome measure will be 3-day bladder diary data (24-hour voiding frequency); secondary outcomes will include the OAB-V8, ICIQ-OAB, and PGI-I scales, as well as transabdominal ultrasonographic measurements of bladder neck elevation (strength and endurance) and PVR.
详细描述
Study Design:
Prospective Single-center Parallel-group 1:1 randomized Assessor-blinded RCT CONSORT-compliant
Inclusion Criteria:
Male Age 18-65 years Complaint of urinary frequency persisting for at least 3 months
On a 3-day bladder diary:
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 (Outcomes Assessor)
盲法说明
Outcome assessors will be blinded to group allocation
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 18-65 years
- •Complaint of urinary frequency persisting for at least 3 months
- •On a 3-day bladder diary: ≥8 voids per 24 hours
- •Provision of written informed consent Sufficient cognitive capacity to learn pelvic floor muscle contraction (assessed by clinical judgment)
排除标准
- •Active urinary tract infection
- •Prostate cancer
- •Prostate surgery within the last 12 months
- •Parkinson's disease, Multiple sclerosis (MS), Stroke, Spinal cord injury
- •Neurogenic bladder due to diabetes mellitus
- •Bladder stones, Bladder tumor, Urethral stricture
结局指标
主要结局
Pelvic floor muscle strength as assessed by ultrasound
时间窗: From enrollment to the end of treatment at 12 weeks
次要结局
未报告次要终点
研究者
Hasan Bingöl
Assoc. Prof.
Bingol University
