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临床试验/NCT07719400
NCT07719400尚未招募不适用

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

Bingol University0 个研究点目标入组 120 人开始时间: 2026年9月1日最近更新:
适应症

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

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

发起方
Bingol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hasan Bingöl

Assoc. Prof.

Bingol University

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