跳至主要内容
临床试验/NCT06740071
NCT06740071招募中不适用

The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy

The University of Hong Kong2 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2023年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)

研究概览

简要总结

The study aims to compare the efficacy of different pelvic floor muscle training (PFMT) modes on improving urinary incontinence (UI) recovery in prostate cancer (PCa) patients after radical prostatectomy (RP). The methods being compared include standard PFMT (S-PFMT) , a somatosensory interactive PFMT (SI-PFMT, an enhanced PFMT) , and a standard PFMT combined with pelvic floor muscle magnetic stimulation (S-PFMT+MS). Eligible participants are randomized into either of the groups to receive different modalities of post-operative PFMT.

Subjects in the S-PFMT group received traditional verbal instructions and paper-based educational materials. For the SI-PFMT group, an interactive experiential education model was adopted. First, an educational video introduced the importance and basic information of postoperative PFMT. Then, synchronized PFMT guidance through a combination of audio and video would be used. Subjects assigned to the S-PFMT+MS group, on the basis of traditional verbal and paper-based education, pelvic floor magnetic stimulation therapy was applied using a pelvic floor magnetic stimulator, operated by the same experienced rehabilitation physician.

Self administered questionnaires and 1-hour pad test would be used to assess the treatment outcomes at 1, 3, and 6 months postoperatively.

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
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •PCa patients aged 18 to 85 years who had undergone laparoscopic radical prostatectomy (RP)

排除标准

  • •patients currently participating in other clinical trials and those unable to cooperate with study interventions and follow-up procedures due to specific factors

研究组 & 干预措施

somatosensory interactive pelvic floor muscle training group

Active Comparator

干预措施: somatosensory interactive pelvic floor muscle training (Behavioral)

standard pelvic floor muscle training combined with pelvic floor magnetic stimulation therapy group

Experimental

干预措施: somatosensory interactive pelvic floor muscle training (Behavioral)

standard pelvic floor muscle training combined with pelvic floor magnetic stimulation therapy group

Experimental

干预措施: pelvic floor magnetic stimulation therapy (Procedure)

standard pelvic floor muscle training group

Active Comparator

干预措施: standard pelvic floor muscle training (Behavioral)

结局指标

主要结局

International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)

时间窗: 1, 3, and 6 months postoperatively.

A higher score indicates a more severe urinary incontinence and thus a worse outcome. Reduction in score is expected for subjects with clinical improvement. Range of score: 0 - 21 Severity of urinary incontinence: slight (1-5), moderate (6-12), severe (13-18) and very severe (19-21)

次要结局

  • urine leakage volume from the 1-hour pad test(1, 3, and 6 months postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yung NA

Clinical Assistant Professor

The University of Hong Kong

研究点 (2)

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