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临床试验/NCT03301142
NCT03301142Unknown不适用

Randomized Trial Comparing the Use of Laser and of Kinesiotherapy for the Treatment of Female Stress Urinary Incontinence - a Pilot Study

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
Improvement of urinary loss

研究概览

简要总结

The purpose of this study is compare the effect of laser and of kinesiotherapy in the treatment of women with stress urinary incontinence

详细描述

the objective of this project is to compare the effect of laser and of kinesiotherapy in the treatment of women with stress urinary incontinence. A randomized controlled clinical trial is proposed involving 40 women diagnosed with stress urinary incontinence randomized into two groups: 1) treatment with application of Erbium Laser: YAG 2940nm, SMOOTH mode, one session per month for three months (n=20); 2) treatment with kinesiotherapy for three months with supervision twice a week (n=20). At baseline assessment, patients shall undergo anamnesis, general physical and gynecological exam, assessments of the pelvic floor based on the modified Oxford scale and of the presence of prolapse using the Pelvic Organ Prolapse Quantification (POP-Q) system. The following exams shall also be performed: Type 1 urine, urine culture, urodynamic study and 1-hour Pad test. Participants shall complete both the King's Health Questionnaire and Incontinence Quality of Life Questionnaire (IQOL). Post-treatment, patients will be assessed during follow-up visits at 1, 3, 6 and 12 months by physical exam and application of the questionnaires. The Pad test will be re-administered at 6 and 12 months. Data will be grouped and statistically assessed.

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)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Post-menopausal women with stress urinary incontinence will be recruited for this study.

排除标准

  • Patients presenting detrusor hyperactivity,stress urinary incontinence with sphincter deficiency genital prolapse, stages 3 and 4 on the POP-Q system, genital cancer, history of painful bladder syndrome, previous history of radiotherapy, keloid, use of photosensitive drugs, uncontrolled diabetes mellitus, active vaginal infection (bacterial vaginosis and candidiasis), abnormal genital bleeding or vaginal stenosis shall be excluded.

研究组 & 干预措施

Device laser

Experimental

treatment with application of Erbium Laser: YAG 2940nm, SMOOTH mode, one session per month for three months (n=20

干预措施: Laser (Procedure)

kinesiotherapy

Active Comparator

with supervision twice a week for three months (n=20)

干预措施: kinesiotherapy (Procedure)

结局指标

主要结局

Improvement of urinary loss

时间窗: twelve months

the urinary loss will be evaluated with the pad test

次要结局

  • improvement of pelvic floor strength(twelve months)

研究者

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

Lucilia Carvalho da Fonseca

Principal investigator

University of Sao Paulo General Hospital

研究点 (2)

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