Randomized Trial Comparing the Use of Laser and of Kinesiotherapy for the Treatment of Female Stress Urinary Incontinence - a Pilot Study
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
- 否
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
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
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
Lucilia Carvalho da Fonseca
Principal investigator
University of Sao Paulo General Hospital
