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临床试验/NCT05304312
NCT05304312Unknown不适用

The Role of Kegel Exercises Book to Improve Treatment in Stress Urinary Incontinence Women by Increasing the Adherence

Indonesia University2 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2020年9月21日最近更新:
适应症

试验速览

阶段
不适用
入组人数
170
试验地点
2
主要终点
Treatment Success

研究概览

简要总结

This research aims to evaluate a Kegel Exercises guidebook to treat stress urinary incontinence (SUI) in female patients. The Kegel Exercises guidebook had been made and evaluated before, this was a clinical trial to test out the book in clinical settings. In measuring the effectiveness of the book, the investigators used some examinations and questionnaires such as UDI-6, IIQ-7, perineometer, and 1-hour pad test improvement. Investigators followed up the patient's symptoms subjectively with UDI-6 and IIQ-7 and objectively with a perineometer and 1-hour pad test every four weeks.

详细描述

This research aims to evaluate the Kegel Exercises guidebook in treating stress urinary incontinence in female patients. The guidebook had been produced through rigorous previous research with many evaluations from many clinicians, urogynecologists, and patients. The editing and evaluation process took some time and before long the guidebook was ready to be tested in the clinical setting.

The Investigators enrolled 85 patients in the intervention group and 85 patients in the control group after population sampling calculation. The patients in the intervention group were supervised by the Kegel guidebook however, the patients in the control group were supervised without the Kegel guidebook. The patients in the intervention group were enrolled from Cipto Mangunkusumo Hospital and YPK Mandiri Hospital. For the control group, the investigators enrolled the patients from Buah Hati Hospital and Fatmawati Hospital. Investigators enrolled the patients from different hospitals to mask the book as the intervention to the patients.

The Kegel regiment the Investigators taught were the same. The exercises consisted of two types of movements that contracted the fast-twitch muscle and the slow-twitch muscle. The Investigators recommended doing the fast repetitions ten times a session and the slow repetitions ten times a session. The patients needed to do three sessions for a day, and every day for a week.

To examine the improvement of the symptoms, the investigators used many parameters such as UDI-6 and IIQ-7 questionnaire, a perineometer, and a 1-hour pad test. The investigators evaluate the parameters before the therapy and followed them every four weeks up until 12 weeks of follow-up. The investigators also count how many kegel exercises they did in four weeks, by checking on their Kegel exercises book or by recalling method in control group

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Participants that received the book (intervention) is followed up with different days and different hospitals with patients that were not receiving any book (control)

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with Stress Urinary Incontinence
  • Good cognitive function (based on Moca-Ina questionnaire > 26)
  • Able to do Kegel Exercises without restrictions
  • Signed the informed consent form

排除标准

  • Patient that had incontinence surgery before or other incontinence therapy other than Kegel exercises
  • Mix urinary incontinence
  • abnormal uterine bleeding
  • Pelvic organ prolapse >2 stage
  • a severe neurological disorder
  • active urinary tract infections
  • malignancy on pelvic
  • Trauma or radiation therapy on pelvic
  • Had other risk factors that may influence persistent high abdominal pressure

结局指标

主要结局

Treatment Success

时间窗: up to 12 weeks

Decrease of symptoms based on UDI-6

Compliance

时间窗: up to 12 weeks

We expect that the patients did a total of 1000 contractions slow and fast twitch muscle. Patients that did less than 1000 contractions a month are classified as non-comply. On the other hand patients who had done 1000 or more contractions were classified as comply

次要结局

  • Improvement of Pelvic floor muscle strength(up to 12 weeks)

研究者

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

Surahman Hakim

Head of Urogynecology Department

Indonesia University

研究点 (2)

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