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临床试验/NCT05792956
NCT05792956已完成不适用

The Effect of Mobile Application and Bladder Training on Quality of Life and Sexual Satisfaction in Women With Overactive Bladder

Marmara University2 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Number of Overactive Bladder have women

研究概览

简要总结

The International Continence Society described overactive bladder as urine urgency, frequently accompanied by frequency and nocturia, with or without urgency incontinence, when there is no evident pathology, such as a urinary tract infection. According to studies in the literature, women who have overactive bladders experience negative effects on their sexual satisfaction and quality of life. According to a study by Juliato et al. (2017), women with more severe urinary symptoms experienced higher degrees of arousal, lubrication, orgasm, and discomfort. According to Chuang et al. (2017) study, women's sexual pleasure and quality of life declined as urinary symptom intensity increased. It is believed that women's quality of life and levels of sexual satisfaction may be positively impacted by the training provided to lessen their symptoms, their follow-up, and their continuity. Additionally, it is anticipated that by encouraging better treatment compliance among women with OAB, hospital expenses will drop, which will benefit the national economy. In order to ascertain the impact of bladder training delivered via mobile application on quality of life and levels of sexual satisfaction in women with overactive bladder, this study was designed.

Between February 2023 and June 2024, this randomized controlled experimental design study will be conducted in the urogynecology clinic of a university hospital on Istanbul's Anatolian side. The sample size was determined via G-Power power analysis, and the groups were chosen using basic randomization. There will be 100 women studied, 50 in the study group (WG) and 50 in the control group (KG), all of whom have been diagnosed with overactive bladder. Through the smartphone application, WG women will receive bladder training, as well as follow-up care. Data will be gathered using the Quality of Life Scale, Sexual Satisfaction Scale, Mobile Application Usage Scales (only mobile application group), and Collection Form, Follow-Up Form. In the third and sixth months, new data will be collected on the Quality of Life Scale, Sexual Satisfaction Scale, and Mobile Application Usage Scales (just for the Mobile Application Group). There will be a data analysis.

详细描述

According to the International Continence Society (ICS), overactive bladder (OAB), usually accompanied by increased urination during the day or nocturia, is defined as a serious symptom of urinary incontinence that occurs without urinary tract infection or other diagnosable disease. The prevalence of OAB ranges from 12-22% in Europe and 16-17% in the USA. According to a comprehensive study conducted in Turkey in 2014, the prevalence of urgent urinary incontinence, which is mostly seen in individuals diagnosed with OAB, was reported as 29.3%. Although the prevalence of OAB is similar in men and women, various symptoms of OAB can be seen more in women due to anatomical and physiological differences in the lower urinary tract. OAB affects an individual's daily life, including work, social interactions, sleep patterns, and sexual functions. In studies, it has been reported that women diagnosed with OAB tend to increase in sleep disorders, affect normal social activities, decrease sexuality and quality of life, and impair self-esteem. In a study by Juliato et al. (2017), it was reported that arousal, lubrication, orgasm and pain levels increased in women with high urinary symptom severity (according to the ICIQ-OAB score). In the study of Chuang et al. (2019), it was determined that increased urinary symptom severity in women decreased sexual satisfaction and quality of life levels. It is of great importance to choose an effective and treatment method for women diagnosed with OAB. There are 3 types of treatment methods to alleviate OAB symptoms: Pharmacological (second-line treatment), non-pharmacological (first and third-line treatments), and surgical intervention. The American Urological Association (AUA) and Urogynecology Society, Female Pelvic Medicine and Pelvic Reconstruction (SUFU) guidelines recommend that OAB be treated step by step, starting with the least invasive treatment. Due to the concern about the side effects of the given drug and the complications of invasive procedures, non-pharmacological interventions are an important part of the treatment of OAB. Antimuscarinics such as solifenacin are used after unsuccessful conservative and behavioral treatments. However, due to the high cost and the presence of side effects (such as dry mouth, headache, constipation and visual irregularity), women's compliance with these drugs decreases and consequently limits their use. However, minimally invasive procedures have risks and complications. In addition, the healing process is supported by non-pharmacological methods after minimally invasive treatment. According to the results of the studies, it was reported that 31-40% of women were supported by non-pharmacological treatment method after minimally invasive intervention. Among the non-pharmacological treatment methods for OAB, bladder training is thought to be the most effective. It has been reported that the training, follow-up and continuity of women to reduce their symptoms can increase their quality of life and sexual satisfaction levels. It is thought that due to the cost of the treatments, the problems of compliance with the treatment process, the decrease in sustainability and the limited accessibility of healthcare professionals, bladder training can be used to increase the compliance and sustainability of women to the treatment process by using different methods. It is thought that it can be used to follow and maintain the training given with the user interface with mobile applications. Therefore, it is important in terms of patient satisfaction and sustainability as well as reducing the cost of treatment. The mobile application the investigators will develop will be an educational tool in the digital environment that allows nurses to communicate with patients, follow the treatment process and enable women to be active in process management. It is aimed to ensure continuity by optimizing the individualized care and well-being of women in line with the results, and accordingly, to minimize the complications that may occur as a result of other treatment methods. Therefore, the effect of the mobile application-based training and notifications the investigators will develop on the quality of life and sexual satisfaction levels in women will be evaluated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Volunteers aged 18 and over,
  • Diagnosed with OAB,
  • Being literate and having no communication problems,
  • Does not have a mental problem that requires treatment,
  • Not mentally handicapped, hearing impaired, visually impaired, language and speech impaired,
  • Not diagnosed with a psychiatric disorder,
  • Able to use a smart phone,
  • Women who can speak Turkish will be included in the study.

排除标准

  • Emergency operation during the research,
  • Not filling in the forms submitted to evaluate the symptoms,
  • Being in the mobile application group and not using the application,
  • Those who do not agree to participate in the research, Women who became pregnant during the study will not be included.

结局指标

主要结局

Number of Overactive Bladder have women

时间窗: 6 month

In the study, R v3.6.1 program was used for Power analysis, alpha error was 5%, beta error was 20%, it was predicted that there would be a difference between the variables as a result of the study process, and a minimum of 100 (50 mobile application groups, 50 control groups) samples would be sufficient.

次要结局

  • Evaluation of symptoms(First, 3rd and 6th months)
  • Mobile application scales evaluation(3rd and 6th months)
  • Evaluation of quality of life(First, 3rd and 6th months)
  • • New Sexual Satisfaction Scale(First, 3rd and 6th months)

研究者

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

Nurdan Demirci

Prof

Marmara University

研究点 (2)

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