Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05792956
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-03
First Post:
2023-03-13
Brief Title:
Mobile Application and Bladder Training
Sponsor:
Marmara University
Organization:
Marmara University
Study Overview
Official Title:
The Effect of Mobile Application and Bladder Training on Quality of Life and Sexual Satisfaction in Women With Overactive Bladder
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 womens sexual pleasure and quality of life declined as urinary symptom intensity increased It is believed that womens 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 Istanbuls 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
Between February 2023 and June 2024 this randomized controlled experimental design study will be conducted in the urogynecology clinic of a university hospital on Istanbuls 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
Detailed Description:
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 293 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 individuals 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 womens 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None