Mobile Application and Bladder Training

NCT05792956 | Completed

• 1 other identifier: Mu_olmezyalazi
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Overactive Bladder Syndrome

Keywords

Overactive bladder; Mobile application; Quality of life; Sexual satisfaction

Outcome Measures

Primary Outcomes (1)

• Number of Overactive Bladder have women

  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.

  6 month

Secondary Outcomes (4)

• 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

Study Arms (2)

Mobile Application group

EXPERIMENTAL

Women with OAB in this group will be informed about mobile application usage. The group using the mobile application will add the times they have consumed fluid and urine leakage to the bladder diary section of the mobile application. During the day, the application will remind participants to consume fluids and urinate. There will also be a question and answer section in the mobile application. Women will be able to direct their questions about OAB to the researcher. After the first meeting, the scales sent through the mobile application will be applied in the 3rd and 6th months.

Behavioral: Using mobile app

Control group

NO INTERVENTION

To the control group, the routine protocol in the clinic (Bladder training is given by the nurses after the women apply. They come to deliver the bladder diary given after the bladder training in the 3rd and 6th months. According to the results of the bladder diary, the nurses provide counseling for the problems detected regarding the symptoms they experience). After the first interview, they will be asked to fill in the required scales one day in the 3rd and 6th months.

Interventions

Using mobile app BEHAVIORAL

Women with OAB in this group will be informed about mobile application usage. The group using the mobile application will add the times they have consumed fluid and urine leakage to the bladder diary section of the mobile application. During the day, the application will remind participants to consume fluids and urinate. There will also be a question and answer section in the mobile application. Women will be able to direct their questions about OAB to the researcher. After the first meeting, the scales sent through the mobile application will be applied in the 3rd and 6th months.

Mobile Application group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Orgasm

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sexual Behavior; Behavior

Study Officials

• Rüveyda ölmez yalazı, PhDc

  Marmara University

  PRINCIPAL INVESTIGATOR

• Nurdan Demirci, Prof

  Marmara University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 31, 2023
• Study Start: July 1, 2023
• Primary Completion: August 30, 2024
• Study Completion: September 30, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)