Virtual Bladder Training for Overactive Bladder Syndrome in Women. Which Symptom Responds Better?

Study Overview
=================
Brief Summary
-----------------
According to International Urogynecological Association and International Continence Society joint report on the terminology for female pelvic floor dysfunction, overactive bladder syndrome (OAB) is defined as urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection or other obvious pathology. Bladder training lasting for a minimum of 4 to 6 weeks is indicated as a first-line treatment. The investigators' goal is to compare changes in satisfaction, measured in terms of quality of life, in 2 groups of women with different main accompanying symptoms in OAB (frequency vs. nocturia), before and after bladder training utilizing telemedicine (virtual bladder training), for 4 to 6 weeks.

Official Title
-----------------
Virtual Bladder Training for Overactive Bladder Syndrome in Women. Which Symptom Responds Better?

Conditions
-----------------
Overactive Bladder Syndrome

Intervention / Treatment
-----------------
* Other: Bladder training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women over 18 years of age Live in Buenos Aires City Overactive Bladder Syndrome Access to virtual appointment Exclusion Criteria: Previous overactive bladder syndrome treatment. Prior stress urinary incontinence or pelvic organ prolapse surgery. History of Neurogenic Bladder, pelvic organs prolapse or pelvic radiation. Pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Quasi-experimental, before-after trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Frequency<br>Main symptom: Increased daytime urinary frequency: complaint that micturition occurs more frequently during waking hours than previously deemed normal by the woman. | Other: Bladder training<br>* Bladder training for overactive bladder syndrome.<br>|
| Other: Nocturia<br>Main symptom: Complaint of interruption of sleep one or more times because of the need to micturate. | Other: Bladder training<br>* Bladder training for overactive bladder syndrome.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in King's Health Questionnaire (KHQ) score | KHQ score: 0-100 points per domain. Higher scores mean a worse outcome.Ten points change in KHQ score, before and after bladder training. | Change from Baseline King's Health Questionnaire at 6 weeks | 
| Change in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) score | ICIQ SF score: 0-21 points. Higher scores mean a worse outcome. Three points change in ICIQ-SF score, before and after bladder training. | Change from Baseline International Consultation on Incontinence Questionnaire Short Form at 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Overactive Bladder Syndrome, Bladder Training