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

Not Applicable

• Conditions: Overactive Bladder Syndrome
• Interventions: Other: Bladder training

• Registration Number: NCT05493748
• Lead Sponsor: Hospital Italiano de Buenos Aires

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-01
• Status Verified: 2022-08
• Study First Submitted: 2022-08-05
• Study First Submitted QC: 2022-08-05
• Last Update Submitted: 2022-08-05
• Study First Posted: 2022-08-09
• Last Update Posted: 2022-08-09
• Primary Completion: 2023-10-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 86

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nocturia	Bladder training	Main symptom: Complaint of interruption of sleep one or more times because of the need to micturate.
Frequency	Bladder training	Main symptom: Increased daytime urinary frequency: complaint that micturition occurs more frequently during waking hours than previously deemed normal by the woman.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Italiano de Buenos Aires; 🇦🇷 Buenos Aires, Argentina