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

Overactive Bladder Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05493748
• Other study ID #: # 6237 PRIISA 6017
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2022
• Source: Hospital Italiano de Buenos Aires
• Contact: Agustina Vendramini, Dra.
• Phone: 5491123950443
• Email: agustina.vendramini[@]hiba.org.ar
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: December 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Overactive Bladder Syndrome
• Syndrome
• Urinary Bladder, Overactive

Intervention

Other:
• Bladder training
Bladder training for overactive bladder syndrome.

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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