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Clinical Trials/NCT05493748
NCT05493748
Unknown
Not Applicable

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

Hospital Italiano de Buenos Aires1 site in 1 country86 target enrollmentMay 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Overactive Bladder Syndrome
Sponsor
Hospital Italiano de Buenos Aires
Enrollment
86
Locations
1
Primary Endpoint
Change in King's Health Questionnaire (KHQ) score
Last Updated
3 years ago

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2022
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

AGUSTINA VENDRAMINI

Principal Investigator

Hospital Italiano de Buenos Aires

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.

Outcomes

Primary Outcomes

Change in King's Health Questionnaire (KHQ) score

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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