Virtual Bladder Training for Overactive Bladder Syndrome in Women. Which Symptom Responds Better?
Primary Purpose
Overactive Bladder Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Bladder training
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder Syndrome focused on measuring Overactive Bladder Syndrome, Bladder Training
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.
Sites / Locations
- Hospital Italiano de Buenos AiresRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Frequency
Nocturia
Arm Description
Main symptom: Increased daytime urinary frequency: complaint that micturition occurs more frequently during waking hours than previously deemed normal by the woman.
Main symptom: Complaint of interruption of sleep one or more times because of the need to micturate.
Outcomes
Primary Outcome Measures
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 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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05493748
First Posted
August 5, 2022
Last Updated
August 5, 2022
Sponsor
Hospital Italiano de Buenos Aires
1. Study Identification
Unique Protocol Identification Number
NCT05493748
Brief Title
Virtual Bladder Training for Overactive Bladder Syndrome in Women. Which Symptom Responds Better?
Official Title
Virtual Bladder Training for Overactive Bladder Syndrome in Women. Which Symptom Responds Better?
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Italiano de Buenos Aires
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder Syndrome
Keywords
Overactive Bladder Syndrome, Bladder Training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Quasi-experimental, before-after trial.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
86 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Frequency
Arm Type
Other
Arm Description
Main symptom: Increased daytime urinary frequency: complaint that micturition occurs more frequently during waking hours than previously deemed normal by the woman.
Arm Title
Nocturia
Arm Type
Other
Arm Description
Main symptom: Complaint of interruption of sleep one or more times because of the need to micturate.
Intervention Type
Other
Intervention Name(s)
Bladder training
Intervention Description
Bladder training for overactive bladder syndrome.
Primary Outcome Measure Information:
Title
Change in King's Health Questionnaire (KHQ) score
Description
KHQ score: 0-100 points per domain. Higher scores mean a worse outcome.Ten points change in KHQ score, before and after bladder training.
Time Frame
Change from Baseline King's Health Questionnaire at 6 weeks
Title
Change in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) score
Description
ICIQ SF score: 0-21 points. Higher scores mean a worse outcome. Three points change in ICIQ-SF score, before and after bladder training.
Time Frame
Change from Baseline International Consultation on Incontinence Questionnaire Short Form at 6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Agustina Vendramini, Dra.
Phone
5491123950443
Email
agustina.vendramini@hiba.org.ar
Facility Information:
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agustina Vendramini
Email
agustina.vendramini@hiba.org.ar
12. IPD Sharing Statement
Learn more about this trial
Virtual Bladder Training for Overactive Bladder Syndrome in Women. Which Symptom Responds Better?
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