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

NCT ID: NCT05493748

Last Updated: 2022-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Overactive Bladder Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Quasi-experimental, before-after trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Frequency

Main symptom: Increased daytime urinary frequency: complaint that micturition occurs more frequently during waking hours than previously deemed normal by the woman.

Group Type OTHER

Bladder training

Intervention Type OTHER

Bladder training for overactive bladder syndrome.

Nocturia

Main symptom: Complaint of interruption of sleep one or more times because of the need to micturate.

Group Type OTHER

Bladder training

Intervention Type OTHER

Bladder training for overactive bladder syndrome.

Interventions

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Bladder training

Bladder training for overactive bladder syndrome.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital Italiano de Buenos Aires

OTHER

Sponsor Role lead

Responsible Party

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AGUSTINA VENDRAMINI

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Italiano de Buenos Aires

Buenos Aires, , Argentina

Site Status RECRUITING

Countries

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Argentina

Central Contacts

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Agustina Vendramini, Dra.

Role: CONTACT

5491123950443

Facility Contacts

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Agustina Vendramini

Role: primary

Other Identifiers

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# 6237 PRIISA 6017

Identifier Type: -

Identifier Source: org_study_id

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