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

NCT05493748 | Unknown

• 1 other identifier: # 6237 PRIISA 6017
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder Syndrome

Keywords

Overactive Bladder Syndrome; Bladder Training

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Frequency

OTHER

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

Other: Bladder training

Nocturia

OTHER

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

Other: Bladder training

Interventions

Bladder training OTHER

Bladder training for overactive bladder syndrome.

Frequency; Nocturia

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women over 18 years of age
• Live in Buenos Aires City
• Overactive Bladder Syndrome
• Access to virtual appointment

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

RECRUITING

Central Study Contacts

Agustina Vendramini, Dra.

CONTACT

5491123950443; agustina.vendramini@hiba.org.ar

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Quasi-experimental, before-after trial.

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 9, 2022
• Study Start: May 1, 2022
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 9, 2022

Record last verified: 2022-08

Locations

AR (1)