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

Sponsor
Hospital Italiano de Buenos Aires (Other)
Overall Status
Recruiting
CT.gov ID
NCT05493748
Collaborator
(none)
86
Enrollment
1
Location
2
Arms
20
Anticipated Duration (Months)
4.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Bladder training
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
86 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Quasi-experimental, before-after trial.Quasi-experimental, before-after trial.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Virtual Bladder Training for Overactive Bladder Syndrome in Women. Which Symptom Responds Better?
Actual Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Frequency

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
Bladder training for overactive bladder syndrome.
Other: Nocturia

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

Other: Bladder training
Bladder training for overactive bladder syndrome.

Outcome Measures

Primary Outcome Measures

  1. Change in King's Health Questionnaire (KHQ) score [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.

  2. Change in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) score [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Italiano de Buenos Aires Buenos Aires Argentina

Sponsors and Collaborators

  • Hospital Italiano de Buenos Aires

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AGUSTINA VENDRAMINI, Principal Investigator, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier:
NCT05493748
Other Study ID Numbers:
  • # 6237 PRIISA 6017
First Posted:
Aug 9, 2022
Last Update Posted:
Aug 9, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by AGUSTINA VENDRAMINI, Principal Investigator, Hospital Italiano de Buenos Aires
Overactive Bladder Syndrome
Bladder Training
Additional relevant MeSH terms:
Urinary Bladder, Overactive
Syndrome

Study Results

No Results Posted as of Aug 9, 2022