Overactive Bladder SyndromeNCT05493748
Virtual Bladder Training for Overactive Bladder Syndrome in Women. Which Symptom Responds Better?
A study testing Bladder training in people with Overactive Bladder Syndrome, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder Syndrome
- What is being tested?
- Bladder training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteArgentina
- Study dates
- 1 May 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women over 18 years of age
- Live in Buenos Aires City
- Overactive Bladder Syndrome
- Access to virtual appointment
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Hospital Italiano de Buenos Aires
Buenos Aires
Agustina Vendramini, agustina.vendramini@hiba.org.ar
About this study
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
- Being tested
- Bladder training
- Keywords
- Overactive Bladder Syndrome, Bladder Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder trainingOther
Bladder training for overactive bladder syndrome.
| Study group | Role | What they receive |
|---|---|---|
| Frequency | Other | Main symptom: Increased daytime urinary frequency: complaint that micturition occurs more frequently during waking hours than previously deemed normal by the woman. Receives: Other: Bladder training |
| Nocturia | Other | Main symptom: Complaint of interruption of sleep one or more times because of the need to micturate. Receives: Other: Bladder training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from Baseline International Consultation on Incontinence Questionnaire Short Form at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start1 May 2022
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Quasi-experimental, before-after trial.
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AGUSTINA VENDRAMINI, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493748
- Sponsor's protocol ID
- # 6237 PRIISA 6017
- Status last verified
- Aug 2022
- First submitted
- 5 Aug 2022
- Last updated
- 9 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Bladder Training for Overactive Bladder Syndrome in Women. Which Symptom Responds Better?
- ClinicalTrials.gov ID
- NCT05493748
- Acronym / sponsor ID
- # 6237 PRIISA 6017
- Conditions
- Overactive Bladder Syndrome
- Keywords
- Overactive Bladder Syndrome, Bladder Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Quasi-experimental, before-after trial.
| Arm | Type | Receives |
|---|---|---|
| Frequency | Other | Other: Bladder trainingMain symptom: Increased daytime urinary frequency: complaint that micturition occurs more frequently during waking hours than previously deemed normal by the woman. |
| Nocturia | Other | Other: Bladder trainingMain symptom: Complaint of interruption of sleep one or more times because of the need to micturate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- women over 18 years of age
- Live in Buenos Aires City
- Overactive Bladder Syndrome
- Access to virtual appointment
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bladder trainingBladder training for overactive bladder syndrome. | Other | Frequency, Nocturia |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bladder training in people with Overactive Bladder Syndrome, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Agustina Vendramini, Dra. (5491123950443, agustina.vendramini@hiba.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in King's Health Questionnaire (KHQ) score (time frame: Change from Baseline King's Health Questionnaire at 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.