Stress Urinary IncontinenceEFFECTNCT04705285
Erb:Yag Laser Versus Pelvic Floor Training for the Treatment of Women With Mild to Moderate Stress Urinary Incontinence
A study testing Erbium Yag Laser and Pelvic Floor Training in people with Stress Urinary Incontinence, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
This is a pilot study to assess the feasibility and safety to run a randomized controlled trial that compared the effectivity of erbium:yag vaginal laser versus pelvic floor training in women with mild to moderate stress urinary incontinence. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Erbium Yag Laser and Pelvic Floor Training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChile
- Study dates
- 15 May 2019to 15 Sep 2021
- 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
- Mild to Moderated Stress Urinary Incontinence
Who cannot join
- Mixed Urinary incontinence
- Pelvic organ prolase greater than stage 2
- Previous surgery for stress urinary incontinence and/or pelvic organ prolapse
- Severe Stress urinary incontinence
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Hospital Clinico de La Florida
Santiago
Sebastian Viguera, MD, +56993316816, sebastian.viguera@gmail.com
Victor Miranda, MD
About this study
Official title: Erbium:Yag Laser Versus Pelvic Floor Training for the Treatment of Women With Mild to Moderate Stress Urinary Incontinence: a Pilot Randomized Controlled Trial
This is a pilot study to assess the feasibility and safety to run a randomized controlled trial that compared the effectivity of erbium:yag vaginal laser versus pelvic floor training in women with mild to moderate stress urinary incontinence.
Read the detailed description
This pilot study attempts to demonstrated the feasibility and security to run a randomized controlled study that compared the effectivity of erbium:yag laser used vaginally versus pelvic floor training, coached by a physiotherapist expert in pelvic floor disorders.
Patients are going to be randomized to pelvic floor exercises (10 sessions) or erbium:yag laser (2 sessions), and assess the results at 6 and 12 moths later on.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Erbium Yag Laser, Pelvic Floor Training
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erbium Yag LaserDevice
Subjets in the laser arm will undergo 2 sessions of vaginal erbium-yag laser, separated by a month
Pelvic Floor TrainingBehavioural
Patients allocated to pelvic floor training, are goin to undergo 10 sessions of pelvic floor exercises coached by an expert physiotherapist
| Study group | Role | What they receive |
|---|---|---|
| Erbium:Yag Laser | Experimental | Patients allocated to the erbium:yag laser are going to undergo 2 sessions of vaginal laser, separated by one month each other. Receives: Device: Erbium Yag Laser |
| Pelvic floor training | Active comparator | Patients allocated to pelvic floor training, are goin to undergo 10 sessions of pelvic floor exercises coached by an expert physiotherapist. Receives: Behavioral: Pelvic Floor Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life
In order to measure quality of life, we are going to use the International Consultation on Incontinence Questionnaire Short Form (ICQI-SF), validate to spanish and in Chile. A higher score in this scale means a worse outcome for the patient.
Measured: The questionnaire will be applied at baseline, 6 month and 1 year
Secondary outcomes (1)
Pad test
A 24 h Pad test will be applied. The pad will be weighted after 24 h of use and the difference between the dry pad and the wet pad is going to be recorded. A great difference means a worse outcome for the patient.
Measured: at baseline, 6 month and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start15 May 2019
- Primary completion21 Jun 2021 (estimated)
- Study completion15 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705285
- Sponsor's protocol ID
- 11145
- Acronym
- EFFECT
- Status last verified
- Jan 2021
- First submitted
- 1 Aug 2020
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erbium:Yag Laser Versus Pelvic Floor Training for the Treatment of Women With Mild to Moderate Stress Urinary Incontinence: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04705285
- Acronym / sponsor ID
- EFFECT / 11145
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 21 Jun 2021 (estimated)
- Study completion
- 15 Sep 2021 (estimated)
- First posted
- 12 Jan 2021 (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.
This is a pilot study to assess the feasibility and safety to run a randomized controlled trial that compared the effectivity of erbium:yag vaginal laser versus pelvic floor training in women with mild to moderate stress urinary incontinence.
Detailed description
This pilot study attempts to demonstrated the feasibility and security to run a randomized controlled study that compared the effectivity of erbium:yag laser used vaginally versus pelvic floor training, coached by a physiotherapist expert in pelvic floor disorders.
Patients are going to be randomized to pelvic floor exercises (10 sessions) or erbium:yag laser (2 sessions), and assess the results at 6 and 12 moths later on.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Erbium:Yag Laser | Experimental | Device: Erbium Yag LaserPatients allocated to the erbium:yag laser are going to undergo 2 sessions of vaginal laser, separated by one month each other. |
| Pelvic floor training | Active comparator | Behavioral: Pelvic Floor TrainingPatients allocated to pelvic floor training, are goin to undergo 10 sessions of pelvic floor exercises coached by an expert physiotherapist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mild to Moderated Stress Urinary Incontinence
Key exclusion criteria (4 listed)
- Mixed Urinary incontinence
- Pelvic organ prolase greater than stage 2
- Previous surgery for stress urinary incontinence and/or pelvic organ prolapse
- Severe Stress urinary incontinence
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 |
|---|---|---|
| Erbium Yag LaserSubjets in the laser arm will undergo 2 sessions of vaginal erbium-yag laser, separated by a month | Device | Erbium:Yag Laser |
| Pelvic Floor TrainingPatients allocated to pelvic floor training, are goin to undergo 10 sessions of pelvic floor exercises coached by an expert physiotherapist | Behavioural | Pelvic floor training |
Primary outcome
Change in quality of life
Time frame: The questionnaire will be applied at baseline, 6 month and 1 year
In order to measure quality of life, we are going to use the International Consultation on Incontinence Questionnaire Short Form (ICQI-SF), validate to spanish and in Chile. A higher score in this scale means a worse outcome for the patient.
1 secondary outcome
Pad test
Time frame: at baseline, 6 month and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Individual participant dataSharing planned: No
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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 Erbium Yag Laser and Pelvic Floor Training in people with Stress Urinary Incontinence, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 1 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 12 Jan 2021. 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 Chile. 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 Victor A Miranda, MD (+56988291697, vmirandah@med.puc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life (time frame: The questionnaire will be applied at baseline, 6 month and 1 year). 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 12 Jan 2021.