Stress Urinary IncontinenceNCT05097456
Carbon Dioxide Acupulse Laser Treatment Versus Sham Treatment and Stress Urinary Incontinence Symptoms
A study testing carbon dioxide laser in people with Stress Urinary Incontinence, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The study is intended to assess the safety and efficacy of Carbon dioxide AcuPulse laser treatment in patients with stress urinary incontinence. Eligible subjects will be randomized to either receive 3 laser or 3 sham treatment sessions, 4 weeks apart and 3 follow up visits 3, 6 and 12 months following the last… Read more about this study
- Who is it for?
- Ages 30 to 70 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- carbon dioxide laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2020to 31 Dec 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 30 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Negative urine analysis.
- Normal Pap smear test from the recent 3 years.
- No previous gynecological laser treatments.
- Able and willing to comply with the treatment/follow-up schedule and requirements.
Who cannot join
- Active genital infection.
- Subject presenting abnormal Pap result from the last three years.
- Recurring urinary tract infection or recurring infection of genital herpes or candida (> 2 episodes in the recent year).
- Transvaginal mesh implant.
- Serious systemic disease or any chronic condition that could interfere with study compliance.
- Any vaginal bleeding of unknown reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Sham-controlled Clinical Trial for Evaluating the Efficacy of Fractional Carbon Dioxide Laser in the Treatment of Stress Urinary Incontinence
The study is intended to assess the safety and efficacy of Carbon dioxide AcuPulse laser treatment in patients with stress urinary incontinence. Eligible subjects will be randomized to either receive 3 laser or 3 sham treatment sessions, 4 weeks apart and 3 follow up visits 3, 6 and 12 months following the last treatment.
Read the detailed description
Following a screening visit, eligible subjects will be enrolled into the study. Subjects will be randomized into either laser treatment or sham treatment. Each subject will receive 3 treatments 4 weeks apart and 3 follow up visits, at 3, 6 and 12 months following the last treatment.
Further demographic information and patient history will be obtained from the subjects' electronic files.
- Conditions
- Stress Urinary Incontinence
- Being tested
- carbon dioxide laser, sham laser
- 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.
carbon dioxide laserDevice
carbon dioxide laser
sham laserDevice
sham laser
| Study group | Role | What they receive |
|---|---|---|
| Laser treatment | Active comparator | carbon dioxide treatment Receives: Device: carbon dioxide laser |
| Sham treatment | Sham comparator | sham treatment Receives: Device: sham laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pad weight test
Change in pad weight
Measured: From treatment up to 12 months post treatment
Secondary outcomes (4)
Cough test
Positive cough test
Measured: From treatment up to 12 months post treatment
Urinary distress index questionnaire
Change in urinary distress index questionnaire scores
Measured: From treatment up to 12 months post treatment
International consultation on incontinence questionnaire-urinary incontinence
Change in international consultation on incontinence questionnaire-urinary incontinence scores
Measured: From treatment up to 12 months post treatment
Pelvic organ prolapse/urinary incontinence sexual questionnaire
Change in pelvic organ prolapse/urinary incontinence sexual questionnaire scores
Measured: From treatment up to 12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start1 Mar 2020
- Primary completion15 Nov 2021
- Study completion31 Dec 2021
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.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ROY LAUTERBACH MD, Rambam Health Care Campus
- Investigators
- Roy Lauterbach, MD, Principal investigator, Rambam healthcare campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097456
- Sponsor's protocol ID
- 0292-20-RMB
- Status last verified
- Feb 2022
- First submitted
- 4 Oct 2021
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Sham-controlled Clinical Trial for Evaluating the Efficacy of Fractional Carbon Dioxide Laser in the Treatment of Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT05097456
- Acronym / sponsor ID
- 0292-20-RMB
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 28 Oct 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.
The study is intended to assess the safety and efficacy of Carbon dioxide AcuPulse laser treatment in patients with stress urinary incontinence. Eligible subjects will be randomized to either receive 3 laser or 3 sham treatment sessions, 4 weeks apart and 3 follow up visits 3, 6 and 12 months following the last treatment.
Detailed description
Following a screening visit, eligible subjects will be enrolled into the study. Subjects will be randomized into either laser treatment or sham treatment. Each subject will receive 3 treatments 4 weeks apart and 3 follow up visits, at 3, 6 and 12 months following the last treatment.
Further demographic information and patient history will be obtained from the subjects' electronic files.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser treatment | Active comparator | Device: carbon dioxide lasercarbon dioxide treatment |
| Sham treatment | Sham comparator | Device: sham lasersham treatment |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Negative urine analysis.
- Normal Pap smear test from the recent 3 years.
- No previous gynecological laser treatments.
- Able and willing to comply with the treatment/follow-up schedule and requirements.
Key exclusion criteria (6 listed)
- Active genital infection.
- Subject presenting abnormal Pap result from the last three years.
- Recurring urinary tract infection or recurring infection of genital herpes or candida (> 2 episodes in the recent year).
- Transvaginal mesh implant.
- Serious systemic disease or any chronic condition that could interfere with study compliance.
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 |
|---|---|---|
| carbon dioxide lasercarbon dioxide laser | Device | Laser treatment |
| sham lasersham laser | Device | Sham treatment |
Primary outcome
Pad weight test
Time frame: From treatment up to 12 months post treatment
Change in pad weight
4 secondary outcomes
Cough test
Time frame: From treatment up to 12 months post treatment
Urinary distress index questionnaire
Time frame: From treatment up to 12 months post treatment
International consultation on incontinence questionnaire-urinary incontinence
Time frame: From treatment up to 12 months post treatment
Pelvic organ prolapse/urinary incontinence sexual questionnaire
Time frame: From treatment up to 12 months post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Individual participant dataSharing planned: No
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Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
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Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
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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.
Roy Lauterbach, MD principal investigator
Rambam healthcare campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing carbon dioxide laser in people with Stress Urinary Incontinence, run by Rambam Health Care Campus at 1 site in Israel.
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 6 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: finished, as of the sponsor's last update on 7 Feb 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 Israel. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pad weight test (time frame: From treatment up to 12 months post treatment). 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 7 Feb 2022.