Exposure LaserNCT02861391
Evaluation of the Safety and Efficacy of Carbon Dioxide (CO2) Acupulse Laser Treatment on Urinary Stress Incontinence.
A study testing CO2 AcuPulse Laser in people with Exposure Laser, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The study is intended to assess the safety and efficacy of CO2 AcuPulse laser treatment in patients with stress urinary incontinence (SUI). Eligible subjects will either receive 3 laser or sham treatment sessions, 4 weeks apart and 4 Follow Up visits, at 1, 3, 6, and 12 months following the last treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Exposure Laser
- What is being tested?
- CO2 AcuPulse 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
- 4 Oct 2019to 30 Jan 2022
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Negative urine culture.
- Positive cough test.
- Normal Papanicolaou (PAP) test from the past 3 years.
Who cannot join
- signs, symptoms or validated test results indicating possible urgency urinary incontinence or mixed urinary incontinence.
- Overactive bladder.
- Previous bulking injections.
- Previous transvaginal mesh implant.
- Previous surgery for stress urinary incontinence.
- Presence of pelvic organ prolapse.
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- Presence of an active or recurring genital infection or urinary tract infection.
- Previous laser-based or other energy-based treatments for gynecological indications.
- Vaginal bleeding of unknown reason.
- Pregnancy.
- Current pelvic floor physiotherapy.
- Current treatment with local or systemic hormone replacement therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Safety and Efficacy of CO2 Acupulse Laser Treatment on Women With Urinary Stress Incontinence.
The study is intended to assess the safety and efficacy of CO2 AcuPulse laser treatment in patients with stress urinary incontinence (SUI). Eligible subjects will either receive 3 laser or sham treatment sessions, 4 weeks apart and 4 Follow Up visits, at 1, 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. Eligibility will be decided depending on the level of SUI the patient has. Each subject will receive either 3 laser or sham treatments 4 weeks apart and 4 Follow Up visits, at 1, 3, 6, and 12 months following the last treatment.
Further demographic information and patient history will be obtained from the subjects' electronical files.
- Conditions
- Exposure Laser
- Being tested
- CO2 AcuPulse Laser, Sham Laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 AcuPulse LaserDevice
Each subject will receive 3 laser treatments 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment.
Sham LaserDevice
Each subject will receive 3 sham treatments 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment.
| Study group | Role | What they receive |
|---|---|---|
| CO2 AcuPulse Laser treatment | Experimental | Subjects with USI as diagnosed by cough test intended to receive 3 laser treatments 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment. Receives: Device: CO2 AcuPulse Laser |
| Sham laser treatment | Sham comparator | Subjects with USI as diagnosed by cough test intended to receive 3 sham treatments 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last 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.
Pad weight results in grams.
Measured: 15 months from recruitment.
Secondary outcomes (5)
Urinary distress index 6 questionnaire.
Total questionnaire score.
Measured: 15 months from recruitment.
Pelvic Organ Prolapse/Urinary Incontinence Sexual questionnaire.
Total questionnaire score.
Measured: 15 months from recruitment.
International Consultation of Incontinence questionnaire.
Total questionnaire score.
Measured: 15 months from recruitment.
Cough test
cough test results.
Measured: 15 months from recruitment.
Visual analogue scale.
Pain rated with the visual analogue score.
Measured: 15 months from recruitment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study start4 Oct 2019
- Primary completion1 Nov 2021
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exposure LaserStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- 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
- Lior Lowenstein, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861391
- Sponsor's protocol ID
- 0205-16-RMB
- Status last verified
- Jan 2023
- First submitted
- 25 Jul 2016
- Last updated
- 17 Jan 2023
- 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 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of CO2 Acupulse Laser Treatment on Women With Urinary Stress Incontinence.
- ClinicalTrials.gov ID
- NCT02861391
- Acronym / sponsor ID
- 0205-16-RMB
- Conditions
- Exposure Laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 4 Oct 2019 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 10 Aug 2016 (estimated)
- 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 CO2 AcuPulse laser treatment in patients with stress urinary incontinence (SUI). Eligible subjects will either receive 3 laser or sham treatment sessions, 4 weeks apart and 4 Follow Up visits, at 1, 3, 6, and 12 months following the last treatment.
Detailed description
Following a screening visit, eligible subjects will be enrolled into the study. Eligibility will be decided depending on the level of SUI the patient has. Each subject will receive either 3 laser or sham treatments 4 weeks apart and 4 Follow Up visits, at 1, 3, 6, and 12 months following the last treatment.
Further demographic information and patient history will be obtained from the subjects' electronical files.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CO2 AcuPulse Laser treatment | Experimental | Device: CO2 AcuPulse LaserSubjects with USI as diagnosed by cough test intended to receive 3 laser treatments 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment. |
| Sham laser treatment | Sham comparator | Device: Sham LaserSubjects with USI as diagnosed by cough test intended to receive 3 sham treatments 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Negative urine culture.
- Positive cough test.
- Normal Papanicolaou (PAP) test from the past 3 years.
Key exclusion criteria (12 listed)
- signs, symptoms or validated test results indicating possible urgency urinary incontinence or mixed urinary incontinence.
- Overactive bladder.
- Previous bulking injections.
- Previous transvaginal mesh implant.
- Previous surgery for 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 |
|---|---|---|
| CO2 AcuPulse LaserEach subject will receive 3 laser treatments 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment. | Device | CO2 AcuPulse Laser treatment |
| Sham LaserEach subject will receive 3 sham treatments 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment. | Device | Sham laser treatment |
Primary outcome
Pad weight test.
Time frame: 15 months from recruitment.
Pad weight results in grams.
5 secondary outcomes
Urinary distress index 6 questionnaire.
Time frame: 15 months from recruitment.
Pelvic Organ Prolapse/Urinary Incontinence Sexual questionnaire.
Time frame: 15 months from recruitment.
International Consultation of Incontinence questionnaire.
Time frame: 15 months from recruitment.
Cough test
Time frame: 15 months from recruitment.
Visual analogue scale.
Time frame: 15 months from recruitment.
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 17 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Exposure Laser
Active, not recruiting
Laser Assisted Pulpotomy Versus MTA Pulpotomy in Permanent Teeth With Irreversible Pulpitis
Irreversible Pulpitis (Toothache)
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.
Lior Lowenstein, MD principal investigator
Rambam Health Care 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 CO2 AcuPulse Laser in people with Exposure Laser, 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 3 inclusion and 12 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 17 Jan 2023. 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: 15 months from recruitment.). 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 17 Jan 2023.