Female Stress Urinary IncontinenceCO2NCT02981654
Safety and Efficacy of Carbone Dioxide (CO2) Laser System in Treatment of Female Stress Urinary Incontinence.
A study testing Alma Lasers Pixel carbon dioxide laser system in people with Female Stress Urinary Incontinence, run by Sheba Medical Center.
Trial summary
This is a prospective, open-label, multi-center, non-comparative study that will be conducted on female subjects between 30 and 75 years of age, diagnosed with stress urinary incontinence (SUI). Read more about this study
- Who is it for?
- Ages 30 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Stress Urinary Incontinence
- What is being tested?
- Alma Lasers Pixel carbon dioxide laser system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to May 2018
- 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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females between 30 and 75 years of age
- Provided written Informed Consent
- Patients with mild to moderate stress urinary incontinence (SUI) [according to the severity index developed by Sandvik]
- Patients with mixed urinary incontinence, while the predominant symptoms are stress related, may also be enrolled
- Normal Papanicolaou smear (up to 1 year prior to screening)
- Negative urine culture
- Vaginal canal, introitus and vestibule free of injuries and bleeding
- Positive urinary stress test (Urine leakage is demonstrated while the patient is examined with full bladder in lithotomy position, and asked to perform 3 strong coughs).
Who cannot join
- Positive pregnancy test
- Planned pregnancy within the next year
- Severe prolapse (POP>= grade 3)
- Use of photosensitive drugs
- Injury or/and active infection in the treatment area
- Active vaginal infection
Show all 15Show fewer
- human papillomavirus/herpes simplex virus
- Undiagnosed vaginal bleeding
- Urge or overflow incontinence
- Patients who are on antidepressants, or α-adrenergic and anticholinergic medications
- Patients with immune system diseases.
- Patients with allergic reaction to laser.
- Patient under treatment with photosensitivity side effects medication.
- Obese women (BMI >30)
- Patient unable to follow post treatment instructions.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective, Open-Label, Multi-Center, Non- Comparative Study to Assess the Safety and Efficacy of CO2 Laser System (FemiLiftTM) in the Treatment of Stress Urinary Incontinence (SUI) in Female Subjects.
This is a prospective, open-label, multi-center, non-comparative study that will be conducted on female subjects between 30 and 75 years of age, diagnosed with stress urinary incontinence (SUI).
Following the screening period, including urodynamic assessment to confirm SUI, each subject will undergo three FemiLiftTM treatment sessions, and will be followed up for a period of one year. The main efficacy endpoint in this study is defined as significant improvement (score of 6 or 7) in the urinary incontinence measured with PGI-I score at the 6 months visit. Various subjective and objective measures of incontinence severity, quality of life, sexual function and tissue effects will be performed at follow up.
Read the detailed description
Improvement in SUI symptoms as measured by the following parameters:
Objective parameters:
- Change from baseline in 3 days Urinary Diary - at 1, 2, 6 and 12 months:
- Number of incontinence episodes per day
- Number of pads used per day
- Change from baseline in 1 hour pad test 1, 2, 6 and 12 months
- Change from baseline as assessed with Vaginal Biopsy
Subjective parameters:
- Patient Global Impression of Severity (PGI-S) - 4-point Likert scale - at screening, 1, 2, 6 and 12 months
- Change from baseline in Pelvic Floor Distress Inventory Questionnaire (PFDI) - at 1, 2, 6 and 12 months
- Change from baseline in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ) - at 1, 2, 6 and 12 months
- Change from baseline in Pelvic Floor Impact Questionnaire (PFIQ) - at 1, 2, 6 and 12 months
- Conditions
- Female Stress Urinary Incontinence
- Being tested
- Alma Lasers Pixel carbon dioxide laser system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alma Lasers Pixel carbon dioxide laser systemDevice
The vaginal handpiece sheath is lubricated with baby oil. Set the initial energy level (startup set up recommendations: High mode, 40 millijoule/pixel; according to the patient reaction you can increase up to 120 max. Pulse mode or Repeat mode). The handpiece is inserted as distally as possible, with the laser energy's window oriented to the 12:00 o'clock position. There are position markings on the handpiece. Trigger a laser pulse by pressing the footswitch. Shoot the laser and rotate the probe by one hour at a time. When you reach the 12:00 o'clock position again, withdrawal the headpiece back by one centimeter and repeat the rotational treatment process.
| Study group | Role | What they receive |
|---|---|---|
| Femilift treatment | Experimental | The Alma Lasers Pixel carbon dioxide laser system delivers fractionated laser energy through a special lens that divides the energy into a 9 x 9 (81) matrix of 1 cm square area. The fractional laser rays cause thermal damage that reaches the vaginal sub - epithelium to stimulate the growth of new collagen.
Intervention: FemiLift vaginal handpiece is inserted into the vagina, to deliver CO2 laser energy. The vaginal epithelium is covered by rotation of vaginal handpiece in 360 degrees, releasing laser energy at 6-8 points, and than withdrawn 1 cm each time to perform the same process, to cover the the total vaginal length. Receives: Device: Alma Lasers Pixel carbon dioxide laser system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate - SUI Symptom Improvement
Success rate - defined as an improvement in SUI symptoms as a score or 6 or 7 measured by the Patient Global Impression of Improvement (PGI-I) - 7-point Likert scale - at the 6 months visit
Measured: 6 months
Secondary outcomes (8)
Urinary Diary
Change from baseline in 3 days Urinary Diary - at 1, 2, 6 and 12 months post first treatment:
- Number of incontinence episodes per day
Measured: 12 months
1 hour pad test
Change from baseline in 1 hour pad test at 1, 2, 6 and 12 months post first treatment
Measured: 12 months
Vaginal Biopsy
Sample will be obtained from the vaginal mucosa 2 cm inside the introitus on the lateral vaginal wall.
Measured: 12 months
PGI-S
Change from baseline in Patient Global Impression of Severity (PGI-S) over time
Measured: 12 months
PFDI
Change from baseline in Pelvic Floor Distress Inventory Questionnaire (PFDI) over time
Measured: 12 months
PISQ
Change from baseline in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ) over time
Measured: 12 months
PFIQ
Change from baseline in Pelvic Floor Impact Questionnaire (PFIQ) over time
Measured: 12 months
Safety Endpoint assessed by the rate of serious device related adverse events
The rate of serious device related adverse events reported during the study
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionMay 2017 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- The Baruch Padeh Medical Center, Poriya, Kaplan Medical Center
- Responsible party
- Sponsor
- Investigators
- Menachem Alcalay, MD, Principal investigator, Head, Urogynecology Unit, Chaim Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981654
- Sponsor's protocol ID
- 2092-15-SMC
- Acronym
- CO2
- Status last verified
- Dec 2016
- First submitted
- 30 Oct 2016
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open-Label, Multi-Center, Non- Comparative Study to Assess the Safety and Efficacy of CO2 Laser System (FemiLiftTM) in the Treatment of Stress Urinary Incontinence (SUI) in Female Subjects.
- ClinicalTrials.gov ID
- NCT02981654
- Acronym / sponsor ID
- CO2 / 2092-15-SMC
- Conditions
- Female Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- The Baruch Padeh Medical Center, Poriya, Kaplan Medical Center
- Study start
- Dec 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 5 Dec 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.
This is a prospective, open-label, multi-center, non-comparative study that will be conducted on female subjects between 30 and 75 years of age, diagnosed with stress urinary incontinence (SUI).
Following the screening period, including urodynamic assessment to confirm SUI, each subject will undergo three FemiLiftTM treatment sessions, and will be followed up for a period of one year. The main efficacy endpoint in this study is defined as significant improvement (score of 6 or 7) in the urinary incontinence measured with PGI-I score at the 6 months visit. Various subjective and objective measures of incontinence severity, quality of life, sexual function and tissue effects will be performed at follow up.
Detailed description
Improvement in SUI symptoms as measured by the following parameters:
Objective parameters:
- Change from baseline in 3 days Urinary Diary - at 1, 2, 6 and 12 months:
- Number of incontinence episodes per day
- Number of pads used per day
- Change from baseline in 1 hour pad test 1, 2, 6 and 12 months
- Change from baseline as assessed with Vaginal Biopsy
Subjective parameters:
- Patient Global Impression of Severity (PGI-S) - 4-point Likert scale - at screening, 1, 2, 6 and 12 months
- Change from baseline in Pelvic Floor Distress Inventory Questionnaire (PFDI) - at 1, 2, 6 and 12 months
- Change from baseline in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ) - at 1, 2, 6 and 12 months
- Change from baseline in Pelvic Floor Impact Questionnaire (PFIQ) - at 1, 2, 6 and 12 months
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Femilift treatment | Experimental | Device: Alma Lasers Pixel carbon dioxide laser systemThe Alma Lasers Pixel carbon dioxide laser system delivers fractionated laser energy through a special lens that divides the energy into a 9 x 9 (81) matrix of 1 cm square area. The fractional laser rays cause thermal damage that reaches the vaginal sub - epithelium to stimulate the growth of new collagen. Intervention: FemiLift vaginal handpiece is inserted into the vagina, to deliver CO2 laser energy. The vaginal epithelium is covered by rotation of vaginal handpiece in 360 degrees, releasing laser energy at 6-8 points, and than withdrawn 1 cm each time to perform the same process, to cover the the total vaginal length. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Females between 30 and 75 years of age
- Provided written Informed Consent
- Patients with mild to moderate stress urinary incontinence (SUI) [according to the severity index developed by Sandvik]
- Patients with mixed urinary incontinence, while the predominant symptoms are stress related, may also be enrolled
- Normal Papanicolaou smear (up to 1 year prior to screening)
Key exclusion criteria (15 listed)
- Positive pregnancy test
- Planned pregnancy within the next year
- Severe prolapse (POP>= grade 3)
- Use of photosensitive drugs
- Injury or/and active infection in the treatment area
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 |
|---|---|---|
| Alma Lasers Pixel carbon dioxide laser systemThe vaginal handpiece sheath is lubricated with baby oil. Set the initial energy level (startup set up recommendations: High mode, 40 millijoule/pixel; according to the patient reaction you can increase up to 120 max. Pulse mode or Repeat mode). The handpiece is inserted as distally as possible, with the laser energy's window oriented to the 12:00 o'clock position. There are position markings on the handpiece. Trigger a laser pulse by pressing the footswitch. Shoot the laser and rotate the probe by one hour at a time. When you reach the 12:00 o'clock position again, withdrawal the headpiece back by one centimeter and repeat the rotational treatment process. | Device | Femilift treatment |
Primary outcome
Success Rate - SUI Symptom Improvement
Time frame: 6 months
Success rate - defined as an improvement in SUI symptoms as a score or 6 or 7 measured by the Patient Global Impression of Improvement (PGI-I) - 7-point Likert scale - at the 6 months visit
8 secondary outcomes
Urinary Diary
Time frame: 12 months
1 hour pad test
Time frame: 12 months
Vaginal Biopsy
Time frame: 12 months
PGI-S
Time frame: 12 months
PFDI
Time frame: 12 months
PISQ
Time frame: 12 months
PFIQ
Time frame: 12 months
Safety Endpoint assessed by the rate of serious device related adverse events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
- 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.
Menachem Alcalay, MD principal investigator
Head, Urogynecology Unit, Chaim Sheba Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Alma Lasers Pixel carbon dioxide laser system in people with Female Stress Urinary Incontinence, run by Sheba Medical Center.
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 8 inclusion and 15 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 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Yair Leopld (972-54-4847271, Yair.Leopold@almasurgical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success Rate - SUI Symptom Improvement (time frame: 6 months). 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 6 Dec 2016.