Urinary IncontinenceNCT03180372
Hybrid Fractional Laser Treatment for Symptoms of Urinary Incontinence
A study testing Hybrid Fractional Laser in people with Urinary Incontinence and Stress Urinary Incontinence, run by Sciton at 5 sites in United States.
Trial summary
This multi-center clinical trial will evaluate the safety and long-term efficacy of hybrid fractional 2940 nm and 1470 lasers for improvement of symptoms of urinary incontinence. 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
- Urinary Incontinence, Stress Urinary Incontinence, Urge Incontinence
- What is being tested?
- Hybrid Fractional Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 5 sitesUnited States
- Study dates
- 19 May 2017to 30 Nov 2019
- 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
- Healthy biological female aged between 30 to 75 years
- Is experiencing at least one or a combination of the following symptoms of urinary incontinence (UI)
- involuntary urine leakage on effort, exertion, sneezing, coughing
- sudden intense urge to urinate followed by involuntary loss of urine
- Has been experiencing symptoms of UI for greater than 3 months
- Normal urinalysis
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- Has indicated willingness to participate in the study by signing an informed consent form
- Can read, understand and sign informed consent form
- Agree to adhere to the treatment and follow-up schedule and post treatment care instructions
Who cannot join
- Undiagnosed abnormal genital bleeding
- Has history of pelvic surgery or other energy-based vaginal therapy within 6 months prior to enrollment
- Is pregnant or planning to get pregnant within the study period
- Is currently breastfeeding
- Has an active sexually transmitted infection (STI)
- Has equal to or greater than stage III prolapse, according to pelvic organ prolapse quantification system (POP-Q test)
Show all 17Show fewer
- Has signs or symptoms of vaginitis/vulvitis
- Has signs or symptoms of acute urinary tract infection (UTI)
- Has voiding dysfunction or urinary retention
- Has predominantly overactive bladder (OAB) as proven by urodynamics
- Is currently taking medication for treating urinary incontinence
- Has a known history of neurologic disease
- Has history of heart failure
- Any medical conditions that might interfere with wound healing
- Has history of abnormal wound healing
- Has participated in any clinical trial involving an investigational drug or procedure within past 30 days
- The investigator feels that for any reason the subject is not eligible to participate in the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Carolinas Healthcare System
Charlotte, North Carolina, 28207
Women's Pelvic Health Institute
Los Gatos, California, 95032
The Female Pelvic Medicine Institute of Virginia
North Chesterfield, Virginia, 23235
Coyle Institute
Pensacola, Florida, 32514
Woodlands Gynecology & Aesthetics
The Woodlands, Texas, 77384
About this study
Official title: Safety and Efficacy of Hybrid Fractional Laser diVa Treatment for Symptoms of Urinary Incontinence
This multi-center clinical trial will evaluate the safety and long-term efficacy of hybrid fractional 2940 nm and 1470 lasers for improvement of symptoms of urinary incontinence.
Read the detailed description
Both 2940 nm Er:YAG (Erbium-doped yttrium aluminium garnet) and 1470 nm diode lasers are cleared by the Food and Drug Administration (FDA) for ablation, vaporization, coagulation of soft tissue and for skin resurfacing. Fractional delivery of laser is a well-established method that stimulates tissue remodeling in the dermis while leaving the surrounding tissue intact in order to decrease healing time. The layers of skin and vaginal mucosal tissue exhibit similarities that suggest the clinical results seen with skin resurfacing may be translated to the vaginal tissue. Improved vaginal tissue tone and increased collagen formation in the lamina propria beneath the urethra may lead to improved urinary control. This multi-centered, 18-month prospective clinical trial will determine the safety and long-term effectiveness of hybrid fractional 2940 nm and 1470 nm lasers (Hybrid Fractional Laser) as an alternative non-surgical, non-hormonal treatment for improvement of symptoms of urinary incontinence.
- Being tested
- Hybrid Fractional Laser
- Medical subject headings
- Urinary Incontinence, Urinary Incontinence, Stress, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid Fractional LaserDevice
Also called diVa
Consecutive and coincident fractional 2940 nm and 1470 nm lasers
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Fractional Laser | Experimental | Hybrid fractional 2940 nm and 1470 nm laser treatment Receives: Device: Hybrid Fractional Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Cough Stress Test
A diagnostic test to simulate accidental release of urine when the patient coughs.
Measured: 14 months
Secondary outcomes (6)
Change from baseline in Incontinence Impact Questionnaire (IIQ-7)
A 7-item self-report instrument designed to assess the impact of urinary incontinence on a patient's life.
Measured: 14 months
Change from baseline in Urogenital Distress Inventory (UDI-6)
A 6-item self-report instrument that assesses symptom distress and the impact on daily life of urinary incontinence.
Measured: 14 months
Change from baseline in Female Sexual Function Index (FSFI)
A multidimensional self-report instrument for assessment of female sexual function.
Measured: 14 months
Change from baseline in Histology
Change from baseline in epithelial thickness, collagen, elastin, vascularity, and fibroblast density.
Measured: 14 months
Change from baseline in Urodynamic Testing
Quantitative measures of uroflowmetry, post-void residual (PVR) urine, cystometry, leak-point pressure, pressure flow, urethral pressure profile, and the functional urethral length.
Measured: 14 months
Incidence and severity of treatment-related Adverse Events
Incidence and severity of treatment-related adverse events (i.e. pain, edema, erythema, altered sensation, scarring, and/or potential infection).
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start19 May 2017
- Primary completion30 Aug 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sciton
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180372
- Sponsor's protocol ID
- DIVACIP001
- Status last verified
- Dec 2019
- First submitted
- 6 Jun 2017
- Last updated
- 4 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Hybrid Fractional Laser diVa Treatment for Symptoms of Urinary Incontinence
- ClinicalTrials.gov ID
- NCT03180372
- Acronym / sponsor ID
- DIVACIP001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- ScitonIndustry (pharma, biotech, devices)
- Study start
- 19 May 2017 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 8 Jun 2017 (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 multi-center clinical trial will evaluate the safety and long-term efficacy of hybrid fractional 2940 nm and 1470 lasers for improvement of symptoms of urinary incontinence.
Detailed description
Both 2940 nm Er:YAG (Erbium-doped yttrium aluminium garnet) and 1470 nm diode lasers are cleared by the Food and Drug Administration (FDA) for ablation, vaporization, coagulation of soft tissue and for skin resurfacing. Fractional delivery of laser is a well-established method that stimulates tissue remodeling in the dermis while leaving the surrounding tissue intact in order to decrease healing time. The layers of skin and vaginal mucosal tissue exhibit similarities that suggest the clinical results seen with skin resurfacing may be translated to the vaginal tissue. Improved vaginal tissue tone and increased collagen formation in the lamina propria beneath the urethra may lead to improved urinary control. This multi-centered, 18-month prospective clinical trial will determine the safety and long-term effectiveness of hybrid fractional 2940 nm and 1470 nm lasers (Hybrid Fractional Laser) as an alternative non-surgical, non-hormonal treatment for improvement of symptoms of urinary incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hybrid Fractional Laser | Experimental | Device: Hybrid Fractional LaserHybrid fractional 2940 nm and 1470 nm laser treatment |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy biological female aged between 30 to 75 years
- Is experiencing at least one or a combination of the following symptoms of urinary incontinence (UI)
- Has been experiencing symptoms of UI for greater than 3 months
- Normal urinalysis
- Has indicated willingness to participate in the study by signing an informed consent form
Key exclusion criteria (17 listed)
- Undiagnosed abnormal genital bleeding
- Has history of pelvic surgery or other energy-based vaginal therapy within 6 months prior to enrollment
- Is pregnant or planning to get pregnant within the study period
- Is currently breastfeeding
- Has an active sexually transmitted infection (STI)
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 |
|---|---|---|
| Hybrid Fractional LaserAlso: diVaConsecutive and coincident fractional 2940 nm and 1470 nm lasers | Device | Hybrid Fractional Laser |
Primary outcome
Change from baseline in Cough Stress Test
Time frame: 14 months
A diagnostic test to simulate accidental release of urine when the patient coughs.
6 secondary outcomes
Change from baseline in Incontinence Impact Questionnaire (IIQ-7)
Time frame: 14 months
Change from baseline in Urogenital Distress Inventory (UDI-6)
Time frame: 14 months
Change from baseline in Female Sexual Function Index (FSFI)
Time frame: 14 months
Change from baseline in Histology
Time frame: 14 months
Change from baseline in Urodynamic Testing
Time frame: 14 months
Incidence and severity of treatment-related Adverse Events
Time frame: 14 months
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 4 Dec 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Fractional Laser in people with Urinary Incontinence and Stress Urinary Incontinence, run by Sciton at 5 sites in United States.
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 9 inclusion and 17 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 4 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
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?
Change from baseline in Cough Stress Test (time frame: 14 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 4 Dec 2019.