Stress Urinary IncontinenceLaserSUINCT04253067
A Single-Blind, Randomized Study to Compare fCO2 Laser Therapy Versus Sham for Treatment of SUI in Women
A study testing Active fCO2 laser treatment in people with Stress Urinary Incontinence and Urinary Incontinence, run by Corewell Health East at 1 site in United States.
Trial summary
This is a prospective randomized sham-controlled study of patients undergoing vaginal treatment with a fractional carbon dioxide (fCO2) laser for stress urinary incontinence (SUI) symptoms. Eligible participants will be randomized (like a flip of a coin) to receive active or sham fCO2 laser treatments. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Stress Urinary Incontinence, Urinary Incontinence
- What is being tested?
- Active fCO2 laser treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2020to Oct 2020
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Age ≥18 years and ≤75 of age
- Mild to moderate SUI defined by Stamey Grade 1 and 2
- Positive bladder stress test at screening
- Negative urinary tract infection (UTI) at the time of study enrollment. If a patient does have a UTI, they may be rescreened after treatment
- No additional SUI therapy in the past 2 months such as pelvic floor physical therapy, medications, or participation in another SUI study
Show all 11Show fewer
- No prior history of midurethral sling or fascial sling for SUI
- No prior history of urethral bulking procedure for SUI
- No prior history of autologous muscle derived stem cell injection in the urethra
- Must sign the informed consent form
- Must be willing to comply with the study protocol
Who cannot join
- Contraindications to fCO2 laser treatment, such as:
- previous pelvic mesh surgery
- current or previous genital cancers,
- radiation to the vaginal or colo-rectal tissue,
- currently pregnant or less than 3 months following pregnancy
- active infections (candidiasis, herpes genitalis, etc.)
Show all 23Show fewer
- vaginal or cervical lesions noted on initial exam
- Patients with undiagnosed vaginal bleeding not related to menses
- Active vulvar or vaginal infection, including herpes
- Current UTI, confirmed by positive urine culture and patient-reported UTI symptoms
- Recurrent UTI defined as 3 UTIs in the past 6 months or 4 UTIs in the past 1 year
- Pelvic or vaginal surgery within the past 9 months
- Pelvic organ prolapse beyond the introitus
- Patient possesses any other characteristics that, per the investigator's judgment, deems them unsuitable (i.e. may increase patient's risk, may affect the conduct of the study, etc.) for the treatment and/or study.
- Participation in an investigational trial that used a study treatment, medication and/or biologic within 30 days or less prior to the date of the screening visit.
- Deferral
- Patients may be deferred and rescreened at a later date under the following conditions:
- Patients with active vulvar or vaginal infections may be rescreened after treatment
- Patients with an active UTI may be rescreened after treatment
- Patients with undiagnosed vaginal bleeding may be rescreened after complete work-up, treatment and resolution of vaginal bleeding
- Patients pregnant within the past 3 months
- Patients with recent vaginal or uterine surgery within the 9 months
- Note: To preserve the scientific integrity of the study some inclusion and exclusion criteria are not listed. At the conclusion of the study all items will be posted.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beaumont Hospital-Royal Oak
Royal Oak, Michigan, 48073
About this study
Official title: A Single-Blind, Randomized Study to Compare the Efficacy and Safety of Fractional Carbon Dioxide Laser Therapy Versus Sham for Treatment of Stress Urinary Incontinence Symptoms in Women
This is a prospective randomized sham-controlled study of patients undergoing vaginal treatment with a fractional carbon dioxide (fCO2) laser for stress urinary incontinence (SUI) symptoms. Eligible participants will be randomized (like a flip of a coin) to receive active or sham fCO2 laser treatments. Three treatments with the fCO2 laser or sham to the vagina will be performed, approximately four weeks apart.
Read the detailed description
Stress urinary incontinence (SUI) is a common problem that affects 35-40% of women worldwide. SUI occurs when a woman experiences involuntary leakage of urine with physical activities such as exercise, coughing and sneezing that increases intra-abdominal pressure. Vaginal laser therapy offers a potential novel treatment for SUI, however there is limited scientific evidence to show benefits to treatment. A sham controlled study will further add to the literature and evidence to support or oppose the use of the fCO2 laser for SUI.
The purpose of this study is to compare active therapy to sham treatment to determine if a true benefit to treatment exists. Eligible participants will be randomized 1:1, to receive active or sham fCO2 laser treatments. Three treatments, active or sham, to the vagina will be performed approximately four weeks apart. The primary efficacy endpoint is four weeks after completing all treatments. Treatment durability and safety will be assessed eight weeks after the primary endpoint.
- Conditions
- Stress Urinary Incontinence, Urinary Incontinence
- Being tested
- Active fCO2 laser treatment, Sham fCO2 laser treatment
- Keywords
- Laser Therapy
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active fCO2 laser treatmentDevice
The laser probe is inserted into the vagina. Laser treatment is delivered at 6 points at each level of the vaginal wall (12, 2, 4, 6, and 10 o'clock positions). Delivery begins at the most proximal and the probe is retracted by 1 cm and another row of laser treatments are delivered. The number of levels is determined by the patient's vaginal length.
Sham fCO2 laser treatmentDevice
The laser probe is inserted into the vagina. The laser will remain in standby mode during the treatment preventing laser exposure. The treatment will appear to be the same as the active treatment with the probe starting at the most proximal and following the same 6 points of treatment delivery. The probe is retracted in the same manner and another row of treatment is simulated. The machine maintains a low humming noise while in standby mode. No active laser treatment is delivered.
| Study group | Role | What they receive |
|---|---|---|
| Active fCO2 laser treatment | Active comparator | Laser probe will be inserted into the vagina. The laser treatment is delivered at 6 points to the vaginal wall. Delivery begins at the most proximal and the wand is retracted by 1 cm and another row of laser treatment is delivered. The number of levels is determined by vaginal length. Receives: Device: Active fCO2 laser treatment |
| Sham fCO2 laser treatment | Sham comparator | Laser probe will be inserted into the vagina. To prevent the delivery of laser energy, the laser will remain in standby mode during the visit. Keeping the laser in standby mode prevents laser exposure. The treatment will appear to be the same as the active treatment. The machine maintains a low humming noise while in standby mode. Receives: Device: Sham fCO2 laser treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of fCO2 laser therapy in women with mild to moderate SUI symptoms compared to sham by evaluating the responder rate.
A patient is called a responder if there is a greater than or equal to 50% reduction from baseline in the number of subject-reported SUI episodes over 3 days on a voiding diary.
Measured: 4 weeks after completing all treatments
Secondary outcomes (11)
To compare fCO2 laser therapy vs. sham in relation to the change in the total number of voids per day as measured by the 3-day voiding diary.
Change in the total number of subject-reported stress urinary incontinence (SUI) episodes over 3 days based on voiding diaries. Each void and urine leak will be recorded over a 3 day period. Patients will determine if each leak is a stress leak or urge leak. Patients will be given a 3 day diary to complete.
Measured: 8 weeks after the primary endpoint
To compare fCO2 laser therapy vs. sham in relation to the change in subject-reported impression of SUI severity.
SUI severity as measured by the Patient Global Impression of Severity Scale (PGI-S). The subject will check the box that describes how their condition is now. Available options are 1= normal, 2 = mild, 3 = moderate, or 4 = severe. A higher score is equivalent to a worse outcome.
Measured: 8 weeks after the primary endpoint
To compare fCO2 laser therapy vs. sham in relation to the change in subject-reported impression of SUI improvement.
SUI improvement as measured by the Patient Global Impression of Improvement Scale (PGI-I). The subject will select one of the following options, (very much better, much better, a little better, no change, a little worse, much worse, very much worse) to describe their SUI symptoms now versus prior to study treatment.
Measured: 8 weeks after the primary endpoint
To compare fCO2 laser therapy vs. sham in relation to the change in subject-reported urogenital distress.
Change in urogenital distress as measured by the Urinary Distress Inventory questionnaire (UDI-6). The UDI-6 is a six point questionnaire, each question is scored as follows: 0 = no, 1 = not at all, 2 = somewhat, 3 = moderately, 4 = quite a bit. Scores are totaled and divided by 6, then multiplied by 25 to calculate the raw score. Higher scores = higher disability.
Measured: 8 weeks after the primary endpoint
To compare fCO2 laser therapy vs. sham in relation to the change in subject-reported impact of urinary incontinence on daily life as measured by the Incontinence Impact Questionnaire (IIQ-7).
Impact of urinary incontinence on daily life as measured by the Incontinence Impact Questionnaire (IIQ-7). The IIQ-7 assesses how a subject's problem effects activities, relationships, and feelings. It is a 7 point questionnaire. Each answer is scored as: 0=not at all, 1=slightly, 2=moderately, 3=greatly. The higher the score the more effected they are by their condition.
Measured: 8 weeks after the primary endpoint
To compare fCO2 laser therapy vs. sham in relation to the change in subject-reported impact of urinary incontinence on daily life as measured by the Incontinence Quality of Life Questionnaire (I-QOL)
The impact on urinary incontinence as measured by the Incontinence Quality of Life questionnaire (I-QOL). The I-QOL is a quality of life measure specific to persons with urinary incontinence. The survey consists of 22 incontinent-specific quality of life items, all having the following five-point ordinal response; 1=extremely, 2=quite a lot, 3=moderately, 4=a little, 5=not at all. The summed total score is transformed to a 0-100 scale ranging from 0 (poor quality of life) to 100 (maximum quality of life).
Measured: 8 weeks after the primary endpoint
To compare fCO2 laser therapy vs. sham in relation to the change in subject-reported fecal incontinence.
Change in fecal incontinence as measured by the Cleveland clinic incontinence score (Wexner). Incontinence of stool may occur with or without urinary leakage. On the Cleveland clinic incontinence score the type of incontinence of stool (solid, liquid, gas, wears pad, lifestyle altered) are reported by the subject. Each question is measured as 0=never, 1=rarely, 2=sometimes, 4=usually, 5=always. The higher the score the more severe the condition.
Measured: 8 weeks after the primary endpoint
To compare fCO2 laser therapy vs. sham in relation to the change in subject-reported sexual function.
Change in sexual function as measured by the Female Sexual Function Index Questionnaire (FSFI). The FSFI is a 19 question survey. A lower score is equivalent to a higher degree of sexual function. Scores range from 0 to 95.
Measured: 8 weeks after the primary endpoint
To compare fCO2 laser therapy vs. sham in relation to the change in subject-reported pain and discomfort.
Change in pain and discomfort as measured by the Visual Analog Scale (VAS). The VAS is a validated questionnaire that assesses pain on a scale from 0=no pain to 10=Worst possible pain. A higher score is equivalent to a worse outcome.
Measured: 8 weeks after the primary endpoint
Durability to determine whether subjects in the fCO2 laser therapy group continue to have a higher responder rate than the sham group.
A patient is called a responder if there is a greater than or equal to 50% reduction from baseline in the number of subject-reported SUI episodes over 3 days on a voiding diary. Change in the total number of subject-reported stress urinary incontinence (SUI) episodes over 3 days based on voiding diaries. Each void and urine leak will be recorded over a 3 day period. Patients will determine if each leak is a stress leak or urge leak. Patients will be given a 3 day diary to complete.
Measured: 8 weeks after the primary endpoint.
Determine the safety of fCO2 laser therapy compared to sham.
Safety of the fCO2 laser therapy compared to sham will be assessed in relation to the incidence of adverse events.
Measured: 8 weeks after the primary endpoint.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study startOct 2020 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Why it stopped: PI decided not to open study, following review of data collected in another study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- Subjects will be randomized 1:1 to active fCO2 laser therapy or sham. Study will be performed in a single-blind manner. (Participant and biostatistician)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth M Peters, MD, Corewell Health East
- Investigators
- Kenneth Peters, Principal investigator, Beaumont Hospital-Royal Oak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253067
- Sponsor's protocol ID
- 2020-LaserSUI
- Acronym
- LaserSUI
- Status last verified
- Nov 2020
- First submitted
- 30 Jan 2020
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ippolito GM, Crescenze IM, Sitto H, Palanjian RR, Raza D, Barboglio Romo P, Wallace SA, Orozco Leal G, Clemens JQ, Dahm P, Gupta P. Vaginal lasers for treating stress urinary incontinence in women. Cochrane Database Syst Rev. 2025 Jul 25;7(7):CD013643. doi: 10.1002/14651858.CD013643.pub2.
PubMed 40709601
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Blind, Randomized Study to Compare the Efficacy and Safety of Fractional Carbon Dioxide Laser Therapy Versus Sham for Treatment of Stress Urinary Incontinence Symptoms in Women
- ClinicalTrials.gov ID
- NCT04253067
- Acronym / sponsor ID
- LaserSUI / 2020-LaserSUI
- Conditions
- Stress Urinary Incontinence, Urinary Incontinence
- Keywords
- Laser Therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI decided not to open study, following review of data collected in another study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 5 Feb 2020 (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 prospective randomized sham-controlled study of patients undergoing vaginal treatment with a fractional carbon dioxide (fCO2) laser for stress urinary incontinence (SUI) symptoms. Eligible participants will be randomized (like a flip of a coin) to receive active or sham fCO2 laser treatments. Three treatments with the fCO2 laser or sham to the vagina will be performed, approximately four weeks apart.
Detailed description
Stress urinary incontinence (SUI) is a common problem that affects 35-40% of women worldwide. SUI occurs when a woman experiences involuntary leakage of urine with physical activities such as exercise, coughing and sneezing that increases intra-abdominal pressure. Vaginal laser therapy offers a potential novel treatment for SUI, however there is limited scientific evidence to show benefits to treatment. A sham controlled study will further add to the literature and evidence to support or oppose the use of the fCO2 laser for SUI.
The purpose of this study is to compare active therapy to sham treatment to determine if a true benefit to treatment exists. Eligible participants will be randomized 1:1, to receive active or sham fCO2 laser treatments. Three treatments, active or sham, to the vagina will be performed approximately four weeks apart. The primary efficacy endpoint is four weeks after completing all treatments. Treatment durability and safety will be assessed eight weeks after the primary endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized 1:1 to active fCO2 laser therapy or sham. Study will be performed in a single-blind manner. (Participant and biostatistician)
| Arm | Type | Receives |
|---|---|---|
| Active fCO2 laser treatment | Active comparator | Device: Active fCO2 laser treatmentLaser probe will be inserted into the vagina. The laser treatment is delivered at 6 points to the vaginal wall. Delivery begins at the most proximal and the wand is retracted by 1 cm and another row of laser treatment is delivered. The number of levels is determined by vaginal length. |
| Sham fCO2 laser treatment | Sham comparator | Device: Sham fCO2 laser treatmentLaser probe will be inserted into the vagina. To prevent the delivery of laser energy, the laser will remain in standby mode during the visit. Keeping the laser in standby mode prevents laser exposure. The treatment will appear to be the same as the active treatment. The machine maintains a low humming noise while in standby mode. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female
- Age ≥18 years and ≤75 of age
- Mild to moderate SUI defined by Stamey Grade 1 and 2
- Positive bladder stress test at screening
- Negative urinary tract infection (UTI) at the time of study enrollment. If a patient does have a UTI, they may be rescreened after treatment
Key exclusion criteria (23 listed)
- Contraindications to fCO2 laser treatment, such as:
- Patients with undiagnosed vaginal bleeding not related to menses
- Active vulvar or vaginal infection, including herpes
- Current UTI, confirmed by positive urine culture and patient-reported UTI symptoms
- Recurrent UTI defined as 3 UTIs in the past 6 months or 4 UTIs in the past 1 year
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 |
|---|---|---|
| Active fCO2 laser treatmentThe laser probe is inserted into the vagina. Laser treatment is delivered at 6 points at each level of the vaginal wall (12, 2, 4, 6, and 10 o'clock positions). Delivery begins at the most proximal and the probe is retracted by 1 cm and another row of laser treatments are delivered. The number of levels is determined by the patient's vaginal length. | Device | Active fCO2 laser treatment |
| Sham fCO2 laser treatmentThe laser probe is inserted into the vagina. The laser will remain in standby mode during the treatment preventing laser exposure. The treatment will appear to be the same as the active treatment with the probe starting at the most proximal and following the same 6 points of treatment delivery. The probe is retracted in the same manner and another row of treatment is simulated. The machine maintains a low humming noise while in standby mode. No active laser treatment is delivered. | Device | Sham fCO2 laser treatment |
Primary outcome
To evaluate the efficacy of fCO2 laser therapy in women with mild to moderate SUI symptoms compared to sham by evaluating the responder rate.
Time frame: 4 weeks after completing all treatments
A patient is called a responder if there is a greater than or equal to 50% reduction from baseline in the number of subject-reported SUI episodes over 3 days on a voiding diary.
11 secondary outcomes
To compare fCO2 laser therapy vs. sham in relation to the change in the total number of voids per day as measured by the 3-day voiding diary.
Time frame: 8 weeks after the primary endpoint
To compare fCO2 laser therapy vs. sham in relation to the change in subject-reported impression of SUI severity.
Time frame: 8 weeks after the primary endpoint
To compare fCO2 laser therapy vs. sham in relation to the change in subject-reported impression of SUI improvement.
Time frame: 8 weeks after the primary endpoint
To compare fCO2 laser therapy vs. sham in relation to the change in subject-reported urogenital distress.
Time frame: 8 weeks after the primary endpoint
To compare fCO2 laser therapy vs. sham in relation to the change in subject-reported impact of urinary incontinence on daily life as measured by the Incontinence Impact Questionnaire (IIQ-7).
Time frame: 8 weeks after the primary endpoint
To compare fCO2 laser therapy vs. sham in relation to the change in subject-reported impact of urinary incontinence on daily life as measured by the Incontinence Quality of Life Questionnaire (I-QOL)
Time frame: 8 weeks after the primary endpoint
To compare fCO2 laser therapy vs. sham in relation to the change in subject-reported fecal incontinence.
Time frame: 8 weeks after the primary endpoint
To compare fCO2 laser therapy vs. sham in relation to the change in subject-reported sexual function.
Time frame: 8 weeks after the primary endpoint
To compare fCO2 laser therapy vs. sham in relation to the change in subject-reported pain and discomfort.
Time frame: 8 weeks after the primary endpoint
Durability to determine whether subjects in the fCO2 laser therapy group continue to have a higher responder rate than the sham group.
Time frame: 8 weeks after the primary endpoint.
Determine the safety of fCO2 laser therapy compared to sham.
Time frame: 8 weeks after the primary endpoint.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Derived from this study: PubMed 40709601Ippolito GM, Crescenze IM, Sitto H, Palanjian RR, Raza D, Barboglio Romo P, Wallace SA, Orozco Leal G, Clemens JQ, Dahm P, Gupta P. Vaginal lasers for treating stress urinary incontinence in women. Cochrane Database Syst Rev. 2025 Jul 25;7(7):CD013643. doi: 10.1002/14651858.CD013643.pub2.
- 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.
Kenneth Peters principal investigator
Beaumont Hospital-Royal Oak
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active fCO2 laser treatment in people with Stress Urinary Incontinence and Urinary Incontinence, run by Corewell Health East at 1 site 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 11 inclusion and 23 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: withdrawn, as of the sponsor's last update on 17 Nov 2020. 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 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
To evaluate the efficacy of fCO2 laser therapy in women with mild to moderate SUI symptoms compared to sham by evaluating the responder rate. (time frame: 4 weeks after completing all treatments). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04253067, which also lists 1 linked publication.
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 Nov 2020.