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A Single-Blind, Randomized Study to Compare fCO2 Laser Therapy Versus Sham for Treatment of SUI in Women (LaserSUI)

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ClinicalTrials.gov Identifier: NCT04253067
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : April 9, 2020
Sponsor:
Information provided by (Responsible Party):
Kenneth M Peters, MD, William Beaumont Hospitals

Brief 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. Three treatments with the fCO2 laser or sham to the vagina will be performed, approximately four weeks apart.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Urinary Incontinence Device: Active fCO2 laser treatment Device: Sham fCO2 laser treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Outcomes Assessor)
Masking Description: Single-blind, participant and biostatistician will be blinded to treatment group. Subjects will be randomized 1:1 to active fCO2 laser treatment group or sham treatment group. Randomization will be performed using a table of random numbers. Randomization envelopes will be provided by the biostatistician and will be securely stored in a locked cabinet. The research coordinator(s) will be responsible for maintaining the confidentiality and security of the randomization envelopes. An enrollment and randomization log will be stored securely. The biostatistician will prepare more envelopes, if necessary.
Primary Purpose: Treatment
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
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active fCO2 laser treatment
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.
Device: Active fCO2 laser treatment
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 Comparator: Sham fCO2 laser treatment
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.
Device: Sham fCO2 laser treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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.

  3. 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 ]
    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.

  4. 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 ]
    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.

  5. 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 ]
    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.

  6. 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 ]
    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).

  7. 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 ]
    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.

  8. 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 ]
    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.

  9. 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 ]
    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.

  10. 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. ]
    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.

  11. Determine the safety of fCO2 laser therapy compared to sham. [ Time Frame: 8 weeks after the primary endpoint. ]
    Safety of the fCO2 laser therapy compared to sham will be assessed in relation to the incidence of adverse events.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female
  2. Age ≥18 years and ≤75 of age
  3. Mild to moderate SUI defined by Stamey Grade 1 and 2
  4. Positive bladder stress test at screening
  5. Negative urinary tract infection (UTI) at the time of study enrollment. If a patient does have a UTI, they may be rescreened after treatment
  6. No additional SUI therapy in the past 2 months such as pelvic floor physical therapy, medications, or participation in another SUI study
  7. No prior history of midurethral sling or fascial sling for SUI
  8. No prior history of urethral bulking procedure for SUI
  9. No prior history of autologous muscle derived stem cell injection in the urethra
  10. Must sign the informed consent form
  11. Must be willing to comply with the study protocol

Exclusion Criteria:

  1. Contraindications to fCO2 laser treatment, such as:

    1. previous pelvic mesh surgery
    2. current or previous genital cancers,
    3. radiation to the vaginal or colo-rectal tissue,
    4. currently pregnant or less than 3 months following pregnancy
    5. active infections (candidiasis, herpes genitalis, etc.)
    6. vaginal or cervical lesions noted on initial exam
  2. Patients with undiagnosed vaginal bleeding not related to menses
  3. Active vulvar or vaginal infection, including herpes
  4. Current UTI, confirmed by positive urine culture and patient-reported UTI symptoms
  5. Recurrent UTI defined as 3 UTIs in the past 6 months or 4 UTIs in the past 1 year
  6. Pelvic or vaginal surgery within the past 9 months
  7. Pelvic organ prolapse beyond the introitus
  8. 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.
  9. 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253067


Contacts
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Contact: Lisa Vergos 248-551-7360 lisa.vergos@beaumont.org
Contact: Jennifer Giordano 248-551-3517 Jennifer.Giordano@beaumont.org

Locations
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United States, Michigan
Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
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Principal Investigator: Kenneth Peters Beaumont Hospital-Royal Oak
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Responsible Party: Kenneth M Peters, MD, Director and Chair of the Department of Urology, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT04253067    
Other Study ID Numbers: 2020-LaserSUI
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Kenneth M Peters, MD, William Beaumont Hospitals:
Laser Therapy
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders