Clinical trial NCT02981654: Safety and Efficacy of Carbone Dioxide (CO2) Laser System in Treatment of Female Stress Urinary Incontinence.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Female Stress Urinary Incontinence
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: The Baruch Padeh Medical Center, Poriya
name: Kaplan Medical Center
First posted: 2016-12-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

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

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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
* 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.

Primary outcomes:
measure: Success Rate - SUI Symptom Improvement
timeFrame: 6 months
Secondary outcomes:
measure: Urinary Diary
timeFrame: 12 months
measure: 1 hour pad test
timeFrame: 12 months
measure: Vaginal Biopsy
timeFrame: 12 months
measure: PGI-S
timeFrame: 12 months
measure: PFDI
timeFrame: 12 months
measure: PISQ
timeFrame: 12 months
measure: PFIQ
timeFrame: 12 months
measure: Safety Endpoint assessed by the rate of serious device related adverse events
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Head, Urogynecology Unit, Chaim Sheba Medical Center
name: Menachem Alcalay, MD
role: PRINCIPAL_INVESTIGATOR
References: