Clinical trial NCT04136652: Vaginal CO2 Laser for Stress Incontinence
Official title: Vaginal CO2 Laser for Stress Incontinence: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Incontinence Female
Laser
Keywords: vaginal laser CO2
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2019-10-23
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our aim with this study is to determine if transvaginal CO2 laser- treatment (DEKA SmartXide2 Laser System, MonaLisa Touch), renders significant effect in women with SUI. To best test this hypothesis, the study will be performed in a prospective, randomised controlled fashion in our institution. We will measure the effect as patient reported improvement using a validated scale (ICIQ-UI SF) as well as an objective measurement (stress test)

Detailed description: Patient will be included from our hospital (a Danish academic hospital) among women referred with incontinence. Eligible patients will be randomized to either laser treatment or "sham" laser treatment.

The study will take place in the department of Gynecology and Obstetrics of Hvidovre University Hospital, Copenhagen Denmark in the period of October 2019 to October 2020. Inclusion criteria for the study cohort and controls will be patients, referred from specialist gynecologists or GPs with SUI, that speak and understand Danish, are found without clinical relevant urogenital prolapse (grad 2 at maximum in al compartments), older than 18 years of age, with BMI under 35 and present with mild to moderate SUI evaluated after ICIQ-UI-SF (slight (1-5), moderate (6-12), severe (13-18) and very severe (19-21). Exclusion criteria presence of pelvic organ prolapse greater than stage II, previous pelvic surgery for incontinence or prolaps, current infections, keloid formation, vaginal pain, dyspareunia, ICIQ-UI-SF\>=19 (very severe) and ongoing pregnancy.

In this study, women will receive a series of three treatments using a fractional (pulsed) CO2 laser system (SmartXide2 MonaLisa Touch, DEKA M.E.L.A Srl, Florence, Italy), each performed in an outpatient setting without analgesia. A tubular laser-probe is inserted in the vaginal canal until reaching the vaginal vault. A burst of laser pulses is transmitted through the probe and deflected at 90degree in four directions towards the vaginal wall, then rotated 45 degrees for a second burst of pulses. Guided by markings on the probe, it is withdrawn 4mm and the procedure is repeated until reaching the introitus. Treatment parameters include power 30W, dwell time 1000us, 1000um spacing, using normal scan mode, with Smartstack setting for 1 at first application and 3 for the next two applications.

Both study- and placebo- treatments will be performed by specialist gynecologists employed in the department. Patients, who meet inclusion criteria and consent to study participation, will be randomized by computer service to conservative treatment, which encompass local estrogens (Vagifem 10ug twice weekly) if relevant (postmenopausal women) and pelvic floor training supervised by specialised physiotherapists in our own institution, whilst the study cohort will receive the same treatment with the addition of transvaginal laser applied thrice with 25- 45 days apart (CO2 laser- treatment (DEKA SmartXide2 Laser System, MonaLisa Touch). The controls will receive placebo treatment, with the use of the inactive laser, but relevant sound effects.

Primary outcome of the study is patient experienced improvement of SUI evaluated by standardized ICIQ-UI-SF questionnaire.

Our secondary outcome is objective improvement as measured by standardized stress test performed by specialist nurse before treatment and 1-2 month after last laser or placebo treatment. The bladder is emptied with a catheter and 300ml of saline is inserted. The patient is then stood up wearing a pad with legs slightly apart and asked to forcefully cough 10 timers, jump 10 times and make 10 squats. The examiner registers whether there is incontinence as either yes or no as well as grams of urin leakage in the pad. Furthermore, side- effects both positive and negative as well as patient satisfaction will be registered by the use of patient questionnaires at 1-2 months post treatment.

Eligibility criteria: Inclusion criteria

* referred from specialist gynecologists or GPs with SUI
* speak and understand Danish
* are found without clinical relevant urogenital prolapse
* older than 18 years of age
* with BMI under 35
* Present with mild to moderate SUI evaluated after ICIQ-UI-SF (slight (1-5), moderate (6-12), severe (13-18) and very severe (19-21))

Exclusion criteria

* presence of pelvic organ prolapse greater than stage II
* previous pelvic surgery for prolapse or incontinence,
* current infections,
* keloid formation
* vaginal pain
* dyspareunia,
* ICIQ-UI-SF\>=19 (very severe)
* ongoing pregnancy.

Primary outcomes:
measure: ICIQ-UI SF
timeFrame: Through study completion, an average of 6-8 months
Secondary outcomes:
measure: Standardized stress test
timeFrame: Through study completion, an average of 6-8 months
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: Hvidovre University Hospital
name: Jeppe B Schroll, MD, PhD
role: STUDY_DIRECTOR
References: