Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04136652 |
Other study ID # |
H-19013894 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 1, 2019 |
Est. completion date |
February 21, 2023 |
Study information
Verified date |
October 2023 |
Source |
Hvidovre University Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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)
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.