NCT04136652

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 23, 2019

Completed
9 days until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2023

Completed
Last Updated

October 12, 2023

Status Verified

October 1, 2023

Enrollment Period

3.3 years

First QC Date

October 10, 2019

Last Update Submit

October 10, 2023

Conditions

Stress Incontinence FemaleLaser

Keywords

vaginal laser CO2

Outcome Measures

Primary Outcomes (1)

  • ICIQ-UI SF

    The ICIQ-UI Short Form is a questionnaire for evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence in men and women in research and clinical practice across the world. Women will answer this questionnaire before they are booked for the first laser treatment. After al three treatments, they will have a control visit in an outpatient setting, where they fill out the questionaire again.

    Through study completion, an average of 6-8 months

Secondary Outcomes (1)

  • Standardized stress test

    Through study completion, an average of 6-8 months

Study Arms (2)

Sham

PLACEBO COMPARATOR

The women are randomized, by a computer program, to a sham laser-treatment with the laser not active.

Procedure: CO2 laser- treatment (DEKA SmartXide2 Laser System, MonaLisa Touch

Laser

ACTIVE COMPARATOR

The women are randomized, by a computer program, to a vaginal CO2 laser-treatment with 30 w.

Procedure: CO2 laser- treatment (DEKA SmartXide2 Laser System, MonaLisa Touch

Interventions

CO2 laser- treatment (DEKA SmartXide2 Laser System, MonaLisa TouchPROCEDURE

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 90degrees in four directions towards the vaginal wall, then rotated 45degree 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.

LaserSham

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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))

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (1)

  • Sigurdardottir HB, Kirschner B, Obel J, Aziz M, Stenz CB, Schroll JB. Vaginal CO2 laser treatment for urinary stress incontinence: A randomized controlled trial. Maturitas. 2025 Aug;199:108658. doi: 10.1016/j.maturitas.2025.108658. Epub 2025 Jul 3.

    PMID: 40617073DERIVED

Study Officials

  • Jeppe B Schroll, MD, PhD

    Hvidovre University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Only the doctor who performs the laser procedure knows which treatment the participant gets. The data analyzer will also know, in data analyses after all treatments are done.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 10, 2019

First Posted

October 23, 2019

Study Start

November 1, 2019

Primary Completion

February 21, 2023

Study Completion

February 21, 2023

Last Updated

October 12, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)