Skip to content

Er:YAG Laser Treatment for Female Stress and Mixed Urinary Incontinence (IncontiLase)

Prospective, Single Centre Study of Er:YAG Laser Treatment for Female Stress and Mixed Urinary Incontinence (IncontiLase)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02418299
Enrollment
175
Registered
2015-04-16
Start date
2012-03-31
Completion date
2013-11-30
Last updated
2015-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female Stress Urinary Incontinence, Mixed Incontinence, Urge and Stress

Keywords

urinary incontinence, Er:YAG laser

Brief summary

The purpose of this study was to evaluate the effect of a non-invasive Er:YAG thermal laser therapy in treating female stress and mixed urinary incontinence.

Detailed description

Urinary incontinence (UI) is a common disorder that affects women of various ages and impacts all aspects of life. Therapeutic approaches range from conservative therapy, which is heavily dependent on patient compliance, to different, more invasive, surgical procedures. The aim of the study was to evaluate the non-invasive erbium:yttrium-aluminum-garnet (Er:YAG) laser treatment (IncontiLase) as a potential treatment strategy for stress UI (SUI) and mixed UI (MUI). The treatment works by thermally affecting vaginal mucosa, with an emphasis on the anterior vaginal wall, resulting with partial denaturation of collagen fibres and stimulation if new collagen formation, all of which leads to firmer support for the urethra and the improvement of incontinence symptoms. The investigators included 175 women with newly diagnosed SUI (66% of women) and MUI (34 %), respectively and performed on average 2.5±0.5 procedures in each woman separated by a two-month period, using Er:YAG laser. Patients were clinically examined and classified by incontinence types (SUI and MUI) and grades (mild, moderate, severe and very severe) using International Consultation on Incontinence Modular Questionnaire (ICIQ) and assessing Incontinence Severity Index (ISI): ISI before the therapy was 5.7±2.1 points. Treatment discomfort was measured at every session with visual analogue system pain scale, and adverse effects and patients' satisfaction were followed. Follow-ups were performed at two, six and twelve months after the treatment.

Interventions

DEVICEIncontiLase Er:YAG laser treatment

Each patient will receive 2-3 sessions of Er:YAG laser treatment for stress and mixed urinary incontinence (IncontiLase)

Sponsors

Juna d.o.o.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* clinically confirmed UI * normal PAP smear (Papanicolaou cytology) * negative urine culture * integrity of the vaginal mucosa (without injuries or bleeding)

Exclusion criteria

* pregnancy * intake of photosensitive drugs * vaginal injuries or vaginal bleeding * infection in the treated area * clinical diagnosis of pure urge urinary incontinence

Design outcomes

Primary

MeasureTime frame
Change in the Incontinence Severity Index (ISI) calculated from the ICIQ-UI short form questionnaireat baseline and 2, 6 and 12 months after treatment

Secondary

MeasureTime frame
VAS index for the assessment of painat baat baseline and 2, 6 and 12 months after treatment

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026