Er:YAG Laser Treatment for Female Stress and Mixed Urinar... | NCT02418299

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

NCT02418299

Sponsor

Juna d.o.o.

Status

Completed

Last Update Posted

Apr 17, 2015Estimated

Enrollment

175Actual

Phase

Not Applicable

Conditions

Female Stress Urinary Incontinence
Mixed Incontinence, Urge and Stress

Interventions

IncontiLase Er:YAG laser treatment

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Nov 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Apr 8, 2015

First Submission Date that Met QC Criteria

Apr 12, 2015

First Posted Date

Apr 16, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2015

Last Update Posted Date

Apr 17, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

175Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IncontiLase Er:YAG laser treatment	Experimental	Er:YAG laser treatment for stress and mixed urinary incontinence	Device: IncontiLase Er:YAG laser treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IncontiLase Er:YAG laser treatment	Device	Each patient will receive 2-3 sessions of Er:YAG laser treatment for stress and mixed urinary incontinence (IncontiLase)	IncontiLase Er:YAG laser treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in the Incontinence Severity Index (ISI) calculated from the ICIQ-UI short form questionnaire		at baseline and 2, 6 and 12 months after treatment

Secondary Outcomes

Measure	Description	Time Frame
VAS index for the assessment of pain		at baat baseline and 2, 6 and 12 months after treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Urška Bizjak-Ogrinc, Dr	Juna d.o.o.	Principal Investigator

Locations

Not provided

Label	URL
The Juna Clinic	View source

Condition Browse Module

MeSH Terms

ID	Term
D014549	Urinary Incontinence

Ancestor Terms

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided