NCT02418299

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2012

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

Study Start

First participant enrolled

March 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 16, 2015

Completed
Last Updated

April 17, 2015

Status Verified

April 1, 2015

Enrollment Period

1.7 years

First QC Date

April 8, 2015

Last Update Submit

April 16, 2015

Conditions

Female Stress Urinary IncontinenceMixed Incontinence, Urge and Stress

Keywords

urinary incontinenceEr:YAG laser

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • VAS index for the assessment of pain

    at baat baseline and 2, 6 and 12 months after treatment

Study Arms (1)

IncontiLase Er:YAG laser treatment

EXPERIMENTAL

Er:YAG laser treatment for stress and mixed urinary incontinence

Device: IncontiLase Er:YAG laser treatment

Interventions

IncontiLase Er:YAG laser treatmentDEVICE

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

Also known as: IncontiLase
IncontiLase Er:YAG laser treatment

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Urška Bizjak-Ogrinc, Dr

    Juna d.o.o.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2015

First Posted

April 16, 2015

Study Start

March 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

April 17, 2015

Record last verified: 2015-04