NCT02130375

Brief Summary

The purpose of this study is to get the effect of IncontiLaseTM procedure; and its impact on urinary symptoms and female sexual function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2014

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

April 28, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 29, 2016

Status Verified

January 1, 2016

Enrollment Period

1.6 years

First QC Date

April 28, 2014

Last Update Submit

January 27, 2016

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • The change of pad weight from baseline

    The change of pad weight from baseline after IncontiLaseTM procedure

    3 months

Secondary Outcomes (1)

  • The change of maximum urethral closure procedure from baseline

    3 months

Other Outcomes (2)

  • The change of female sexual functional score from baseline after treatment

    3 months

  • The change of periurethral blood flow from baseline

    3 months

Study Arms (1)

stress urinary incontinence

EXPERIMENTAL

Women with stress urinary incontinence

Procedure: the IncontiLaseTM procedure

Interventions

the IncontiLaseTM procedurePROCEDURE

Utilizing laser (IncontiLaseTM) to treat the anterior vaginal wall area to intensify periurethral tissue and achieve urinary continence

stress urinary incontinence

Eligibility Criteria

Age20 Years - 99 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All consecutive sexually active and parous adult women with the complaint of stress urinary incontinence

You may not qualify if:

  • \< 20 years old female

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics & Gynecology, National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ho-Hsiung Lin, MD, PhD

    Department of Obstetrics & Gynecology, National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2014

First Posted

May 5, 2014

Study Start

May 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 29, 2016

Record last verified: 2016-01

Locations

TW(1)