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Clinical and Urodynamic Effects of Minimally Laser (IncontiLaseTM) Procedure for Female Stress Urinary Incontinence

Clinical and Urodynamic Effects of Minimally Laser (IncontiLaseTM) Procedure for Female Stress Urinary Incontinence

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02130375
Enrollment
35
Registered
2014-05-05
Start date
2014-05-31
Completion date
2015-12-31
Last updated
2016-01-29

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

Conditions

Stress Urinary Incontinence

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.

Detailed description

To get the objective urodynamic and sonographic effects of IncontiLaseTM procedure on women with stress urinary incontinence; and its impact on urinary symptoms and female sexual function.

Interventions

PROCEDUREthe IncontiLaseTM procedure

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

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* \< 20 years old female

Design outcomes

Primary

MeasureTime frameDescription
The change of pad weight from baseline3 monthsThe change of pad weight from baseline after IncontiLaseTM procedure

Secondary

MeasureTime frameDescription
The change of maximum urethral closure procedure from baseline3 monthsThe change of maximum urethral closure procedure from baseline after the IncontiLaseTM procedure by urodynamic studies

Other

MeasureTime frameDescription
The change of female sexual functional score from baseline after treatment3 monthsThe change of female sexual functional score from baseline after treatment
The change of periurethral blood flow from baseline3 months

Countries

Taiwan

Outcome results

None listed

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