Stress Urinary IncontinencePhase 4NCT02130375
Clinical and Urodynamic Effects of Minimally Laser (IncontiLaseTM) Procedure for Female Stress Urinary Incontinence
A Phase 4 study testing the IncontiLaseTM procedure in people with Stress Urinary Incontinence, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to get the effect of IncontiLaseTM procedure; and its impact on urinary symptoms and female sexual function. Read more about this study
- Who is it for?
- Ages 20 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- the IncontiLaseTM procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2014to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All consecutive sexually active and parous adult women with the complaint of stress urinary incontinence
Who cannot join
- < 20 years old female
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Obstetrics & Gynecology, National Taiwan University Hospital
Taipei, 100
About this study
The purpose of this study is to get the effect of IncontiLaseTM procedure; and its impact on urinary symptoms and female sexual function.
Read the 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.
- Conditions
- Stress Urinary Incontinence
- Being tested
- the IncontiLaseTM procedure
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the IncontiLaseTM procedureProcedure or surgery
Utilizing laser (IncontiLaseTM) to treat the anterior vaginal wall area to intensify periurethral tissue and achieve urinary continence
| Study group | Role | What they receive |
|---|---|---|
| stress urinary incontinence | Experimental | Women with stress urinary incontinence Receives: Procedure: the IncontiLaseTM procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of pad weight from baseline
The change of pad weight from baseline after IncontiLaseTM procedure
Measured: 3 months
Secondary outcomes (1)
The change of maximum urethral closure procedure from baseline
The change of maximum urethral closure procedure from baseline after the IncontiLaseTM procedure by urodynamic studies
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ho-Hsiung Lin, MD, PhD, Principal investigator, Department of Obstetrics & Gynecology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130375
- Sponsor's protocol ID
- 201402021RINB
- Status last verified
- Jan 2016
- First submitted
- 28 Apr 2014
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Urodynamic Effects of Minimally Laser (IncontiLaseTM) Procedure for Female Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT02130375
- Acronym / sponsor ID
- 201402021RINB
- Conditions
- Stress Urinary Incontinence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stress urinary incontinence | Experimental | Procedure: the IncontiLaseTM procedureWomen with stress urinary incontinence |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All consecutive sexually active and parous adult women with the complaint of stress urinary incontinence
Key exclusion criteria (1 listed)
- < 20 years old female
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the IncontiLaseTM procedureUtilizing laser (IncontiLaseTM) to treat the anterior vaginal wall area to intensify periurethral tissue and achieve urinary continence | Procedure or surgery | stress urinary incontinence |
Primary outcome
The change of pad weight from baseline
Time frame: 3 months
The change of pad weight from baseline after IncontiLaseTM procedure
1 secondary outcome
The change of maximum urethral closure procedure from baseline
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2016.
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RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ho-Hsiung Lin, MD, PhD principal investigator
Department of Obstetrics & Gynecology, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing the IncontiLaseTM procedure in people with Stress Urinary Incontinence, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of pad weight from baseline (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2016.