Laser Thermotherapy, Stress Urinary IncontinenceNCT03693690
Factors Affecting Therapeutic Efficacy of Vaginal Laser Therapy for Female Stress Urinary Incontinence, and the Effect of Vaginal Laser Therapy on Overactive Bladder Syndrome and Sexual Function
An observational study of Laser Thermotherapy, Stress Urinary Incontinence, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
The main aim of this study is to elucidate factors affecting treatment efficacy of vaginal laser therapy. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Laser Thermotherapy, Stress Urinary Incontinence
- What is being tested?
- Vaginal laser thermotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2018to 31 Dec 2023
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with stress urinary incontinence
Who may be able to join
- >20 years old female
- had stress urinary incontinence symptoms
- Sexual behavior
- No urinary tract infection
- At their own expense for vaginal laser therapy
Who cannot join
- Abnormal vaginal bleeding
- Vaginal fistula
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
New Taipei City, Banqiao, 22060
Sheng-Mou Hsiao, M.D., +886-2-89667000 ext. 1818, smhsiao2@gmail.com
About this study
Official title: Far Eastern Memorial Hospital
The main aim of this study is to elucidate factors affecting treatment efficacy of vaginal laser therapy.
Read the detailed description
Laser thermotherapy can increase the stiffness of vaginal wall. It has been reported that vaginal laser therapy can be used to treat stress urinary incontinence. However, factor affecting treatment efficacy of vaginal laser therapy remains unknown. Thus the main aim of this study is to elucidate factors affecting treatment efficacy of vaginal laser therapy. Besides, the durability of vaginal laser therapy will be assessed. The above knowledge should be helpful for clinical decision making.
- Being tested
- Vaginal laser thermotherapy
- 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.
Vaginal laser thermotherapyProcedure or surgery
Laser thermotherapy can increase the stiffness of vaginal wall. It has been reported that vaginal laser therapy can be used to treat stress urinary incontinence.
What is being measured
The primary outcome is the main question the study is designed to answer.
Global response assessment
Measured: 2 years
Secondary outcomes (1)
Duration of sustained efficacy
Duration of global response assessment ≥ 2 at each visit
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start1 Oct 2018
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laser Thermotherapy, Stress Urinary IncontinenceStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Mou Hsiao, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03693690
- Sponsor's protocol ID
- 107089-F
- Status last verified
- Sep 2023
- First submitted
- 1 Oct 2018
- Last updated
- 15 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hsiao SM, Wu WY, Lin HH. Predictors of the efficacy of CO 2 laser therapy for female stress urinary incontinence. J Chin Med Assoc. 2025 Feb 1;88(2):145-150. doi: 10.1097/JCMA.0000000000001193. Epub 2024 Nov 18.
PubMed 39792642
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Far Eastern Memorial Hospital
- ClinicalTrials.gov ID
- NCT03693690
- Acronym / sponsor ID
- 107089-F
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 3 Oct 2018 (actual)
- 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 main aim of this study is to elucidate factors affecting treatment efficacy of vaginal laser therapy.
Detailed description
Laser thermotherapy can increase the stiffness of vaginal wall. It has been reported that vaginal laser therapy can be used to treat stress urinary incontinence. However, factor affecting treatment efficacy of vaginal laser therapy remains unknown. Thus the main aim of this study is to elucidate factors affecting treatment efficacy of vaginal laser therapy. Besides, the durability of vaginal laser therapy will be assessed. The above knowledge should be helpful for clinical decision making.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with stress urinary incontinence
Key inclusion criteria (5 listed)
- >20 years old female
- had stress urinary incontinence symptoms
- Sexual behavior
- No urinary tract infection
- At their own expense for vaginal laser therapy
Key exclusion criteria (2 listed)
- Abnormal vaginal bleeding
- Vaginal fistula
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 |
|---|---|---|
| Vaginal laser thermotherapyLaser thermotherapy can increase the stiffness of vaginal wall. It has been reported that vaginal laser therapy can be used to treat stress urinary incontinence. | Procedure or surgery | – |
Primary outcome
Global response assessment
Time frame: 2 years
1 secondary outcome
Duration of sustained efficacy
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Derived from this study: PubMed 39792642Hsiao SM, Wu WY, Lin HH. Predictors of the efficacy of CO 2 laser therapy for female stress urinary incontinence. J Chin Med Assoc. 2025 Feb 1;88(2):145-150. doi: 10.1097/JCMA.0000000000001193. Epub 2024 Nov 18.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laser Thermotherapy, Stress Urinary Incontinence, run by Far Eastern Memorial 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Sep 2023. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheng-Mou Hsiao, MD (+89667000 ext. 1818, smhsiao2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global response assessment (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03693690, which also lists 1 linked publication.
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 15 Sep 2023.