Vaginal AtrophyNCT06136975
Low-level Laser Therapy for Genitourinary Syndromes and Stress Urinary Incontinence
An observational study of Vaginal Atrophy and Urinary Incontinence,Stress, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Genitourinary syndrome of menopause (GSM) and stress urinary incontinence (SUI) are common for women. Low-level laser therapy (LLLT) was applied for wound healing, but there was no study regarding treatment effect of GSM and SUI. This retrospective study aims to assess the efficacy of LLLT in alleviating GSM and SUI. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Vaginal Atrophy, Urinary Incontinence,Stress
- What is being tested?
- Low-level laser therapy
- Type of treatment
- Medical device
- How many people
- 41 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Sep 2022to 14 Aug 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The consecutive women who received LLLT at the gynecologic outpatient clinic were retrospectively reviewed. Menopause was defined as no spontaneous menstruation for at least one year. GSM is defined as vulvovaginal dryness and related symptoms, such as irritation, dyspareunia, or lower urinary tract symptoms (LUTS) including urinary urgency, dysuria, and recurrent urinary tract infection after menopause. SUI was defined as involuntary loss of urine on effort or physical exertion including sporting activities, or on sneezing or coughing.
Who may be able to join
- women with GSM and SUI
- Received LLLT at the gynecologic outpatient clinic
Who cannot join
- More or equal to stage 2 pelvic organ prolapse defined by pelvic organ prolapse-quantification system
- Ongoing urinary tract infection or vaginitis with the pathogen in the previous 2 weeks
- Bladder calculus
- Neurogenic bladder due to radical hysterectomy or injury of the central nervous system
- A preexisting malignant pelvic tumor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Low-level Laser Therapy in Relieving Vaginal Dryness and Lower Urinary Tract Symptoms
Genitourinary syndrome of menopause (GSM) and stress urinary incontinence (SUI) are common for women. Low-level laser therapy (LLLT) was applied for wound healing, but there was no study regarding treatment effect of GSM and SUI. This retrospective study aims to assess the efficacy of LLLT in alleviating GSM and SUI.
Read the detailed description
Between September 2022 and August 2023, all women who received LLLT for GSM and SUI at the gynecologic outpatient clinic of a hospital were retrospectively reviewed. The treatment was once a week for eight weeks. Vaginal health index (VHI) and questionnaires before and after treatment for evaluation of lower urinary tract symptoms (LUTS) and quality of life are the outcome assessment.
- Conditions
- Vaginal Atrophy, Urinary Incontinence,Stress
- Being tested
- Low-level laser therapy
- Keywords
- Menopause, Stress urinary incontinence, Vaginal atrophy, Low-level laser therapy
- 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.
Low-level laser therapyDevice
The treatment was once a week for eight weeks. The patient was in a supine position. The gain medium of the laser was Gallium-Aluminum-Arsenide. The laser was introduced into vagina via a silicon vaginal probe inserted by a doctor for 30 minutes (wavelength 660nm, power density 18.17mW/cm2, energy density 0.018J/cm2s, total energy density 32.4J/cm2).
| Study group | Role | What they receive |
|---|---|---|
| genitourinary symptoms of menopause | Women with genitourinary symptoms of menopause (GSM). Menopause was defined as no spontaneous menstruation for at least one year. GSM defined as vulvovaginal dryness and related symptoms, such as irritation, dyspareunia, or lower urinary tract symptom (LUTS) including urinary urgency, dysuria and recurrent urinary tract infection after menopause . Receives: Device: Low-level laser therapy | |
| stress urinary incontinence | Women with stress urinary incontinence (SUI). SUI was defined as involuntary loss of urine on effort or physical exertion including sporting activities, or on sneezing or coughing. Receives: Device: Low-level laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal health
Vaginal health index, each of these 5 items is evaluated by means of a scale from 1 (none) to 5 (excellent) and then the average of the scores is calculated. A value of ≤15 (= cut-off) is generally considered for the diagnosis of low vaginal health.
Measured: 8 weeks
Secondary outcomes (1)
Urinary incontinence
ICIQ-SF: International Consultation on Incontinence Questionnaire - Short Form. Scoring scale: 0-21. Higher scores mean a worse outcome.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start30 Sep 2022
- Primary completion14 Aug 2023
- Study completion14 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Vaginal AtrophyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pei-chi Wu, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136975
- Sponsor's protocol ID
- 202310054RIND
- Status last verified
- Nov 2023
- First submitted
- 13 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets analyzed during the study are available from the corresponding author on reasonable request.
Publications
Phillips NA, Bachmann GA. The genitourinary syndrome of menopause. Menopause. 2021 Feb 1;28(5):579-588. doi: 10.1097/GME.0000000000001728.
PubMed 33534428Gambacciani M, Palacios S. Laser therapy for the restoration of vaginal function. Maturitas. 2017 May;99:10-15. doi: 10.1016/j.maturitas.2017.01.012. Epub 2017 Feb 4.
PubMed 28364861Long CY, Wu PC, Chen HS, Lin KL, Loo Z, Liu Y, Wu CH. Changes in sexual function and vaginal topography using transperineal ultrasound after vaginal laser treatment for women with stress urinary incontinence. Sci Rep. 2022 Mar 2;12(1):3435. doi: 10.1038/s41598-022-06601-0.
PubMed 35236871Rola P, Doroszko A, Derkacz A. The Use of Low-Level Energy Laser Radiation in Basic and Clinical Research. Adv Clin Exp Med. 2014 September-October;23(5):835-842. doi: 10.17219/acem/37263.
PubMed 25491701Bump RC, Mattiasson A, Bo K, Brubaker LP, DeLancey JO, Klarskov P, Shull BL, Smith AR. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol. 1996 Jul;175(1):10-7. doi: 10.1016/s0002-9378(96)70243-0.
PubMed 8694033Palacios S. Assessing symptomatic vulvar, vaginal, and lower urinary tract atrophy. Climacteric. 2019 Aug;22(4):348-351. doi: 10.1080/13697137.2019.1600499.
PubMed 31157569Huang L, Zhang SW, Wu SL, Ma L, Deng XH. The Chinese version of ICIQ: a useful tool in clinical practice and research on urinary incontinence. Neurourol Urodyn. 2008;27(6):522-4. doi: 10.1002/nau.20546.
PubMed 18351586
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Low-level Laser Therapy in Relieving Vaginal Dryness and Lower Urinary Tract Symptoms
- ClinicalTrials.gov ID
- NCT06136975
- Acronym / sponsor ID
- 202310054RIND
- Conditions
- Vaginal Atrophy, Urinary Incontinence,Stress
- Keywords
- Menopause, Stress urinary incontinence, Vaginal atrophy, Low-level laser therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 14 Aug 2023 (actual)
- Study completion
- 14 Aug 2023 (actual)
- First posted
- 18 Nov 2023 (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.
Genitourinary syndrome of menopause (GSM) and stress urinary incontinence (SUI) are common for women. Low-level laser therapy (LLLT) was applied for wound healing, but there was no study regarding treatment effect of GSM and SUI. This retrospective study aims to assess the efficacy of LLLT in alleviating GSM and SUI.
Detailed description
Between September 2022 and August 2023, all women who received LLLT for GSM and SUI at the gynecologic outpatient clinic of a hospital were retrospectively reviewed. The treatment was once a week for eight weeks. Vaginal health index (VHI) and questionnaires before and after treatment for evaluation of lower urinary tract symptoms (LUTS) and quality of life are the outcome assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| genitourinary symptoms of menopause | – | Device: Low-level laser therapyWomen with genitourinary symptoms of menopause (GSM). Menopause was defined as no spontaneous menstruation for at least one year. GSM defined as vulvovaginal dryness and related symptoms, such as irritation, dyspareunia, or lower urinary tract symptom (LUTS) including urinary urgency, dysuria and recurrent urinary tract infection after menopause . |
| stress urinary incontinence | – | Device: Low-level laser therapyWomen with stress urinary incontinence (SUI). SUI was defined as involuntary loss of urine on effort or physical exertion including sporting activities, or on sneezing or coughing. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The consecutive women who received LLLT at the gynecologic outpatient clinic were retrospectively reviewed. Menopause was defined as no spontaneous menstruation for at least one year. GSM is defined as vulvovaginal dryness and related symptoms, such as irritation, dyspareunia, or lower urinary tract symptoms (LUTS) including urinary urgency, dysuria, and recurrent urinary tract infection after menopause. SUI was defined as involuntary loss of urine on effort or physical exertion including sporting activities, or on sneezing or coughing.
Key inclusion criteria (2 listed)
- women with GSM and SUI
- Received LLLT at the gynecologic outpatient clinic
Key exclusion criteria (5 listed)
- More or equal to stage 2 pelvic organ prolapse defined by pelvic organ prolapse-quantification system
- Ongoing urinary tract infection or vaginitis with the pathogen in the previous 2 weeks
- Bladder calculus
- Neurogenic bladder due to radical hysterectomy or injury of the central nervous system
- A preexisting malignant pelvic tumor.
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 |
|---|---|---|
| Low-level laser therapyThe treatment was once a week for eight weeks. The patient was in a supine position. The gain medium of the laser was Gallium-Aluminum-Arsenide. The laser was introduced into vagina via a silicon vaginal probe inserted by a doctor for 30 minutes (wavelength 660nm, power density 18.17mW/cm2, energy density 0.018J/cm2s, total energy density 32.4J/cm2). | Device | genitourinary symptoms of menopause, stress urinary incontinence |
Primary outcome
Vaginal health
Time frame: 8 weeks
Vaginal health index, each of these 5 items is evaluated by means of a scale from 1 (none) to 5 (excellent) and then the average of the scores is calculated. A value of ≤15 (= cut-off) is generally considered for the diagnosis of low vaginal health.
1 secondary outcome
Urinary incontinence
Time frame: 8 weeks
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 18 Nov 2023.
- Results publication: PubMed 33534428Phillips NA, Bachmann GA. The genitourinary syndrome of menopause. Menopause. 2021 Feb 1;28(5):579-588. doi: 10.1097/GME.0000000000001728.
- Results publication: PubMed 28364861Gambacciani M, Palacios S. Laser therapy for the restoration of vaginal function. Maturitas. 2017 May;99:10-15. doi: 10.1016/j.maturitas.2017.01.012. Epub 2017 Feb 4.
- Results publication: PubMed 35236871Long CY, Wu PC, Chen HS, Lin KL, Loo Z, Liu Y, Wu CH. Changes in sexual function and vaginal topography using transperineal ultrasound after vaginal laser treatment for women with stress urinary incontinence. Sci Rep. 2022 Mar 2;12(1):3435. doi: 10.1038/s41598-022-06601-0.
- Results publication: PubMed 25491701Rola P, Doroszko A, Derkacz A. The Use of Low-Level Energy Laser Radiation in Basic and Clinical Research. Adv Clin Exp Med. 2014 September-October;23(5):835-842. doi: 10.17219/acem/37263.
- Results publication: PubMed 8694033Bump RC, Mattiasson A, Bo K, Brubaker LP, DeLancey JO, Klarskov P, Shull BL, Smith AR. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol. 1996 Jul;175(1):10-7. doi: 10.1016/s0002-9378(96)70243-0.
- Results publication: PubMed 31157569Palacios S. Assessing symptomatic vulvar, vaginal, and lower urinary tract atrophy. Climacteric. 2019 Aug;22(4):348-351. doi: 10.1080/13697137.2019.1600499.
- Results publication: PubMed 18351586Huang L, Zhang SW, Wu SL, Ma L, Deng XH. The Chinese version of ICIQ: a useful tool in clinical practice and research on urinary incontinence. Neurourol Urodyn. 2008;27(6):522-4. doi: 10.1002/nau.20546.
- Individual participant dataSharing planned: No. The datasets analyzed during the study are available from the corresponding author on reasonable request.
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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.
Pei-chi Wu principal investigator
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?
An observational study of Vaginal Atrophy and Urinary Incontinence,Stress, 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 2 inclusion and 5 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 18 Nov 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?
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?
Vaginal health (time frame: 8 weeks). 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 NCT06136975, which also lists 7 linked publications.
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 18 Nov 2023.