Laser-Induced ScarNCT03238053
Laser Treatment of Genito-urinary Syndrome in Women
A study testing Vaginal laser treatment and laser system in people with Laser-Induced Scar and Breast Cancer, run by Herning Hospital at 1 site in Denmark.
Trial summary
Women with genitourinary syndrome of menopause, overactive bladder, with breast or endometrial cancer are randomized to either laser treatment og sham treatment for 3 months. The randomization is stratified for estrogen treatment. The effect is evaluated by questionnaire, histology and microbiology swaps Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Laser-Induced Scar, Breast Cancer, Endometrial Cancer
- What is being tested?
- Vaginal laser treatment and laser system
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2022to 31 Dec 2026
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- menopause i.e. age more than 50 years and absence of menstruation for twelve months
- breast cancer
- endometrial cancer
- symptoms of vaginal dryness
- dyspareunia rated as moderate or severe most bothersome symptoms
Who cannot join
- use of vaginal moisturizers, lubricants or any other local preparation within the thirty days prior to inclusion
- acute or recurrent urinary tract infections
- active genital infections i.e. herpes genitalis, candida
- previous reconstructive pelvic surgery
- pelvis organ prolapse stage 2
- any serious disease or chronic condition that could interfere with study compliance except from breast and endometrial cancer
- psychiatric disorders precluding informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laser Treatment of Genito-urinary Syndrome in Women With Breast and Endometrial Cancer and Menopausal Women
Women with genitourinary syndrome of menopause, overactive bladder, with breast or endometrial cancer are randomized to either laser treatment og sham treatment for 3 months. The randomization is stratified for estrogen treatment. The effect is evaluated by questionnaire, histology and microbiology swaps
Read the detailed description
Genitourinary syndrome of menopause (GSM) is characterized by symptoms such as vaginal dryness, dyspareunia, irritation, urinary incontinence, overactive bladder , and urinary tract infections. GSM replaces the previous term vulvovaginal atrophy as agreed upon by a joint terminology conference sponsored by the North American Menopause Society and the International Society for the Study of Women's Sexual Health. GSM is a new terminology more accurate than the terms of VVA/atrophic vaginitis, because it describes the clinical signs and symptoms of the vulva, vagina and lower urinary system. In contrast, VVA/atrophic vaginitis describes the appearance of the vulvovaginal structures only. The GSM has a prevalence of more or less 50%, depending on country of origin, with a negative impact on sexuality, quality of life and well-being.
The aging process is genetically determined and environmentally modulated. Estrogen deficiency occurring after menopause causes a series of modifications in many different areas of the female body, including the pelvic floor. Menopause can, therefore, lead to functional genital or urinary symptoms impacting women's quality of life. It is debatable to which extent modifications and symptoms occurring after menopause are related to estrogen deficiency or to the aging process per se. Vulvovaginal atrophy (VVA) involves histological, morphological, microbiological, and clinical changes. These include alteration in collagens, decreased quantity of elastic fibers, reduced vascularization, thinning and flattening of the vaginal epithelium, and production of glycogen, an essential factor for the growth of vaginal lactobacilli. As a consequence, the vaginal canal becomes shorter and narrower, and the vaginal epithelium becomes paler and more likely to develop petechiae. Further, a decrease in Lactobacillus species and a rise of vaginal pH values over 4.5 are observed, resulting in the loss of the local vaginal defense mechanisms against bacterial pathogens, which may predispose to local inflammation and/or infections.
Women with VVA commonly complain of vaginal dryness, burning, irritation or itching, and dyspareunia. Local estrogens represent the first-line therapy for VVA. However, women's compliance with and preference for this treatment are poor; alternatives and palliative solutions, such as moisturizing or lubricant local creams or gels, are commonly proposed. In recent years, fractional CO 2 laser has become a popular, efficient, precise, and safe system, particularly for dermatologists and plastic surgeons. CO 2 laser has many applications, including treatment of skin lesions (ie, seborrheic keratosis, syringomas, and xanthelasmas around the eye), warts, and toenail diseases, as well as anti-aging function.
Various therapeutic strategies, hormonal or not, oral or local, have been proposed for the improvement of the vaginal microecosystem of postmenopausal women (e.g. estrogens, probiotics, combination of vaginal estrogens with live Lactobacillus). Hormonal therapy (oral or local) has been associated with a healthier vaginal microecosystem by repopulating the Lactobacillus species to a premenopausal status and by reducing the pH of vaginal fluid.
In women treated for estrogen dependent cancer i.e. endometrial and breast cancer women and practioners are reluctant to use estrogens and favor non-hormonal treatment modalities. The effect of these on the histological, microbiological and clinical symptoms is poorly understood and lack randomized trials to evaluate effect. Several proof of concept and feasibility studies have shown clinical effects of laser as potential treatment but little is known if it can stand alone or if supplementation with estrogens may benefit the clinical symptoms and vulvovaginal environment further. Thus, the ideal management for the achievement of the optimal benefit - risk balance is still under investigation. The choice of treatment is often guided by clinical experience and patient preference.
In postmenopausal women, the disturbance of Lactobacillary flora was correlated with the presence of Gardnerella vaginalis, Trichomonas vaginalis, enterococci, group B streptococci, and Escherichia coli. Available data indicate that pre-existing vaginal colonization with pathogenic enterobacteria is essential for the appearance and recurrence of urinary tract infections (UTIs). Indeed, postmenopausal women are prone to UTIs with an incidence of about 8% per year and a 4% likelihood of recurrence, while symptomatic bacteriuria was estimated in up to 15% of women. The general population of lactobacilli, as assessed in the routine practice, provides indirect information regarding the estrogenic status. To our knowledge there is currently no evidence regarding the potential impact that the intravaginal laser therapy may have on the vaginal microenvironment in women with symptoms of GSM.
Laser treatment improves significantly the VVA symptoms, sexual function and quality of life of postmenopausal women, as well as the vaginal health index. Other studies found restored thickness of the squamous stratified epithelium of the vaginal mucosa with a significant storage of glycogen in the epithelial cells and remodelling the vaginal connective tissue with the production of new collagen and ground substance molecules.
Breast cancer is the most common cancer in women in Denmark, annually ca. 4600 women are diagnosed with the disease, of whom 30% are under the age of 55. Most patients undergo breast conserving surgery followed by adjuvant therapy. Adjuvant therapy varies according to stage of disease, but radiotherapy is often added, as well as chemotherapy. If the cancer is hormonally responsive, long term antihormonal treatment is also given, such as the selective estrogen receptor modulator (SERM) tamoxifen for pre-menopausal women, that works as a inhibitor of estrogen in breast tissue, but as an estrogen in other tissues such as the endometrium. Post-menopausal women with hormone responsive breast cancer are treated with aromatase inhibitors for five years. Most side effects associated with tamoxifen (TAM) and aromatase inhibitors (AIs) are related to estrogen deprivation, and the symptoms are similar to those experienced during natural menopause. It has been reported that up to 50-75% of breast cancer survivors experience one or more genitourinary symptoms and puts the sexual life of women under stress. Postmenopausal women may have many common age-related symptoms but also have the above mentioned iatrogenic factors entering their lives to aggravate the symptom complex.
The aim of the current study was to assess the effect of laser laser therapy with and without local estrogens. The study groups consist of 1) postmenopausal women and 2 ) women treated for breast cancer. The laser treatment was given randomized to these women. The effects were evaluated in the histopathology of the vagina, the vaginal microenvironment, and health related questionnaires.
- Conditions
- Laser-Induced Scar, Breast Cancer, Endometrial Cancer, Menopause, Vaginal Atrophy, Bladder, Overactive
- Being tested
- Vaginal laser treatment, sham, laser system
- Keywords
- laser treatment, randomized trial, menopause, vaginitis, urge
- Medical subject headings
- Breast Neoplasms, Endometrial Neoplasms, Urinary Bladder, Overactive, Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal laser treatmentProcedure or surgery
Fractional CO 2 laser system (SmartXide 2 V 2 LR,DEKA, Florence, Italy), using the following setting: dot power 30 watt, dwell time 1000 μ s, dot spacing 1000 μ m and the smart stack parameter from 1 to 3. The laser beam is provided using a vaginal probe, which is gently inserted up to the top of the vaginal canal and subsequently withdrawn and rotated in order to provide a complete treatment of the vaginal wall. At the level of the vaginal introitus, the dot power is decreased to 20 watt 27 . A treatment cycle includes three laser applications (every 4 weeks). The procedure is performed in the outpatient clinic and does not require any specific preparation (e.g. analgesia/anesthesia).
shamDevice
Fractional CO 2 laser system (SmartXide 2 V 2 LR,DEKA, Florence, Italy), using the following setting: dot power 30 watt, dwell time 1000 μ s, dot spacing 1000 μ m and the smart stack parameter from 1 to 3. The laser beam is provided using a vaginal probe, which is gently inserted up to the top of the vaginal canal and subsequently withdrawn and rotated in order to provide a complete treatment of the vaginal wall. At the level of the vaginal introitus, the dot power is decreased to 20 watt 27 . A treatment cycle includes three laser applications (every 4 weeks). The procedure is performed in the outpatient clinic and does not require any specific preparation (e.g. analgesia/anesthesia).
laser systemDevice
FractionalCO 2 laser system (SmartXide 2 V 2 LR,DEKA, Florence, Italy), using the following setting: dot power 30 watt, dwell time 1000 μ s, dot spacing 1000 μ m and the smart stack parameter from 1 to 3. The laser beam is provided using a vaginal probe, which is gently inserted up to the top of the vaginal canal and subsequently withdrawn and rotated in order to provide a complete treatment of the vaginal wall. At the level of the vaginal introitus, the dot power is decreased to 20 watt 27 . A treatment cycle includes three laser applications (every 4 weeks). The procedure is performed in the outpatient clinic and does not require any specific preparation (e.g. analgesia/anesthesia).
| Study group | Role | What they receive |
|---|---|---|
| Menopausal Laser | Active comparator | 20 women with vaginal laser treatment Receives: Procedure: Vaginal laser treatment; Device: laser system |
| Menopausal sham | Sham comparator | 20 women with probe, no active laser ray Receives: Device: sham |
| breast cancer laser | Active comparator | 20 women with breast cancer with vaginal laser treatment Receives: Procedure: Vaginal laser treatment; Device: laser system |
| breast cancer sham | Sham comparator | 20 women with breast cancer with vaginal probe, no active laser rays Receives: Device: sham |
| endometrial cancer laser | Active comparator | 20 women with endometrial cancer with vaginal laser treatment Receives: Procedure: Vaginal laser treatment; Device: laser system |
| endometrial cancer sham | Sham comparator | 20 women with endometrial cancer with vaginal probe, no active laser rays Receives: Device: sham |
| overactive bladder laser | Active comparator | 20 women with overactive bladder with vaginal laser treatment Receives: Procedure: Vaginal laser treatment; Device: laser system |
| Overactive bladder sham | Sham comparator | 20 women with overactive bladder with vaginal probe, no active laser rays Receives: Device: sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue score on vaginal symptoms
10-cm VAS to measure the overall satisfaction with vaginal symptoms, where the left extreme of the scale indicated ' the worst level of satisfaction ' and the right indicated ' the best level of satisfaction
Measured: three months
Secondary outcomes (2)
histopathology
Qualitative analysis of the microscopic and ultrastructural aspects of the collagenic and elastic components of the matrix is performed. A specific image analysis with computerized morphometry is performed to demonstrate the specific action of CO2 laser and possibly to correlate the modifications of the ultrastructural pattern with specific molecular modifications. We also consider the fine cytological aspects of connective tissue proper cells, particularly fibroblasts, under the conditions of the specific laser stimulation.
Measured: three months
microbiology
a sterile swab is inserted into the vaginal canal and a sample obtained from the posterior fornix of the vagina. Vaginal samples are placed in a transport gel (Stuart). pH indicator strips (MColorpHastTM, Merck, Germany) are applied against the lateral vaginal wall using sterile forceps, followed by a vaginal lavage for wet mount. Smears from vaginal samples are placed on a glass slide, observed under microscope for Trichomonas vaginalis and Candida species and stained afterwards according to standard Gram stain procedure. Cultures for aerobic and anaerobic bacteria species are performed, using MacConkey agar, blood agar, Sabouraud dextrose agar, chocolate agar as culture media, focusing on bacteria with potential clinical impact (e.g. aerobic vaginitis39, UTIs, vaginal candidiasis).
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start1 Oct 2022 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: Hospital terminated treatment with laser
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Laser-Induced ScarStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Four Groups of women randomized for thre months to either laser og sham treatment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herning Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Finn Lauszus, Herning Hospital
- Investigators
- Sine Jakobsen, MD, PhD, Principal investigator, Randers Regional HospitalFinn F Lauszus, Study chair, Herning Hopsital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238053
- Sponsor's protocol ID
- Laser treatment
- Status last verified
- Oct 2024
- First submitted
- 1 Aug 2017
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Salvatore S, Nappi RE, Parma M, Chionna R, Lagona F, Zerbinati N, Ferrero S, Origoni M, Candiani M, Leone Roberti Maggiore U. Sexual function after fractional microablative CO(2) laser in women with vulvovaginal atrophy. Climacteric. 2015 Apr;18(2):219-25. doi: 10.3109/13697137.2014.975197. Epub 2014 Dec 16.
PubMed 25333211Salvatore S, Leone Roberti Maggiore U, Athanasiou S, Origoni M, Candiani M, Calligaro A, Zerbinati N. Histological study on the effects of microablative fractional CO2 laser on atrophic vaginal tissue: an ex vivo study. Menopause. 2015 Aug;22(8):845-9. doi: 10.1097/GME.0000000000000401.
PubMed 25608269Athanasiou S, Pitsouni E, Antonopoulou S, Zacharakis D, Salvatore S, Falagas ME, Grigoriadis T. The effect of microablative fractional CO2 laser on vaginal flora of postmenopausal women. Climacteric. 2016 Oct;19(5):512-8. doi: 10.1080/13697137.2016.1212006. Epub 2016 Aug 24.
PubMed 27558459Ippolito GM, Crescenze IM, Sitto H, Palanjian RR, Raza D, Barboglio Romo P, Wallace SA, Orozco Leal G, Clemens JQ, Dahm P, Gupta P. Vaginal lasers for treating stress urinary incontinence in women. Cochrane Database Syst Rev. 2025 Jul 25;7(7):CD013643. doi: 10.1002/14651858.CD013643.pub2.
PubMed 40709601
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Treatment of Genito-urinary Syndrome in Women With Breast and Endometrial Cancer and Menopausal Women
- ClinicalTrials.gov ID
- NCT03238053
- Acronym / sponsor ID
- Laser treatment
- Conditions
- Laser-Induced Scar, Breast Cancer, Endometrial Cancer, Menopause, Vaginal Atrophy, Bladder, Overactive
- Keywords
- laser treatment, randomized trial, menopause, vaginitis, urge
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Hospital terminated treatment with laser
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Herning HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Aug 2017 (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.
Women with genitourinary syndrome of menopause, overactive bladder, with breast or endometrial cancer are randomized to either laser treatment og sham treatment for 3 months. The randomization is stratified for estrogen treatment. The effect is evaluated by questionnaire, histology and microbiology swaps
Detailed description
Genitourinary syndrome of menopause (GSM) is characterized by symptoms such as vaginal dryness, dyspareunia, irritation, urinary incontinence, overactive bladder , and urinary tract infections. GSM replaces the previous term vulvovaginal atrophy as agreed upon by a joint terminology conference sponsored by the North American Menopause Society and the International Society for the Study of Women's Sexual Health. GSM is a new terminology more accurate than the terms of VVA/atrophic vaginitis, because it describes the clinical signs and symptoms of the vulva, vagina and lower urinary system. In contrast, VVA/atrophic vaginitis describes the appearance of the vulvovaginal structures only. The GSM has a prevalence of more or less 50%, depending on country of origin, with a negative impact on sexuality, quality of life and well-being.
The aging process is genetically determined and environmentally modulated. Estrogen deficiency occurring after menopause causes a series of modifications in many different areas of the female body, including the pelvic floor. Menopause can, therefore, lead to functional genital or urinary symptoms impacting women's quality of life. It is debatable to which extent modifications and symptoms occurring after menopause are related to estrogen deficiency or to the aging process per se. Vulvovaginal atrophy (VVA) involves histological, morphological, microbiological, and clinical changes. These include alteration in collagens, decreased quantity of elastic fibers, reduced vascularization, thinning and flattening of the vaginal epithelium, and production of glycogen, an essential factor for the growth of vaginal lactobacilli. As a consequence, the vaginal canal becomes shorter and narrower, and the vaginal epithelium becomes paler and more likely to develop petechiae. Further, a decrease in Lactobacillus species and a rise of vaginal pH values over 4.5 are observed, resulting in the loss of the local vaginal defense mechanisms against bacterial pathogens, which may predispose to local inflammation and/or infections.
Women with VVA commonly complain of vaginal dryness, burning, irritation or itching, and dyspareunia. Local estrogens represent the first-line therapy for VVA. However, women's compliance with and preference for this treatment are poor; alternatives and palliative solutions, such as moisturizing or lubricant local creams or gels, are commonly proposed. In recent years, fractional CO 2 laser has become a popular, efficient, precise, and safe system, particularly for dermatologists and plastic surgeons. CO 2 laser has many applications, including treatment of skin lesions (ie, seborrheic keratosis, syringomas, and xanthelasmas around the eye), warts, and toenail diseases, as well as anti-aging function.
Various therapeutic strategies, hormonal or not, oral or local, have been proposed for the improvement of the vaginal microecosystem of postmenopausal women (e.g. estrogens, probiotics, combination of vaginal estrogens with live Lactobacillus). Hormonal therapy (oral or local) has been associated with a healthier vaginal microecosystem by repopulating the Lactobacillus species to a premenopausal status and by reducing the pH of vaginal fluid.
In women treated for estrogen dependent cancer i.e. endometrial and breast cancer women and practioners are reluctant to use estrogens and favor non-hormonal treatment modalities. The effect of these on the histological, microbiological and clinical symptoms is poorly understood and lack randomized trials to evaluate effect. Several proof of concept and feasibility studies have shown clinical effects of laser as potential treatment but little is known if it can stand alone or if supplementation with estrogens may benefit the clinical symptoms and vulvovaginal environment further. Thus, the ideal management for the achievement of the optimal benefit - risk balance is still under investigation. The choice of treatment is often guided by clinical experience and patient preference.
In postmenopausal women, the disturbance of Lactobacillary flora was correlated with the presence of Gardnerella vaginalis, Trichomonas vaginalis, enterococci, group B streptococci, and Escherichia coli. Available data indicate that pre-existing vaginal colonization with pathogenic enterobacteria is essential for the appearance and recurrence of urinary tract infections (UTIs). Indeed, postmenopausal women are prone to UTIs with an incidence of about 8% per year and a 4% likelihood of recurrence, while symptomatic bacteriuria was estimated in up to 15% of women. The general population of lactobacilli, as assessed in the routine practice, provides indirect information regarding the estrogenic status. To our knowledge there is currently no evidence regarding the potential impact that the intravaginal laser therapy may have on the vaginal microenvironment in women with symptoms of GSM.
Laser treatment improves significantly the VVA symptoms, sexual function and quality of life of postmenopausal women, as well as the vaginal health index. Other studies found restored thickness of the squamous stratified epithelium of the vaginal mucosa with a significant storage of glycogen in the epithelial cells and remodelling the vaginal connective tissue with the production of new collagen and ground substance molecules.
Breast cancer is the most common cancer in women in Denmark, annually ca. 4600 women are diagnosed with the disease, of whom 30% are under the age of 55. Most patients undergo breast conserving surgery followed by adjuvant therapy. Adjuvant therapy varies according to stage of disease, but radiotherapy is often added, as well as chemotherapy. If the cancer is hormonally responsive, long term antihormonal treatment is also given, such as the selective estrogen receptor modulator (SERM) tamoxifen for pre-menopausal women, that works as a inhibitor of estrogen in breast tissue, but as an estrogen in other tissues such as the endometrium. Post-menopausal women with hormone responsive breast cancer are treated with aromatase inhibitors for five years. Most side effects associated with tamoxifen (TAM) and aromatase inhibitors (AIs) are related to estrogen deprivation, and the symptoms are similar to those experienced during natural menopause. It has been reported that up to 50-75% of breast cancer survivors experience one or more genitourinary symptoms and puts the sexual life of women under stress. Postmenopausal women may have many common age-related symptoms but also have the above mentioned iatrogenic factors entering their lives to aggravate the symptom complex.
The aim of the current study was to assess the effect of laser laser therapy with and without local estrogens. The study groups consist of 1) postmenopausal women and 2 ) women treated for breast cancer. The laser treatment was given randomized to these women. The effects were evaluated in the histopathology of the vagina, the vaginal microenvironment, and health related questionnaires.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 8
- Model description
- Four Groups of women randomized for thre months to either laser og sham treatment
| Arm | Type | Receives |
|---|---|---|
| Menopausal Laser | Active comparator | Procedure: Vaginal laser treatment, Device: laser system20 women with vaginal laser treatment |
| Menopausal sham | Sham comparator | Device: sham20 women with probe, no active laser ray |
| breast cancer laser | Active comparator | Procedure: Vaginal laser treatment, Device: laser system20 women with breast cancer with vaginal laser treatment |
| breast cancer sham | Sham comparator | Device: sham20 women with breast cancer with vaginal probe, no active laser rays |
| endometrial cancer laser | Active comparator | Procedure: Vaginal laser treatment, Device: laser system20 women with endometrial cancer with vaginal laser treatment |
| endometrial cancer sham | Sham comparator | Device: sham20 women with endometrial cancer with vaginal probe, no active laser rays |
| overactive bladder laser | Active comparator | Procedure: Vaginal laser treatment, Device: laser system20 women with overactive bladder with vaginal laser treatment |
| Overactive bladder sham | Sham comparator | Device: sham20 women with overactive bladder with vaginal probe, no active laser rays |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- menopause i.e. age more than 50 years and absence of menstruation for twelve months
- breast cancer
- endometrial cancer
- symptoms of vaginal dryness
- dyspareunia rated as moderate or severe most bothersome symptoms
Key exclusion criteria (7 listed)
- use of vaginal moisturizers, lubricants or any other local preparation within the thirty days prior to inclusion
- acute or recurrent urinary tract infections
- active genital infections i.e. herpes genitalis, candida
- previous reconstructive pelvic surgery
- pelvis organ prolapse stage 2
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 treatmentFractional CO 2 laser system (SmartXide 2 V 2 LR,DEKA, Florence, Italy), using the following setting: dot power 30 watt, dwell time 1000 μ s, dot spacing 1000 μ m and the smart stack parameter from 1 to 3. The laser beam is provided using a vaginal probe, which is gently inserted up to the top of the vaginal canal and subsequently withdrawn and rotated in order to provide a complete treatment of the vaginal wall. At the level of the vaginal introitus, the dot power is decreased to 20 watt 27 . A treatment cycle includes three laser applications (every 4 weeks). The procedure is performed in the outpatient clinic and does not require any specific preparation (e.g. analgesia/anesthesia). | Procedure or surgery | Menopausal Laser, breast cancer laser, endometrial cancer laser, overactive bladder laser |
| shamFractional CO 2 laser system (SmartXide 2 V 2 LR,DEKA, Florence, Italy), using the following setting: dot power 30 watt, dwell time 1000 μ s, dot spacing 1000 μ m and the smart stack parameter from 1 to 3. The laser beam is provided using a vaginal probe, which is gently inserted up to the top of the vaginal canal and subsequently withdrawn and rotated in order to provide a complete treatment of the vaginal wall. At the level of the vaginal introitus, the dot power is decreased to 20 watt 27 . A treatment cycle includes three laser applications (every 4 weeks). The procedure is performed in the outpatient clinic and does not require any specific preparation (e.g. analgesia/anesthesia). | Device | Menopausal sham, Overactive bladder sham, breast cancer sham, endometrial cancer sham |
| laser systemFractionalCO 2 laser system (SmartXide 2 V 2 LR,DEKA, Florence, Italy), using the following setting: dot power 30 watt, dwell time 1000 μ s, dot spacing 1000 μ m and the smart stack parameter from 1 to 3. The laser beam is provided using a vaginal probe, which is gently inserted up to the top of the vaginal canal and subsequently withdrawn and rotated in order to provide a complete treatment of the vaginal wall. At the level of the vaginal introitus, the dot power is decreased to 20 watt 27 . A treatment cycle includes three laser applications (every 4 weeks). The procedure is performed in the outpatient clinic and does not require any specific preparation (e.g. analgesia/anesthesia). | Device | Menopausal Laser, breast cancer laser, endometrial cancer laser, overactive bladder laser |
Primary outcome
Visual analogue score on vaginal symptoms
Time frame: three months
10-cm VAS to measure the overall satisfaction with vaginal symptoms, where the left extreme of the scale indicated ' the worst level of satisfaction ' and the right indicated ' the best level of satisfaction
2 secondary outcomes
histopathology
Time frame: three months
microbiology
Time frame: three months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Background: PubMed 25333211Salvatore S, Nappi RE, Parma M, Chionna R, Lagona F, Zerbinati N, Ferrero S, Origoni M, Candiani M, Leone Roberti Maggiore U. Sexual function after fractional microablative CO(2) laser in women with vulvovaginal atrophy. Climacteric. 2015 Apr;18(2):219-25. doi: 10.3109/13697137.2014.975197. Epub 2014 Dec 16.
- Background: PubMed 25608269Salvatore S, Leone Roberti Maggiore U, Athanasiou S, Origoni M, Candiani M, Calligaro A, Zerbinati N. Histological study on the effects of microablative fractional CO2 laser on atrophic vaginal tissue: an ex vivo study. Menopause. 2015 Aug;22(8):845-9. doi: 10.1097/GME.0000000000000401.
- Background: PubMed 27558459Athanasiou S, Pitsouni E, Antonopoulou S, Zacharakis D, Salvatore S, Falagas ME, Grigoriadis T. The effect of microablative fractional CO2 laser on vaginal flora of postmenopausal women. Climacteric. 2016 Oct;19(5):512-8. doi: 10.1080/13697137.2016.1212006. Epub 2016 Aug 24.
- Derived from this study: PubMed 40709601Ippolito GM, Crescenze IM, Sitto H, Palanjian RR, Raza D, Barboglio Romo P, Wallace SA, Orozco Leal G, Clemens JQ, Dahm P, Gupta P. Vaginal lasers for treating stress urinary incontinence in women. Cochrane Database Syst Rev. 2025 Jul 25;7(7):CD013643. doi: 10.1002/14651858.CD013643.pub2.
- Individual participant dataSharing planned: No
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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.
Sine Jakobsen, MD, PhD principal investigator
Randers Regional Hospital
Finn F Lauszus study chair
Herning Hopsital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal laser treatment and laser system in people with Laser-Induced Scar and Breast Cancer, run by Herning Hospital at 1 site in Denmark.
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 7 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: withdrawn, as of the sponsor's last update on 16 Oct 2024. 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 Denmark. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Visual analogue score on vaginal symptoms (time frame: three months). 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 NCT03238053, which also lists 4 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 16 Oct 2024.