Non-ablative laser in genitourinary menopause syndrome
| ISRCTN | ISRCTN52370656 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52370656 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | RAPbarcelona |
| Funder | RAPbarcelona |
- Submission date
- 25/08/2025
- Registration date
- 31/08/2025
- Last edited
- 27/08/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Genitourinary syndrome of menopause (GSM) negatively impacts quality of life in postmenopausal women. This study aimed to evaluate the effects of non-ablative Er:YAG laser therapy on anatomical, functional, and subjective outcomes in women with GSM.
Who can participate?
Postmenopausal women with GSM
What does the study involve?
Participants underwent two sessions of non-ablative vaginal laser (IncontiLase® and IntimaLase®). Clinical evaluations were performed at baseline, first follow-up, and second follow-up. Instruments included sexual functions, incontinence, quality of life, and pelvic health
What are the possible benefits and risks of participating?
Participants may benefit from a potential reduction of symptoms related to GSM, such as improvement in vaginal anatomy, reduction in cystocele, and enhancement in certain quality-of-life domains (e.g., social embarrassment, psychosocial impact, and behavioral limitations). Some women may also experience a decrease in pain during sexual activity.
The risks associated with participation are minimal, as the procedure involves non-ablative Er:YAG laser therapy. Possible adverse effects may include temporary discomfort, mild vaginal irritation, or transient changes in arousal. No major complications have been reported in previous studies, and the intervention is considered safe.
Where is the study run from?
RAPbarcelona, Spain
When is the study starting and how long is it expected to run for?
January 2024 to January 2025
Who is funding the study?
1. RAPbarcelona, Spain, supports the research
2. The Faculty of Health Sciences Blanquerna – Ramon Llull University will support review, translation, and publication costs
Who is the main contact?
Prof Inés Ramírez-García, inesrg@blanquerna.url.edu, iraga73@gmail.com
Contact information
Public, Scientific, Principal investigator
RAPbarcelona
Avinguda Diagonal 363, 3-2
Barcelona
08037
Spain
 ORCID ID |
0000-0002-1058-0577 |
|---|---|
| Phone | +34 93 677745765 |
| inesrg@blanquerna.url.edu |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective single-arm pre-post interventional study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Impact of non-ablative Er:YAG laser on genitourinary menopause syndrome: prospective interventional study |
| Study acronym | NALinGMS |
| Study objectives | Genitourinary syndrome of menopause (GSM) negatively impacts quality of life in postmenopausal women. This study aimed to evaluate the effects of non-ablative Er:YAG laser therapy on anatomical, functional, and subjective outcomes in women with GSM. |
| Ethics approval(s) |
Approved 14/01/2024, Ramon Llull University Research Ethics Committee (CER)-FCSB (Padilla, 326-332, Barcelona, 08025, Spain; +34 93 253 32 56; bsalutcer@blanquerna.url.edu), ref: 2024/01/01 |
| Health condition(s) or problem(s) studied | Genitourinary menopause syndrome |
| Intervention | Each subject underwent treatment using the IncontiLase® and/or IntimaLase® protocols, delivered through a non-ablative Er:YAG laser device (model SP DYNAMIS, S/N 14003339). The laser applies controlled photothermal energy to elevate epithelial temperatures to approximately 65 °C, promoting collagen remodeling and mucosal tightening. Two sessions were scheduled per participant with an intersession interval of 6–8 weeks. A third session was prescribed selectively, based on individual clinical progression and medical criteria. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Vaginal anatomical outcomes (Anatomical assessments involved measuring vaginal hiatus and total vaginal length) measured using a Sims speculum to retract vaginal walls and enable direct visualization. The vaginal hiatus was recorded as the maximal transverse distance between the vaginal borders during a Valsalva maneuver, and total vaginal length was measured from the posterior fornix to the hymenal ring, with manual repositioning of point C or D when required. These measures were conducted at three specific time points. The baseline evaluation (EB) was performed before the first laser session. The first follow-up (FU1) took place between 6 and 8 weeks after the initial treatment, while the second follow-up (FU2) was scheduled 6 to 8 weeks after the second laser session. |
| Key secondary outcome measure(s) |
The following secondary outcome measures were assessed at the baseline evaluation (EB) before the first laser session, the first follow-up (FU1) between 6 and 8 weeks after the initial treatment, and the second follow-up (FU2) 6 to 8 weeks after the second laser session: |
| Completion date | 25/01/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 49.11 Years |
| Upper age limit | 67.1 Years |
| Sex | Female |
| Target sample size at registration | 47 |
| Total final enrolment | 47 |
| Key inclusion criteria | 1. Treated at the participating unit 2. Presented with clinical manifestations of GSM such as vaginal dryness, dyspareunia, a sensation of laxity, urinary incontinence, or sexual dysfunction 3. Written informed consent obtained before enrollment |
| Key exclusion criteria | 1. Not having menopause or GMS 2. No written informed consent |
| Date of first enrolment | 27/01/2024 |
| Date of final enrolment | 03/10/2024 |
Locations
Countries of recruitment
- Spain
Study participating centre
Barcelona
08037
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated and analysed during the current study will be available upon request from Prof Inés Ramírez García (inesrg@blanquerna.url.edu); type of data: all raw data; timing: not yet known; consent obtained: yes; anonymization: coded/anonymous; restrictions: none; additional comments: none. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
27/08/2025: Study's existence confirmed by the Faculty of Health Sciences Blanquerna - Ramon Llull University Research Ethics Committee (CER)-FCSB, Spain.
