Non-ablative laser in genitourinary menopause syndrome

ISRCTN ISRCTN52370656
DOI https://doi.org/10.1186/ISRCTN52370656
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Prof Inés Ramírez-García
Public, Scientific, Principal Investigator

RAPbarcelona
Avinguda Diagonal 363, 3-2
Barcelona
08037
Spain

ORCiD logoORCID ID 0000-0002-1058-0577
Phone +34 93 677745765
Email inesrg@blanquerna.url.edu

Study information

Study designProspective single-arm pre-post interventional study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Other therapist office
Study typeQuality of life, Treatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleImpact of non-ablative Er:YAG laser on genitourinary menopause syndrome: prospective interventional study
Study acronymNALinGMS
Study objectivesGenitourinary 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) studiedGenitourinary menopause syndrome
InterventionEach 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 typeProcedure/Surgery
Primary outcome measureVaginal 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.
Secondary outcome measuresThe 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:
1. Sexual function measured using the Female Sexual Function Index (FSFI)
2. Incontinence severity measured using the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
3. Quality of life measured using the Incontinence Quality of Life Questionnaire (I-QOL)
4. The pelvic floor strength measured using the Oxford Grading Scale for Pelvic Floor Muscle Strength
Overall study start date01/01/2024
Completion date25/01/2025

Eligibility

Participant type(s)Patient
Age groupMixed
Lower age limit49.11 Years
Upper age limit67.1 Years
SexFemale
Target number of participants47
Total final enrolment47
Key inclusion criteria1. 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 criteria1. Not having menopause or GMS
2. No written informed consent
Date of first enrolment27/01/2024
Date of final enrolment03/10/2024

Locations

Countries of recruitment

  • Spain

Study participating centre

RAPbarcelona
Avinguda Diagonal 263
Barcelona
08037
Spain

Sponsor information

RAPbarcelona
Hospital/treatment centre

Avinguda Diagonal 363, 3-2
RAPbarcelona-Inés Ramírez
Barcelona
08037
Spain

Website https://rapbarcelona.com/

Funders

Funder type

Hospital/treatment centre

RAPbarcelona

No information available

Results and Publications

Intention to publish date01/09/2025
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned dissemination activities include the submission of the study results to peer-reviewed scientific journals related to pelvic health and physiotherapy, preferably indexed in JCR Q3 or Q4 (e.g., International Urogynecology Journal, Urogynecology, or JWPHPT). Additionally, results will be presented at relevant national and international conferences on pelvic floor rehabilitation, women's health, or physical therapy. Communication to clinical and academic communities will also be promoted through professional networks, institutional channels, and, when appropriate, social media platforms to enhance accessibility and impact.
IPD sharing planThe 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.

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.