Exploring how gentle vaginal laser treatment may help women with pelvic floor problems
| ISRCTN | ISRCTN11575756 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11575756 |
| Sponsor | RAPbarcelona, Spain |
| Funders | RAPbarcelona, The Faculty of Health Sciences Blanquerna- Ramon Llull University |
- Submission date
- 15/11/2025
- Registration date
- 18/11/2025
- Last edited
- 18/11/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Pelvic floor dysfunction is a common condition in women that can cause symptoms such as a feeling of vaginal bulging, discomfort, and sexual difficulties. Many women want treatments that work but are not invasive. This study looks at whether a gentle laser treatment called non-ablative Er:YAG laser can improve the structure and function of the vagina in the short term. We are interested in whether the treatment can reduce the size of the vaginal opening, change vaginal length, or improve sexual function.
Who can participate?
Women diagnosed with pelvic floor dysfunction who meet the study’s eligibility criteria.
What does the study involve?
Participants receive one to three laser treatment sessions. Measurements and questionnaires are completed before treatment, about 6–8 weeks after the first session, and again 6–8 weeks after the second session. We check changes in vaginal measurements, pelvic organ support, and sexual function, and monitor for any side effects.
What are the possible benefits and risks of participating?
The treatment may improve symptoms related to pelvic floor dysfunction, but this is not guaranteed. There may be mild side effects, which will be monitored during the study.
Where is the study run from?
RAP Barcelona (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?
RAP Barcelona (Spain)
Who is the main contact?
Inés Ramírez García (ines.ramirez@rapbarcelona.com)
Contact information
Public, Scientific, Principal investigator
Avinguda Diagonal 363, 3-2
Barcelona
08037
Spain
 ORCID ID |
0000-0002-1058-0577 |
|---|---|
| Phone | +34 677745765 |
| inesrg@blanquerna.url.edu |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | A prospective single-arm pre-post interventional study |
| Secondary study design | Non randomised study |
| Scientific title | Anatomical and functional effects of non-ablative vaginal laser in women with pelvic floor dysfunction: a prospective single-arm interventional study |
| Study acronym | NAVILAS |
| Study objectives | To evaluate short-term changes in vaginal hiatus, vaginal length, and sexual function following non-ablative laser therapy in women with PFD. |
| Ethics approval(s) |
Approved 24/01/2024, Ramon Llull University Ethics Committee -FCSB (Padilla, 326-332, Barcelona, 08025, Spain; +34 932533256; bsalutcer@blanquerna.url.edu), ref: 2024/01/01 |
| Health condition(s) or problem(s) studied | Pelvic floor dysfunction |
| Intervention | The intervention consisted of IncontiLase® and IntimaLase® protocols delivered with the SP DYNAMIS system (S/N 14003339), aiming for controlled mucosal heating to approximately 65 °C to promote tissue tightening and collagen remodeling. Two sessions were administered 6–8 weeks apart by experienced operators; analgesia was provided as needed, eye protection and antiseptic preparation were used, and standard post-procedure instructions were given. The total pulse energy delivered to the anterior wall, posterior wall, 360° region, and vulvar region was recorded per session. Safety was assessed clinically at each treatment and follow-up visit; transient post-procedural sensations (local warmth, mild stinging, watery discharge, transient vulvovaginal erythema/edema) were recorded separately from adverse events (persistent pain, dysuria, vaginal spotting, irritation, or vaginal/urinary tract infection). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
At baseline (prior to the first laser session), follow-up 1 (6–8 weeks after the first session), follow-up 2 (6–8 weeks after the second session): |
| Key secondary outcome measure(s) |
At baseline (prior to the first laser session), follow-up 1 (6–8 weeks after the first session), follow-up 2 (6–8 weeks after the second session): |
| Completion date | 25/01/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 90 Years |
| Sex | Female |
| Target sample size at registration | 163 |
| Total final enrolment | 163 |
| Key inclusion criteria | 1. Women self-reported symptoms of pelvic floor dysfunction, which could include urinary incontinence, pelvic organ prolapse, or sexual dysfunction. 2. They perceived vaginal laxity, defined as a score of 4 or higher on the Vaginal Laxity Questionnaire (VLQ). 3. They were able to complete validated questionnaires used in the study. 4. They provided written informed consent to participate. 5. They authorized the use of their anonymized clinical data for research purposes. |
| Key exclusion criteria | 1. Previous vaginal laser therapy 2. Contraindications to non-ablative vaginal laser 3. Concomitant interventions expected to confound outcomes during the evaluation period, such as pelvic floor physiotherapy, vaginal radiofrequency, or other concurrent treatments |
| 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 | Available on request. The datasets generated and analysed during the current study will be available upon request from Prof. In (és Ramírez-García (inesrg@blanquerna.url.edu); type of data: all raw data; timing. not yet known; consent obtained: yes; anonymiztion: coded/anonymous; restrictions: none; additional comments: none |
Editorial Notes
17/11/2025: Trial's existence confirmed by Ramon Llull University Ethics Committee -FCSB.
