Pelvic floor dysfunction Musculoskeletal Diseases
Conditions
Interventions
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
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, poste
transient post-procedural sensations (local warmth, mild stinging, watery discharge, transient vulvovaginal erythema/edema) were recorded separately from adverse events (persistent pain, dysuria, vagi
Sponsors
RAPbarcelona, Spain
Eligibility
Sex/Gender
Female
Age
18 Years to 90 Years
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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): 1. The vaginal hiatus was assessed following the criteria set forth by the joint report of the International Continence Society and the International Urogynecological Association (ICS/IUGA) on terminology for female pelvic floor dysfunction 2. Total vaginal length was defined as the distance in centimeters from the posterior fornix to the hymen, with point C or D reduced to its normal position. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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): 1. Pelvic floor muscle strength was assessed by vaginal palpation using the Oxford scale 2. Sexual function was evaluated with the self-administered Female Sexual Function Index (FSFI), which assesses six domains (desire, arousal, lubrication, orgasm, satisfaction, pain) | — |
Countries
Spain
Contacts
Public ContactInés Ramirez Garcia
Outcome results
None listed