Non-ablative laser in genitourinary menopause syndrome

Impact of non-ablative Er:YAG laser on genitourinary menopause syndrome: prospective interventional study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN52370656

Enrollment

Registered

2025-08-31

Start date

2024-01-27

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genitourinary menopause syndrome Urological and Genital Diseases

Interventions

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 controlle

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Not having menopause or GMS 2. No written informed consent

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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: 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	—

Measure

Time frame

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: 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

—

Countries

Spain

Contacts

Public ContactInés Ramírez-García

inesrg@blanquerna.url.edu+34 93 677745765

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026