An interventional study of Photobiomodulation in Menopause, Urinary Incontinence and Atrophic Vaginitis, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 3 sites in France. Open to female participants. Per ClinicalTrials.gov, last updated 2025-12-31.
Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Other
Vulvovaginal atrophy is common after menopause, with a significant negative effect on quality of life. Large cohort studies have reported the prevalence of vaginal dryness to be between 27% and 55% and dyspareunia between 32% and 41%. Management of urogenital atrophy includes lifestyle modification, nonhormonal treatments (vaginal lubricants or moisturizers, laser treatments), as well as hormonal treatments. The disadvantages of the non-surgical methods are average results, discontinuation, and frequent contraindications to hormonal treatments.This has led to a strong interest in the development of non-invasive or minimally invasive methods that are easy to implement, effective and durable.
Photobiomodulation therapy (PBMT) has been proposed as an alternative for the treatment of genitourinary menopausal syndrome (GMS) and stress urinary incontinence. PBMT devices exert their effect via non-thermal mechanisms. PBMT stimulates collagen and elastin synthesis in the vaginal tissue, to support the urethrovaginal sphincter and urethra, and to promote vasodilation in the vaginal and urethral submucosa. PHYSIOQUANTA has developed a vaginal probe coupled with its innovative MILTA™ process synergistically combining NPCL (Nano-Pulsed Cold Laser) laser emitters, infrared diodes and RGB (Red Green Blue) diodes, operating in a magnetic tunnel. The MILTA acts deeper than LEDs, due to the diffusion of photons in soft tissues.
In this study, the study investigators aimed to evaluate the safety and performance of the MILTA™ GYNECO vaginal probe in a pilot study of first use in women. This clinical study on the MILTA vaginal probe is expected to result in its CE marking Class IIb DM.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 25 is below the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.
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Exclusion Criteria:
Patient presenting with pelvic pain of physical and / or psychological origin.
Device: Photobiomodulation
Six weekly photobiomodulation sessions (PBMT) using the MILTA ™ GYNECO vaginal probe.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe
Collection and investigation of the causality of adverse events linked to the treatment (expected adverse effects: burns, pain on penetration, tingling, edema, allergic reaction).
Time frame: Day 1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe
Collection and investigation of the causality of adverse events linked to the treatment (expected adverse effects: burns, pain on penetration, tingling, edema, allergic reaction).
Time frame: Week 1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe
Collection and investigation of the causality of adverse events linked to the treatment (expected adverse effects: burns, pain on penetration, tingling, edema, allergic reaction).
Time frame: Week 2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe
Collection and investigation of the causality of adverse events linked to the treatment (expected adverse effects: burns, pain on penetration, tingling, edema, allergic reaction).
Time frame: Week 3
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe
Collection and investigation of the causality of adverse events linked to the treatment (expected adverse effects: burns, pain on penetration, tingling, edema, allergic reaction).
Time frame: Week 4
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe
Collection and investigation of the causality of adverse events linked to the treatment (expected adverse effects: burns, pain on penetration, tingling, edema, allergic reaction).
Time frame: Week 5
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of the use of the MILTA™ GYNECO vaginal probe
Collection and investigation of the causality of adverse events linked to the treatment (expected adverse effects: burns, pain on penetration, tingling, edema, allergic reaction).
Time frame: Week 6
Performance of the MILTA™ GYNECO vaginal probe on pain linked to vaginal atrophy
Visual analogue scale (0-10): the device will be considered effective if the VAS pain score decreases by at least 30%
Time frame: Day 0
Performance of the MILTA™ GYNECO vaginal probe on pain linked to vaginal atrophy
Visual analogue scale (0-10): the device will be considered effective if the VAS pain score decreases by at least 30%
Time frame: Week 6
Performance of the MILTA™ GYNECO vaginal on the vaginal mucosa
Vaginal Health Index: Score 1-5
Time frame: Day 0
Performance of the MILTA™ GYNECO vaginal on the vaginal mucosa
Vaginal Health Index: Score 1-5
Time frame: Week 6
Vaginal pH
pH value between 4 - 7.5
Time frame: Day 0
Vaginal pH
pH value between 4 - 7.5
Time frame: Week 6
Vaginal flora
Nugent score: score from 0 to 10: 0 to 3: normal flora predominantly lactobacilli, 4 to 6: intermediate flora with scant lactobacilli and associated with other poorly differentiated bacterial morphotypes in small quantities, 7 to 10: suggestive of bacterial vaginosis
Time frame: Day 0
Vaginal flora
Nugent score: score from 0 to 10: 0 to 3: normal flora predominantly lactobacilli, 4 to 6: intermediate flora with scant lactobacilli and associated with other poorly differentiated bacterial morphotypes in small quantities, 7 to 10: suggestive of bacterial vaginosis
Time frame: Week 6
Patient satisfaction Patient satisfaction
Patient Global Impression of Change (PGI-C): Patients will be classified into 3 categories according to their score: deterioration (score of 1 to 3), stable (score of 4), improvement (score of 5 to 7)
Time frame: Week 6
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nīmes