Effect of Laser Therapy on Vaginal Tissue

Institute for the Care of Mother and Child, Prague, Czech Republic

Status: Active, not recruiting

Conditions: Pelvic Floor Disorders; Vaginal Atrophy

Treatments: Other: vaginal laser treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05898191

UPMDPrague 07032019

Details and patient eligibility

About

Pelvic floor disorders, including prolapse, incontinence, and vulvovaginal atrophy decrease the quality of life of every fourth woman. Recent therapy including habits change, rehabilitation, surgery, or hormonal replacement is not possible in all patients. Laser therapy is currently being proposed as an alternative. Laser therapy was brought to the gynecological field from dermatology, where it is used for facial rejuvenation (wrinkles) and treatment of other skin abnormalities. In dermatology, the laser has proven its efficacy at the molecular and histological levels. However, this concept was brought to gynecology without comparable confirmation. The skin and vagina have a different structures, therefore effects of laser may differ. Patient satisfaction with the clinical effects of laser has been reported. However, based on recent reviews and sheep studies knowledge about histological and other effects is limited. The goal of this study is to gain knowledge about the histological, biomechanical effects and molecular effects of laser on vagina. Control samples were collected from women undergoing colporrhaphy. The laser group underwent laser treatment prior to the surgery. The gained knowledge may improve laser protocols and in the future maybe laser therapy will become standard treatment in urogynecology.

Enrollment: 15 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• pelvic organ prolapse stage II (cystocele Ba ≥ -1)
• planned surgical treatment (anterior colporrhaphy)
• menopausal

Exclusion criteria

• surgical treatment at a location of interest
• use of systemic or vaginal estrogens within last 12 months

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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15 participants in 2 patient groups

laser

Experimental group

Description:

laser treatment (Laser CO² MIXTO PRO, LASERING SRL, Modena, Italy; three sessions, one per month)

Treatment:

Other: vaginal laser treatment

control

No Intervention group

Description:

no intervention