An interventional study of Fotona Dynamis Er:YAG Laser System and Sham in Vaginal Atrophy, Dyspareunia and Laser, sponsored by Istanbul University - Cerrahpasa. Completed at 2 sites in Turkey. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-30.
Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Treatment
This study is a randomized controlled sham applied study. Its aim is to evaluate the efficacy of Er:YAG laser for the treatment of atrophic vaginitis in postmenopausal women.
In this study, demonstration of the efficacy of Er:YAG laser for the treatment of atrophic vaginitis in postmenopausal women is intended with Maturation Index (MI), vaginal pH measurement, Female Sexual Function Index (FSFI), Vaginal Health Index (VaHI), Visual Analogue Scale (VAS) and ultrasonographic elastography
In the postmenopausal period, especially due to estrogen deficiency, vaginal atrophy occurs in the vulvo-vagina, lower urinary tract, pelvic floor muscles and endopelvic fascia. Vaginal dryness secondary to atrophy in genital organs, pain and tenderness especially during sexual intercourse, and decreased genital elasticity are the most common symptoms and signs during the postmenopausal period. With regard to the urinary system, frequent urination, feeling of urgency, recurrent urinary tract infections, organ prolapses-urethrocele, cystocele, urethral prolapse and stress or urge type urinary incontinence could be seen.These signs and symptoms were recognized in 2014 by the International Society for the Study of Women's Sexual Health (ISSWSH) and the North American Menopause Society (NAMS) under the main title OF "genito-urinary syndrome of menopause" (GSM). During the postmenopausal period, a detailed history should be taken, a complete physical examination should be performed, and various tests should be performed for the evaluation of GSM.
Laser is a treatment option for the genitourinary symptoms that could occur at the postmenopausal period. Laser can be applied to vulva by giving an external beam, or it can be applied intravaginally or directly to the urethra using vaginal and urethral cannula.
The smooth mode application of the Er:YAG laser ensures that the laser beam retains the heat it gives without ablation and penetrates deeper into the tissue. After laser application, thermomechanical and thermochemical effects occur in the tissue, respectively. It provides controlled thermal energy and causes shrinkage of the collagen fibrils in the vaginal epithelium and lamina propria. It also induces neocollagenesis, elastogenesis and neoangiogenesis by temperature change. With minimum damage to the peripheral tissue, the viable cells in the target tissue reacts to this temperature change by expressing heat shock proteins (HSP). Then, HSP increases the levels of transforming growth factor-beta, fibroblast growth factor, epidermal growth factor, platelet-derived growth factor, vascular epithelial growth factor which induce neocollagenesis and neoangiogenesis. Therefore, the thermal energy stored in the vaginal wall induces proliferation of the epithelium which is rich in glycogen, neovascularization and collagen production in the lamina propria.
In this study, evaluation and demonstration of the efficacy of Er:YAG laser for the treatment of atrophic vaginitis in postmenopausal women is intended with Maturation Index (MI), vaginal pH measurement, Female Sexual Function Index (FSFI), Vaginal Health Index (VaHI), Visual Analogue Scale (VAS) and ultrasonographic elastography.
158 studies on the registry are indexed under Dyspareunia; 40 are open to participants now.
This study's enrollment of 20 is below the median of 63 across 126 interventional studies indexed under Dyspareunia.
Browse Dyspareunia studies →Istanbul University - Cerrahpasa is the lead sponsor of 699 studies on the registry; 213 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Non-ablative thermal-only Er:YAG laser (Fotona Dynamis) treatment using R11 and PS03 handpieces
Device: Fotona Dynamis Er:YAG Laser System
The same procedure is applied but with a sham handpiece.
Device: Sham
The patient receives 2940 nm Er:YAG Laser (XS Dynamis, Fotona, Slovenia) at intervals of 21 days. She receives 3 sessions, in total. Each session consists of application of PS03 handpiece intravaginal with spot size of 7 mm, fluence of 10 j/cm2, frequency of 1.6 Hz and 4-7 pulses per point and 6 passes followed by R11 handpiece intravaginal with spot size of 7 mm, fluence of 10 j/cm2, frequency of 1.6 Hz and 4-7 pulses per point and 3 passes.
Er:YAG laser is applied with sham handpiece.
Also known as: Placebo
Efficacy: Rate of improvement in vaginal atrophy
Evaluation of the efficacy and safety of vaginal atrophy by using ultrasonographic Elastography
Time frame: 6 months
Efficacy:Rate of improvement in sexual function
Evaluation of dyspareunia by Female Sexual Function Index
Time frame: 6 months
Efficacy: Rate of improvement in vaginal atrophy
Evaluation of Maturation Index
Time frame: 6 months
Efficacy: Rate of improvement in vaginal atrophy
Evaluation of Vaginal Health Index
Time frame: 6 months
Efficacy: Rate of improvement in pain
Evaluated by Visual Analogue Scale
Time frame: 6 months
Safety:Incidence and severity of device related Adverse Events
Incidence and severity of device related Adverse Events (i.e., infections, edema, superficial burns, wound dehiscence)
Time frame: 6 months
Plan to share: Yes — The results will be available after the completion of the study for a year.
Supporting information: Clinical study report
Time frame: It will be available after the completion of the study for a year.
No publications or documents are linked to this record.
Ran from Aug 2023 to primary completion in Jan 2024, 4 months.
Of 51 non-industry interventional studies with no phase under Dyspareunia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's 4 months is below that.
Counting every sponsor, half of 59 studies reached it within 33 months; a quarter within 13 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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