N/A
Completed N=69
Comparison of Vaginal Laser Therapy to Vaginal Estrogen Therapy
Atrophic Vaginitis · Menopause
Source: ClinicalTrials.gov NCT02691936 ↗
Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Vaginal Dryness — -5.48; -5.76 units on a scale
Summary
This is a multi-centered, randomized prospective single blinded clinical trial comparing CO2 fractionated vaginal laser therapy and vaginal estrogen cream therapy in the treatment of vulvovaginal atrophy/GSM.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vaginal Dryness |
-5.48; -5.76 | — |
| SECONDARY Objective Evaluation of Vaginal Atrophy/Estrogenization |
0.9; 1.2 | — |
| SECONDARY Effect of GMS Symptoms on Quality of Life |
-3.3; -4.4 | — |
| SECONDARY Effect of Treatment on Vaginal Maturation Index |
3.9; 25 | — |
| SECONDARY Vaginal Wall Elasticity Assessed by Number of Participants Able to Tolerate a Larger Vaginal Dilator Size |
16; 17 | — |
| SECONDARY Effect of Treatment on Female Sexual Function |
1.7; 4.9 | — |
| SECONDARY Effect of Treatment on Urinary Symptoms |
-9.4; -6.2 | — |
| SECONDARY Rate of Satisfaction of Patients With Treatment |
24; 24; 25; 22; 3; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Menopausal with absence of menstruation for at least 12 months
- Presence of vaginal atrophy symptoms [subjective assessment of vaginal dryness >7cm on VAS)
- Prolapse stage < II, according to the pelvic organ prolapse quantification (POP-Q) system[31]
- No pelvic surgery within 6 months prior to treatment (vulva biopsy may be included after 2 weeks)
- Understanding and acceptance of the obligation to return for all scheduled follow-up visits
Exclusion Criteria
- Personal history of vulvovaginal condyloma, ,vaginal intraepithelial neoplasia (VAIN), vaginal carcinoma, lichen sclerosis, lichen planus, history of vaginal radiation, history of cervical cancer, other gynecologic cancer, or pelvic radiation
- Acute or recurrent urinary tract infection (UTI), or genital infection (e.g. bacterial; vaginosis, herpes genitalis, candida).
- Personal history of Scleroderma
- Any serious disease, or chronic condition, that could interfere with the study compliance
- Previously undergone reconstructive pelvic surgery within the past 6 months
- Previously undergone reconstructive pelvic surgery with transvaginal mesh kits and sacrocolpopexy with synthetic mesh for prolapse, excluding synthetic slings (unless current untreated exposure or extrusion)
- Have used vaginal estrogen cream, ring or tablet within 1 month prior to entering the study
- Vaginal moisturizers, lubricants or homeopathic preparations within 2 weeks of therapy
- Personal history of thrombophlebitis
- Personal history of heart failure or myocardial infarction within 12 months of procedure
- Use or anticipated use of antiplatelet therapy, anticoagulants, thrombolytics, vitamin E or nonsteroidal anti-inflammatory drugs within 2 weeks pre-treatment
- Taking medications that are photosensitive
- Contraindication to Vaginal Estrogen Therapy
- Unwilling to Take Vaginal Estrogen
- Inability to give informed consent
Data sourced from ClinicalTrials.gov (NCT02691936). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.