Clinical trial · Interventional
Laser Treatment of Genito-urinary Syndrome in Women
Laser Treatment of Genito-urinary Syndrome in Women With Breast and Endometrial Cancer and Menopausal Women
NCT03238053CI-TRIAL-00081640withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Hospital terminated treatment with laser
Summary
Brief summary (as posted)
Women with genitourinary syndrome of menopause, overactive bladder, with breast or endometrial cancer are randomized to either laser treatment og sham treatment for 3 months. The randomization is stratified for estrogen treatment. The effect is evaluated by questionnaire, histology and microbiology swaps
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder, Overactive | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Laser-Induced Scar | — | UNRESOLVED | — |
| Menopause | — | UNRESOLVED | — |
| Vaginal Atrophy | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laser system | Device | — | UNRESOLVED |
| sham | Device | — | UNRESOLVED |
| Vaginal laser treatment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (8)
- type
- ACTIVE_COMPARATOR
- label
- Menopausal Laser
- description
- 20 women with vaginal laser treatment
- interventionNames
- Procedure: Vaginal laser treatment
- Device: laser system
- type
- SHAM_COMPARATOR
- label
- Menopausal sham
- description
- 20 women with probe, no active laser ray
- interventionNames
- Device: sham
- type
- ACTIVE_COMPARATOR
- label
- breast cancer laser
- description
- 20 women with breast cancer with vaginal laser treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * menopause i.e. age more than 50 years and absence of menstruation for twelve months * breast cancer * endometrial cancer * symptoms of vaginal dryness * dyspareunia rated as moderate or severe most bothersome symptoms Exclusion Criteria: * use of vaginal moisturizers, lubricants or any other local preparation within the thirty days prior to inclusion * acute or recurrent urinary tract infections * active genital infections i.e. herpes genitalis, candida * previous reconstructive pelvic surgery * pelvis organ prolapse stage 2 * any serious disease or chronic condition that could interfere with study compliance except from breast and endometrial cancer * psychiatric disorders precluding informed consent
References
Publications (4)
- BACKGROUNDSalvatore S, Nappi RE, Parma M, Chionna R, Lagona F, Zerbinati N, Ferrero S, Origoni M, Candiani M, Leone Roberti Maggiore U. Sexual function after fractional microablative CO(2) laser in women with vulvovaginal atrophy. Climacteric. 2015 Apr;18(2):219-25. doi: 10.3109/13697137.2014.975197. Epub 2014 Dec 16. PMID 25333211
- BACKGROUNDSalvatore S, Leone Roberti Maggiore U, Athanasiou S, Origoni M, Candiani M, Calligaro A, Zerbinati N. Histological study on the effects of microablative fractional CO2 laser on atrophic vaginal tissue: an ex vivo study. Menopause. 2015 Aug;22(8):845-9. doi: 10.1097/GME.0000000000000401. PMID 25608269
- BACKGROUNDAthanasiou S, Pitsouni E, Antonopoulou S, Zacharakis D, Salvatore S, Falagas ME, Grigoriadis T. The effect of microablative fractional CO2 laser on vaginal flora of postmenopausal women. Climacteric. 2016 Oct;19(5):512-8. doi: 10.1080/13697137.2016.1212006. Epub 2016 Aug 24. PMID 27558459
- DERIVEDIppolito GM, Crescenze IM, Sitto H, Palanjian RR, Raza D, Barboglio Romo P, Wallace SA, Orozco Leal G, Clemens JQ, Dahm P, Gupta P. Vaginal lasers for treating stress urinary incontinence in women. Cochrane Database Syst Rev. 2025 Jul 25;7(7):CD013643. doi: 10.1002/14651858.CD013643.pub2. PMID 40709601