Clinical trial · Interventional
Laser Therapy Following Radiotherapy for Gynecological Cancer
The Efficacy of Intravaginal Laser Therapy in Women With History of Gynecological Cancer Treated With Pelvic Radiotherapy: Double-blind Randomized Placebo-controlled Trial
NCT03714581CI-TRIAL-00039796unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Women with a history of pelvic radiotherapy due to gynecological cancer, will receive laser therapy for the management of genitourinary syndrome of menopause.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dyspareunia | — | UNRESOLVED | — |
| Gynecological Cancer | — | UNRESOLVED | — |
| Pelvic Radiotherapy | — | UNRESOLVED | — |
| Vaginal Dryness | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Microablative Fractional CO2 Laser Therapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Laser
- description
- Microablative Fractional CO2 Laser Therapy (The parameters that will be used are the following: 1) Power: 30 ή 40 watts, 2) Dwell time:1000μs, 3) Spacing 1000 μm, 4) Depth: SmartStak parameter from 1-3 depending on the treatment status, 5) D-pulse mode.)
- interventionNames
- Device: Microablative Fractional CO2 Laser Therapy
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo therapy (The parameters that will be used are the following: 1) Power: 0.5 watts, 2) Dwell time:1000μs, 3) Spacing 1000 μm, 4) Depth: SmartStak parameter 1, 5) Smart-pulse mode.
- interventionNames
- Device: Microablative Fractional CO2 Laser Therapy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * History of gynecological cancer treated with pelvic radiotherapy * last radiotherapy \>1 year * women sexually active or willing to resume sexual activity * symptoms of dyspareunia, vaginal dryness, itching/burning and vaginal bleeding related to sexual intercourse Exclusion Criteria: * Relapse of gynecological cancer * prolapse stage \>1 * active genital infection (i.e herpes, vaginitis) * underlying pathologies that could interfere with patients compliance to the protocol (i.e any psychiatric condition)
References
Publications (2)
- 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
- DERIVEDAthanasiou S, Pitsouni E, Grigoriadis T, Michailidis G, Tsiveleka A, Rodolakis A, Loutradis D. A study protocol of vaginal laser therapy in gynecological cancer survivors. Climacteric. 2020 Feb;23(1):53-58. doi: 10.1080/13697137.2019.1646720. Epub 2019 Sep 2. PMID 31474161