Clinical trial · Interventional
Fractional CO2 Laser Therapy in Minimizing Genitourinary Syndrome of Menopause in Gynecological Cancer Survivors
Fractional CO2 Laser Therapy for Survivors of Gynecologic Malignancies
NCT03372720CI-TRIAL-00057980completedN/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)
This randomized pilot trial studies how well fractional carbon dioxide (CO2) laser therapy works in minimizing genitourinary syndrome of menopause (GSM) in gynecological cancer survivors. Fractional CO2 laser therapy may reduce symptoms of GSM in survivors of gynecologic cancers.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Carcinoma | Cervical Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Dyspareunia | — | UNRESOLVED | — |
| Endometrial Carcinoma | Endometrial Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Carcinoma | Ovarian Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Vaginal Carcinoma | Vaginal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Vaginal Dryness | — | UNRESOLVED | — |
| Vulvar Carcinoma | Vulvar Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laser Therapy | Procedure | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Sham Intervention | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (fractional CO2 laser therapy)
- description
- Patients undergo fractional CO2 laser therapy at 3 time points 30 days apart.
- interventionNames
- Procedure: Laser Therapy
- Other: Questionnaire Administration
- type
- SHAM_COMPARATOR
- label
- Arm II (sham laser therapy)
- description
- Patients undergo sham laser therapy at 3 time points 30 days apart. Patients may then crossover to Arm I.
- interventionNames
- Other: Questionnaire Administration
- Procedure: Sham Intervention
Primary outcomes (1)
- measure
- Change in genitourinary syndrome of menopause (GSM) symptoms
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Women with cervical, endometrial, vaginal, vulvar or ovarian cancer who have completed all cancer related treatment \>= 6 months prior to enrollment * Any form of hysterectomy, including radical hysterectomy permitted * Must have no evidence of recurrent disease on pelvic exam within past 3 months * Radiation therapy is permitted but not required * Patient reported dyspareunia and/or vaginal dryness with severity of \>= 4 on a scale from 0 (none) to 10 (most severe) that has been persistent over \>= 4 weeks and/or the inability to be sexually active due to pain Exclusion Criteria: * Patients with recurrent or metastatic endometrial, vaginal, vulvar, cervical, or ovarian cancer * Pelvic organ prolapse stage II or higher * Prior reconstructive pelvic surgery involving mesh * Hormone replacement therapy or vaginal estrogen therapy within 6 weeks prior to enrollment
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
- DERIVEDQuick AM, Dockter T, Le-Rademacher J, Salani R, Hudson C, Hundley A, Terstriep S, Streicher L, Faubion S, Loprinzi CL, Coleman JS, Wang KC, Lustberg M. Pilot study of fractional CO2 laser therapy for genitourinary syndrome of menopause in gynecologic cancer survivors. Maturitas. 2021 Feb;144:37-44. doi: 10.1016/j.maturitas.2020.10.018. Epub 2020 Dec 2. PMID 33358206