Mario Preti1, Pedro Vieira-Baptista2,3, Giuseppe Alessandro Digesu4, Carol Emi Bretschneider5, Margot Damaser5,6,7, Oktay Demirkesen8, Debra S Heller9, Naside Mangir10,11, Claudia Marchitelli12, Sherif Mourad13, Micheline Moyal-Barracco14, Sol Peremateu12, Visha Tailor4, Tufan Tarcan15, Elise J B De16, Colleen K Stockdale17. 1. Department of Obstetrics and Gynecology, University of Torino, Torino, Italy. 2. Hospital Lusíadas Porto, Porto, Portugal. 3. Lower Genital Tract Unit, Centro Hospitalar de São João, Porto, Portugal. 4. Department of Urogynaecology, Imperial College Healthcare, London, UK. 5. Center for Urogynecology and Pelvic Reconstructive Surgery, Obstetrics, Gynecology and Women's Health Institute, Cleveland Clinic, Cleveland, Ohio. 6. Glickman Urological and Kidney Institute and Department of Biomedical Engineering Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio. 7. Advanced Platform Technology Center, Louis Stokes Cleveland VA Medical Center, Cleveland, Ohio. 8. Faculty of Medicine, Department of Urology, Istanbul University Cerrahpaşa, Istanbul, Turkey. 9. Department of Pathology and Laboratory Medicine, Rutgers-New Jersey Medical School, Newark, New Jersey. 10. Kroto Research Institute, Department of Material Science and Engineering, University of Sheffield, Sheffield, UK. 11. Department of Urology, Royal Hallamshire Hospital, Sheffield, UK. 12. Department of Gynecology, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina. 13. Department of Urology, Massachusetts General Hospital-Harvard Medical School Boston, Boston, Massachusetts. 14. Department of Dermatology, Hôpital Tarnier-Cochin, Paris, France. 15. Department of Urology, Ain Shams University, Cairo, Egypt. 16. Department of Urology, Marmara University School of Medicine, Istanbul, Turkey. 17. Department of Obstetrics and Gynecology, University of Iowa, Iowa City, Iowa.
Abstract
BACKGROUND: The clinical role of LASER for vulvar and vaginal treatments in gynecology and female urology is controversial. AIMS: In this best practice document, we propose recommendations for the use of LASER for gynecologic and urologic conditions such as vulvovaginal atrophy, urinary incontinence, vulvodynia, and lichen sclerosus based on a thorough literature review. MATERIALS & METHODS: This project was developed between January and September 2018. The development of this document followed the ICS White Paper Standard Operating Procedures. RESULTS: Most of the available studies are limited by their design; for example they lack a control group, patients are not randomized, follow up is short term, series are small, LASER is not compared with standard treatments, and studies are industry sponsored. Due to these limitations, the level of evidence for the use of LASER in the treatment of these conditions remains low and does not allow for definitive recommendations for its use in routine clinical practice. Histological evidence is commonly reported as proof of tissue regeneration following LASER treatment. However, the histological changes noted can also be consistent with reparative changes after a thermal injury rather than necessarily representing regeneration or restoration of function. The use of LASER in women with vulvodynia or lichen sclerosus should not be recommended in routine clinical practice. There is no biological plausibility or safety data on its use on this population of women. DISCUSSION: The available clinical studies do not present convincing data regarding the efficacy of LASER for the treatment of vaginal atrophy or urinary incontinence. Also, while short-term complications seem to be uncommon, data concerning long-term outcomes are lacking. CONCLUSION: At this point, LASER is not recommended for routine treatment of the aforementioned conditions unless part of well-designed clinical trials or with special arrangements for clinical governance, consent, and audit.
BACKGROUND: The clinical role of LASER for vulvar and vaginal treatments in gynecology and female urology is controversial. AIMS: In this best practice document, we propose recommendations for the use of LASER for gynecologic and urologic conditions such as vulvovaginal atrophy, urinary incontinence, vulvodynia, and lichen sclerosus based on a thorough literature review. MATERIALS & METHODS: This project was developed between January and September 2018. The development of this document followed the ICS White Paper Standard Operating Procedures. RESULTS: Most of the available studies are limited by their design; for example they lack a control group, patients are not randomized, follow up is short term, series are small, LASER is not compared with standard treatments, and studies are industry sponsored. Due to these limitations, the level of evidence for the use of LASER in the treatment of these conditions remains low and does not allow for definitive recommendations for its use in routine clinical practice. Histological evidence is commonly reported as proof of tissue regeneration following LASER treatment. However, the histological changes noted can also be consistent with reparative changes after a thermal injury rather than necessarily representing regeneration or restoration of function. The use of LASER in women with vulvodynia or lichen sclerosus should not be recommended in routine clinical practice. There is no biological plausibility or safety data on its use on this population of women. DISCUSSION: The available clinical studies do not present convincing data regarding the efficacy of LASER for the treatment of vaginal atrophy or urinary incontinence. Also, while short-term complications seem to be uncommon, data concerning long-term outcomes are lacking. CONCLUSION: At this point, LASER is not recommended for routine treatment of the aforementioned conditions unless part of well-designed clinical trials or with special arrangements for clinical governance, consent, and audit.
Authors: Ana Silvia Seki; Ana Maria H M Bianchi-Ferraro; Eliana S M Fonseca; Marair G F Sartori; Manoel J B C Girão; Zsuzsanna I K Jarmy-Di Bella Journal: Int Urogynecol J Date: 2022-03-07 Impact factor: 2.894