A comment on Climacteric Editor’s Choice “Can pelvic organ prolapse in postmenopausal women be treated with laser therapy?” by Athanasiou S, et al.
This study from the urogynaecology department in Athens is a randomized, assessor-blinded controlled trial of the Erbium YAG smooth laser in postmenopausal women with symptomatic stage 2 or 3 vaginal prolapse who had opted to undergo surgery (1).
All 30 women in the study had extensive assessment of their symptoms by various appropriately validated questionnaires and by physical assessment using the POP-Q scoring system (Pelvic Organ Prolapse Quantification System). The primary endpoint, defined as the ‘objective cure rate,’ was the proportion of patients with POP-Q stage 0 or 1. Secondary endpoints included measurements of all POP-Q points and subjective cure rates assessed by the Pelvic Floor Distress Inventory Questionnaire short-form [PFDI-20], Pelvic Floor Impact Questionnaire short- form [PFIQ-7] and the Patients Global Impression of Improvement [PGI-I]). The women were randomised to receive either Laser therapy (n=15) or a watchful-waiting group (n=15) who were not offered any additional therapy such as pelvic floor muscle training or a pessary. Laser therapy was performed using the Er:YAG laser (Intimalase Fotona SMOOTHTM), and all women in the laser group received one treatment at monthly intervals for three consecutive months. The treatments were all performed by an experienced independent physician blinded to the study objective. Outcomes in both groups were assessed at baseline and 4 months post-baseline. The POP-Q assessment was carried out by another independent physician who was blinded to participant allocation. Patient-reported outcome questionnaires, as above, were completed at baseline and 4 months.
The study found that after three Er:YAG laser treatments, there was no improvement in the pelvic anatomy as judged by the POP-Q assessment, and none of the participants in this study were objectively or subjectively cured following laser therapies. There were no changes in the patient-reported outcomes, and the laser therapy results were no different from those of the watchful-waiting group. No adverse events were reported by any of the participants. The authors conclude that their study results do not support the use of intravaginal Er:YAG laser as a therapeutic option in postmenopausal patients with symptomatic pelvic organ prolapse.
This is a well-conducted study of women who had documented prolapse that was bothersome enough to warrant surgical correction. In other words, it was clinically significant to them. The laser made no difference to their prolapse or their symptoms. The trial was done by a recognised urogynaecology centre that uses the laser regularly and has published previously on the use of laser for Genitourinary Syndrome of the Menopause (GSM) (2). There was no commercial funding, and the operator and assessor were blinded to the study protocol. The parameters measured were those recommended by the International Continence Society and International Urogynecological Association
The use of laser in gynaecology is becoming more widespread, but as highlighted in our recent Climacteric editorial (3), even for Uro-genital atrophy or GSM, the evidence is not yet sufficient to support its widespread adoption. However, this has not stopped the laser being increasingly being used and marketed for this and other gynaecological problems such as stress urinary incontinence (SUI), pelvic organ prolapse (POP), vaginal relaxation syndrome and lichen sclerosis. The evidence for SUI is reviewed in the latest edition of Climacteric (4) and elsewhere (5). For POP, the evidence is very weak and primarily based on one study (6). Thus, this current study is a significant addition to the literature.
The limitations of the study (small numbers, short follow up and lack of placebo group) are explored by authors who conclude, reasonably in my view, that these are unlikely to have materially affected the results. Given that the previous study found benefits within one month (6), it is logical to conclude that any impact in this study would be expected after three laser sessions. The authors explore the reasons why these results differ from the previous study. The initial study looked at postmenopausal women with a primary complaint of GSM and who had concomitant mild POP. This is a very different clinical category of women to those presenting with a primary complaint of symptomatic POP who have already had standard conservative therapy (e.g. pelvic floor exercises) and were opting for surgery. It is not clear whether the results from the previous study were due to the effect of laser on GSM or on the prolapse itself. It is certainly possible that, given the relatively superficial mode of laser action, it may improve the connective tissue overlying any prolapse but would be unlikely to have any effect on the deeper structural defects that are an integral part of the pathophysiology of an established prolapse. Whether or not the laser could have a potential role in women with mild asymptomatic POP and perhaps prevent progression or deterioration of its severity is speculative and would need further analysis in appropriately conducted trials. Any such trials should include assessing laser therapy alongside and in combination with other standard conservative therapies (i.e. pelvic floor muscle training). Surgical intervention for POP does, of course, have its risks (7), so anything along the clinical pathway that may prevent deterioration is worthy of further study. This potential role for laser is separate from the claimed treatment of the so-called “vaginal relaxation syndrome” or “vaginal rejuvenation,” which are arbitrary terms with no clearly defined meaning and with an emphasis more on sexual function (8,9). Until these terms have clearly standardised definitions with explainable pathophysiology and diagnostic criteria, they will have no scientific basis and will remain primarily a marketing slogan for laser companies.
Overall, this small well-conducted study demonstrates that vaginal laser therapy has no role in managing symptomatic POP. It highlights the importance of waiting for appropriate independent trials before adopting new therapies for any given condition. Whether or not vaginal laser therapy has any role in the earlier part of the management pathway of pelvic organ prolapse remains to be seen.
Tim Hillard, Consultant Gynaecologist
University Hospitals Dorset, Poole, UK
- Athanasiou S, Pitrrantouni E, Cardozo L et al. Can pelvic organ prolapse in postmenopausal women be treated with laser therapy? Climacteric 2020.
- Athanasiou S, Pitsouni E, Grigoriadis T, et al. Microablative fractional CO2 laser for the genitourinary syndrome of menopause: Up to 12-month results. Menopause 2019;26:248–55.
- Hillard TC & Nappi R. The Heat is on. Climacteric 2020.
- Hillard TC. Lasers in the era of evidence based medicine. Climacteric 2020.
- Robinson D, Flint R, Veit-Rubin N, et al. Is there enough evidence to justify the use of laser and other thermal therapies in female lower urinary tract dysfunction? Report from the ICI-RS 2019. Neurol Urodyn 2020;39(Suppl 3): S140–S7.
- Ogrinc UB, Sencar S. Non-ablative vaginal erbium YAG laser for the treatment of cystocele. It J Gynecol Obstet 2017;29:19–25.
- Baessler K, Christmann-Schmid C, Maher C et al. Surgery for women with pelvic organ prolapse with or without stress urinary incontinence. Cochrane Database Syst Rev 2018;8:CD013108.
- Abbas Shobeiri S, Kerkhof MH, Minassian VA, et al. IUGA Committee opinion: laser-based vaginal devices for treatment of stress urinary incontinence, genitourinary syndrome of menopause, and vaginal laxity. Int Urogynecol J 2019;30:371–6.
- Jha S, Hillard T. Energy devices in vaginal therapy. Obstet Gynecol 2019;21:233–6.