Can pelvic organ prolapse in postmenopausal women be treated with laser therapy?

PURPOSE: This study aims to assess the effectiveness of the non-ablative photothermal erbium laser (Er:YAG laser) for managing anterior and/or posterior vaginal compartment prolapse. METHODS: A randomized, single-blind, 1:1 trial was performed comparing Er:YAG laser treatment to watchful waiting in postmenopausal women with symptomatic cystocele and/or rectocele stage 2 or 3 who opted to undergo surgery due to bothersome prolapse symptoms. Three Er:YAG laser treatments at monthly intervals were applied for the Er:YAG laser group, while there was no treatment for the watchful-waiting group. The primary outcome was the proportion of patients with stage 0 or 1 following laser treatment, while secondary outcomes included the Pelvic Organ Prolapse Quantification System (POP-Q points), Pelvic Floor Distress Inventory Questionnaire short-form, Pelvic Floor Impact Questionnaire short-form, and Patients Global Impression of Improvement (PGI-I). All outcomes were evaluated at baseline and 4 months post baseline. RESULTS: Thirty women (15 vs. 15) were eligible to be included. No participants (0%) in either group had POP-Q stage 0 or 1 at 4 months. Moreover, no change was present in the secondary outcomes. In the PGI-I, 2/15 (14%) and 0/15 (0%) participants declared much better/very much better in the laser and watchful-waiting group, respectively. CONCLUSIONS: The findings of this study do not support use of the intravaginal Er:YAG laser for treatment of the anterior/posterior vaginal wall. Clinical trial identification number: NCT03714607.

CO2 laser and the genitourinary syndrome of menopause: a randomized sham-controlled trial.

PURPOSE: This study aimed to clarify the efficacy of intravaginal CO2-laser treatment in postmenopausal women with genitourinary syndrome of menopause (GSM). MATERIALS AND METHODS: This double-blind, randomized, sham-controlled trial included postmenopausal women diagnosed with GSM and bothersome dryness and dyspareunia. Treatment consisted of three sessions. Active CO2-laser treatments (active group) were compared to sham treatments (sham group) with the primary endpoints being changes in dryness and dyspareunia intensity, as assessed by the 10-cm visual analog scale. Secondary endpoints were as follows: changes in Female Sexual Function Index (FSFI; total score and all domains), itching, burning, dysuria, and Urogenital Distress Inventory (UDI-6); incidence of symptoms; and presence of adverse events. All outcomes were evaluated at baseline and 4 months post baseline. RESULTS: Fifty-eight women (28 in the active group and 30 in the sham group) were eligible for inclusion. In the active group, dryness, dyspareunia, FSFI (total score), itching, burning, dysuria, and UDI-6 were significantly improved (mean [standard deviation] -5.6 [2.8], -6 [2.6], 12.3 [8.9], -2.9 [2.8], -2.3 [2.8], -0.9 [2.1], and -8.0 [15.3], respectively). In the sham group, dryness, itching, and burning were significantly improved (-1.9 [2], -1.4 [1.9], and -1 [1.9], respectively). All changes were in favor of the active group. After completion of the protocol, the proportion of participants with dryness, dyspareunia, and sexual dysfunction was significantly lower in the active group compared to those in the sham group (all p < 0.005). CONCLUSIONS: CO2 laser could be proposed as an effective alternative treatment for the management of GSM as it is superior to sham treatments.

A study protocol of vaginal laser therapy in gynecological cancer survivors.

Objectives: Sexual dysfunction and radiation cystitis are common adverse events following radiotherapy for gynecological cancer (GC). This study aims to assess the efficacy of intravaginal CO2 laser on GC survivors with dyspareunia following pelvic radiation and/or brachytherapy.Methods: This is the study protocol of a randomized double-blind placebo-controlled trial. All participants will receive five therapies (active or placebo) at monthly intervals. Outcomes will include a 10-cm visual analog scale measuring dyspareunia, vaginal dryness, and other symptom intensity, 3-day voiding diary, Day-to Day Impact of Vaginal Aging questionnaire, Female Sexual Function Index, European Organization for Research and Treatment of Cancer Quality of Life questionnaire cervical cancer module, Urogenital Distress Inventory short form, King's Health Questionnaire, International Consultation on Incontinence Questionnaire short form/female lower urinary tract symptoms, patient perception of improvement, sexual satisfaction of male partners, vaginal maturation value, and Vaginal Health Index. Differences between groups will be assessed at baseline and 1, 3, 6, 9, and 12 months following the five laser therapies.Results: As this is a study protocol, the study is ongoing with an expected end of recruitment and analysis date of 2021.Conclusion: Pelvic radiotherapy for GC increases the 5-year survival rate but with a negative impact on women's quality of life due to sexual dysfunction and radiation cystitis onset. With this study, CO2 laser therapy will be evaluated for the first time in GC survivors treated with radiotherapy. ClinicalTrials.gov registration number: NCT03714581.

Rationale and design for fractional microablative CO2 laser versus photothermal non-ablative erbium:YAG laser for the management of genitourinary syndrome of menopause: a non-inferiority, single-blind randomized controlled trial.

Genitourinary syndrome of menopause (GSM) is a common condition affecting up to 50% of postmenopausal women and up to 70% of postmenopausal breast cancer survivors. GSM is a chronic condition with a significant impact on sexual health and quality of life. The mainstay of treatment has been with symptomatic relief using topical emollients or lubricants. Second-line treatment is with topical vaginal estrogens to restore the physiology of the vaginal epithelium. For some, the latter is not suitable or acceptable. Newer treatments with ospemifene and vaginal lasers have now been introduced. The two main types of laser currently used for the treatment of GSM are the fractional microablative CO2 laser and the non-ablative photothermal erbium:YAG laser. We present a study protocol for a multicenter, prospective, non-inferiority, single-blinded, randomized controlled trial comparing the fractional microablative CO2 laser versus the photothermal non-ablative erbium:YAG laser for the management of GSM. We will recruit 88 postmenopausal women across two sites who will be randomized to one of the two laser groups. Participants will all have GSM symptoms and a Vaginal Health Index Score < 15. All participants will receive an active treatment. Each participant will receive three applications of vaginal laser 1 month apart and will be followed up at 1 month, 6 months, and 12 months. Our primary outcomes will look at all changes of GSM symptoms (dryness, dyspareunia, itching, burning, dysuria, frequency, urgency), urinary incontinence (if present), and overall sexual satisfaction. Both subjective and objective means will be used to assess participants. The findings of this trial have the potential to allow clinicians and women suffering from GSM to make an informed decision when opting for a specific laser type. The trial will add to the current growing body of evidence for the safe use of vaginal lasers in GSM as an alternative treatment. We hope this trial will provide robust and long-term data for the safe use of both lasers.

The effect of microablative fractional CO2 laser on vaginal flora of postmenopausal women.

OBJECTIVES: To assess the effect of microablative fractional CO2 laser (MFCO2-Laser) therapy on the vaginal microenvironment of postmenopausal women. METHODS: Three laser therapies at monthly intervals were applied in postmenopausal women with moderate to severe symptoms of genitourinary syndrome of menopause, pH of vaginal fluid >4.5 and superficial epithelial cells on vaginal smear <5%. Vaginal fluid pH values, fresh wet mount microscopy, Gram stain and aerobic and anaerobic cultures were evaluated at baseline and 1 month after each subsequent therapy. Nugent score and Hay-Ison criteria were used to evaluate vaginal flora. RESULTS: Fifty-three women (mean age 57.2 ± 5.4 years) participated and completed this study. MFCO2-Laser therapy increased Lactobacillus (p < 0.001) and normal flora (p < 0.001) after the completion of the therapeutic protocol, which decreased vaginal pH from a mean of 5.5 ± 0.8 (initial value) to 4.7 ± 0.5 (p < 0.001). The prevalence of Lactobacillus changed from 30% initially to 79% after the last treatment. Clinical signs and symptoms of bacterial vaginosis, aerobic vaginitis or candidiasis did not appear in any participant. CONCLUSION: MFCO2-Laser therapy is a promising treatment for improving the vaginal health of postmenopausal women by helping repopulate the vagina with normally existing Lactobacillus species and reconstituting the normal flora to premenopausal status.

Evaluation of commercial amplification kit for detection of Legionella pneumophila in clinical specimens.

A commercial kit (EnviroAmp) designed to detect the DNA of Legionella species in environmental water samples using PCR and reverse dot hybridization was applied to clinical specimens. Results correlated well with culture for bronchoalveolar lavages. In addition, this test was easy to perform and showed good sensitivity.

Use of the insertion element IS6110 for DNA fingerprinting of Mycobacterium tuberculosis isolates presenting various profiles of drug susceptibility.

IS6100 is an insertion sequence of the IS3 family and it is present in multiple copies in the chromosome of Mycobacterium tuberculosis. Four to 15 copies are present in various strains of M. tuberculosis. In this study, the value of IS6110 as an epidemiological marker of tuberculosis was examined. Unrelated clinical strains from Greek patients presented, in restriction fragment length polymorphism analysis, a high degree of polymorphism, whereas patterns of related clinical strains from familial outbreaks were identical. Since RFLP analysis with acetylaminofluorene labeled IS6110 as the probe gave satisfactory results, it is suggested that this non-radioactive probe can be used in hospitals and health centres for the epidemiological survey of M. tuberculosis infections.