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1.
Lasers Med Sci ; 37(4): 2157-2164, 2022 Jun.
Article in English | MEDLINE | ID: mdl-35067817

ABSTRACT

Stress urinary incontinence (SUI) is a common health problem that affects roughly 35% of women in the reproductive period. A prospective uncontrolled study was conducted to assess the long-term efficacy and safety of a non-ablative Er:YAG laser treatment of SUI. Forty-three patients participated in the study. All women underwent three sessions of IncontiLase® procedure, and efficacy of laser treatment was assessed by 1-h pad test, 24-h pad test, 3-day voiding diary, and ICIQ-UI SF questionnaire at multiple follow-ups. Statistical analysis was performed using one-way repeated measures ANOVA. Patients were questioned about discomfort during treatment and any adverse events following the laser procedures. All outcome measures showed a significant change over a period of the entire clinical trial. Eighteen-month follow-up revealed a fading of the effect, which was alleviated by single-session maintenance treatments every 6 months. There were no serious adverse events reported during the study. All reported side effects were mild and transient. The application of non-ablative Er:YAG laser for SUI treatment significantly improves the SUI symptoms. High improvement rates and patient satisfaction can be maintained with single-session maintenance treatments performed every 6 months. Long-term safety profile of multiple non-ablative Er:YAG laser treatment is shown. NCT04348994, 16.04.2020, retrospectively registered.


Subject(s)
Lasers, Solid-State , Urinary Incontinence, Stress , Erbium , Female , Humans , Lasers, Solid-State/adverse effects , Prospective Studies , Treatment Outcome , Urinary Incontinence, Stress/radiotherapy
2.
Lasers Surg Med ; 50(8): 802-807, 2018 10.
Article in English | MEDLINE | ID: mdl-29667744

ABSTRACT

OBJECTIVES: Genitourinary syndrome of menopause (GSM) combines the conditions of vulvovaginal atrophy (VVA) and urinary tract dysfunction, which is a result of urethral atrophy. There are several treatment methods available for the management of vulvovaginal symptoms of GSM, whereas urinary tract dysfunction often remains overlooked and undertreated. The objective of this pilot study was to assess the safety and efficacy of intraurethral Er:YAG laser treatment of urinary symptoms of GSM. PATIENTS AND METHODS: Patients with diagnosed GSM, having less than 5% of vaginal superficial cells in the cytology, vaginal pH higher than 5, with urinary symptoms of GSM (dysuria, frequency, urgency) and impaired continence due to urethral atrophy, received two sessions of intraurethral Er:YAG laser with a 3-week interval in-between the sessions. Laser energy was delivered in non-ablative way using Erbium SMOOTH™ mode technology and a 4-mm thick cannula. Therapeutic efficacy was determined using ICIQ-SF, the 1-hour pad test and VAS scores. Occurrence of adverse effects was followed at every visit. Follow ups (FU) were at 3 and 6 months. RESULTS: 29 female patients fulfilling the inclusion criteria were included in this pilot study and received two sessions of the intraurethral non-ablative Erbium SMOOTH™ laser therapy. Significant improvement was observed in all measured parameters at both FU. ICIQ-SF improved by an average of 64% at 3 months FU and by 40% at 6 months. The 1-hour pad test showed a reduction of the quantity of leaked urine by 59% at 3 months FU and by 42% at 6 months FU. All urinary symptoms of GSM improved. Dysuria dropped to 13% and 31% of baseline values at three and 6 months respectively, urinary urgency dropped to 23% and 47% and frequency dropped to 22% and 43% after 3 and 6 months, respectively. Adverse effects were mild and transient. CONCLUSIONS: Our findings suggest that intraurethral Er:YAG laser is an efficacious and safe modality for treatment of urinary symptoms of GSM, however, prospective, randomized, and controlled trials with larger number of patients are needed to better assess the long-term effect of this novel procedure. Lasers Surg. Med. 50:802-807, 2018. © 2018 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.


Subject(s)
Female Urogenital Diseases/etiology , Female Urogenital Diseases/therapy , Laser Therapy/methods , Lasers, Solid-State/therapeutic use , Menopause , Aged , Female , Humans , Laser Therapy/instrumentation , Middle Aged , Pilot Projects , Prospective Studies , Syndrome
3.
Lasers Med Sci ; 32(3): 685-691, 2017 Apr.
Article in English | MEDLINE | ID: mdl-28210823

ABSTRACT

The objective of this pilot study was to determine the safety and efficacy of a new non-ablative erbium YAG laser procedure for the treatment of type III stress urinary incontinence (intrinsic sphincter deficiency) in women. Twenty-two patients with a Valsalva leak point pressure less than 60 cm H2O were recruited and treated with a non-ablative erbium laser delivering low fluence pulses inside the whole length of the urethra through a specially designed cannula. Treatment consisted of two treatment sessions with a 3-week interval in-between. Therapeutic efficacy, as assessed by a questionnaire addressing quality of life during urinary incontinence and the 1-h pad test, was measured at 3 and 6 months after the procedure. Both methods of assessment showed similar levels of improvement in terms of incontinence severity and improvement in quality of life. All patients tolerated the therapy well and adverse effects were mild and transient. The results of this pilot study showed significant improvement of type III stress urinary incontinence. Despite the limitations of this study, being small patient number and short follow-up, this non-ablative intraurethral erbium YAG laser procedure seems to be a safe and efficacious alternative for patients with type III stress urinary incontinence. More controlled studies should be performed to confirm this data and to evaluate the long-term effects.


Subject(s)
Laser Therapy , Lasers, Solid-State/therapeutic use , Urinary Incontinence, Stress/surgery , Adult , Aged , Female , Humans , Lasers, Solid-State/adverse effects , Male , Middle Aged , Pilot Projects , Quality of Life , Surveys and Questionnaires , Urethra/radiation effects
4.
Lasers Surg Med ; 49(2): 160-168, 2017 02.
Article in English | MEDLINE | ID: mdl-27546524

ABSTRACT

OBJECTIVES: The objective of this prospective comparative cohort study was to establish the effectiveness and safety of Erbium:YAG (Er:YAG) laser treatment for genitourinary syndrome of menopause and to compare it with an established topical estriol treatment. METHODS: Fifty patients with genitourinary syndrome of menopause were divided into two groups. The estriol group received a treatment of 0.5 mg estriol ovules for 8 weeks and the laser group was first treated for 2 weeks with 0.5 mg estriol ovules 3 times per week to hydrate the mucosa and then received three sessions with 2,940 nm Er:YAG laser in non-ablative mode. Biopsies were taken before and at 1, 3, 6, and 12 months post-treatment. Maturation index, maturation value and pH where recorded up to 12-months post-treatment, while the VAS analysis of symptoms was recorded up to 18 months post-treatment. RESULTS: Statistically significant (P < 0.05), reduction of all assessed symptoms was observed in the laser group at all follow-ups up to 18 months post-treatment. Significant improvement in maturation value and a decrease of pH in the laser group was detected up to 12 months after treatment. The improvement in all endpoints was more pronounced and longer lasting in the laser group. Histological examination showed changes in the tropism of the vaginal mucosa and also angiogenesis, congestion, and restructuring of the lamina propria in the laser group. Side effects were minimal and of transient nature in both groups, affecting 4% of patients in the laser group and 12% of patients in the estriol group. CONCLUSIONS: Our results show that Er:YAG laser treatment successfully relieves symptoms of genitourinary syndrome of menopause and that the results are more pronounced and longer lasting compared to topical estriol treatment. Lasers Surg. Med. 49:160-168, 2017. © 2016 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.


Subject(s)
Female Urogenital Diseases/therapy , Laser Therapy , Lasers, Solid-State/therapeutic use , Menopause , Administration, Topical , Estriol , Female , Female Urogenital Diseases/complications , Female Urogenital Diseases/pathology , Humans , Middle Aged , Pilot Projects , Prospective Studies , Syndrome , Treatment Outcome
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