Effect of photobiomodulation associated with strengthening pelvic floor muscles in volunteers with urinary incontinence: a randomized, double-blinded, and placebo-controlled clinical trial.

The dysfunctions of the female pelvic floor have a great influence on the quality of life of women, in all areas, social, psychological, and sexual. Stress urinary incontinence is the clinical condition in which the woman involuntarily loses urine to efforts, such as coughing and sneezing, causing great embarrassment and affecting her quality of life. The physiotherapeutic treatments include muscle strengthening; however, muscle fatigue is present when performing the exercises. Here we investigate the effects of photobiomodulation to prevent muscle fatigue in the pelvic floor in the treatment of stress urinary incontinence, associated with a muscle strengthening exercise protocol. We used an infrared laser (808 nm, 100 mW) and 3 J/point and fluence of 107.1 J/cm2. The application was performed at 3 points on the vaginal introits and at another 3 points inside the vaginal canal cavity for the treatment of stress urinary incontinence associated with strengthening exercises with vaginal cones. Twenty-two volunteers participated in the study, divided into two groups: group 1 (laser therapy + strengthening) and group 2 (placebo laser + strengthening). In the group 1 quality of life score, the assessment (11.63 ± 4.33) was the highest score at 17 and in the reevaluation (7.81 ± 5.14) the lowest was 0 (p < 0.05). The muscular strength increased considerably (p < 0.05) for group 1, where the vast majority of patients gained more than twice the strength in the pelvic apparatus (8.36 ± 6.65 before X 13.81 ± 8.92 after). The volunteers acquired an increase in the contraction of the muscles of the pelvic apparatus (p < 0.05) (3.45 ± 1.07); after laser application, this number increased considerably (4.27 ± 0.61). Endurance had an increase of almost 50% compared to placebo, demonstrating the resistance gain in the perineal muscles (3.90 ± 2.35 X 5 ± 1.90). We concluded that photobiomodulation treatment showed significant efficacy in relation to muscle fatigue in the pelvic apparatus right after a strengthening program in women with stress urinary incontinence.

Effect evaluation and influencing factor analysis of vaginal carbon dioxide laser in the treatment of stress urinary incontinence.

To evaluate the clinical efficacy of carbon dioxide laser in the treatment of female stress urinary incontinence and analyze the influencing factors. A total of 46 patients with stress urinary incontinence treated in the Affiliated Hospital of Nantong University from March 2021 to August 2022 were included through strict inclusion criteria and exclusion criteria. All patients were treated with transvaginal carbon dioxide laser therapy, and Patient Global Impression of Change (PGI-C) was used to evaluate patients' subjective satisfaction after treatment. The efficacy was evaluated by patient's subjective assessment of leakage, IngelmanSundberg scale, 1-h urine pad test, and international consultation on incontinence questionnaire short form (ICI-Q-SF) before and after treatment, and the adverse reactions after treatment were recorded. The treatment effect was divided into "significant effect group" and "no significant effect group" by subjective satisfaction and post-treatment-related scale evaluation. After laser treatment, patients' subjective symptom improved, the volume of 1-h urine pad test was reduced, and the ICI-Q-SF score was decreased, and the differences were statistically significant (P < 0.05). There was no significant difference in IngelmanSundberg scale before and after treatment (P = 1.00). Multivariate logistic regression analysis showed that pad test volume was significantly correlated with treatment effect (P = 0.007). Transvaginal carbon dioxide laser is a safe and effective method for the treatment of mild to moderate stress urinary incontinence in females. The less severe the urinary leakage, the better the treatment effect.

Vaginal erbium laser for treatment of stress urinary incontinence: optimization of treatment regimen for a sustained long-term effect.

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.

Pixel-CO2 laser for the treatment of stress urinary incontinence.

The aim of this study was to assess the safety and efficacy of a minimally invasive pixel-CO2 laser procedure for the treatment of stress urinary incontinence (SUI). This was a prospective, open-label study with a cohort of 59 women. Patients were treated intravaginally with a fractional/pixel CO2 laser every 4-6 weeks for a total of three treatments and assessed at 3, 6, and 12 months. Evaluation tools included a Sandvik severity score based on a validated questionnaire, 1-h pad test, vaginal health index score (VHIS), validated female sexual function index (FSFI), patient's impression of disease severity (PGI-S), global impression of improvement (PGI-I), and the short-term pelvic floor impact questionnaire (PFIQ-7) to assess improvements in quality of life. Reduction in SUI severity was noticed throughout the duration of the study, as compared to the baseline in which 2% of the patients were defined as "slight," 73% "moderate," and 25% "severe." Gradual improvement of symptoms resulted in redistribution of severity score and the best outcome observed between 3 and 6 months. Sanitary pad weight declined from an average of 35.45 g per day at baseline to 12.47 g at the 3rd treatment, and increased to 23.06 g at 12 months. Vaginal acidity changes showed a similar pattern. No serious adverse events were reported. Pixel-CO2 laser is safe and effective for treating SUI. Additional maintenance treatments should be considered during the 6-12-month post-treatment period in order to maintain the beneficial effects. Pixel-CO2 laser is a safe and effective treatment for SUI. Maintenance treatments should be considered at 6-12 months.

Advance Xp® Male Sling can be an Effective and Safe Treatment for Post-Prostatectomy Stress Urinary Incontinence Also in Patients with Prior History of External Beam Radiation Therapy: A Multicentric Experience.

Background. Post-prostatectomy stress urinary incontinence (PPSUI) is one of the major complaints after radical prostatectomy. Transoburator male sling (TMS) placement is indicated in persistent mild to moderate PPSUI. External beam radiation therapy (EBRT) might be a negative prognostic factor for TMS outcomes. Study objective was to analyze EBRT impact on TMS outcome. Methods. We retrospectively investigated patients submitted to TMS for PPSUI, with or without previous EBRT, in two tertiary referral centers since 2010. Objective outcome was measured through ICIQ-SF, 1-hour pad test, and pad per die and subjective improvement through PGI-I. Patients were divided according to EBRT to make in-group and between-group comparisons. Results. Patients were 56, 18 (32.1%) had previous EBRT. Median follow-up was 43.0 months (IQR: 22.3-64.0). TMS was placed at mean 18.8 months (SD 4.6) after EBRT. TMS determined a statistically significant reduction of pads, 1-hour pad test, and ICIQ-SF score (P<.05). Improvement diminished during long-term follow-up. At last follow-up, 12 patients (21.4%) used 1 safety pad, while 15 (26.8%) used 0 pads. Median PGI-I was 2 (IQR 2-3). Recorded complications were 9 (16.1%) and none exceeded Clavien-Dindo grade 2. There were no differences in outcomes, failures, and complications between groups. TMS failures were 6 (10.7%), 2 of whom in the EBRT group. Four of them (7.1%) subsequently placed an artificial urinary sphincter (AUS). Conclusion. Advance XP© placement seems effective and safe in well-selected patients complaining with PPSUI, even after EBRT. Surgical outcomes slightly deteriorate over time. Further studies are needed in these patients to assess TMS efficacy.

The Rationale for Photobiomodulation Therapy of Vaginal Tissue for Treatment of Genitourinary Syndrome of Menopause: An Analysis of Its Mechanism of Action, and Current Clinical Outcomes.

Objective: Light, particularly in the visible to far-infrared spectrum, has been applied to the female genital tract with lasers and other devices for nearly 50 years. These have included procedures on both normal and neoplastic tissues, management of condylomata, endometriosis, and menometrorrhagia, and, more recently, a number of fractional laser devices have been applied for the management of genitourinary syndrome of menopause (GSM) and stress urinary incontinence (SUI), and to achieve so-called vaginal rejuvenation. Photobiomodulation therapy (PBMT) has been proposed as an alternative for use in managing GSM and SUI. Methods: This article reviews the biological basis, symptoms, and management of GSM, and investigates the current status and rationale for the use of PBMT. Results and conclusions: Based on the preliminary evidence available, PBMT is safe and appears to be efficacious in treating GSM.

Evaluation and treatment of female stress urinary incontinence after pelvic radiotherapy.

INTRODUCTION: Pelvic radiotherapy is associated with both acute and chronic voiding dysfunction. A review of the success and complications of surgical treatments for female stress urinary incontinence after pelvic radiotherapy has not been summarized in the published literature. METHODS: A systematic review of female stress urinary incontinence after pelvic radiotherapy was conducted using MeSH terminology (1988-2018). RESULTS: There is limited published literature on the treatment of stress urinary incontinence in women following pelvic radiotherapy. Long term indwelling urethral catheter should be avoided in all women given the risk of iatrogenic hypospadias. Surgical treatments can be classified into those for the intact versus failed outlet. Urethral bulking injections have been studied in a prospective fashion specifically in women with stress urinary incontinence after radiotherapy and although not randomized, have the highest level of evidence. Patients should be screened for a history of prior radiotherapy before considering sling placement. Artificial urinary sphincter is associated with a high rate of erosion after prior radiotherapy. The role of Burch colposuspension in patients with prior radiotherapy is poorly defined. Urinary diversion should be considered for patients with a devastated outlet. CONCLUSIONS: Since the long-term effects of radiotherapy on lower urinary tract voiding function are typically irreversible and progressive, further research is needed to mitigate the adverse effects of irradiation and identify more durable treatment options for women with radiation induced bladder dysfunction and stress urinary incontinence.

Sistema masculino transobturador ajustable (ATOMS(R)) como tratamiento de la incontinencia urinaria de esfuerzo secundaria a resección transuretral de la próstata / Adjustable transobturator male system (ATOMS(R)) as treatment of stress urinary incontinence secondary to transurethral resection of the prostate

Objetivos: Estudio de viabilidad para evaluar la eficacia y la seguridad del sistema masculino transobturador ajustable (ATOMS(R)) para la incontinencia urinaria de esfuerzo (IUE) masculina después de la resección transuretral de la próstata. Materiales y métodos: Se implantó ATOMS(R) a 20 pacientes con IUE causada por resección transuretral de la próstata con o sin radioterapia. La severidad de la incontinencia fue evaluada como leve (2 compresas/día), moderada (3-5 compresas/día) o severa (≥6 compresas/día), y se consideró paciente seco aquel sin compresas o con una compresa de seguridad al día. Se investigó el cambio en el recuento de compresas (pad-count) y en el peso de las compresas (pad-test), así como otros parámetros operatorios, la satisfacción del paciente con el procedimiento, y el número y grado de complicaciones (Clavien-Dindo). Resultados: La mediana de edad fue de 76,5 años. Cinco pacientes habían recibido radioterapia pélvica (3 por cáncer de próstata, 2 por cáncer rectal) y 2 (10%) habían tenido esfínter urinario artificial con erosión uretral y fallo mecánico, respectivamente. La IUE preoperatoria fue leve en 4 (20%), moderada en 7 (35%) y severa en 9 (45%). La mediana de relleno del sistema fue de 13,5 ml. La mediana de pad-test disminuyó de 375 ± 855 ml basal a 10 ± 31,5 ml y el pad-count, de 4 ± 3 a 0 ± 1,5 tras el ajuste (1 ± 3 rellenos). La IUE postoperatoria fue leve en 2 (10%) pacientes, moderada en uno (5%) y severa en 2 (10%). La tasa de satisfacción fue del 80%, igual para pacientes con o sin radioterapia previa. Ningún paciente tuvo retención urinaria al retirar el catéter. Hubo complicaciones en 3 (15%) casos, todas menores. Tras una mediana de seguimiento de 38,5meses no se ha retirado ningún sistema; 19 (95%) pacientes se consideran mejor que antes y 11 (55%) muchísimo mejor. Conclusión: Según la eficacia a corto plazo y la satisfacción del paciente, ATOMS(R) puede considerarse una alternativa realista para IUE después de la resección transuretral de la próstata, incluso en pacientes radiados. La ausencia de erosión uretral y la escasez de problemas hacen esta alternativa especialmente atractiva para pacientes con destreza disminuida, edad avanzada y tratamientos previos fallidos

Objectives: Feasibility study to evaluate efficacy and safety of Adjustable Transobturator Male System (ATOMS(R)) for male stress urinary incontinence (SUI) after transurethral resection of the prostate. Materials and methods: Twenty patients were implanted ATOMS(R) for SUI caused by transurethral resection of the prostate with or without radiotherapy. Incontinence severity was evaluated as mild (2 pads/day), moderate (3-5 pads/day) or severe (≥ 6pads/day), and dryness as none or one security pad/day. Changes in pad-test and pad-count after adjustment were investigated, together with operative parameters, patient satisfaction with the procedure, and number and grade of complications (Clavien-Dindo). Results: Median age was 76.5 years. Five patients received previous pelvic radiation (3 prostate, 2 rectal cancer) and 2 (10%) previous failed artificial urinary sphincter with urethral erosion and mechanical failure, respectively. Preoperative SUI was mild in 4 (20%), moderate in 7 (35%) and severe in 9 (45%). Median filling of the system was 13.5 ml. Median pad-test decreased from 375 ± 855 ml baseline to 10 ± 31.5 ml and pad-count from 4 ± 3 to 0 ± 1.5 after adjustment (1 ± 3 fillings). Postoperative SUI distribution was mild in 2 (10%), moderate in one (5%) and severe in 2 (10%). Satisfaction rate was 80%, equal for transurethral resection of the prostate with/without previous radiotherapy. No patient had urinary retention after catheter removal. Complications presented in 3 (15%) patients, all minor. After median 38.5mo follow-up no system has been removed, 19 (95%) self-considered better than before and 11 (55%) very much better. Conclusion: Based on short-term efficacy and patient satisfaction ATOMS(R) can be considered a realistic alternative for SUI after transurethral resection of the prostate, even after irradiation. Absence of urethral erosion and very limited problems make this alternative especially attractive for cases with diminished dexterity, advanced age and previous failed treatments

[Outcomes of ER:YAG LASER treatment of stress urinary incontinence in women].

AIM: To evaluate the effectiveness of a new method of treatment for stress urinary incontinence in women using an ER: YAG laser in SMOOTH mode and investigate pathophysiological and pathomorphological changes induced by erbium laser. MATERIALS AND METHODS: This study comprised 98 women aged 37-63 years, who between 2014 and 2016 were diagnosed with SUI (type 1 and 2a, 2b) and grade 0-2 vaginal prolapse. The treatment was performed with a 2940 nm Er:YAG laser (Fotona, Slovenia) using a SMOOTH mode. Clinical assessment included PFIQ-7 and PISQ-12 questionnaires, uroflowmetry, laser Doppler flowmetry and biopsy of the anterior vaginal wall. The examination was carried out at baseline and 1-2 months after the treatment. RESULTS: The effectiveness of treatment was 73%. There was no deterioration after the procedure. Analysis of PFIQ-7 and PISQ-12 questionnaires showed that patients with mild incontinence had the greatest difference between pre- and posttreatment results. Uroflowmetry parameters improved in a majority of patients. Results of laser Doppler flowmetry demonstrated the improvement of blood flow in the microvascular bed. An important feature of the vaginal biopsy after laser exposure was an increase in neoangiogenesis. DISCUSSION: The findings of questionnaires and clinical evaluation of patients with SUI and vaginal prolapse before and after treatment with Er: YAG laser showed high therapeutic effectiveness of this treatment modality. CONCLUSION: Clinical effectiveness of ER: YAG laser in SMOOTH mode was 73%. Patients with type 1 and 2a SUI and mild or moderate incontinence have the best prognosis after treatment with this method.

No. 358-Intravaginal Laser for Genitourinary Syndrome of Menopause and Stress Urinary Incontinence.

OBJECTIVE: This technical bulletin reviews the evidence relating to risks and benefits of using intravaginal laser technology in the management of genitourinary syndrome of menopause and stress urinary incontinence. INTENDED USERS: Gynaecologists, urogynaecologists, urologists, and other health care professionals who assess, counsel, and provide care for women with genitourinary syndrome of menopause and stress urinary incontinence. TARGET POPULATION: Adult women with genitourinary syndrome of menopause and stress urinary incontinence seeking complementary or alternative treatment options to topical estrogen, non-hormonal vaginal moisturizers, physiotherapy, intravaginal devices, and surgery. OPTIONS: The discussion relates to intravaginal laser treatments for genitourinary syndrome of menopause compared with topical estrogen and that for stress urinary incontinence. OUTCOMES: The outcomes of interest are objective and subjective rates of response to treatment, histologic outcomes, and procedural complications. EVIDENCE: PubMed, Medline, the Cochrane Database, and EMBASE were searched using the key words "genitourinary syndrome of menopause," "vaginal laser," "topical estrogen," and "urogenital atrophy." Results were restricted to English and human research. Articles were included until the end of September 2016. Clinical practice guidelines and guidelines of specialty societies were reviewed. Included studies were observational or prospective cohort when available. Only publications with study groups larger than or equal to 20 individuals were included, and non-peer-reviewed papers were excluded. VALIDATION METHODS: The content and recommendations were drafted and agreed upon by the principal authors. The Board of the SOGC approved the final draft for publication. The quality of evidence was rated using the criteria described in the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology framework. BENEFITS, HARMS, AND/OR COSTS: It is expected that this technical bulletin will benefit patients with genitourinary syndrome of menopause by ensuring treating physicians are aware of all treatment options including the potential benefit and associated risk with intravaginal laser therapy. This should guide patient informed consent before such procedures are undertaken. There are no direct harms or costs identified with the implementation of this guideline. SPONSORS: The SOGC. SUMMARY STATEMENTS: RECOMMENDATIONS.

Effect of non-ablative laser treatment on overactive bladder symptoms, urinary incontinence and sexual function in women with urodynamic stress incontinence.

OBJECTIVE: To investigate the effects of non-ablative laser treatment on overactive bladder (OAB) syndromes, stress urinary incontinence and sexual function in women with urodynamic stress incontinence (USI). MATERIALS AND METHODS: Between April 2015 and June 2015, consecutive patients with USI with OAB syndromes underwent two sessions of Erbium:YAG laser treatment in a tertiary hospital. Patients received validated urological questionnaires, urodynamic studies, 1-h pad test and measurement of vaginal pressure before, one and three months after laser treatment. Questionnaires at 12 months were completed by telephone interview. Adverse effects and patients' satisfaction were also assessed. RESULTS: We included 30 patients with a mean age of 52.6 ± 8.8 years. Three months after therapy, mean 1-h pad test significantly decreased (P = 0.039). Significant improvement in OAB symptoms in four questionnaires were noted at three months post treatment, but not sustained for 12 months in two of them. Three months after therapy, mean vaginal pressure significantly improved (P = 0.009). Of 24 (82.7%) sexually active patients, 62.5% (15/24) and 54.2% (13/24) of their sexual partners reported improved sexual gratification three months later. No major adverse effects were noticed. CONCLUSIONS: Erbium:YAG laser treatment can resolve USI and coexistent OAB symptoms three months after therapy. Sexual experience is also improved. However, repeated laser therapy may be necessary after six months.

Treatment of female stress urinary incontinence with Erbium-YAG laser in non-ablative mode.

OBJECTIVE: To evaluate the efficacy of laser photothermal therapy in a group of Chilean women with SUI. MATERIAL AND METHODS: Longitudinal prospective study based on 42 women with mild-to-severe SUI, intervened with non ablative Er:YAG laser, between July 2014 and October 2015, in Santiago, Chile. The therapy efficacy was evaluated through the difference between every patient's scores obtained, before and after treatment, with the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-SF), at a confidence level of 95%. Also, the patient satisfaction with treatment was reported through an ordinal scale. RESULTS: ICIQ-SF median score was 11 before treatment and 3 after 6 months, with a significant difference per patient (p<0.001). 78.6% (n=33) reported improvement and 38.1% (n=16), a complete healing of SUI at follow up. 66.7% (n=28) reported high satisfaction and 81.8% (n=27) of sexually active women, also reported improvement of sexual gratification. Only mild pain during the procedure was reported as adverse effect. CONCLUSIONS: Based on this short-term pilot study, non-ablative Er:YAG laser procedure seems to be a safe and efficacious alternative for patients with SUI. Further controlled studies will help to validate the use of non-ablative Er:YAG for treatment of SUI.

Transcorporal artificial urinary sphincter in radiated and non - radiated compromised urethra. Assessment with a minimum 2 year follow-up.

PURPOSE: to assess the efficacy of transcorporal artificial urinary sphincter (AUS) implantation on continence for male stress urinary incontinence in cases of prior surgical treatment or/and radiation failure, and as a first option in radiation patients. MATERIALS AND METHODS: From March 2007 to August 2012, 37 male patients were treated with transcorporal AUS AMS™ 800. Twelve patients had primary placement of transcorporal cuff, a surgical option due to a previous history of radiation and 25 patients had secondary procedure after failure of AUS or urinary incontinence surgery. Functional urinary outcomes were assessed by daily pad use, 24-hour Pad-test and ICIQ-SF questionnaire. Quality of life and satisfaction were assessed based on I-QoL and PGI-I questionnaires. RESULTS: After a median of 32 months, the continence rate (0 to 1 pad) was 69.7%. Median pad test was 17.5g (0-159), mean ICIQ-SF score was 7.3/21 (±5.4) and mean I-QoL score was 93.9/110. A total of 88% of the patients reported satisfaction with the AUS. The 5-year actuarial revision-free for AUS total device was 51%. Patients for primary implant for radiation were not more likely to experience revision than non-radiation patients. Preservation of erections was reported in half of the potent patients. CONCLUSIONS: Transcorporal AUS cuff placement is a useful alternative procedure option for severe male UI treatment, especially in patients with a compromised urethra after prior surgery or radiation. A high continence rate was reported and implantation as first option in radiation patients should be considered.

Transcorporal artificial urinary sphincter in radiated and non - radiated compromised urethra. Assessment with a minimum 2 year follow-up

ABSTRACT Purpose to assess the efficacy of transcorporal artificial urinary sphincter (AUS) implantation on continence for male stress urinary incontinence in cases of prior surgical treatment or/and radiation failure, and as a first option in radiation patients. Materials and Methods From March 2007 to August 2012, 37 male patients were treated with transcorporal AUS AMS™ 800. Twelve patients had primary placement of transcorporal cuff, a surgical option due to a previous history of radiation and 25 patients had secondary procedure after failure of AUS or urinary incontinence surgery. Functional urinary outcomes were assessed by daily pad use, 24-hour Pad-test and ICIQ-SF questionnaire. Quality of life and satisfaction were assessed based on I-QoL and PGI-I questionnaires. Results After a median of 32 months, the continence rate (0 to 1 pad) was 69.7%. Median pad test was 17.5g (0-159), mean ICIQ-SF score was 7.3/21 (±5.4) and mean I-QoL score was 93.9/110. A total of 88% of the patients reported satisfaction with the AUS. The 5-year actuarial revision-free for AUS total device was 51%. Patients for primary implant for radiation were not more likely to experience revision than non-radiation patients. Preservation of erections was reported in half of the potent patients. Conclusions Transcorporal AUS cuff placement is a useful alternative procedure option for severe male UI treatment, especially in patients with a compromised urethra after prior surgery or radiation. A high continence rate was reported and implantation as first option in radiation patients should be considered.

Minimally invasive, non-ablative Er:YAG laser treatment of stress urinary incontinence in women--a pilot study.

The study presents an assessment of mechanism of action and a pilot clinical study of efficacy and safety of the Er:YAG laser for the treatment of stress urinary incontinence (SUI). The subject of this study is a treatment of SUI with a 2940 nm Er:YAG laser, operating in a special SMOOTH mode designed to increase temperature of the vaginal mucosa up to maximally 60-65 °C without ablating the epidermis. Numerical modelling of the temperature distribution within mucosa tissue following an irradiation with the SMOOTH mode Er:YAG laser was performed in order to determine the appropriate range of laser parameters. The laser treatment parameters were further confirmed by measuring in vivo temperatures of the vaginal mucosa using a thermal camera. To investigate the clinical efficacy and safety of the SMOOTH mode Er:YAG laser SUI treatment, a pilot clinical study was performed. The study recruited 31 female patients suffering from SUI. Follow-ups were scheduled at 1, 2, and 6 months post treatment. ICIQ-UI questionnaires were collected as a primary trial endpoint. Secondary endpoints included perineometry and residual urine volume measurements at baseline and all follow-ups. Thermal camera measurements have shown the optimal increase in temperature of the vaginal mucosa following treatment of SUI with a SMOOTH mode Er:YAG laser. Primary endpoint, the change in ICIQ-UI score, showed clinically relevant and statistically significant improvement after all follow-ups compared to baseline scores. There was also improvement in the secondary endpoints. Only mild and transient adverse events and no serious adverse events were reported. The results indicate that non-ablative Er:YAG laser therapy is a promising minimally invasive non-surgical option for treating women with SUI symptoms.

Cost effectiveness of radiofrequency microremodeling for stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: Stress urinary incontinence (SUI) is a common and growing problem among adult women and affects individuals and society through decreased quality of life (QoL), decreased work productivity, and increased health care costs. A new, nonsurgical treatment option has become available for women who have failed conservative therapy, but its cost effectiveness has not been evaluated. This study examined the cost effectiveness of transurethral radiofrequency microremodeling of the female bladder neck and proximal urethra compared with synthetic transobturator tape (TOT), retropubic transvaginal tape (TVT) sling, and Burch colposuspension surgeries for treating SUI. METHODS: A Markov model was used to compare the cost effectiveness of five strategies for treating SUI for patients who had previously failed conservative therapy. The strategies were designed to compare the value of starting with a less invasive treatment. The cost-effectiveness analysis was conducted from the health care system perspective. Efficacy and adverse event rates were obtained from the literature; reimbursement costs were based on Medicare fee schedule. The model cycle was 3 months, with a 3-year time horizon. Single-variable sensitivity analyses were conducted to assess stability of base-case results. RESULTS: Two of the five strategies employed the use of transurethral radiofrequency microremodeling and achieved 17-30 % lower mean costs relative to their comparative sling or Burch strategies. CONCLUSIONS: Superior safety and cost effectiveness are recognized when patients are offered a sequential approach to SUI management that employs transurethral radiofrequency microremodeling before invasive surgical procedures. This sequential approach is consistent with treatment strategies for other conditions and offers a solution for women with SUI who want to avoid the inherent risks and costs of invasive continence surgery.

Transurethral collagen denaturation for women with stress urinary incontinence.

Transurethral collagen denaturation was approved by the US Food and Drug Administration in 2005 for the nonsurgical treatment of stress urinary incontinence in women. In this procedure, controlled, nonablative radiofrequency energy applied through a transurethral probe produces microscopic submucosal sites of collagen denaturation, resulting in reduced tissue compliance. Treatment is administered in about 30 minutes in an outpatient setting without incisions, general anesthesia, or use of cystoscopy or other visualization. The safety and efficacy of this treatment were demonstrated in a pilot trial in 41 women and then in a subsequent 12-month sham procedure-controlled trial in more than 170 women. Ongoing clinical trials include a 3-year, open-label durability study and an evaluation of this technique in women who have failed prior surgical intervention. To date, patients who received transurethral collagen denaturation have experienced improvements in quality of life and in Valsalva leak point pressure. This procedure presents a beneficial nonsurgical treatment option for women with stress urinary incontinence.

Oral and local anesthesia in the nonsurgical radiofrequency-energy treatment of stress urinary incontinence.

STUDY OBJECTIVE: To demonstrate the feasibility, safety, and patient comfort associated with nonsurgical radiofrequency-energy (RF) tissue micro-remodeling in women with stress urinary incontinence (SUI) given oral and local anesthesia. DESIGN: Prospective, open-label pilot clinical trial (Canadian Task Force classification II-2). SETTING: Department of urology in a major academic teaching hospital in Mexico City, Mexico. PATIENTS: Sixteen women with SUI and hypermobility (based on history and physical examination) with no history of previous definitive incontinence therapy. INTERVENTIONS: Nonsurgical, transurethral, outpatient RF tissue micro-remodeling with women given oral plus local anesthesia. MEASUREMENTS AND MAIN RESULTS: The women had a mean age of 49.7 years (range 30-76 years) and a mean duration of incontinence of 7.6 years (range 1-30 years). The nonsurgical RF micro-remodeling treatment, which was previously demonstrated to be of significant benefit when administered under intravenous (IV) sedation in an outpatient surgicenter setting, was successfully completed in all 16 women. Either the treating physician or the patient had the option to convert to IV sedation during the procedure if there was too much discomfort; however, this did not occur in any of the 16 patients. Thus neither the treating physician nor any patient determined that conversion to IV conscious sedation was required for treatment completion. The first six patients received an oral sedative and oral analgesic as well as a local periurethral anesthetic block with 10 mL of 2% lidocaine. The final 10 patients (63%) received only one oral sedative or analgesic and a total of 10mL lidocaine local anesthetic. Two women who received the maximum oral regimen (both oral sedation and analgesics) experienced nausea and emesis when drinking immediately after treatment, and one of these women also experienced urinary retention, which resolved after 24 hours of catheterization. Immediately before discharge, subjects classified their pain on a scale from zero ("no pain") to 10 ("terrible pain"). Mean score was 1.8, and 38% of subjects selected "zero." CONCLUSION: This pilot trial demonstrated the feasibility, safety, and patient comfort associated with performing a novel new successful technique of nonsurgical RF of the urethra for treatment of SUI, which was previously studied under IV sedation in an outpatient surgery center, on women in an office-based setting using oral plus local anesthesia.

Comparison of the quality of life after nonsurgical radiofrequency energy tissue micro-remodeling in premenopausal and postmenopausal women with moderate-to-severe stress urinary incontinence.

OBJECTIVE: This study was undertaken to determine the effect of menopause and hormone replacement therapy (HRT) on incontinence quality of life (I-QOL) score improvement in women with moderate-to-severe stress urinary incontinence (SUI) after nonsurgical, transurethral radiofrequency energy (RF) tissue micro-remodeling. STUDY DESIGN: Retrospective review of prospective, randomized, controlled clinical trial. Women with moderate-to-severe SUI were analyzed by menopausal status and HRT use for 10-point or greater I-QOL score improvement (an increase associated with subjective and objective SUI improvement). RESULTS: RF micro-remodeling resulted in 81% of subjects achieving 10-point or greater I-QOL score improvement versus 49% of sham subjects at 12 months ( P = .04). Outcomes did not differ statistically when premenopausal (85%), postmenopausal using HRT (70%), and postmenopausal not using HRT (71%) groups were compared. CONCLUSION: Menopausal status and HRT demonstrated no impact on the quality of life improvement experienced by women with moderate-to-severe SUI who underwent RF tissue micro-remodeling.

Advancements in minimally invasive treatments for female stress urinary incontinence: radiofrequency and bulking agents.

Continuous advancements in materials technology have provided the possibility that multiple new urethral bulking agents will be available soon. Experience continues to accrue in clinical trials for urethral bulking with these agents. Parallel use for the indication of pediatric vesicourethral reflux also has provided evidence of biologic activity related to these compounds. All of the agents closest to complete analysis are synthetic and represent a variety of material types and characteristics. As these materials evolve, understanding of the preferential injection technique is being gained. Delivery methods and sites may prove to alter the biologic activity of these compounds substantially. Emphasis on other minimally invasive options for the surgical treatment of stress incontinence also has resulted in the development of radiofrequency vesicourethral suspension. Improved understanding of thermal application to tissue, acute and chronic tissue response to this application, and accumulating human experience with this method of therapy has provided an acceptable tolerability profile for this therapy. This profile may provide application of this method of therapy to an in-office treatment setting, precluding hospitalization and substantially decreasing convalescence times.