Vaginal Laser Therapy for Female Stress Urinary Incontinence: New Solutions for a Well-Known Issue-A Concise Review.

Background and Objectives: Insufficient connective urethra and bladder support related to childbirth and menopausal estrogen decrease leads to stress urinary incontinence (SUI). The aim of this review is to narratively report the efficacy and safety of new mini-invasive solutions for SUI treatment as laser energy devices, in particular, the microablative fractional carbon dioxide laser and the non-ablative Erbium-YAG laser. Materials and Methods: For this narrative review, a search of literature from PubMed and EMBASE was performed to evaluate the relevant studies and was limited to English language articles, published from January 2015 to February 2022. Results: A significant subjective improvement, assessed by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-UI-SF) was reported at the 6-month follow up, with a cure rate ranged from 21% to 38%. A reduction of effect was evidenced between 6 and 24-36 months. Additionally, the 1-h pad weight test evidence a significant objective improvement at the 2-6-month follow up. Conclusions: SUI after vaginal laser therapy resulted statistically improved in almost all studies at short-term follow up, resulting a safe and feasible option in mild SUI. However, cure rates were low, longer-term data actually lacks and the high heterogeneity of methods limits the general recommendations. Larger RCTs evaluating long-term effects are required.

The Learning Curve of Urodynamics for the Evaluation of Lower Urinary Tract Symptoms.

Background and Objectives: Urodynamics is considered the gold standard for lower urinary tract functional assessment. However, it requires very specific skills and training, which are currently difficult to master due to its reduced use. Moreover, no studies or data are available to define the workload and the learning curve of this diagnostic tool. As a consequence, we aimed to evaluate the learning curve of residents with no previous experience to correctly perform and interpret urodynamics, and properly address and manage patients with pelvic floor disorders based on urodynamics findings. Materials and Methods: This prospective study analyzed a series of proficiency parameters in residents performing urodynamics under consultant supervision, including the following: duration of procedure, perceived difficulty, need for consultant intervention, accuracy of interpretation, and therapeutic proposal. The number of procedures performed was then divided into groups of five to evaluate the progressive grade of autonomy (technical and full management autonomy) reached by each resident. Results: In total, 69 patients underwent urodynamics performed by three residents, with every resident performing at least 20 exams. Duration of procedure, perceived difficulty, need for consultant intervention, accuracy of interpretation, and the appropriateness of the hypothetical proposal of management/treatment based on their interpretation of clinical data and urodynamic findings was shown to be directly related to the number of exams performed. Technical autonomy in the execution of uroflowmetry was reached in the group performing 6-10 procedures, while technical autonomy in the execution of cystomanometry with pressure/flow study was obtained in the group of 16-20 procedures. The latter corresponded also to the gain of full autonomy which also included an optimal therapeutic proposal. Conclusion: We found that there is a tangible learning curve for urodynamics in terms of several proficiency parameters. A workload of 5 uroflowmetries and 15 cystomanometries with pressure/flow studies may be adequate to complete the learning curve.

Tension-free vaginal tape for treatment of pure urodynamic stress urinary incontinence: efficacy and adverse effects at 17-year follow-up.

OBJECTIVE: To assess the efficacy and safety of retropubic tension-free vaginal tape (TVT) 17 years after implantation for the treatment of female pure stress urinary incontinence (SUI). PATIENTS AND METHODS: A prospective study was conducted in two urogynaecological units in two countries. All consecutive women with urodynamically proven pure SUI treated by TVT were included. Patients with mixed incontinence and/or anatomical evidence of pelvic organ prolapse were excluded. Data regarding subjective outcomes (International Consultation on Incontinence Questionnaire-Short Form, Patient Global Impression of Improvement, and patient satisfaction scores), objective cure (stress test) rates, and adverse events were collected during follow-up. Univariable analysis was performed to investigate outcomes. RESULTS: A total of 52 women underwent TVT implantation. At 17-year follow-up, 46 women (88.4%) were available for the evaluation. We did not find any significant change in surgical outcomes during this time. At 17 years after surgery, 41 of 46 women (89.1%) declared themselves cured (P = 0.98). Similarly, at 17-year evaluation, 42 of 46 women (91.4%) were objectively cured. No significant deterioration in objective cure rates was observed over time (P for trend 0.50). The univariate analysis did not find any risk factor statistically associated with the recurrence of SUI. Of the 46 women, 15 (32.6%) reported the onset of de novo overactive bladder at 17-year follow-up. No other late complications were reported. CONCLUSIONS: The 17-year results of this study showed that TVT is a highly effective and safe option for the treatment of SUI.

Vaginal cystocele repair and hysteropexy in women with anterior and central compartment prolapse: efficacy and safety after 30 months of follow-up.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to assess the safety and efficacy of vaginal native tissue repair and uterine suspension after a follow-up of at least 1 year. METHODS: We included all consecutive women with an anterior vaginal prolapse of stage II or higher and a concomitant uterine prolapse of stage II who underwent this surgical procedure. We considered women with a descensus with maximum point of less than -1 in any compartment as objectively cured. Overall success was defined as no prolapse symptoms, together with a Patient Global Impression of Improvement (PGI-I) score of 2 or less, prolapse of stage lower than II, and no need for other surgery. RESULTS: A total of 102 patients underwent this surgical procedure during the study period and met all the inclusion criteria for statistical analysis. The mean follow-up was 31 ± 8.2 months; no patient was lost to follow-up. Five patients (4.9%) showed postoperative complications. In terms of subjective outcomes, at the last available follow-up, failure of this surgical procedure was seen in 2% of patients. The objective cure rate and the overall cure rate were the 95.1%. No significant deterioration in objective cure rates was observed over time (p = 0.6). CONCLUSIONS: Vaginal repair and hysteropexy appear to be an effective and safe option for women with advanced uterovaginal prolapse.

Urethral bulking agents versus other surgical procedures for the treatment of female stress urinary incontinence: a systematic review and meta-analysis.

Bulking agents provide an alternative option in the management of women with stress urinary incontinence and they seem to have an important role in the management flow chart of SUI. However, evidence on this issue is scanty. The most important aspect is to understand whether bulking agents are comparable with the other first-line anti-incontinence surgical procedure (MUS, Burch colposuspension and pubovaginal slings). Hence, the primary aim of the current review was to assess the objective and subjective outcomes of bulking agents in comparison with the other surgical procedures for the treatment of SUI. PubMed and Medline were systematically searched and we included studies evaluating the use of bulking agents in comparison with other surgical approaches for either primary or recurrent treatment of female SUI. Three studies meeting the inclusion criteria were identified. Two of these studies were RCTs evaluating the use of bulking agents versus other surgical procedures for the treatment of primary female SUI; the remnant article was a retrospective cohort study that compared the effectiveness and safety of repeat midurethral sling with urethral bulking after failed midurethral sling. The combined results of all analyses showed that the objective recurrence rate of peri- or trans-urethral injections is significantly higher in comparison with the other surgical procedures. Similar findings were observed when considering separately the treatment for primary or recurrent SUI. Furthermore, lower subjective recurrence rate was observed among patients undergoing other surgical treatment in comparison with those undergoing bulking agents; however, this trend was not statistically significant. Moreover, patients undergoing injection of bulking agents experienced a lower rate of voiding dysfunctions in comparison to the control group. According to current evidence, bulking agents should not be proposed as first-line treatment in those women seeking permanent cure for both primary and recurrent SUI. However, the effectiveness of a procedure should be balanced with its invasiveness and patients' expectations. Bulking agents are a minimally invasive approach to treat SUI and their use should be considered as an alternative strategy particularly in special conditions: patients who are fragile, in those who do not wish to have surgery, or in whom surgical options are restricted (postoperatively, after irradiation).

Iliococcygeus fixation for the treatment of apical vaginal prolapse: efficacy and safety at 5 years of follow-up.

INTRODUCTION AND HYPOTHESIS: Sacrocolpopexy is considered the gold standard treatment for vaginal vault prolapse. However, the vaginal approach is very common, with 80-90 % of procedures being performed via this route. The aim of this study was to evaluate the safety and efficacy of iliococcygeus (ICG) fixation in the treatment of vaginal vault prolapse, with a minimum follow-up of 5 years. METHODS: We prospectively enrolled women with symptomatic vaginal vault prolapse (Pelvic Organ Prolapse Quantification [POP-Q] stage ≥2) who were treated with ICG fixation. Subjective success was defined in the case of Patient Global Impression of Improvement ≤ 2 and an absence of bulging symptoms. Objective success was defined as stage of prolapse < 2 in all compartments. Overall success rate was defined as women without prolapse symptoms, PGI-I ≤ 2, stage of prolapse < 2, and no need for other surgery. All women filled in the Prolapse Quality of Life (P-QOL) questionnaire both at the preoperative visit and at every follow-up visit. Multiple logistic regression was performed to identify factors involved in the risk of recurrent POP. RESULTS: After a median (range) follow-up of 68.8 (60-92) months the subjective, objective, and overall cure rates were 88.6 % (39 out of 44), 84.1 % (37 out of 44), and 84.1 % (37 out of 44) respectively. Only preoperative stage IV vault descensus independently predicted POP recurrence after iliococcygeus fixation (OR: 8.78 [95 % CI: 1.31-9.42]; p < 0.001). CONCLUSIONS: Iliococcygeus fixation is a safe and effective surgical technique for the treatment of vaginal vault prolapse with long-lasting effectiveness.

Is there a learning curve for the TVT-O procedure? A prospective single-surgeon study of 372 consecutive cases.

OBJECTIVES: To evaluate for the first time in the literature the learning curve of Inside-out transobturator tape (TVT-O™). STUDY DESIGN: A prospective observational study was conducted in a tertiary reference center. Consecutive women treated by TVT-O™ performed by one surgeon were included. Data regarding subjective, objective cure rates, and adverse events were collected. Trends, over the number of procedures, were estimated using assay analyses. Number of procedures and variables were interpolating in standard curves using linear lines. RESULTS: Three hundred and seventy two procedures were included. Postoperative pain levels decreased with the increase in the level of expertise (pain levels: 1-day: from 6.6 (±3.3) to 4.3 (±3.1); 95%CI: -0.01603 to 0.001235, p=0.04; 2-day: from 5.6 (±4.1) to 3.6 (±3.7); 95%CI: -0.02092 to -0.002497, p=0.01; 12-month: from 0.1 (±0.7) to 0 (±0); 95%CI: -0.001814 to 0.05019, p=0.07). Overall, objective cure rate was achieved in 93.5% of patients. Additionally, 88.2% and 88.7% patients reported "much better" feeling at PGI-I scale and 80% reduction in UDI score, respectively. We observed, that delta ICIQ-sf (from 12 (±8.7) to 14 (±6.0); p=0.04) and delta-UDI (from 91% to 97%; p=0.04) improved over the time. CONCLUSIONS: TVT-O procedure offers excellent outcomes with high objective and subjective cure rates and low complications rate, even at the beginning of the surgeon's learning curve. However, a high experience of the surgeon could significantly improve the subjective cure rate and could reduce postoperative the groin pain.

Medication adherence and persistence in the treatment of rheumatoid arthritis with adalimumab and etanercept. Six years of analysis.

OBJECTIVE: The aim of this study was to evaluate medication adherence and persistence of patients treated with Etanercept and Adalimumab for Rheumatoid Arthritis, also giving economic evaluations on therapy costs for Received Daily Dose (RDD). MATERIALS AND METHODS: This retrospective study took into account 6 years from January 1, 2007 to December 31, 2012. Medication adherence was quantified utilizing the ratio between RDD and Prescribed Daily Dose (PDD). Persistence has been reckoned taking into account the actual days of therapy comparing posology with supplied dose. The persistence has been graphed according to Kaplan-Meier method. The cost per RDD was reckoned starting from the expense incurred by Pescara General Hospital. RESULTS: Medication adherence gave results in values between 0.88-0.97 for Etanercept and 0.83-0.90 for Adalimumab. The value of persistence was 100% for Etanercept and 90% for Adalimumab for the first year, and 70% for Etanercept and 80% for Adalimumab for the second year. In the 3rd year the persistence for Etanercept was 50% while for Adalimumab it was 60%. In the fourth year the persistence for Etanercept was 21% while for Adalimumab it was 27%. The statistical analysis was conducted using the Log rank test. The average cost per RDD was €32.97 for Etanercept and for Adalimumab it was €32.00 as an average of 6 years. CONCLUSION: The medication adherence was good for both Etanercept and Adalimumab. The rate of persistence decreased strictly in the fourth year of treatment. This data suggests the need for continuous monitoring of patients in treatment with TNF blockers.

Robot-assisted sacrocolpopexy for pelvic organ prolapse: a systematic review and meta-analysis of comparative studies.

CONTEXT: Surgery represents the mainstay of treatment for pelvic organ prolapse (POP). Among different surgical procedures, abdominal sacrocolpopexy (SC) is the gold standard for apical or multicompartmental POP. Research has recently focused on the role of robot-assisted sacrocolpopexy (RASC). OBJECTIVE: To conduct a systematic review on the outcomes of RASC. EVIDENCE ACQUISITION: PubMed, Scopus, and Web of Science databases as well as ClinicalTrials.gov were searched for English-language literature on RASC. A total of 509 articles were screened; 50 (10%) were selected, and 27 (5%) were included. Studies were evaluated per the Grading of Recommendations, Assessment, Development, and Evaluation system and the European Association of Urology guidelines. EVIDENCE SYNTHESIS: Overall, data on 1488 RASCs were collected from 27 studies, published from 2006 to 2013. Objective and subjective cures ranged from 84% to 100% and from 92% to 95%, respectively. Conversion rate to open surgery was <1% (range: 0-5%). Intraoperative, severe postoperative complications, and mesh erosion rates were 3% (range: 0-19%), 2% (range: 0-8%), and 2% (range: 0-8%), respectively. Surgical-related outcomes have improved with increased experience, with an estimated learning curve of about 10-20 procedures. Laparoscopic SC is less costly than RASC, although the latter has lower costs than abdominal SC. CONCLUSIONS: RASC is a safe and feasible procedure for POP; it allows the execution of complex surgical steps via minimally invasive surgery without medium- and long-term anatomic detriments. Further prospective studies are needed to confirm these findings. PATIENT SUMMARY: We looked at the outcomes of robotic sacrocolpopexy for prolapse. We found that the use of robotic technology is safe and effective for the treatment of prolapse in women.

Urodynamic evaluation: can it prevent the need for surgical intervention in women with apparent pure stress urinary incontinence?

OBJECTIVES: To identify how many patients with symptoms of pure stress urinary incontinence (SUI) do not require any surgical treatment on the basis of urodynamics (UDS) and how many patients still do not require surgery 1 year after UDS. To assess the outcomes of these patients at 12-month follow-up. PATIENTS AND METHODS: Women with pure SUI received UDS and were prospectively divided into four groups, comprising women with: urodynamic stress incontinence (USI); detrusor overactivity (DO); USI + DO; and inconclusive UDS. Women with USI underwent a Tension Free Vaginal Tape (Obturator) (TVT-O) procedure (Gynecare; Ethicon Inc., Somerville, NJ, USA), whereas women with DO ±/- USI were recommended 24-week antimuscarinic therapy. Follow-up was scheduled at 3 and 12 months. To define subjective outcomes, all patients completed the International Consultation on Incontinence Questionnaire - short form, the Patient Global Impression - Improvement and the Urinary Distress Inventory. Patients were considered cured if they presented a negative stress test, a score reduction of at least 80% on the Urinary Distress Inventory and a response of 'much better' or 'very much better' on the Patient Global Impression - Improvement. RESULTS: Of the 263 women with pure SUI, 74.5% had a urodynamic diagnosis of USI, 10.6% had DO, 8% had USI + DO and 6.8% had inconclusive UDS. At 12-month follow-up, 165/181 (91.6%) women in group 1 were considered cured post-TVT-O; in the other groups, 33/67 (49.2%) patients were considered cured simply as a result of taking antimuscarinics; 13 of these 67 patients required TVT-O. CONCLUSIONS: UDS is able to show that several patients with symptoms of pure SUI present an underlying DO and do not require surgery, even 1 year after UDS. In these patients, antimuscarinic treatment appears to ensure a good rate of cure; thus, UDS could lead to the avoidance of several surgical procedures.

Patient adherence and persistence with Imatinib, Nilotinib, Dasatinib in clinical practice.

INTRODUCTION: The aim of this study is to evaluate adherence and persistence of patients treated with Imatinib, Nilotinib or Dasatinib, also giving economic evaluations on therapy costs for Received Daily Dose (RDD). MATERIALS AND METHODS: In this retrospective study, we took into account 3 years from 1st Jan. 2009 to 31st March.2012. Treatment adherence was quantified utilizing ratio between RDD and PDD (Prescribed Daily Dose). Persistence is reckoned taking into account the actual therapy days, comparing posology with supplied dose, drawing the graph using Kaplan-Meir method. RESULTS: Adherence results in values between 0.8 and 1.0 for Nilotinib (Adh  = 0.93), Imatinib (Adh  = 0.83) and Dasatinib (0.85). Imatinib has better persistence, 90% of patients in treatment exceed one year of treatment versus 83.3% for Nilotinib and 80% for Dasatinib. The cost per single day of treatment (cost per RDD) was € 39.41 for Imatinib, € 113.60 for Nilotinib and € 94.84 for Dasatinib. CONCLUSION: Patients with CML have a loose of adherence both in first line with Imatinib and in second line of therapy with Dasatinib and Nilotinib. Loss of adherence remains a big problem and could be minimized by a patient-oriented project invlolving physicians, nurses, pharmacists and caregiver.

Urinary symptoms and urodynamic findings in women with pelvic organ prolapse: is there a correlation? Results of an artificial neural network analysis.

BACKGROUND: International official guidelines recommend urodynamic (UDS) evaluation in patients with pelvic organ prolapse (POP). However, the real benefit of this examination is still the subject of heated and controversial debate. Therefore, we aimed to assess the correlation between urinary symptoms and UDS findings in women with POP through the implementation of a sophisticated computer-based technology in the outpatient workup. DESIGN, SETTING, AND PARTICIPANTS: A prospective cohort study was performed in a single, tertiary, urogynaecologic referral department, enrolling consecutive women seeking care for pelvic floor dysfunctions. INTERVENTION: Patients underwent clinical and urodynamic evaluation. Data regarding baseline characteristics, symptoms, anatomic, and urodynamic findings were gathered for each patient. Multiple linear regression (MLR) and artificial neural networks (ANNs) were performed to design predicting models. RESULTS AND LIMITATIONS: A total of 802 women with POP were included. POP quantification stages and baseline data poorly correlated to final UDS findings. Stress urinary incontinence and overactive bladder were both independently associated to each UDS diagnosis, including detrusor overactivity (DO), urodynamic stress incontinence (USI), and mixed urinary incontinence (USI plus DO). Receiver operating characteristic comparison confirmed that ANNs were more accurate than MLR in identifying predictors of UDS diagnosis, but none of these methods could successfully overcome UDS. Case-control studies are needed to confirm our findings. CONCLUSIONS: Despite the current debate based on the actual value of UDS in women with POP, even the implementation of ANN, a sophisticated computer-based technology, does not permit an accurate diagnosis just on the basis of symptoms or avoiding UDS. Therefore, in women with POP, especially if scheduled for surgery, UDS should be considered as mandatory, since misleading counselling could result in unpleasant unexpected events.