Efficacy and safety of polydimethylsiloxane injection (Macroplastique® ) for the treatment of female stress urinary incontinence: results of a series of 85 patients with ≥3 years of follow-up.

OBJECTIVE: To assess the long-term efficacy and safety of polydimethylsiloxane injection (Macroplastique® , Cogentix Medical, Orangeburg, New York, USA) for the treatment of female stress urinary incontinence (SUI), with a minimum follow-up of 3 years. PATIENTS AND METHODS: This is an observational analytical prospective cohort study conducted in a single uro-gynaecological unit. All consecutive women with urodynamically confirmed pure SUI treated with the Macroplastique procedure, were included. Data regarding patient outcomes (International Consultation on Incontinence Questionnaire-Short Form, Patient Global Impression of Improvement, and patient satisfaction scores), objective cure rates, and adverse events were collected during follow-up. Uni- and multivariable analyses were performed to investigate outcomes. Multiple logistic regression was performed to identify factors involved in the risk of failure of the procedures or recurrence of SUI. RESULTS: In all, 85 women had the Macroplastique procedure. At the 3-year follow-up, all 85 (100%) patients were available for the evaluation. We did not find any significant change in the surgical outcomes during this time. At 3 years after surgery, 42 of 85 patients (49%) declared themselves cured (P = 0.67). Similarly, at the 3-year evaluation, 40 of 85 patients (47%) were objectively cured. There was no significant deterioration of objective cure rates over time (P = 0.3). A history of radical pelvic surgery and a low surgeon's skill were significantly associated with the risk of failure of Macroplastique. The multivariate analysis confirmed these findings; a previous history of radical pelvic surgery and a low surgeon's skill independently predicted the subjective and objective failure of Macroplastique. CONCLUSIONS: The 3-year results of this study showed that Macroplastique could be an acceptable alternative for the treatment of SUI with stable results over time and a negligible complication rate.

The impact of Mirabegron on sexual function in women with idiopathic overactive bladder.

BACKGROUND: Overactive bladder (OAB) can frequently exert a negative effect on female sexual function. Mirabegron, a ß3 receptor agonist, improves OAB symptoms, but there are very few information about its role on female sexual dysfunction (FSD). Aim of the study was to assess the impact of Mirabegron on FSD in women affected by OAB. METHODS: Fifty sexually active women suffering from idiopathic OAB were included in the study. Patients were assessed by means of a urogynecologic physical examination and were asked to complete the 3-day voiding diary, the International Consultation on Incontinence Questionnaire- Short Form (ICIQ-SF), the Female Sexual Function Index (FSFI) questionnaire and VAS, before and 12 weeks after treatment with Mirabegron. In addition, at the same time points, patients underwent uroflowmetry with the measurement of post- void residual volume (PVR). RESULTS: At baseline all patients were affected by OAB symptoms, with 49/50 patients (98%) presenting with FSD. At 12- weeks follow- up, OAB symptoms improved significantly in all patients, with 59.5% of subjects achieving a complete urinary continence. FSFI Total Score significantly improved in 42/50 patients (84%) from 18.9 ± 4.3 to 21.8 ± 4.5 (p < 0.0001). Sixteen cases (32%) presented with no FSD. Also mean ± SD scores of ICIQ-SF and VAS significantly improved (from 17.1 ± 5 to 7.9 ± 4.8 and from 3.9 ± 1.2 to 6.9 ± 1.2 respectively, p < 0.000). CONCLUSIONS: Mirabegron not only is able to control urinary symptoms in women with OAB, but also induces a significant improvement in their sexual life.

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.

TVT for the treatment of urodynamic stress incontinence: Efficacy and adverse effects at 13-year follow-up.

AIM: To assess long-term subjective, objective, and urodynamic outcomes of retropubic mid-urethral slings at 13-year follow-up. METHODS: This was a prospective observational study. Consecutive women with proven urodynamic stress incontinence were treated with standard retropubic tension free vaginal tape (TVT). Patients with mixed incontinence and/or anatomic evidence of pelvic organ prolapse were excluded. All the included patients underwent preoperative clinical and urodynamic evaluations. During follow-up examinations, women were assessed for subjective satisfaction and objective cure rates. The Cox model was used in order to investigate factors predicting the risk of recurrent stress urinary incontinence (SUI), over the study period. RESULTS: Overall, 55 patients were suitable for the analysis. At 13-year follow-up, 47 out of 55 (85.5%) patients declared themselves cured (p-for-trend 0.02) and 48 out of 58 (87.2%) were at least improved (p-for-trend 0.07). No significant deterioration of objective cure rates was observed over time (P = 0.29). At the time of the last evaluation, 50 out of 55 (90.9%) women were objectively cured; urodynamic evaluation confirmed this finding in 49 (89.1%) patients. Considering factors predictive of SUI recurrence, we observed that, via multivariate analysis, obesity (HR 7.2; P = 0.01) and maximum detrusor pressure during the voiding phase ≤29 cmH2 O (HR 8.0; P = 0.01) were the only independent predictors of recurrent SUI. CONCLUSION: Our data confirmed that TVT is a highly effective and safe procedure also at 13-year follow-up. Interestingly, we observed a significant decrease of subjective satisfaction over time. Neurourol. Urodynam. 36:192-197, 2017. © 2015 Wiley Periodicals, Inc.

Is mirabegron equally as effective when used as first- or second-line therapy in women with overactive bladder?

INTRODUCTION AND HYPOTHESIS: No previous studies have investigated the efficacy of mirabegron 50 mg as the first-line therapy in OAB patients. Hence, the primary objective of this study was to evaluate the efficacy of mirabegron in treatment-naive patients in comparison with those who had discontinued antimuscarinic therapy because of insufficient efficacy. METHODS: All consecutive women who had pure OAB symptoms (including urgency with or without urgency incontinence and frequency) for at least 3 months were considered for this study. Women were divided into two groups: women without any previous pharmacological treatment for OAB (group 1) and women with a previous history of failed antimuscarinics therapy (group 2). RESULTS: At 3-month follow-up, the objective results on the basis of the frequency-volume chart showed a significant improvement in both groups. Furthermore, a significant reduction in the Overactive Bladder Questionnaire Short Form (OABq-SF) score and in the Indevus Urgency Severity Scale (IUSS) questionnaire were reported in both groups. However, the improvement in objective and subjective outcomes was superior in group 1 to that in group 2. CONCLUSIONS: Mirabegron is efficacious in improving OAB symptoms in both naïve patients and those who discontinued primary antimuscarinic therapy; however, its efficacy is superior when prescribed as first-line therapy.

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.

Is urodynamic evaluation able to change and improve the management of women with idiopathic overactive bladder?

BACKGROUND: For women with overactive bladder (OAB), current guidelines recommend the use of urodynamic studies (UDS) only in complicated cases. This study aimed to investigate whether UDS can also be helpful in uncomplicated cases. Specific aims of the study were: 1) to evaluate objective benefit and subjective patient satisfaction with tailored treatment based on the UDS diagnosis compared to the outcomes of the pharmacological treatment only based on the symptoms; 2) to investigate the correlation between symptoms and UDS findings in women with uncomplicated idiopathic OAB symptoms; 3) to assess the ability of UDS to modify management decisions in these patients. METHODS: Women presenting to our clinic with a history of uncomplicated OAB symptoms for the past three months or more, and who completed the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), were considered for this study. We proposed UDS to all participants. In women who accepted UDS (group 1), management decisions were made on the basis of urodynamic findings and post-treatment evaluation was scheduled at three months. The outcomes of treatments in these patients were compared to the results in women who did not accept UDS and who received pharmacological treatment symptoms-based (group 2). Objective outcomes were based on completion of a 3-day micturition diary. Subjective outcomes were captured using the Overactive Bladder Questionnaire Short Form (OABq-SF), the Patient Global Impression of Improvement (PGI-I) scale, and a patient satisfaction scale. RESULTS: A total of 680 women were enrolled in the study; 478 underwent UDS and 202, at the contrary, declined UDS. In 53.6% of cases, UDS led to modification of the proposed management approach. At the 3-month follow-up, the overall patient satisfaction rate in group 1 and group 2 was 77% and 65.8%, respectively (P=0.003). CONCLUSIONS: We showed that OAB management tailored according to the UDS diagnosis results in higher subjective satisfaction if compared with a pharmacological treatment symptoms-based. Our study confirmed a lack of correlation between OAB symptoms and the urodynamically proven diagnosis of detrusor overactivity (DO). It also suggested that UDS can determine the underlying pathophysiology of every woman with OAB syndrome, whether complicated or uncomplicated, allowing treatment to be appropriately tailored with better results.

Laparoscopic duplication of the uterosacral ligaments following hysterectomy for stage III-IV apical pelvic organ prolapse.

Different techniques have been proposed over the last decades to avoid the vaginal vault prolapse following hysterectomy for severe (stage III-IV) apical pelvic organ prolapse. In this scenario, the laparoscopic duplication of the uterosacral ligaments to the vaginal apex might represent a simple alternative procedure, associated with low morbidity and optimal surgical outcomes. In this paper, we present the preliminary results of 25 consecutive patients, who underwent total laparoscopic hysterectomy followed by uterosacral ligament duplication for stage III-IV apical pelvic organ prolapse. A detailed description of the surgical procedure is also provided.

Impact of urodynamic evaluation on the treatment of women with idiopathic overactive bladder: a systematic review.

INTRODUCTION: Overactive bladder (OAB) is a common clinical condition affecting women. The impact of urodynamics (UDS) on the management of idiopathic OAB in women is highly debated. This systematic review analyzes the impact of UDS on the choice and on the outcomes of treatment of female idiopathic OAB. EVIDENCE ACQUISITION: A systematic literature search in the PubMed/Medline, Web of Science, Scopus and Cochrane databases was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis statement to identify clinical trials, randomized controlled trials, meta-analyses, and guidelines on female OAB and UDS published from 2000. A total of 1554 records were initially identified and 12 articles were included in the final qualitative synthesis. EVIDENCE SYNTHESIS: UDS represents the main tool to diagnose detrusor overactivity (DO) in OAB female patients which is considered one of the major OAB underlying pathophysiology factor. UDS can underline the presence of voiding dysfunction that could be considered as another underlying cause of uncomplicated female OAB. On the basis of this urodynamic findings, we can better define different aspects of OAB syndrome leading to a more tailored and proper treatment. CONCLUSIONS: UDS can have a useful role in the diagnosis of idiopathic OAB in women given the possibility to gain a precise diagnosis and, therefore, a tailored treatment based on the underlying cause. The integration of clinics with UDS and all the other diagnostic available tools is desirable.

Lower urinary tract and gastrointestinal dysfunction in sportswomen: a systematic review and meta-analysis of observational studies.

INTRODUCTION: The aim of this review was to assess the prevalence of gastrointestinal (GI) and lower urinary tract symptoms (LUTS) in sportswomen having high intensity training and to determine whether the type of sport might also affect LUTS and GI symptoms. EVIDENCE ACQUISITION: A systematic review of the literature was performed by searching PubMed, CINAHL, Cochrane Library and Web of Science up to November 2018. The search strategy included several keywords concerning pelvic floor disorders, urinary dysfunction, bowel dysfunction, sportswomen, and elite sports. Inclusion criteria were studies of women who performed any kind of sport with a prevalence of LUTS and/or bowel symptoms without any restriction for age, sport modality or frequency of training. Outcomes were prevalence of LUTS and GI symptoms and meta-analyses and moderator analyses to identify risk factors for the occurrence of these symptoms in female athletes. EVIDENCE SYNTHESIS: During the search, 1263 records were screened, 31 of which met the methodological criteria for qualitative analysis and 5 for meta-analysis. Sportswomen during daily activity showed a threefold higher risk to develop urinary incontinence (UI) than controls (OR 3.13; 95% CI: 2.39-4.00). No differences were found stratifying data for UI types. Cumulative prevalence rates were: 58.7% of all kinds of UI (daily life together with sport time), 32.8% at rest (during daily life out of sport time), 36.3% during sport time; 23% of stress urinary incontinence (SUI) during sport time versus 38.6% at rest; 11% of urge urinary incontinence (UUI) during sport time versus 17.8% at rest; 11.9% of mixed urinary incontinence (MUI) during sport time versus 20.7% at rest. Prevalence rates of GI symptoms before sport time were 57.6%, during sport competition 35.2% and 58.2% after competition. CONCLUSIONS: All the analyzed studies showed bias. This meta-analysis indicated that competitive sport activities represent a risk factor for urinary incontinence and gastrointestinal disorders. To prevent urinary leakage athletes should be instructed to strengthen the pelvic floor muscles.