Italian validation of the Pelvic Floor Distress Inventory (PFDI-20) questionnaire.

INTRODUCTION AND HYPOTHESIS: The use of validated Quality of Life (QoL) questionnaires is useful in the standardization and interpretation process of pelvic floor patient symptoms, due to their functional nature and high prevalence. The Pelvic Floor Distress Inventory QoL questionnaire (PFDI-20) serves both as a symptom inventory and a measure of the degree of bother and distress caused by pelvic floor symptoms. It includes items related to pelvic organ prolapse and lower gastrointestinal and bladder dysfunction. METHODS: After consensus translation and a comprehension test, the Italian version of the questionnaire was submitted to patients reporting bowel, bladder, or pelvic disorders (cases) and to asymptomatic women (controls). Cases received the questionnaire once again 2 weeks later by email. RESULTS: A total of 254 patients answered the questionnaire. Construct validity was demonstrated by discriminating between cases and controls. Convergent validity was demonstrated for each domain (F < 0.001). In-ernal consistency reliability showed a satisfactory range (0.816-0.860). CONCLUSIONS: The PFDI-20 allows a comprehensive assessment of the effect of pelvic floor disorders on the quality of life of women. Moreover, the PFDI-20 represents a very solid QoL tool, since it has been extensively used in literature, and its use is highly recommended by the International Consultation on Incontinence. The present study demonstrated good features for the Italian version of the PFDI-20 questionnaire.

Update on Italian-validated questionnaires for pelvic floor disorders.

INTRODUCTION: Pelvic floor disorders (PFDs), which include urinary incontinence, pelvic organ prolapse, sexual dysfunction and gastrointestinal disorders, affect over 20% of the adult population. Prevalence may also be underestimated, since a certain portion of patients may be reluctant to talk to physicians about PFDs due to embarrassment. Consequently, there is a need for self-assessed diagnostic tools with the capability to screen population and collect clinical information. Symptom and quality of life (QoL) questionnaires - also identified as patient-reported outcomes (PROs) - have been developed with this purpose. Despite the large number of questionnaires available for the assessment of PFDs and QoL-related issues in the English language, few of them have been validated for the Italian language. The objective of this article is to update the list of Italian-validated PROs for PFDs along with practical information concerning literature references and suggestions on how to obtain every single questionnaire. EVIDENCE ACQUISITION: PubMed/MEDLINE databases and websites were used to update the list of available Italian-validated questionnaires about PFDs. Once identified, the possibility to get a copy of the questionnaire was verified and steps to obtain it are reported in the tables. EVIDENCE SYNTHESIS: Eight additional questionnaires validated into the Italian language, for diagnosis and overall management of common urinary, vaginal, sexual and bowel conditions, were retrieved. The complete list of PFDs PROS is reported in a modular format for consultation. CONCLUSIONS: This format is intended to serve as a tool to promote appropriateness in PROs adoption while investigating PFDs in Italian patients.

Medium Term Outcomes of TVT-Abbrevo for the Treatment of Stress Urinary Incontinence: Efficacy and Safety at 5-Year Follow-Up.

Background and objectives: Stress urinary incontinence (SUI) is the most common type of urinary incontinence, affecting approximately 46% of adult women. After failure of conservative treatment, the mid-urethral sling (MUS) is considered the most effective and safe surgical procedure for SUI. In 2012, Waltregny et al. introduced a new trans-obturator tension-free vaginal tape (TVT) procedure, named TVT-abbrevo (TVT-A). The aim of the present study is to evaluate the efficacy and safety of the TVT-A procedure in women with pure SUI at 5-year follow-up. Materials and Methods: All women who complained of pure SUI symptoms with concomitant urodynamic stress incontinence (USI) were prospectively enrolled and treated with the TVT-A procedure. Postoperative subjective outcome measures included: International Consultation on Incontinence Questionnaire-Short Form (ICI-Q SF), Patient Global Impression of Improvement (PGI-I) scale, and patient degree of satisfaction scale. A PGI-I score ≤ 2 and a patient-satisfaction score ≥8 were used to define subjective success. Objective success was defined as the absence of urine leakage during a cough stress test. Adverse events were collected according to the Clavien-Dindo classification during follow-up. Results: Univariable analysis was used to investigate outcomes. Fifty women who met the inclusion criteria underwent TVT-A implantation. At 5 years after TVT-A implantation, 38 out of 45 (84.4%) patients were subjectively cured (p for trend 0.05), and 40 out of 45 (88.9%) patients were objectively cured (p for trend 0.04). A significant trend of de novo OAB symptoms was reported (22.2% [10/45]) at the 5-year follow-up. No serious early or late complications such as urethral/bladder injury, persistent groin-thigh pain, and sexual dysfunction that required mesh removal were detected. The univariate analysis did not reveal any risk factors (i.e., age, body mass index (BMI), menopause, obstetric factors, and preoperative ICIQ- SF questionnaire) statistically associated with failure of the TVT-A procedure. Conclusions: In conclusion, the 5-year follow-up results of this study demonstrated that TVT-A is a safe and effective option for treatment of SUI with a very low rate of post-operative groin-thigh pain.

Urethral bulking agents for the treatment of recurrent stress urinary incontinence: A systematic review and meta-analysis.

Recurrent stress urinary incontinence (rSUI) represents a major challenge for most clinicians as there is little evidence in the literature on the best option after sling failure. The objective of this study is to summarise the findings on the use of urethral bulking agents (UBAs) in the management of rSUI after the failure of a mid-urethral sling (MUSs). We performed a systematic review and meta-analysis, according to PRISMA 2020 guidelines, and selected eleven publications for inclusion in the analysis. We found that the overall cure and improvement rate ranged from 64% to 85% in the included studies, with a pooled value of 75%, compared with pooled failure and re-operation rates of 32% (95% CI: 22%-43%) and 25% (95% CI: 17%-34%), respectively. The I2 test indicated significant statistical heterogeneity among the studies in relation to all the outcome measures; however, no risk of publication bias was found. To explore this heterogeneity in more depth, we performed a sub-group analysis of the two most commonly used bulking agents (Bulkamid and Macroplastique). The pooled values of the cure and improvement rate were 84% (95% CI: 77.0%-90.0%) and 80% (95% CI: 74.0%-85.0%) for Macroplastique and Bulkamid, respectively. We did not find significant heterogeneity or significant differences in the outcome measures in either group. For the first time in literature, our study provides an insight into the use of UBAs after failed MUSs. Although the results seem very promising, future studies with shared protocols are needed in order to recommend the use of UBAs in the treatment of recurrent cases.

Efficacy of 3 Tesla Functional Magnetic Stimulation for the Treatment of Female Urinary Incontinence.

Functional magnetic stimulation (FMS) is a new technique for the conservative treatment of Urinary incontinence (UI), based on magnetic induction. It induces controlled depolarization of the nerves, resulting in pelvic muscle contraction and sacral S2-S4 roots neuromodulation. The aim of this study was to assess the efficacy of the new 3 Tesla FMS chair, both in patients with pure stress urinary incontinence (SUI) and in women with pure overactive bladder (OAB) symptoms. A prospective observational study was conducted in our urogynaecologic unit. All the patients involved were consecutive women with pure SUI or pure OAB symptoms treated by a 3 Tesla electromagnetic chair. The primary outcome was a subjective outcome evaluation by the PGI-I Scale and a patient-satisfaction scale. The secondary outcome was the change score of the UDI-6, IIQ-7, ICIQ-SF and OAB-q SF questionnaires from baseline to final visit. At 2 months follow-up, 28 out of 60 patients (47%) with SUI symptoms and 20 out of 40 patients (50%) with OAB symptoms declared themselves cured. Considering cured and improved patients, the subjective cure rates were 68.3% (41/60) and 70% (28/40) for patients with SUI and OAB symptoms, respectively. The results of this study showed that the 3 Tesla electromagnetic chair may be an effective option for the treatment of UI.

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.

The subjective and objective very long-term outcomes of TVT in the COVID era: A 20-year follow-up.

INTRODUCTION AND HYPOTHESIS: Few studies in literature have assessed the long-term durability and mesh-related complications of mid-urethral slings (MUSs). The aim of this study is to assess the efficacy and safety of retro-pubic tension-free vaginal tape (TVT) 20 years after implantation for the treatment of female stress urinary incontinence (SUI). METHODS: A prospective observational study was conducted in two urogynaecologic units in two countries. All the patients involved were consecutive women with urodynamically proven pure SUI treated by TVT. The patients underwent preoperative clinical and urodynamic evaluations. Subjective outcomes, objective outcomes and adverse events were recorded during the follow-up period. RESULTS: Fifty-two patients underwent a TVT surgical procedure. Twenty years after surgery, 32 out of 36 patients (88.8%) declared themselves cured (p = 0.98). Similarly, 33 out of these 36 patients (91.7%) were objectively cured (p = 0.98). No significant deterioration of subjective and objective cure rates was observed over time (p for trend 0.50 and 0.48). Fifteen of the 36 patients (41.6%) at the 20-year follow-up reported the onset of de novo overactive bladder (OAB) (p = 0.004). No significant vaginal bladder or urethral erosion or de novo dyspareunia was recorded and no patient required tape release or resection during this period. The cause of death of seven out of ten women who died in the last year of the follow-up period was coronavirus disease 19 (COVID 19). CONCLUSIONS: The 20-year results of this study showed that TVT is a highly effective and safe option for the treatment of SUI. The impact of COVID 19 on the mortality rate of elderly women has drastically reduced the number of eligible patients for future evaluations in our region.

Bulking agents for the treatment of recurrent stress urinary incontinence: a suitable option?

BACKGROUND: The management of recurrent female stress urinary incontinence (SUI) still needs worldwide standardization. Few data on the role of urethral bulking agents (UBA) for the treatment of recurrent stress urinary incontinence exist. The aim of this study is to assess the efficacy and safety of urethral bulking agents for the treatment of recurrent SUI. METHODS: A multicenter, prospective study was conducted in four tertiary referral centers in two countries. All consecutive women with urodynamically-proven recurrent SUI, and with a history of previous failed anti-incontinence surgical procedure (mid-urethral sling or single incision sling), treated by UBAs were included. We evaluated only patients who completed at least a 3-year follow-up. Data regarding subjective outcomes (International Consultation on Incontinence Questionnaire-Short Form, Patient Global Impression of Improvement, Urogenital Distress Inventory score and patient satisfaction score), objective cure (stress test) rates, and adverse events were collected during follow-up. Univariable and multivariable analyses was performed to investigate outcomes. RESULTS: Forty-seven consecutive patients were enrolled. At 3-year follow-up, all women were available for the evaluation. At 3 years after surgery, 38 of 47 patients (81%) declared themselves cured. Similarly, at 3-year evaluation, 39 of 47 patients (83%) were objectively cured. Only five patients (10.6%) required re-operation for UBA failure. The urodynamic diagnosis of preoperative detrusor overactivity and the PDet Max filling phase ≥15 cmH2O (hazard ratio: 2.74; 95% CI, 1.64-10.7; P=0.009 and 1.62; 95% CI, 1.11-3.42; P=0.04, respectively) were the only predictors of failure. Only four complications were reported (8.5%). CONCLUSIONS: The 3-year results of this study showed that bulking agents is an appropriately effective and safe option for the treatment of recurrent SUI. The presence of preoperative concomitant detrusor overactivity is associated with a significant decrease of the efficacy of this procedure.