Minimum important difference of the ICIQ-UI SF score after self-management of urinary incontinence.

BACKGROUND: This study aimed to evaluate clinically relevant improvement after conservative self-management of urinary incontinence via a mobile app. It further aimed to establish Minimum Important Differences (MIDs) based on the severity and type of urinary incontinence. METHODS: Data was collected in a prospective cohort study that evaluated the freely available app Tät®. The app provided pelvic floor muscle training (PFMT) and life-style advice. Non-pregnant, non-postpartum women (≥ 18 years) who downloaded the app to treat urinary incontinence were included, if they completed the Patient Global Impression of Improvement (PGI-I) question at the 3-month follow-up (n = 1,733). Participants answered the International Consultation on Incontinence Questionnaire (ICIQ-UI SF) at baseline and after 3 months. The score change was analysed for correlation (Spearman) with the PGI-I. We then analysed one-way ANOVAs to determine whether there were significant differences between the groups based on the answers to the PGI-I. The MID was set to the mean change of the group that selected the answer "a little better" to the PGI-I question. RESULTS: The one-way ANOVA showed significant differences between PGI-I groups (p < 0.001). The MID for the general group was set to 1.46 (95% Confidence Interval [CI] 1.26-1.67). In the sub-group analyses, a MID for the group with slight incontinence could not be determined. For the group with moderate severity the MID was determined to be 1.33 (95% CI 1.10-1.57) and for the severe/very severe group it was 3.58 (95% CI 3.08-4.09). Analysis of different types of incontinence showed no difference in MIDs. CONCLUSIONS: The MID for self-management via a mobile app was lower than previously established MIDs, but differed depending on baseline severity. This study shows that MIDs need adjustment for baseline severity and treatment intensity when interpreting clinical trial results. If using MIDs as exact numbers, the study population and the treatment must be comparable.

Novel clinically meaningful scores for the ICIQ-UI-SF and ICIQ-FLUTS questionnaires in women with stress incontinence.

AIM: To establish, for the first time, the clinically important differences for the ICIQ-UI-SF and ICIQ-FLUTS questionnaires following surgical and conservative treatments for stress-predominant urinary incontinence in women. METHODS: Data from the SIMS and OPAL randomised controlled trials were analysed using an anchor-based method. Clinically important difference (CID; score change indicating a successful outcome) and minimal important difference (MID; score change indicating the smallest noticeable difference) were estimated using the PGI-I scale as the anchor. RESULTS: For ICIQ-UI-SF, following surgical management, CIDs were 5.0 (95%CI 4.3, 5.6) at 1 year and 4.9 points (95%CI 4.2, 5.5) at 3 years, while following conservative management, CIDs were 4.0 (95%CI 3.4, 4.5) at 1 year and 4.6 points (95%CI 4.0, 5.2) at 2 years. For ICIQ-FLUTS, the CID was 3.4 points (95%CI 2.9, 4.0) at 1 year for both surgical and conservative management. MIDs for ICIQ-UI-SF, after surgical treatment, were 4.7 (95% CI 3.2, 6.1) at 1 year and 1.6 points (95%CI -0.2, 3.0) at 3 years, and after conservative treatment they were 1.7 (95% CI 1.0, 2.5) at 1 year and 1.9 points (95%CI 1.1, 2.7) at 2 years. For ICIQ-FLUTS, MIDs were 1.8 (95% CI 0.6, 3.1) at 1 year and 3.2 points (95%CI 2.0, 4.4) at 2 years after surgical treatment, and 1.3 (95%CI 0.6, 1.9) at 1 year and 1.9 points (95%CI 1.1, 2.6) at 2 years after conservative treatment. CONCLUSION: Our study is the first to establish the CID for the ICIQ-UI-SF and ICIQ-FLUTS that women would associate with a successful outcome 3-years post-surgery and 2-years post-conservative treatment of stress-predominant urinary incontinence. The MID was lower following conservative compared to surgical treatment.

Long-term efficacy and patient satisfaction of Le Fort colpocleisis for the treatment of severe pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: The objective was to investigate the long-term efficacy and patient satisfaction of Le Fort colpocleisis for the treatment of severe pelvic organ prolapse. METHODS: This was a retrospective study of patients who underwent Le Fort colpocleisis from January 2007 to August 2018 in our hospital. Follow-up was conducted via outpatient visits or the telephone. Records were reviewed for anatomical recurrence, complications, urinary and intestinal symptoms post-operation, reoperation rate, patient satisfaction, Patient Global Impression of Improvement (PGI-I) score, regret rate etc. RESULTS: A total of 208 patients underwent follow-up. The follow-up time was 60.7 ± 34.18 (12-140) months. There were no intraoperative complications. Postoperative urinary retention occurred in 3.8% of patients (8 out of 208). There was no anatomical recurrence. New or more severe urinary symptoms occurred in 8.7% of patients (18 out of 208); new or more severe intestinal symptoms occurred in 1.9% of patients (4 out of 208). The reoperation rate was 1.44% (3 out of 208). Three cases of reoperation occurred for the following reasons: a case of severe stress urinary incontinence, a case of abscess in the vaginal septum, and a case of uterine malignancy after 2 years of colpocleisis. Patient satisfaction was as follows: 98.6% (205 out of 208) of patients were very satisfied. The PGI-I score was very much improved or improved in 99.5% (207 out of 208) of patients. A total of 0.96% (2 out of 208) of patients regretted undergoing colpocleisis. CONCLUSIONS: The long-term follow-up results showed that Le Fort colpocleisis was a safe and effective surgical procedure associated with high satisfaction. There was a very low regret rate, but the procedure should be taken seriously.

Evaluation of the effect of multipoint intra-mucosal vaginal injection of a specific cross-linked hyaluronic acid for vulvovaginal atrophy: a prospective bi-centric pilot study.

BACKGROUND: Vulvo-vaginal atrophy (VVA) is one of the common consequences of estrogen deficiency especially after the menopause. Several studies have assessed the effects of Hyaluronic acid (HA) on physical and sexual symptoms associated with VVA with promising results. However, most of these studies have focused on subjective assessment of symptom response to topically administered preparations. Nonetheless, HA is an endogenous molecule and it is logical that its effects are best realized if injected in the superficial epithelial layers. Desirial® is the first crosslinked HA that is administered by injection in the vaginal mucosa. The aim of this study was to explore the effect of multipoint vaginal intra-mucosal injections of specific cross-linked hyaluronic acid (DESIRIAL®, Laboratoires VIVACY) on several clinical and patient reported core outcomes. METHODS: A cohort bi-centric pilot study. The chosen outcomes included change in vaginal mucosa thickness, biological markers for collagen formation, vaginal flora, vaginal pH, vaginal health index, vulvo-vaginal atrophy symptoms and sexual function 8 weeks post Desirial® injection. Patients' satisfaction was also assessed using the patient global impression of improvement (PGI-I) scale. RESULTS: A total of 20 participants were recruited between 19/06/2017 and 05/07/2018. At the end of the study, there was no difference in the median total thickness of the vaginal mucosa or in procollagen I, III or Ki67 fluorescence. However, there was a statistically significant increase in COL1A1 and COL3A1 gene expression (p = 0.0002 and p = 0.0010 respectively). There was also a significant reduction in reported dyspareunia, vaginal dryness, vulvar pruritus, vaginal chafing and significant improvement in all female sexual function index dimensions. Based on PGI-I, 19 patients (95%) reported varying degrees of improvement where, 4 (20%) felt slightly better; 7 (35%) better and 8 (40%) much better. CONCLUSIONS: Multi-point vaginal intra-mucosal injections, of Desirial® (a crosslinked HA) was significantly associated with the expression of CoL1A1 and CoL3A1 suggesting stimulation of collagen formation. Furthermore, there was a significant reduction in VVA symptomatology and a significant improvement in patient satisfaction and sexual function scores. However, there was no demonstrable change in the total vaginal mucosal thickness. Study registration ID-RCB: 2016-A00124-47, Protocol code number: LOCAL/2016/PM-001.

Pelvic organ prolapse and uterine preservation: a cohort study (POP-UP study).

BACKGROUND: Abdominal and laparoscopic sacro-colpopexy (LSC) is considered the standard surgical option for the management of a symptomatic apical pelvic organ prolapse (POP). Women who have their uterus, and for whom an LSC is indicated, can have a laparoscopic sacro-hysteropexy (LSH), a laparoscopic supra-cervical hysterectomy and laparoscopic sacro-cervicopexy (LSCH + LSC) or a total laparoscopic hysterectomy and laparoscopic sacro-colpopexy (TLH + LSC). The main aim of this study was to compare clinical and patient reported outcomes of uterine sparing versus concomitant hysterectomy LSC procedures. METHODS: A retrospective analysis of clinical, imaging and patient reported outcomes at baseline, 3 and 12 months after LSH versus either LSCH + LSC or TLH + LSC between January 2015 and January 2019 in a tertiary referral urogynecology center in Pilsen, the Czech Republic. RESULTS: In total, 294 women were included in this analysis (LSH n = 43, LSCH + LSC n = 208 and TLH + LSC n = 43). There were no differences in the incidence of perioperative injuries and complications. There were no statistically significant differences between the concomitant hysterectomy and the uterine sparing groups in any of the operative, clinical or patient reported outcomes except for a significantly lower anterior compartment failure rate (p = 0.017) and higher optimal mesh placement rate at 12 months in women who had concomitant hysterectomy procedures (p = 0.006). CONCLUSION: LSH seems to be associated with higher incidence of anterior compartment failures and suboptimal mesh placement based on postoperative imaging techniques compared to LSC with concomitant hysterectomy.

Pelvic organ prolapse surgery and quality of life-a nationwide cohort study.

BACKGROUND: Patient satisfaction and health-related quality of life are nowadays considered as the most important outcomes of pelvic organ prolapse treatment, and large, prospective clinical studies reporting the patient-reported surgical outcomes are needed. OBJECTIVE: To evaluate the effect of female pelvic organ prolapse surgery on health-related quality of life and patient satisfaction and to determine predictors of outcome. STUDY DESIGN: This prospective nationwide cohort study consisted of 3515 women undergoing surgery for pelvic organ prolapse in 2015. The outcomes were measured by validated health-related quality of life instruments (generic 15D, Pelvic Floor Distress Inventory-20, and Patient Global Impression of Improvement) at 6 months and 2 years postoperatively. The baseline predictors of outcomes were studied with logistic regression analysis. RESULTS: In total, 2528 (72%) women were eligible for analysis at 6 months and 2351 (67%) at 2 years. The mean change in the total 15D score suggested a clinically important improvement at 6 months but not at 2 years. However, an improvement in sexual activity, discomfort and symptoms, and excretion was observed during both follow-up assessments. Altogether, 77% and 72% of the participants reported a clinically significant improvement in Pelvic Floor Distress Inventory-20 at the 6-month and 2-year follow-ups, respectively. A total of 84% were satisfied with the outcome and 90% reported an improvement in comparison with the preoperative state with Patient Global Impression of Improvement-I. The strongest predictive factors for a favorable outcome were advanced apical prolapse (adjusted odds ratio, 2.06; 95% confidence interval, 1.58-2.70) and vaginal bulge (1.90, 1.30-2.80). Smoking was associated with an unfavorable outcome as measured by Patient Global Index of Improvement-I (1.69, 1.02-2.81). CONCLUSION: Pelvic organ prolapse surgery improved health-related quality of life in 7 of 10 patients over a 2-year follow-up period, and patient satisfaction was high. Apical prolapse beyond the hymen and vaginal bulge were the most consistent predictors for improvement. Our results suggest that patients should be encouraged to stop smoking to avoid an unfavorable outcome.

Agreement between patient global impression scale of improvement, pelvic floor distress inventory and 15D in measuring the outcome of pelvic organ prolapse surgery.

AIMS: To evaluate the correlation between three commonly used patient-reported outcome measures, two generic and one condition-specific instrument, in assessing the change in health-related quality of life following pelvic organ prolapse surgery. METHODS: The generic health-related quality of life measure 15-dimensional instrument (15D), Patient Global Impression of Improvement (PGI-I), and prolapse-specific Pelvic Floor Distress Inventory (PDFI-20) were used to assess the effectiveness of pelvic organ prolapse surgery in the national FINPOP study of 3535 surgeries (83% of all pelvic organ prolapse operations) performed in Finland in 2015. Spearman correlations between PGI-I, change in 15D and its dimensions and change in PFDI-20 and its subscales over a 2-year follow-up were investigated. The proportion of concordant ratings was also studied by investigating the proportion of women rated similarly (worse/no change/better/much better) by two instruments according to validated cutoffs. RESULTS: Among 2248 women for whom the 2-year change in all instruments could be measured, changes in PFDI-20 and 15D and its dimensions were weak (ρ < 0.2 for all except excretion; ρ = 0.39 and sexual activity; ρ = 0.27). PFDI-20 change (ρ = 0.39) and its subscales (ρ = 0.19-0.40, all P < .001) were more strongly correlated with PGI-I. The proportion of fully concordant ratings were higher for PFDI-20 and PGI-I (50.6%) than for PFDI-20 and 15D (33.0%). CONCLUSION: The weak correlations between 15D, PGI-I, and PDFI-20 observed in this study show that the quantified health gains are strongly dependent on the chosen patient-reported outcome measures. This demonstrates the importance of using condition-specific sensitive outcome measures in assessing the impact of surgical treatment in pelvic organ prolapse.

Psychometric properties and validation of two global impression questionnaires (PGI-S, PGI-I) for stress incontinence in a German-speaking female population.

AIMS: The Patient Global Index of Severity (PGI-S) and the Patient Global Index of Improvement (PGI-I) are global impression questionnaires developed in English and validated in women with stress urinary incontinence (SUI). This validation study tested the psychometric properties of German-language versions of the two questionnaires in German-speaking women with SUI. METHODS: The German-language PGI-S and PGI-I were psychometrically tested and validated using the SF-12 questionnaire, the Kinǵs Health Questionnaire (KHQ), clinical parameters, incontinence episode frequency and pad use in 311 patients before and 3 months after receiving a TVT-O or TVT tape for SUI. RESULTS: At baseline and 3 months postoperatively there was a positive correlation between PGI-S response categories and clinical parameters, IEF and pad use, and nearly all KHQ subscales. There were no correlations between response categories of PGI-S at baseline and PGI-I at 3 months and the SF-12 scales PCS-12 and MCS-12. CONCLUSION: Our results demonstrated good psychometric properties of the German-language PGI-S and PGI in German-speaking women with SUI.

Laparoscopic sacral colpopexy: how to place the posterior mesh into rectovaginal space?

AIMS: Laparoscopic sacral colpopexy (LSC) for pelvic prolapse is a complex procedure, characterized by an anterior mesh suspension to the sacral promontory and a posterior tension-free mesh fixation. METHODS: Totals of 150 age-BMI and parity matched consecutive POP patients were selected from our Diaconesses Hospital database among women who underwent a laparoscopic supracervical hysterectomy (LSH) plus sacral colpopexy (LSC) from June 2005 to March 2010. We analyzed two group of LSC populations, according to different tension-free apical fixation of the posterior mesh: Promontory (P) group and Utero-Sacral (US) group. Studied endpoints were the anatomical and functional results linked to these different tension-free posterior mesh placements. RESULTS: Baseline characteristics were similar between the groups. No differences in terms of anatomical and functional outcomes were observed between the groups. Pelvic organ mobility at rest versus under Valsalva highlighted a significant reduction of median differential vaginal apex only in the P population (preoperative: 30 mm and 32 mm; postoperative: 8 mm and 24 mm; for P and US, respectively; P < 0.01). No differences were found in terms of intra- or post-operative complications. CONCLUSIONS: Uterosacral tension-free fixation of posterior mesh during LSC could be considered a simple procedure and guarantees a more physiological movement of the pelvic organs if compared with promontory suspension.

A new validated score for detecting patient-reported success on postoperative ICIQ-SF: a novel two-stage analysis from two large RCT cohorts.

INTRODUCTION AND HYPOTHESIS: The Patient Global Impression of Improvement (PGI-I) and International Consultation of Incontinence Questionnaire - Short Form (ICIQ-SF) are validated instruments for the assessment of patient reported outcome measures (PROM) following treatment of stress urinary incontinence (SUI). However, there is a paucity of evidence as to what represents a successful postintervention ICIQ-SF score. To determine the correlation between the postoperative ICIQ-SF scores with the PGI-I outcomes, the latter was considered one of the standard PROM following surgical treatment for SUI. The aim of this study was to determine, and if appropriate validate, an ICIQ-SF cut-off score that can predict a successful PROM as determined by PGI-I. METHODS: Four large datasets yielding 674 ICIQ-SF score/PGI-I outcome data pairs were used in this study for (a) determining and (b) validating the cut-off ICIQ-SF score for a successful PGI-I outcome. Two long-term follow-up datasets were used representing follow-up periods of 3 and 8 years of a randomized controlled trial (RCT) performed between April 2005 and April 2007 in a tertiary urogynaecology centre in Scotland, UK. All patients had urodynamic SUI or mixed urinary incontinence (MUI, with predominant SUI) and were randomized to treatment with either an inside-out or an outside-in transobturator tape (TVT-O or TOT, respectively) as a sole procedure. The datasets yielded 432 ICIQ-SF score/PGI-I outcome data pairs. Successful outcome was defined as "very much improved/much improved" on the PGI-I scale. SPSS v. 22.0 (IBM Corp., Armonk, NY) was used for all statistical analyses. The correlations and cut-off scores generated were then validated on two independent datasets representing the 1-year and 4-year follow-up periods of the multicentre RCT in six units in the UK. The datasets yielded 242 ICIQ-SF score/PGI-I outcome data pairs. All patients had urodynamic SUI or MUI (with predominant SUI) and were randomized to either adjustable single incision minisling (SIMS) or TVT-O. RESULTS: Significant correlations at the 0.01 level (two-tailed) were clearly demonstrated between ICIQ-SF scores at follow up and PGI-I outcomes in terms of success/failure in both the generation and validation datasets. Higher ICIQ-SF scores correlated with a 'poorer' PGI-I score. Using ROC analysis, a postoperative ICIQ-SF score of 6 was validated as approximately 90 % sensitive and 85 % specific for success/failure with a high Cohen's kappa coefficient of 0.83 (95 % CI 0.74 - 0.89). CONCLUSIONS: This two-stage study provided a robust well-validated postoperative ICIQ-SF cut-off score (of 6/21) that is likely to be associated with a patient-reported successful outcome on the PGI-I following surgical treatment with a midurethral sling in women at different stages of follow-up over 1 - 8 years. Such a cut-off score could enable the comparison of results between various studies and serve as a valuable guide for surgeons to counsel patients before and/or after surgical treatment. Our study fills a research gap in providing a way to compare trial results when baseline ICIQ-SF scores are not available.

ICIQ symptom and quality of life instruments measure clinically relevant improvements in women with stress urinary incontinence.

AIMS: To determine whether changes in questionnaire scores on symptoms and condition-specific quality of life reflect clinically relevant improvements in women with stress urinary incontinence (SUI). METHODS: We retrospectively analyzed questionnaires collected during a randomized controlled trial in women with SUI, that received pelvic floor muscle training (PFMT) in two different formats. We included 218 women that answered validated self-assessment questionnaires at baseline and at a 4-month follow-up. We registered changes on two questionnaires, the International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) and the Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol). We compared these score changes to responses from the Patient Global Impression of Improvement (PGI-I) questionnaire. Differences were analyzed with the Spearman rho and one-way-ANOVA. The minimum important difference (MID) was the mean change in score for women that experienced a small improvement. RESULTS: The PGI-I correlated significantly to both the ICIQ-UI SF (r = 0.547, P < 0.0001) and ICIQ-LUTSqol (r = 0.520, P < 0.0001). Thus, larger reductions in symptoms or quality of life scores were associated with greater impressions of improvement. The changes in ICIQ-UI SF and ICIQ-LUTSqol scores were significant across all PGI-I groups from "no change" to "very much improved" (P < 0.05). The MIDs were 2.52 (SD 2.56) for ICIQ-UI SF and 3.71 (SD 4.95) for ICIQ-LUTSqol. CONCLUSIONS: The change in ICIQ-UI SF and ICIQ-LUTSqol scores after PFMT reflected clinically relevant improvements in women with SUI. The MIDs established for this population may facilitate future research, treatment evaluations, and comparisons between studies.

Quality of Life and Sexual Function after Laparoscopic Posterior Vaginal Plication Plus Sacral Colpopexy for Severe Posterior Vaginal Prolapse.

BACKGROUND: Laparoscopic sacral colpopexy (LSC) is the gold standard treatment for women with apical/anterior pelvic organ prolapse (POP). For isolated posterior vaginal prolapse, instead, the literature suggests fascial native tissue repair. This is a retrospective 2-year quality-of-life follow-up study after laparoscopic posterior plication (LPP) combined with LSC in patients with anterior/apical prolapse combined with severe posterior colpocele. The primary endpoint was to evaluate the subjective outcomes quality of life (QoL), sexual function, and patient satisfaction rate. The secondary endpoint was to evaluate perioperative and anatomical outcomes at the 2-year follow-up. METHODS: A total of 139 consecutive patients with anterior and/or apical prolapse (POP-Q stage ≥ II) and severe posterior vaginal prolapse (posterior POP-Q stage ≥ III) were retrospectively selected from our database among women who underwent, from November 2018 to February 2021, a "two-meshes" LSC. The patients were classified into Group A (81 patients; LSC plus LPP) and Group B (67 patients; LSC alone). The primary endpoint was evaluated using the Patient Global Impression of Improvement (PGI-I), the Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6), the Pelvic Floor Impact Questionnaire-7 (PFIQ-7), the Female Sexual Distress Scale (FSDS), the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), and the EuroQol (EQ-5D). The secondary endpoint was studied using the POP-Q study and an intra-, peri-, and post-operative complications assessment. Two-year follow-up data were analyzed for the study. RESULTS: At 2 years, all women showed a statistically significant amelioration of their symptoms on the QoL questionnaires. We found a statistical difference in favor of posterior plication in terms of the PGI-I successful outcome rate (Group A versus B: 85.3% versus 67.1%), FSDS (median 11 versus 21), and PISQ-12 (median 89 versus 62) (p < 0.05 for all comparisons). A significant improvement of all EQ-5D values was observed from baseline to 2-year follow-up, and only for the "pain/discomfort" domains did we observe a significant improvement in LSC plus LPP patients versus LSC alone (p < 0.05). LSC plus LPP women showed, at 2 years, a significant amelioration of their Ap and GH POP-Q points. We observed no statistical differences in terms of intra-post-operative complications or anatomic failure rate between groups. CONCLUSIONS: Our LPP approach to LSC appears to be a safe, feasible, and effective treatment for advanced pelvic organ prolapse with a significant impact on the patient's general health and sexual quality of life. Adding laparoscopic posterior vaginal plication to "two-meshes" sacral colpopexy is recommended in patients with apical/anterior prolapse and concomitant severe posterior colpocele. This surgical approach, in addition to improving the anatomical results of these patients, is associated with a significant improvement in sexual and quality of life indexes.

Salvage surgery after failed treatment of synthetic mesh sling complications.

PURPOSE: We report our experience with the diagnosis and treatment of refractory synthetic sling complications in women. MATERIALS AND METHODS: This is a retrospective study of consecutive women with failed treatments for mesh sling complications. Before and after surgery the patients completed validated questionnaires and voiding diaries, and underwent uroflow with post-void residuals, pad test, cystourethroscopy and videourodynamic studies. Treatment was individualized, and results were subdivided into the 2 groups of conditions and symptoms. Outcomes were assessed with the Patient Global Impression of Improvement with success classified as a score of 1, improvement as 2 to 3 and failure as 4 to 7. RESULTS: A total of 47 women 35 to 83 years old (mean 60) had undergone at least 1 prior operation (range 1 to 4) to correct sling complications. Original sling composition was type 1 mesh in 36 patients and types 2 and 3 in 11. Surgical procedures included sling incision, sling excision, urethrolysis, urethral reconstruction, ureteroneocystotomy, cystectomy and urinary diversion, and enterocystoplasty. Median followup was 2 years (range 0.25 to 12, mean 3). Overall a successful outcome was achieved in 34 of 47 patients (72%) after the first salvage surgery. Reasons for failure were multiple for each patient. Of the 13 patients with treatment failure 9 subsequently underwent 14 operations. Success/improvement was achieved in 5 women (56%) after continent urinary diversion (1), continent urinary diversion and cystectomy (1), partial cystectomy and augmentation cystoplasty (1), biological sling and sinus tract excision (1), and vaginal mesh excision (1). CONCLUSIONS: Success after the initial failure of mesh sling complications repair is possible but multiple surgeries may be required. Each symptom should be addressed separately.

Selective Serotonin Reuptake Inhibitors and Nutraceutical Combination in Major Depression Disorder: A Case-Control Study.

Introduction: Major depressive disorder (MDD) is a primary cause of disability in adults, affecting daily functioning and decreasing quality of life. The focus on the role of nutraceuticals as adjunctive treatments to improve antidepressant response is paying growing interest. The study aims to compare the antidepressants response in the utilization of selective serotonin reuptake inhibitors (SSRIs) versus a combination of SSRIs and nutraceutical supplements based on S-Adenosyl methionine (SAMe), N-acetylcysteine (NAC) and folate in terms of efficacy and tolerability. Methods: A case-control study was carried out between March 2018 and September 2019. Cases and controls were evaluated through the following scales: Hospital Anxiety Depression Scale (HADS); Clinical Global Impression (CGI); Patient Global Impression of Improvement (PGI-I); Antidepressant Adverse Events checklist (AES). Results: A significant difference between the two groups of patients emerged at T1 in the HADS-A (p = 0.004) score and in the CGI score (p = 0.01), due to a major improvement in patients with a nutraceutical co-prescription. At T3 a significant statistical difference emerged, showing a greater improvement at HADS-D in the case group (p = 0.006), confirmed by a higher remission rate in patients taking a nutraceutical co-prescription. No differences in terms of adverse events emerged. Conclusion: This study shows promising data about the role of nutraceuticals as adjunctive treatment in major depressive disorder to improve SSRIs efficacy, with good tolerability. More data are needed to confirm these results, particularly about the role of nutraceuticals to decrease the latency of SSRIs response.

Treatment Satisfaction of Galcanezumab in Japanese Patients with Episodic Migraine: A Phase 2 Randomized Controlled Study.

INTRODUCTION: This analysis evaluated the treatment satisfaction of Japanese patients receiving galcanezumab (GMB) as a preventive medication for episodic migraine (4-14 monthly migraine headache days). METHODS: This phase 2, randomized, double-blind, placebo-controlled study enrolled patients aged 18-65 years at 40 centers in Japan. Patients were randomized 2:1:1 to receive monthly subcutaneous injections of placebo (PBO, n = 230), GMB 120 mg (n = 115), or GMB 240 mg (n = 114) for 6 months. Patients' experience with treatment was measured using the Patient Global Impression of Severity (PGI-S), Patient Global Impression of Improvement (PGI-I), and Patient Satisfaction with Medication Questionnaire-Modified (PSMQ-M) scales. PGI-S was administered at baseline and months 1-6, PGI-I at months 1-6, and PSMQ-M at months 1 and 6. Prespecified analyses were differences between GMB and PBO in PGI-I and the change from baseline in PGI-S, and evaluating positive responses for the PGI-I and PSMQ-M. RESULTS: Average change ± SE from baseline across months 1-6 was - 0.09 ± 0.05 (PBO), - 0.17 ± 0.07 (GMB 120 mg, p = 0.33), and - 0.30 ± 0.07 (GMB 240 mg, p = 0.013) for PGI-S. Average PGI-I across months 1-6 was 3.39 ± 0.05 (PBO), 2.55 ± 0.07 (GMB 120 mg, p < 0.05), and 2.71 ± 0.07 (GMB 240 mg, p < 0.05). Reductions of 2.8-3.0 monthly migraine headache days corresponded to 25-31% higher positive PGI-I response rates with GMB compared with PBO. Positive PSMQ-M response rates for satisfaction and preference were statistically significantly higher for GMB compared with PBO (odds ratio [95% confidence interval], all p < 0.05 vs. PBO): satisfaction GMB 120 mg (3.142 [1.936-5.098]) and GMB 240 mg (3.924 [2.417-6.369]), and preference GMB 120 mg (3.691 [2.265-6.017]) and GMB 240 mg (3.510 [2.180-5.652]). CONCLUSION: Japanese patients with episodic migraine receiving preventive treatment with GMB are significantly more satisfied than those receiving PBO. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02959177 (registered November 7, 2016).

Laparoscopic sacrocolpopexy (LSCP) using an ultra-lightweight polypropylene mesh.

OBJECTIVES: Since 2005 the preferred method for surgical treatment of vaginal vault prolapse within the department has been laparoscopic sacrocolpopexy with an ultra-lightweight polypropylene mesh. The study aimed to explore the functional and anatomical outcomes and mesh adverse events of women following this procedure. STUDY DESIGN: All women who had a Laparoscopic Sacrocolpopexy (LSCP) using an ultra-lightweight (19 g/m2) polypropylene mesh in two units in the North West of England between March 2005 and January 2013 (n = 238) were invited to participate in the study.Functional outcome data was collected using the Patient Global Impression Questionnaire (PGI-I), the Pelvic Floor Distress Inventory (PFDI-20) and the Electronic Personal Assessment Questionnaire (EPAQ) post-operatively. Anatomical outcome was assessed by Pelvic Organ Prolapse Quantification System (POP-Q) measurement. A mesh palpability assessment was performed and any mesh complications were recorded using the International Continence Society/International Urogynecology Association (ICS/IUGA) classification system. The results were compared to those in our previously published series using the same surgical technique but a standard weight mesh (82.5 g/m2). RESULTS: 89% of participants reported that they felt their post-operative condition had improved. POP-Q results revealed that the median position of C changed from -3 pre-op to -7 post-operatively. Mesh was palpable during vaginal examination in only 3 women (3%). No mesh extrusion was identified during the study. CONCLUSIONS: The study demonstrates that LSCP performed with an ultra-lightweight polypropylene mesh improves women's functional and anatomical symptoms and appears to have a low risk of mesh extrusion.

Patient centric measures for a patient centric era: Agreement and convergent between ratings on The Patient Global Impression of Improvement (PGI-I) scale and the Clinical Global Impressions - Improvement (CGI-S) scale in bipolar and major depressive disorder.

BACKGROUND: Concordant with an increased emphasis on consumer engagement, the Patient Global Impression Scale of Improvement (PGI-I) is commonly used as an outcome measure in studies evaluating the efficacy of treatments in medical and psychiatric conditions with subjective symptom domains. The current study evaluated the agreement between PGI-I and Clinician Global Impression Scale of Improvement (CGI-I) ratings and convergent validity of PGI-I among individuals with bipolar or major depressive disorders. METHOD: Data were derived from three double-blind, placebo-controlled, multicentre studies conducted from 2007 to 2015 among adult individuals (N = 472). Clinicians were asked to rate participants symptoms using the CGI-I as well as severity of depression by the Montgomery-Åsberg Depression (MADRS), quality of life (Q-LES-Q), social and occupational functioning (SOFAS), and functional impairment (LIFE-RIFT). Participants were asked to assess their symptom improvement with the PGI-I. Bland-Altman agreement plots and Intra-class correlations were used to evaluate agreement, and Spearman correlation coefficients were implemented to examine convergent validity. Sub-group analyses for disorder type (bipolar and major depression) were performed. RESULTS: There was high agreement between the PGI-I and CGI-I ratings across follow-up time points (weeks 2, 4, 6, 8, 12, 16, 20, 24, and 28). Similar results were observed in male only and female only data and after adjustment for age and gender. Both PGI-I and CGI-I ratings were robustly positively correlated with MADRS, and LIFE-RIFT and negatively correlated with SOFAS and Q-LES-Q, supporting the convergent validity of the PGI-I. Sub-group analyses for bipolar and major depressive disorder showed similar findings. CONCLUSION: Our findings support the utility of the PGI-I as a participant rated measure of global improvement among individuals with bipolar or major depressive disorders.

Supervised pelvic floor muscle training versus attention-control massage treatment in patients with faecal incontinence: Statistical analysis plan for a randomised controlled trial.

INTRODUCTION: Faecal incontinence affects approximately 8-9% of the adult population. The condition is surrounded by taboo; it can have a devastating impact on quality of life and lead to major limitations in daily life. Pelvic floor muscle training in combination with information and fibre supplements is recommended as first-line treatment for faecal incontinence. Despite this, the effect of pelvic floor muscle training for faecal incontinence is unclear. No previous trials have investigated the efficacy of supervised pelvic floor muscle training in combination with conservative treatment and compared this to an attention-control massage treatment including conservative treatment. The aim of this trial is to investigate if 16 weeks of supervised pelvic floor muscle training in combination with conservative treatment is superior to attention-control massage treatment and conservative treatment in patients with faecal incontinence. DESIGN: Randomised, controlled, superiority trial with two parallel arms. METHODS: 100 participants with faecal incontinence will be randomised to either (1) individually supervised pelvic floor muscle training and conservative treatment or (2) attention-control massage treatment and conservative treatment. The primary outcome is participants' rating of symptom changes after 16 weeks of treatment using the Patient Global Impression of Improvement Scale. Secondary outcomes are the Vaizey Incontinence Score, the Fecal Incontinence Severity Index, the Fecal Incontinence Quality of Life Scale, a 14-day bowel diary, anorectal manometry and rectal capacity measurements. Follow-up assessment at 36 months will be conducted. DISCUSSION: This paper describes and discusses the rationale, the methods and in particular the statistical analysis plan of this trial.