Minimal important difference and patient acceptable symptom state for PFDI-20 and POPDI-6 in POP surgery.

INTRODUCTION AND HYPOTHESIS: Patient-reported outcome measures are fundamental tools when assessing effectiveness of treatments. The challenge lies in the interpretation: which magnitude of change in score is meaningful for the patients? The minimal important difference (MID) is defined as the smallest difference in score that patients perceive as important. The Patient Acceptable Symptom State (PASS) represents the value of score beyond which patients consider themselves well. We aimed to determine the MID and PASS for Pelvic Floor Distress Inventory-20 (PFDI-20) and Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6) in pelvic organ prolapse (POP) surgery. METHODS: We used data from 2704 POP surgeries from a prospective, population-based cohort. MID was determined with three anchor-based and one distribution-based method. PASS was defined using two different methods. Medians of the estimates were identified. RESULTS: The MID estimates with (1) mean change, (2) receiver-operating characteristic (ROC) curve, (3) 75th percentile, and (4) distribution-based method varied between 22.9-25.0 (median 24.2) points for PFDI-20 and 9.0-12.5 (median 11.3) for POPDI-6. The PASS cutoffs with (1) 75th percentile and (2) ROC curve method varied between 57.7-62.5 (median 60.0) for PFDI-20 and 16.7-17.7 (median 17.2) for POPDI-6. CONCLUSION: A mean difference of 24 points in the PFDI-20 or 11 points in the POPDI-6 can be used as a clinically relevant difference between groups. Postoperative scores ≤ 60 for PFDI-20 and ≤ 17 for POPDI-6 signify acceptable symptom state.

Minimal important change in the pelvic floor distress inventory-20 among women opting for conservative prolapse treatment.

BACKGROUND: The Pelvic Floor Distress Inventory-20 is used to evaluate symptoms and treatment effects in women with pelvic floor disorders. To interpret changes in the scores of this inventory, information is needed about what patients and clinicians perceive as the minimal important (meaningful) change. Although this change in the inventory score has been investigated previously in women who have undergone pelvic floor surgery, the results could not be generalized to women with milder symptoms (ie, lower scores) who often require only conservative treatment. OBJECTIVE: We aimed to estimate the minimal important change in the Pelvic Floor Distress Inventory-20 that was needed to demonstrate clinical improvement in women who qualify for conservative pelvic floor treatment. STUDY DESIGN: The data of 214 women aged ≥55 years were used. All participants were from 2 randomized controlled trials that compared conservative prolapse treatments in primary care in The Netherlands. The degree of prolapse was assessed with the use of the Pelvic Organ Prolapse Quantification system; participants completed the Pelvic Floor Distress Inventory-20 at baseline and at 12 months, with a global perception of improvement question at 12 months. To assess both the patient perspective and the clinical perspective, 2 anchors were assessed: (1) the global perception of improvement was considered the anchor for the patients' perspective, and (2) the difference in the degree of prolapse was considered the anchor for the clinical perspective. Provided that the anchors were correlated by at least 0.3 to the Pelvic Floor Distress Inventory-20 change scores, we estimated the following minimal important changes: (1) the optimal cutoff-point of the receiver operating characteristics curve that discriminates between women with and without improvement in the global perception of improvement scale and (2) the mean Pelvic Floor Distress Inventory-20 change score of participants who improved 1 assessment stage. We then calculated the smallest detectable change to check whether the minimal important change was larger than the measurement error of the questionnaire. RESULTS: Using the global perception of improvement as the anchor, we found a minimal important change for improvement of 13.5 points (95% confidence interval, 6.2-20.9). The Pelvic Organ Prolapse Quantification change scores correlated poorly to the Pelvic Floor Distress Inventory-20 change scores and therefore could not be used as an anchor. The smallest detectable change at the group level was 5.5 points. Thus, the minimal important change was larger than the smallest detectable change at the group level. CONCLUSION: In women with relatively mild pelvic floor symptoms, an improvement of 13.5 points (or a 23% reduction) in the Pelvic Floor Distress Inventory-20 score can be considered clinically relevant. This minimal important change can be used for clinical trial planning and evaluation of treatment effects in women whose condition is considered suitable for conservative treatment.

Prevalence and Risk Factors of Pelvic Floor Disorders After Delivery in Japanese Women Using the Pelvic Floor Distress Inventory: A Retrospective Cohort Study.

Introduction Female pelvic floor disorders (PFDs) include clinical conditions such as urinary and fecal incontinence and pelvic organ prolapse. Disease-specific questionnaires like the Pelvic Floor Distress Inventory-20 (PFDI-20) have facilitated pelvic floor disorder assessment. We aimed to investigate the prevalence of pelvic floor disorders in Japanese women after different modes of delivery and the association of pelvic floor disorders with epidural anesthesia. Material and methods We included 212 women who gave birth at our institution. The PFDI-20 questionnaire (validated in Japanese) was used to evaluate the symptoms of pelvic floor disorders 6-15 months postpartum. Results Out of the 212 postpartum women who participated in this study, 156 (73.6%) had symptoms of pelvic floor disorder; the most prevalent symptom was urinary distress inventory in 114 (53.8%) women [79 (37.3%) of them experienced urine leakage related to increased abdominal pressure]. A comparison of the epidural and non-epidural groups to determine the association between pelvic floor disorder and delivery mode revealed a higher disease burden score of 8.67 points in the epidural group. Conclusion The prevalence of pelvic floor disorder symptoms is relatively high, affecting 156 (73.6%) of 212 women. Accurate diagnosis of women and appropriate and regular follow-up until improvement of their symptoms are crucial. Furthermore, healthcare workers should advise pregnant women on whether to choose vaginal delivery with or without anesthesia. To the best of our knowledge, our study is the first to investigate postpartum pelvic floor disorder in Japan.

Impact of pelvic floor distress on non-invasive urodynamic findings in women.

OBJECTIVE (S): To compare non-invasive urodynamic findings in women with and without pelvic floor distress and to investigate the patient characteristics affecting maximum flow rates. STUDY DESIGN: This is a retrospective study including data derived from a prospective cohort study evaluating free uroflowmetry findings in asymptomatic and symptomatic women with urinary dysfunction attending the gynecology outpatient clinic for routine annual control, infertility, abnormal uterine bleeding and pelvic floor dysfunction. Data regarding baseline characteristics, questionnaires, urogynecologic examination findings and free uroflowmetry results were retrieved. Women were grouped according to the Turkish validated Pelvic Floor Distress Inventory (PFDI-20); women who scored 0 or 1 points for each item ("no" or "not at all") were considered as asymptomatic in terms of pelvic floor dysfunction, and women who scored 2 or more points to any item were accepted as symptomatic. Baseline characteristics, clinical examination findings and free uroflowmetry data were compared among the groups using Student's-t or Mann-Whitney U tests, Chi-square test or Fisher's exact tests, where appropriate. Correlations and their significance, and patient characteristics affecting Qmax were investigated using the Pearson test. A multiple linear regression model was used to identify independent factors affecting Qmax. RESULTS: The study population (n = 186) comprised asymptomatic (n = 70, 37.6%) and symptomatic (n = 116, 62.4%) women according to the scores of the PFDI-20. Corrected Qmax, TQmax, Tvv and PVR were found significantly lower in asymptomatic women (p ≤ 0.001). In asymptomatic women, PVR was <100 mL in 98.5%, and <50 mL in 80%. In multivariate linear regression analysis parity, obstructive subscale score of the UDI-6, previous mid-urethral sling surgery and hysterectomy were found to affect Qmax negatively, whereas VV was found to affect Qmax positively. CONCLUSION(S): Although significantly different, overlapping wide ranges of non-invasive urodynamic findings have been observed in women with and without pelvic floor distress in the present study population. Maximum urinary flow rates were significantly affected by patient characteristics such as parity, obstructive symptoms, prior incontinence surgery and hysterectomy. There is need for further larger studies considering all possible factors that may affect voiding.

Role of Preoperative and Postoperative Pelvic Floor Distress Inventory-20 in Evaluation of Posthysterectomy Vault Prolapse.

BACKGROUND: Posthysterectomy vault prolapse is a common problem after vaginal or abdominal hysterectomy. The objective was to assess the role of Pelvic Floor Distress Inventory 20 (PFDI-20) in evaluation of vault prolapse. MATERIALS AND METHODS: Prospective study in 20 women with posthysterectomy vault prolapse of Stage 2 and above. The outcome measure was to calculate PFDI-20 score in all cases before surgical intervention and to recalculate it again in 6 months after different surgical procedures for vault prolapse and to statistically compare the PFDI-20 score in different types of surgery over 4 years period at a tertiary referral hospital for surgical treatment. Prolapse was classified using Pelvic Organ Prolapse Quantification and intraoperative findings. All women were operated for vault prolapse as per hospital protocol and stage of prolapse by either vaginal sacrospinous fixation or abdominal sacrocolpopexy. RESULTS: Mean age, parity, and body mass index were 54.8 years, 3.5, and 22.71 kg/m2 respectively. Preceding surgery was vaginal hysterectomy in 75% women and abdominal hysterectomy in 25% women. Complaints were bulge or mass feeling at perineum (100%), pressure in lower abdomen and perineum (55%), and constipation (60%). The type of prolapse was vault prolapse (100%), cystocele (100%), rectocele (100%), and enterocele (45%). The range of PFDI-20 was 88-152 with mean being 123.50 ± 22.71 before surgery while its range decreased significantly to 80-126 with mean being 106.40 ± 16.45 after surgery (P < 0.01). Mean postoperative PFDI-20 score was 107.40 in vaginal sacrospinous fixation group and was 105.30 in abdominal sacrocolpopexy group and was not statistically different (P = 0.18). CONCLUSION: PFDI-20 score can be used to see the adverse impact of vault prolapse on pelvic floor and to assess the beneficial effect of different types of surgeries on the score.