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.

Predictors of unsuccessful pessary fitting in women with prolapse: a cross-sectional study in general practice.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse is a common condition. There is inconsistency between predictors of unsuccessful pessary fitting in urological/gynaecological clinics. Research in general practice is scarce. The aim was to estimate the proportion of women in general practice with a symptomatic pelvic organ prolapse and unsuccessful pessary fitting, and to identify characteristics associated with unsuccessful pessary fitting. METHODS: A cross-sectional study in general practice (n = 20) was carried out among women (≥55 years) with symptomatic prolapse (n = 78). Multivariate logistic regression analysis was used to identify predictors of unsuccessful pessary fitting. RESULTS: In total, 33 women (42 %) had unsuccessful pessary fitting. Factors associated with unsuccessful pessary fitting were age (per year, OR 0.93 [95 % CI 0.87-1.00]), body mass index (per kg/m2, OR 1.14 [95 % CI 1.00-1.30]), and having underactive pelvic floor muscles (OR 2.60 [95 % CI 0.81-8.36]). CONCLUSIONS: Pessary fitting was successful in 58 %, indicating that pessary treatment may be suitable for many, but not for all women in general practice with symptomatic prolapse. The condition of the pelvic floor probably plays a role in the success of pessary fitting, as demonstrated by the association with underactive pelvic floor muscles, and body mass index. The association with age may reflect the higher acceptance of conservative treatments for prolapse in older women. This is the first study on predictive factors for unsuccessful pessary fitting in general practice. Therefore, further research should seek to confirm these associations before we can recommend the use of this information in patient counselling.

Predictors of Success for Pelvic Floor Muscle Training in Pelvic Organ Prolapse.

Background: Although the effectiveness of pelvic floor muscle training in women with prolapse has been demonstrated in several studies, there seem to be subgroups of responders and nonresponders. Objective: The objective of this study was to identify factors that predict treatment success in women receiving pelvic floor muscle training for prolapse. Design: The design was a secondary analysis of data from 2 randomized controlled trials comparing conservative prolapse treatments. Methods: After 12 months, 172 women subjectively assessed treatment success ("better") or failure ("the same" or "worse"). Potential predictors were identified by a literature search and by consultation with experts in the field of urogynecology and pelvic floor muscle training. The relationship between potential predictors and treatment success was explored using logistic regression analysis. Results: Treatment was successful in 94 women (55%) and unsuccessful in 78 women (45%). The presence of ≥1 indicators of obstetric trauma (eg, high birth weight, episiotomy, perineal laceration during vaginal delivery, forceps delivery, or vacuum extraction) (odds ratio = 4.4; 95% CI = 1.6-12.0) and younger age (odds ratio = 0.94 per year; 95% CI = 0.9-1.0) independently predicted treatment success. The area under the receiver operating characteristic curve for the final model was 0.65 (95% CI = 0.57-0.74), and the model explained 11.7% of the variance. Limitations: Although attempts were made to include all relevant predictors, the selection or operationalization of variables could have been incomplete or insufficient. Conclusions: Identifying women who have prolapse and are likely to benefit most from pelvic floor muscle training is of great importance to clinical practice. In this study, 2 factors that independently predicted favorable outcomes were identified with this management approach. However, further research is needed to identify other predictive factors and to validate a new model in another population.

Is the hymen a suitable cut-off point for clinically relevant pelvic organ prolapse?

OBJECTIVES: The primary objective was to evaluate the ability of different anatomic cut-off points, as established in specialist urogynecology populations, to identify clinically relevant prolapse in a population of postmenopausal women with pelvic floor symptoms recruited from primary care. STUDY DESIGN: Cross-sectional study among 890 women (≥55 years) screened for pelvic floor symptoms. MAIN OUTCOME MEASURES: The Pelvic Floor Distress Inventory 20 was used to measure symptoms, and the Pelvic Organ Prolapse Quantification (POP-Q) system was used to assess prolapse. Areas under the curves, sensitivity, and specificity were calculated for the hymen as a cut-off point for symptomatic prolapse of the anterior and posterior vaginal wall. For the apical compartment, a cut-off point of -5cm relative to the hymen was used. RESULTS: Vaginal bulging was the only symptom reported more often with increasing POP-Q stages. Areas under the curves (95% confidence intervals) to discriminate between women with and without vaginal bulging symptoms were 0.66 (0.61-0.72), 0.56 (0.50-0.63), and 0.61 (0.55-0.66) for the anterior (Ba), posterior (Bp) and apical (C) compartment, respectively. When the hymen was used as the cut-off point, Ba had a sensitivity of 38.1% and a specificity of 82.4%, and Bp had a sensitivity of 13.3% and a specificity of 96.5%. For C, the cut-off point of -5cm relative to the hymen had a sensitivity of 37.9% and a specificity of 73.1%. CONCLUSIONS: The anatomic cut-off points for clinically relevant prolapse established in the specialist urogynecology population cannot adequately identify symptomatic prolapse in a population of postmenopausal women with pelvic floor symptoms recruited from primary care.

Effectiveness and cost-effectiveness of pessary treatment compared with pelvic floor muscle training in older women with pelvic organ prolapse: 2-year follow-up of a randomized controlled trial in primary care.

OBJECTIVE: We investigated the effectiveness and cost-effectiveness of pessary treatment compared with pelvic floor muscle training (PFMT) in women with pelvic organ prolapse over a 2-year period. METHODS: Randomized controlled trial with women (≥55 y) with symptomatic pelvic organ prolapse, identified by screening. Participants were recruited from 20 primary care practices (October 2009-December 2012). Primary outcome was the difference in change of pelvic floor symptoms (PFDI-20 score) between groups over 24 months. Secondary outcomes included prolapse, urinary, and anorectal symptoms; quality of life; costs; sexual functioning; prolapse stage; pelvic floor muscle function; and participants' perceived symptom improvement. RESULTS: There was a nonsignificant difference in the primary outcome between pessary treatment (n = 82) and PFMT (n = 80) with a mean difference of -3.7 points (95% CI, -12.8 to 5.3; P = 0.42) in favor of pessary treatment. A significantly greater improvement in the prolapse symptom score was, however, seen with pessary treatment (mean difference -3.2 points [95% CI, -6.3 to -0.0; P = 0.05]). Direct medical costs over the 2-year study were $309 and $437 per person for pessary treatment and PFMT, respectively. CONCLUSIONS: In older women with symptomatic prolapse, there was no significant difference between pessary treatment and PFMT in reducing pelvic floor symptoms, but specific prolapse-related symptoms did improve more with pessary treatment. Pessary treatment was preferable in the cost-effectiveness analysis. When counseling women for prolapse treatment it should, however, be taken into account that pessary fitting fails in a considerable portion of women and that pessary treatment was associated with more side effects compared with PFMT.

Effect of pelvic floor muscle training compared with watchful waiting in older women with symptomatic mild pelvic organ prolapse: randomised controlled trial in primary care.

OBJECTIVE: To compare the effects of pelvic floor muscle training and watchful waiting on pelvic floor symptoms in a primary care population of women aged 55 years and over with symptomatic mild pelvic organ prolapse. DESIGN: Randomised controlled trial. SETTING: Dutch primary care. PARTICIPANTS: Women aged 55 years or over with symptomatic mild prolapse (leading edge above the hymen) were identified by screening. Exclusion criteria were current prolapse treatment or treatment in the previous year, malignancy of pelvic organs, current treatment for another gynaecological disorder, severe/terminal illness, impaired mobility, cognitive impairment, and insufficient command of the Dutch language. INTERVENTIONS: Pelvic floor muscle training versus watchful waiting. MAIN OUTCOME MEASURES: The primary outcome was change in bladder, bowel, and pelvic floor symptoms measured with the Pelvic Floor Distress Inventory-20 (PFDI-20), three months after the start of treatment. Secondary outcomes were changes in condition specific and general quality of life, sexual function, degree of prolapse, pelvic floor muscle function, and patients' perceived change in symptoms. RESULTS: Of the 287 women who were randomised to pelvic floor muscle training (n=145) or watchful waiting (n=142), 250 (87%) completed follow-up. Participants in the intervention group improved by (on average) 9.1 (95% confidence interval 2.8 to 15.4) points more on the PFDI-20 than did participants in the watchful waiting group (P=0.005). Of women in the pelvic floor muscle training group, 57% (82/145) reported an improvement in overall symptoms from the start of the study compared with 13% (18/142) in the watchful waiting group (P<0.001). Other secondary outcomes showed no significant difference between the groups. CONCLUSIONS: Although pelvic floor muscle training led to a significantly greater improvement in PFDI-20 score, the difference between the groups was below the presumed level of clinical relevance (15 points). Nevertheless, 57% of the participants in the intervention group reported an improvement of overall symptoms. More studies are needed to identify factors related to success of pelvic floor muscle training and to investigate long term effects.Trial registration Dutch Trial Register (www.trialregister.nl) identifier: NTR2047.

Pelvic floor muscle training versus watchful waiting or pessary treatment for pelvic organ prolapse (POPPS): design and participant baseline characteristics of two parallel pragmatic randomized controlled trials in primary care.

Pelvic floor muscle training (PFMT) and pessaries are commonly used in the conservative treatment of pelvic organ prolapse (POP). Because there is a lack of evidence regarding the optimal choice between these two interventions, we designed the "Pelvic Organ prolapse in primary care: effects of Pelvic floor muscle training and Pessary treatment Study" (POPPS). POPPS consists of two parallel open label randomized controlled trials performed in primary care, in women aged ≥55 years, recruited through a postal questionnaire. In POPPS trial 1, women with mild POP receive either PFMT or watchful waiting. In POPPS trial 2, women with advanced POP receive either PFMT or pessary treatment. Patient recruitment started in 2009 and was finished in December 2012. Primary outcome of both POPPS trials is improvement in POP-related symptoms. Secondary outcomes are quality of life, sexual function, POP-Q stage, pelvic floor muscle function, post-void residual volume, patients' perception of improvement, and costs. All outcomes are measured 3, 12, and 24 months after the start of treatment. Cost-effectiveness will be calculated based on societal costs, using the PFDI-20 and the EQ-5D as outcomes. In this paper the POPPS design, the encountered challenges and our solutions, and participant baseline characteristics are presented. For both trials the target numbers of patients in each treatment group are achieved, giving this study sufficient power to lead to promising results.