Cost-effectiveness of physiotherapy in childhood functional constipation: a randomized controlled trial in primary care.

OBJECTIVE: Health care expenditures for children with functional constipation (FC) are high, while conservative management is successful in only 50% of the children. The aim is to evaluate whether adding physiotherapy to conventional treatment (CT) is a cost-effective strategy in the management of children with FC aged 4-18 years in primary care. METHODS: A cost-effectiveness analysis was performed alongside a randomized controlled trial (RCT) with 8-month follow-up. Costs were assessed from a societal perspective, effectiveness included both the primary outcome (treatment success defined as the absence of FC and no laxative use) and the secondary outcome (absence of FC irrespective of laxative use). Uncertainty was assessed by bootstrapping and cost-effectiveness acceptability curves (CEACs) were displayed. RESULTS: One hundred and thirty-four children were randomized. The incremental cost-effectiveness ratio (ICER) for one additional successfully treated child in the physiotherapy group compared with the CT group was €24,060 (95% confidence interval [CI] €-16,275 to €31,390) and for the secondary outcome €1,221 (95% CI €-12,905 to €10,956). Subgroup analyses showed that for children with chronic laxative use the ICER was €2,134 (95% CI -24,975 to 17,192) and €571 (95% CI 11 to 3,566), respectively. At a value of €1,000, the CEAC showed a probability of 0.53 of cost-effectiveness for the primary outcome, and 0.90 for the secondary outcome. CONCLUSIONS: Physiotherapy added to CT as first-line treatment for all children with FC is not cost-effective compared with CT alone. Future studies should consider the cost-effectiveness of physiotherapy added to CT in children with chronic laxative use. TRIAL REGISTRATION: The RCT is registered in the Netherlands Trial Register (NTR4797), on the 8th of September 2014. The first child was enrolled on the 2nd of December 2014. https://www.trialregister.nl/trial/4654.

Physiotherapy for Children with Functional Constipation: A Pragmatic Randomized Controlled Trial in Primary Care.

OBJECTIVE: To determine the effectiveness of physiotherapy plus conventional treatment compared with conventional treatment alone for the treatment of functional constipation in children age 4-17 years in primary care. STUDY DESIGN: Pragmatic randomized controlled trial with 8 months follow-up. Primary care physicians recruited children diagnosed with functional constipation (n = 234), and pediatricians recruited newly referred children with a diagnosis of functional constipation (n = 11). Conventional treatment comprised toilet training, nutritional advice, and laxative prescribing, whereas physiotherapy focused on resolving dyssynergic defecation. The primary outcome was treatment success over 8 months, defined as the absence of functional constipation (Rome III criteria) without laxative use. Secondary outcomes included the absence of functional constipation irrespective of continuation of laxative use and global perceived treatment effect. RESULTS: Children were allocated to conventional treatment plus physiotherapy or conventional treatment alone (67 per group), mean (SD) age was 7.6 (3.5) years. Results of longitudinal analyses in the intention-to-treat population showed that the treatment success percentage was not statistically improved by adding physiotherapy to conventional treatment (adjusted relative risk [aRR] 0.80, 95% CI 0.44-1.30). At 4 months, fewer children receiving physiotherapy had treatment success (17%) than children receiving conventional treatment alone (28%), but this had equalized by 8 months (42% and 41%, respectively). The percentage of children without functional constipation, irrespective of continuation of laxative use, was not statistically different between groups over 8 months (aRR 1.12, 95% CI 0.82-1.34). Notably, parents reported significantly more global symptom improvement after physiotherapy than after conventional treatment (aRR 1.40; 95% CI 1.00-1.73). CONCLUSIONS: We find no evidence to recommend physiotherapy for all children with functional constipation in primary care. TRIAL REGISTRATION: Netherlands Trial Registry: NTR4797.

Discontinuation of alpha-blocker therapy in men with lower urinary tract symptoms: a systematic review and meta-analysis.

OBJECTIVES: We aimed to synthesise the available data for the effect of stopping alpha-blocker therapy among men with lower urinary tract symptoms. The focus was on symptom, uroflowmetry and quality of life outcomes, but we also reviewed the adverse events (AEs) and the number of patients who restarted therapy. DATA SOURCES: We searched MEDLINE/PubMed, EMBASE/Ovid and The Cochrane Central Register of Controlled Trials from inception to May 2018. ELIGIBILITY CRITERIA: We selected studies regardless of study design in which men were treated with an alpha-blocker for at least 3 months and in which the effects of alpha-blocker discontinuation were subsequently studied. Only controlled trials were used for the primary objective. DATA EXTRACTION AND SYNTHESIS: Two reviewers independently extracted data and assessed the risk of bias for the controlled studies only using the Cochrane Collaboration's tool for assessing risk of bias. Data were pooled using random-effects meta-analyses. RESULTS: We identified 10 studies (1081 participants) assessing the primary objective. Six studies (733 participants) assessed differences in AEs between continuation and discontinuation, and six studies (501 participants) reported the numbers of subjects that restarted treatment after discontinuation. No studies in primary care were identified. After discontinuing monotherapy, symptom scores increased and peak flow rates decreased at 3 and 6 months, but not at 12 months; however, neither parameter changed when alpha-blockers were stopped during combination therapy. Small differences in post-void residual volumes and quality of life scores were considered clinically irrelevant. We also found that 0%-49% of patients restarted after stopping alpha-blocker therapy and that AEs did not increase with discontinuation. CONCLUSIONS: Discontinuing alpha-blocker monotherapy leads to a worsening compared with continuing therapy. Discontinuing the alpha-blocker after combination therapy had no significant effects on outcomes in either the short or long term. Discontinuation may be appropriate for the frail, elderly or those with concomitant illness or polypharmacy. However, studies in primary care are lacking. PROSPERO REGISTRATION NUMBER: CRD42016032648.

Physiotherapy plus conventional treatment versus conventional treatment only in the treatment of functional constipation in children: design of a randomized controlled trial and cost-effectiveness study in primary care.

BACKGROUND: Our aim was to design a study to evaluate the effectiveness and cost-effectiveness of adding physiotherapy to conventional treatment for children with functional constipation in primary care. Physiotherapy is focusing on improving the coordination between the pelvic floor and abdominal musculature during bowel movement, while conventional treatment is mainly focusing on symptomatic relief of symptoms, therefore, we expect the effects of physiotherapy will be more sustainable than the effects of conventional treatment. In this paper we describe the final study design and how the design was adapted, to overcome recruitment problems. METHODS: We designed a randomized controlled trial of children aged 4-17 years with functional constipation diagnosed by a general practitioner or pediatrician. Children in the intervention group received physiotherapy plus conventional treatment, and those in the control group received conventional treatment only. Follow-up measurements took place at 4 and 8 months. The primary outcome was treatment success defined according to the Rome-III criteria as the absence of functional constipation, with no laxative use. Secondary outcomes were absence of functional constipation irrespective of laxative use, quality of life, global perceived effect, and costs. Children were recruited from September 2014 to February 2017. Initially, we aimed to include children with recent symptom onset. However, in the first phase of enrollment we were confronted with an unforeseen recruitment problem: many children and their parents refused randomization because physiotherapy was considered too burdensome for the stage of disease. Therefore, we decided to also include children with a longer duration of symptoms. In total 134 children were included. DISCUSSION: The target number of participants is achieved. Therefore, the results may change thinking about the management of functional constipation in children. TRAIL REGISTRATION: Netherlands Trial Register ( NTR4797 ), registered 8 September 2014.

Diagnostic test strategies in children at increased risk of inflammatory bowel disease in primary care.

BACKGROUND: In children with symptoms suggestive of inflammatory bowel disease (IBD) who present in primary care, the optimal test strategy for identifying those who require specialist care is unclear. We evaluated the following three test strategies to determine which was optimal for referring children with suspected IBD to specialist care: 1) alarm symptoms alone, 2) alarm symptoms plus c-reactive protein, and 3) alarm symptoms plus fecal calprotectin. METHODS: A prospective cohort study was conducted, including children with chronic gastrointestinal symptoms referred to pediatric gastroenterology. Outcome was defined as IBD confirmed by endoscopy, or IBD ruled out by either endoscopy or unremarkable clinical 12 month follow-up with no indication for endoscopy. Test strategy probabilities were generated by logistic regression analyses and compared by area under the receiver operating characteristic curves (AUC) and decision curves. RESULTS: We included 90 children, of whom 17 (19%) had IBD (n = 65 from primary care physicians, n = 25 from general pediatricians). Adding fecal calprotectin to alarm symptoms increased the AUC significantly from 0.80 (0.67-0.92) to 0.97 (0.93-1.00), but adding c-reactive protein to alarm symptoms did not increase the AUC significantly (p > 0.05). Decision curves confirmed these patterns, showing that alarm symptoms combined with fecal calprotectin produced the diagnostic test strategy with the highest net benefit at reasonable threshold probabilities. CONCLUSION: In primary care, when children are identified as being at high risk for IBD, adding fecal calprotectin testing to alarm symptoms was the optimal strategy for improving risk stratification.

Use of Laboratory Markers in Addition to Symptoms for Diagnosis of Inflammatory Bowel Disease in Children: A Meta-analysis of Individual Patient Data.

Importance: Blood markers and fecal calprotectin are used in the diagnostic workup for inflammatory bowel disease (IBD) in pediatric patients. Any added diagnostic value of these laboratory markers remains unclear. Objective: To determine whether adding laboratory markers to evaluation of signs and symptoms improves accuracy when diagnosing pediatric IBD. Data Sources: A literature search of MEDLINE and EMBASE from inception through September 26, 2016. Studies were identified using indexing terms and free-text words related to child, target condition IBD, and diagnostic accuracy. Study Selection: Two reviewers independently selected studies evaluating the diagnostic accuracy of more than 1 blood marker or fecal calprotectin for IBD, confirmed by endoscopy and histopathology or clinical follow-up, in pediatric patients with chronic gastrointestinal symptoms. Studies that included healthy controls and/or patients with known IBD were excluded. Data Extraction and Synthesis: Individual patient data from each eligible study were requested from the authors. In addition, 2 reviewers independently assessed quality with Quality Assessment of Diagnostic Accuracy Studies-2. Mean Outcomes and Measures: Laboratory markers were added as a single test to a basic prediction model based on symptoms. Outcome measures were improvement of discrimination by adding markers as a single test and improvement of risk classification of pediatric patients by adding the best marker. Results: Of the 16 eligible studies, authors of 8 studies (n = 1120 patients) provided their data sets. All blood markers and fecal calprotectin individually significantly improved the discrimination between pediatric patients with and those without IBD, when added to evaluation of symptoms. The best marker-fecal calprotectin-improved the area under the curve of symptoms by 0.26 (95% CI, 0.21-0.31). The second best marker-erythrocyte sedimentation rate-improved the area under the curve of symptoms by 0.16 (95% CI, 0.11-0.21). When fecal calprotectin was added to the model, the proportion of patients without IBD correctly classified as low risk of IBD increased from 33% to 91%. The proportion of patients with IBD incorrectly classified as low risk of IBD decreased from 16% to 9%. The proportion of the total number of patients assigned to the intermediate-risk category decreased from 55% to 6%. Conclusions and Relevance: In a hospital setting, fecal calprotectin added the most diagnostic value to symptoms compared with blood markers. Adding fecal calprotectin to the diagnostic workup of pediatric patients with symptoms suggestive of IBD considerably decreased the number of patients in the group in whom challenges in clinical decision making are most prevalent.

Incidence and treatment of heavy menstrual bleeding in general practice.

Background: Heavy menstrual bleeding (HMB) is a common problem in women of reproductive age. In 2008, the Dutch guideline for general practitioners (GPs) was revised to recommend the levonorgestrel intrauterine system (LNG-IUS) as a first-choice treatment for HMB. However, GP prescribing practices have not been studied in depth. Objectives: To investigate the incidence and initial treatment of HMB in general practice, and to identify if there were changes in prescribing practices after the revision of the national guideline in 2008. Methods: Retrospective analysis of data from the Registration Network Groningen, the Netherlands. We selected data for prescriptions and referrals related to women consulting their GP for HMB between 2004 and 2013. We calculated the incidence rates and investigated potential trends in prescribing over time, with particular attention to the prescribing of LNG-IUS. Results: Over 10 years, 881 women consulted their GP for HMB, with a mean annual incidence of 9.3 per 1000 person years (95% confidence interval: 8.5-10.2). Most women received hormonal treatment (406/881; 46%) within three months of diagnosis, but many (387/881; 44%) received no medication. The LNG-IUS was prescribed for 2.4%, but there was no significant increase in the number of prescriptions over time. Conclusion: In this cohort, most women with HMB were treated with oral hormone therapy, and few received the LNG-IUS. If patients are to benefit from the LNG-IUS, further research is needed into the reasons for this lack of change in prescribing practices.

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.

Dientamoeba fragilis colonization is not associated with gastrointestinal symptoms in children at primary care level.

BACKGROUND: Dientamoeba fragilis is commonly identified in children in primary care and is suspected to cause gastrointestinal disease. OBJECTIVE: To determine the association between D. fragilis colonization and gastrointestinal symptoms in children. METHODS: We performed a cross-sectional study with children who presented in primary care with gastrointestinal symptoms. The associations between D. fragilis colonization and specific symptoms were explored by means of logistic regression analyses. Asymptomatic siblings of these cases were invited as control subjects for a case-control analysis, where we explored the association between D. fragilis and gastrointestinal symptoms with conditional logistic regression analysis. RESULTS: In the cross-sectional study, 107 children were included. Their median age was 9 years (interquartile range = 6-12) and 38 (35.5%) were boys. Colonization of D. fragilis was present in 59 children (55.1%). The absence of D. fragilis was associated with soft to watery stool [odds ratio (OR) = 0.29; 95% confidence interval (CI) = 0.10-0.85], chronic diarrhoea (OR = 0.42; 95% CI = 0.18-0.97) and fatigue (OR = 0.45; 95% CI = 0.20-0.99). The case-control analyses included 44 children in each group. Dientamoeba fragilis colonization was not observed more often in cases than in controls after adjustment for age and sex (OR = 1.02; 95% CI = 0.28-3.65). CONCLUSION: Dientamoeba fragilis is a common parasite in children with and without gastrointestinal symptoms. The anomalous finding of the association between the absence of D. fragilis with soft to watery stools, chronic diarrhoea and fatigue are inexplicable. Our study suggests that D. fragilis colonization does not increase the risk for gastrointestinal symptoms.

Evaluation of point-of-care test calprotectin and lactoferrin for inflammatory bowel disease among children with chronic gastrointestinal symptoms.

Background: Faecal calprotectin is considered to be a valid test for ruling out inflammatory bowel disease (IBD) in children with chronic gastrointestinal symptoms in specialist care. In contrast, faecal lactoferrin has higher specificity. The recent availability of both as point-of-care tests (POCTs) makes them attractive for use in primary care. Objective: To evaluate the test characteristics of calprotectin and lactoferrin POCTs for diagnosing IBD in symptomatic children. Methods: We defined two prospective cohorts of children with chronic gastrointestinal symptoms: (i) children presenting to primary care (primary care cohort); (ii) children referred for specialist care (referred cohort). Baseline POCT results were compared with the outcome of either endoscopic assessment or 12 months follow-up. Clinicians were blinded to the POCT results. Results: In the primary care cohort, none of the 114 children had IBD, and the calprotectin and lactoferrin POCTs had specificities of 0.95 (0.89-0.98) and 0.98 (0.93-0.99), respectively. In the referred cohort, 17 of the 90 children had IBD: the sensitivity of POCT calprotectin and POCT lactoferrin were both 0.94 (0.72-0.99); and the specificity was 0.93 (0.84-0.97) and 0.99 (0.92-1.00), respectively. The POCT calprotectin could reduce the referral rate by 76% and POCT lactoferrin by 81%, while missing one child with IBD (6%). Conclusion: A diagnostic test strategy in primary care using a simple POCT calprotectin or lactoferrin has the potential to reduce the need for referral for further diagnostic work-up in specialist care, with a low risk of missing a child with IBD.

Diagnostic Accuracy of Fecal Calprotectin for Pediatric Inflammatory Bowel Disease in Primary Care: A Prospective Cohort Study.

PURPOSE: In specialist care, fecal calprotectin (FCal) is a commonly used noninvasive diagnostic test for ruling out inflammatory bowel disease (IBD) in children with chronic gastrointestinal symptoms. The aim of this study was to evaluate the diagnostic accuracy of FCal for IBD in symptomatic children in primary care. METHODS: We studied 2 prospective cohorts of children with chronic diarrhea, recurrent abdominal pain, or both: children initially seen in primary care (primary care cohort) and children referred to specialist care (referred cohort). FCal (index test) was measured at baseline and compared with 1 of the 2 reference standards for IBD: endoscopic assessment or 1-year follow-up. Physicians were blinded to FCal results, and values greater than 50 µg/g feces were considered positive. We determined specificity in the primary care cohort and sensitivity in the referred cohort. RESULTS: None of the 114 children in the primary care cohort ultimately received a diagnosis of IBD. The specificity of FCal in the primary care cohort was 0.87 (95% CI, 0.80-0.92). Among the 90 children in the referred cohort, 17 (19%) ultimately received a diagnosis of IBD. The sensitivity of FCal in the referred cohort was 0.99 (95% CI, 0.81-1.00). CONCLUSIONS: The findings of this study suggest that a positive FCal result in children with chronic gastrointestinal symptoms seen in primary care is not likely to be indicative of IBD. A negative FCal result is likely to be a true negative, which safely rules out IBD in children in whom a primary care physician considers referral to specialist 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.

Avoid Endoscopy in Children With Suspected Inflammatory Bowel Disease Who Have Normal Calprotectin Levels.

In children with suspected inflammatory bowel disease, adding calprotectin stool testing to the screening strategy has been recommended to distinguish organic from nonorganic disease. In this cohort study with historical controls, we could not confirm that screening with stool calprotectin improves the diagnostic yield (ratio inflammatory bowel disease-positive endoscopies and total number of endoscopies); however, in patients with normal fecal calprotectin levels (<50 µg/g) endoscopic and histological abnormalities were not seen. We propose to refrain from endoscopy when stool calprotectin levels are normal.

Noninvasive Tests for Inflammatory Bowel Disease: A Meta-analysis.

BACKGROUND: The clinical presentation of pediatric inflammatory bowel disease (IBD) is often nonspecific and overlaps with functional gastrointestinal disorders. OBJECTIVE: To determine the diagnostic accuracy of symptoms, signs, noninvasive tests, and test combinations that can assist the clinician with the diagnosis of IBD in symptomatic children. METHODS: A literature search was conducted of Medline and Embase. Two reviewers independently selected studies reporting on the diagnostic accuracy of tests for IBD, with confirmation by endoscopy and histopathology or clinical follow-up, in children with chronic gastrointestinal symptoms. Two reviewers independently extracted data and assessed study quality with the QUADAS-2, an evidence-based quality assessment tool for diagnostic accuracy studies. RESULTS: Nineteen studies were included (N = 2806). Symptoms (abdominal pain, diarrhea, rectal bleeding, and weight loss) had pooled sensitivities ranging from 0.48 to 0.82 and specificities ranging from 0.17 to 0.78. Of all the blood markers, C-reactive protein (CRP) (9 studies) and albumin (6 studies) had the best performance, with pooled sensitivities of 0.63 (0.51-0.73) and 0.48 (0.31-0.66), respectively, and specificities of 0.88 (0.80-0.93) and 0.94 (0.86-0.98). Assessment of fecal calprotectin (FCal) (10 studies) had a pooled sensitivity of 0.99 (0.92-1.00) and a specificity of 0.65 (0.54-0.74). One limitation was that none of the studies was conducted in nonreferred children. CONCLUSIONS: In children whose pediatrician is considering an endoscopy, symptoms are not accurate enough to identify low-risk patients in whom an endoscopy can be avoided. FCal, CRP, and albumin findings are potentially of clinical value, given their ability to select children at low risk (negative FCal test result) or high risk (positive CRP or albumin test result) for IBD.

Predictors of chronic abdominal pain affecting the well-being of children in primary care.

PURPOSE: Abdominal pain is a frequent symptom among children but is rarely associated with organic disease. Although it may persist for years, no factors have been identified that predict its prognosis. Our aim was to determine whether patient characteristics at initial consultation can predict chronic abdominal pain severe enough to influence the child's well-being at 1 year of follow-up. METHODS: We conducted this prospective cohort study in primary care, including consecutive children aged 4 to 17 years seen for abdominal pain by their family physician. Multivariate logistic regression analysis was used to identify prognostic factors that predicted chronic abdominal pain 1 year later. Discriminative ability of identified predictors was assessed using the area under the receiver operating characteristic curve and explained variance. RESULTS: The risk of having chronic abdominal pain at 1 year of follow-up was 37.1% in the cohort overall. Increasing age, waking up at night with pain, high levels of other somatic complaints, and chronic abdominal pain at baseline independently predicted chronic abdominal pain at 1 year. These predictors had a poor to moderate discriminative ability, however; the area under the receiver operating characteristic curve was only 0.69, and the predictors collectively explained only 14.3% of variance in the development of chronic abdominal pain. The absolute risk ranged from 19.4% among children having none of the predictors to 65.5% among children having 3 or 4 predictors. CONCLUSIONS: Chronic abdominal pain sufficient to affect well-being is common among children initially seen for abdominal pain by family physicians. Although the risk of this outcome increases with number of predictors, these predictors are of limited value in identifying children in whom pain will become chronic, suggesting that other, as yet unidentified factors play an important role.

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.

Sexual function in older women with pelvic floor symptoms: a cross-sectional study in general practice.

BACKGROUND: Pelvic floor symptoms are common and are negatively associated with sexual function which, in turn, is an important aspect of quality of life. The majority of older women with pelvic floor symptoms are treated in general practice but evidence from studies in general practice on the sexual functioning of these women is scarce. AIM: This study examined predictors of sexual inactivity in older women with pelvic floor symptoms in general practice and of sexual functioning in those women who are sexually active. DESIGN AND SETTING: Cross-sectional study in women (aged ≥55 years) from 20 general practices who screened positive on a pelvic floor symptom questionnaire. METHOD: Logistic and linear regression analyses were used to determine predictors of sexual inactivity and sexual functioning (PISQ-12) by assessing their association with patient characteristics, symptoms (PFDI-20) and degree of prolapse (POP-Q). RESULTS: A total of 639 women were included (sexually active n = 393, sexually inactive n = 246). Predictors of sexual inactivity were increasing age (odds ratio [OR] = 1.13; 95% confidence interval [CI] = 1.10 to 1.17) and lower education (OR = 2.31; 95% CI = 1.50 to 3.54; Nagelkerke R(2) = 0.208). In sexually active women, sexual functioning was associated with pelvic floor symptom distress (P<0.001) and pelvic floor surgery (P = 0.018; R(2) = 0.138). CONCLUSION: In older women with pelvic floor symptoms, increasing age and lower educational level are predictors of sexual inactivity. Many of these older women are sexually active and pelvic floor symptom distress is negatively associated with sexual functioning. These results may encourage GPs to ask about sexual problems in women with pelvic floor symptoms.

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.