Marian Wiegersma

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.

Two‐year effects and cost‐effectiveness of pelvic floor muscle training in mild pelvic organ prolapse: a randomised controlled trial in primary care

To compare effects and cost‐effectiveness of pelvic floor muscle training (PFMT) and watchful waiting in women with pelvic organ prolapse.

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.

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

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

309 and

Free uroflowmetry for voiding dysfunction measurement in women with pelvic organ prolapse and urinary incontinence in primary care

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.

More research is needed before we regard POP-Q stage 1 prolapse as normal

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.

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

DOI: 10.1111/iju.12789 Voiding dysfunction might exist in women with POP, which can be determined by free uroflowmetry. Uroflowmetry in combination with PVR measurement could be used to evaluate the micturition process in women with POP in primary care. This evaluation could be useful in the diagnostic approach and decision-making process regarding referral of patients with POP and urinary symptoms from primary to secondary care. We aimed to investigate the prevalence of voiding dysfunction in women with POP in primary care and to explore potential predictors for the existence of voiding dysfunction. This was a cross-sectional study of 233 female patients aged ≥55 years, registered in 23 general practices in the northern part of the Netherlands between February 2008 andMarch 2011. Urinary symptoms were assessed by the Urinary Distress Inventory-6, POP by the POP-Q stage measurement, and voiding dysfunction by free uroflowmetry and PVR. Voiding dysfunction was defined as a urine flow below the 10th maximum flow rate centile of the Liverpool Nomograms or as a flow with a maximum flow rate ≤15 mL/s and/or a PVR ≥50 mL. Women were included in the present study if they reported having urinary incontinence in a questionnaire, and POP was diagnosed during physical examination. Statistical analysis was carried out using Fishers exact test, as well as univariate and multivariate logistic regression analyses. Overall, the included patients had amean age 65 8 years, median parity was two (range 2–3) and 4.7% had previous gynecological surgery (Table S1). A total of 91 (39.7%) patients had obstructive urinary symptoms according to the Urinary Distress Inventory-6. Gynecological examination showed that 40.8% of the participants had POP-Q stage I, 50.6% had stage II and 8.6% had stage III. No significant differences in urinary symptomswere observed between the POP-Q stages. The Liverpool Nomograms resulted in a higher percentage of interpretable uroflowmetry results than the flow parameters + PVR (95.5% vs 67.1%; P < 0.001). With the Liverpool Nomograms, significantly more cases of voiding dysfunction were found compared with the flow parameters + PVR (33.2% vs 24.8%; P < 0.001). In multivariate logistic analyses, with the Liverpool Nomograms, increasing age (OR 1.04, 95% CI 1.00–1.08) and posterior wall prolapse (OR 1.38, 95% CI 1.03–1.99) were predictors (Table ). Increasing age (OR 1.08, 95% CI 1.02–1.14) and anterior wall prolapse (OR 1.79, 95% CI 1.01–2.81) as well as posterior wall prolapse (OR 1.88, 95% CI 1.10–3.08) were predictors for voiding dysfunction defined with flow parameters + PVR. The present study showed that free uroflowmetry can be carried out in primary care. First, we found 95% interpretable flows, which is rather high compared with the literature. Other researchers reported percentages between 64% and 89% of interpretable flows. In addition, we found that increasing age, and prolapse of the anterior and posterior vaginal wall were risk factors for voiding dysfunction, which was in line with the current literature. To our knowledge, the exact prevalence of voiding dysfunction in women with POP is unknown. It is estimated to be between 18% and 39%. In the study by Haylen et al., 39% of the women with symptoms of POP had voiding dysfunction according to free uroflowmetry parameters, but no vaginal examination was carried out to confirm POP. In the study by Serati et al., the prevalence of voiding dysfunction was 18% after full urodynamic studies and all women had POP by vaginal examination. As the present study results were closest to that found by Haylen et al., we suggested that free uroflowmetry could possibly overestimate the prevalence of voiding dysfunction. Evaluation of the micturition process in primary care could lead to a change of treatment. It has already been reported that urodynamic evaluations could influence the selection of patients who could benefit for surgical treatment of pelvic floor dysfunction in secondary care. There were several limitations in the present study, our data were collected only from women with POP as well as urinary symptoms, and the uroflowmetry results were not compared with a complete urodynamic study, the gold standard. Because only a limited number of women with POP-Q stageIIIandIVwereincludedinthepresentstudy,statementsaboutthecorrelationbetweenprolapse stageandvoidingdysfunctionshouldbeinterpretedwithcaution.

Antidepressiva bij enuresis nocturna

Dear Editor, With great interest we read the article by Dietz and Mann entitled “What is clinically relevant prolapse? An attempt at defining cutoffs for the clinical assessment of pelvic organ descent” [1]. In this article, the authors try to find an optimal cutoff value for predicting prolapse symptoms. Their results show a strong relation between prolapse symptoms and the POP-Q measurement points Ba, C, and Bp, with the optimal cutoff value for Ba and Bp being −0.5. In their conclusion, the authors therefore argue that mild (stage 1) prolapse of the anterior and posterior vaginal wall should be regarded as part of the normal range. Because the study was conducted in a tertiary urogynecological unit, this conclusion may not be generalizable to the general population. Furthermore, prolapse symptoms were defined as the sensation of a lump or bulge and/or a dragging sensation in the vagina, while other possibly prolapse-related symptoms, like pain in the lower back or abdomen and urinary or bowel symptoms, are not accounted for. Regarding mild prolapse of the anterior and posterior vaginal wall as part of the normal range indicates that there is no treatment indication. However, there is some evidence that women with mild pelvic organ prolapse benefit from pelvic floor muscle therapy (PFMT) [2–4]. Current evidence for the effectiveness of PFMT in women with mild prolapse comes from small studies, two ofwhich are pilot studies [2, 3] and the other is of moderate methodological quality [4]. A larger trial investigating the effect of PFMTcomparedwith watchful waiting in a primary care population of women aged ≥55 years with symptomatic mild POP is currently ongoing [5]. We agree with the authors that mild pelvic organ prolapse is probably not an indication for surgical correction, but it may be an indication for conservative treatment like pelvic floor muscle training. More research, preferably in a primary care population, is needed before we decide to regard stage 1 prolapse of the anterior and posterior vaginal wall as normal.

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

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.