Quality of life in Dutch patients with primary biliary cholangitis: Discrepancies between patients' perspectives and objective disease parameters.

AIM: This study aims to assess the health-related quality of life (HRQoL) in a Dutch population of patients with primary biliary cholangitis (PBC) in relation to the prognosis and need for second line-therapy, based on both objective disease parameters and patients' perspectives. METHODS: In this cross-sectional multicenter study, HRQoL was assessed by using the Dutch PBC-40 according to objective clinical parameters and patients' perspectives on treatment and prognosis. RESULTS: In total, 178/269 (66%) patients responded; mean age 61.2 (SD 9.9) years and 165 (92.7%) women. The PBC-40 domain scores did not differ according to the GLOBE score response (p > 0.05 for all) or according to the POISE criteria (p > 0.05), except for the domain itch (p = 0.031). Patients who considered their survival to be impaired scored higher on all domains as compared to those expecting a normal prognosis (p < 0.05). Similarly, PBC-40 domain scores were higher among patients who considered that they were in need of additional therapy compared to those who did not (p < 0.05 for all, except for domain itch [p = 0.056]). However, 45/62 (72.6%) patients with a self-expected impaired prognosis had a GLOBE score indicative of a normal prognosis. Twenty-five of the 40 (62.5%) patients who believed they needed additional therapy were below POISE criteria. CONCLUSION: The HRQoL of patients with PBC was impaired in terms of nonfavorable disease status according to the expectations of patients, but not according to objective disease parameters. Substantial discrepancies between patients' perspectives and objective parameters were observed, which highlights the need for better patient guidance among patient with PBC.

Measurement properties of the PBC-40 and PBC-27: a Dutch validation study.

OBJECTIVE: Patients with primary biliary cholangitis (PBC) have an impaired health-related quality of life (HRQoL). Practice guidelines recommend evaluating the HRQoL in all patients with PBC. The aim of this study was to assess the reliability and validity of our Dutch translation of the PBC-40, a PBC-specific measure of the HRQoL. DESIGN: The PBC-40 was translated into Dutch following standardised forward-backward procedures. Participants received the Dutch PBC-40 and the RAND-36 (a validated Dutch version of the 36-Item Short Form Health Survey) through postal mail. The PBC-27 is an abridged version of the PBC-40. Internal consistency between the items within the PBC-40/PBC-27 domains was assessed by Cronbach's alpha. In addition, score distributions were analysed on floor and ceiling effects. Construct validity was assessed by hypotheses testing using Pearson's correlation between the PBC-40/PBC-27 domains and RAND-36 scales. RESULTS: 177 patients with PBC were included. The mean age was 61.1 (SD 9.9) years and the majority of patients was female (n=164, 92.7%). From the 7080 PBC-40 items, 61 items (0.9%) were missing and 342 items (4.8%) were answered with the 'does not apply' option. Each PBC-40 domain had a Cronbach's α of >0.70, with the highest in the domain fatigue (0.95). For the PBC-27, the lowest Cronbach's α was 0.69. Floor effects were present in three domains (cognition 19.3%, itch 27.0% and social 25.0% (only for PBC-27)). No ceiling effects were observed. All domains were significantly correlated with the corresponding RAND-36 scale(s) (p<0.001 for all). The strongest correlation was between the PBC-40 domain fatigue and the RAND-36 vitality scale (r=-0.834). CONCLUSION: Our findings demonstrate the reliability and validity of the Dutch PBC-40 and PBC-27 for the assessment of the HRQoL in patients with PBC. This PBC-specific measure can be used in Dutch-speaking patients with PBC for both research and clinical purposes.

The fecal incontinence quality of life scale (FIQL) and fecal incontinence severity index (FISI): Validation of the Dutch versions.

AIMS: Fecal incontinence (FI) is known to have a major impact on quality of life. The Fecal Incontinence Quality of Life scale (FIQL) and Fecal Incontinence Severity Index (FISI) have been developed to assess this impact. The aim of this study was to validate the FIQL and FISI in the Dutch language. METHODS: The study population consisted of women and men experiencing FI and a reference group. The FIQL (four domains) and FISI questionnaires were validated by testing standardized measurement properties: discriminative ability, internal consistency, reproducibility, construct validity, and responsiveness. RESULTS: A total of 55 patients and 277 reference participants were included. Patients had significant lower and higher scores at the FIQL and FISI, respectively, than references (FIQL: 2.58 ± 0.70 and 3.92 ± 0.36, FISI: 38.57 ± 10.73 and 23.17 ± 15.01; P < 0.001), indicating worse functioning in patients and with this the discriminative abilities of the measures. The FIQL demonstrated adequate internal consistency on all domains (0.72-0.96), except for the embarrassment domain (0.55). The reproducibility was good for both measures. A negative correlation was found between the FIQL and FISI. Furthermore, the FIQL showed a positive (0.77) and the FISI a negative correlation (-0.31) with the Mental Component Summary scale of the SF-12. Responsiveness analysis showed a minimal important change of 0.40 points for the FIQL. CONCLUSIONS: Validity and reliability were good in the Dutch FIQL, but inconclusive in the FISI. The Dutch FIQL can support physicians in determining the impact of FI on patient's quality of life. Neurourol. Urodynam. 36:710-715, 2017. © 2016 Wiley Periodicals, Inc.

The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12): validation of the Dutch version.

OBJECTIVES AND HYPOTHESIS: To establish the reliability and validity of the Dutch version of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) in women with pelvic floor dysfunction. METHODS: The PISQ-12 was translated into Dutch following a standardized translation process. A group of 124 women involved in a heterosexual relationship who had had symptoms of urinary incontinence, fecal incontinence and/or pelvic organ prolapse for at least 3 months were eligible for inclusion. A reference group was used for assessment of discriminative ability. Data were analyzed for internal consistency, reproducibility, construct validity, responsiveness, and interpretability. An alteration was made to item 12 and was corrected for during the analysis. RESULTS: The patient group comprised 70 of the 124 eligible women, and the reference group comprised 208 women from a panel representative of the Dutch female population. The Dutch PISQ-12 showed an adequate internal consistency with a Cronbach's alpha of 0.57 - 0.69, increasing with correction for item 12 to 0.69 - 0.75, for the reference and patient group, respectively. Scores in the patient group were lower (32.6 ± 6.9) than in the reference group (36.3 ± 4.8; p = 0.0001), indicating a lower sexual function in the patient group and good discriminative ability. Reproducibility was excellent with an intraclass correlation coefficient for agreement of 0.93 (0.88 - 0.96). A positive correlation was found with the Short Form-12 Health Survey (SF-12) measure representing good criterion validity. Due to the small number of patients who had received treatment at the 6-month follow-up, no significant responsiveness could be established. CONCLUSIONS: This study showed that the Dutch version of the PISQ-12 has good validity and reliability. The PISQ-12 will enable Dutch physicians to evaluate sexual dysfunction in women with pelvic floor disorders.

Validation of the Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7) in a Dutch population.

AIMS: The Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7) assess symptom distress and the impact on daily life of urinary incontinence. The UDI-6 has not been validated before in males. Our aim was to validate the UDI-6 and IIQ-7 in Dutch men and women. METHODS: The translation to Dutch followed standardized procedures. We validated the IIQ-7 with and without an additional gender-neutral item (IIQ-SF). Adults with urinary incontinence for at least 3 months, completed the measures at inclusion; 1-week after inclusion to evaluate the test-retest reproducibility; and 6 months after inclusion with the addition of the RAND-36 health transition item to assess responsiveness and interpretability. To assess the discriminate ability, a reference population was enrolled. To assess construct validity, the urodynamic diagnosis was used. RESULTS: Questionnaire data of 160 patients were analyzed. Patients reported more symptoms and bother than the reference population (P < 0.001). The internal consistency was good in the IIQ-SF baseline scores (Cronbach's alphas 0.86-0.92), though moderate in the UDI-6 (Cronbach's alphas 0.44-0.66). Both measures showed good reproducibility at the test-retest (Intraclass Correlations Coefficients 0.75-0.85). Construct was adequate with 75% confirmed hypotheses of urodynamic data with measure scores. The measures were responsive after treatment with smaller measurement errors than the minimal important change. No floor or ceiling effects were observed in baseline data. CONCLUSIONS: The Dutch UDI-6 and IIQ-7 are reliable, valid, and responsive instruments for assessing symptom distress of urinary incontinence and its impact on daily life in both men and women.

Surgical management of functional bladder outlet obstruction in adults with neurogenic bladder dysfunction.

BACKGROUND: The most common type of functional bladder outlet obstruction in patients with neurogenic bladder is detrusor-sphincter dyssynergia (DSD). The lack of co-ordination between the bladder and the external urethral sphincter muscle (EUS) in DSD can result in poor bladder emptying and high bladder pressures, which may eventually lead to progressive renal damage. OBJECTIVES: To assess the effectiveness of different surgical therapies for the treatment of functional bladder outlet obstruction (i.e. DSD) in adults with neurogenic bladder dysfunction. SEARCH METHODS: We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, and handsearching of journals and conference proceedings (searched 20 February 2014), and the reference lists of relevant articles. SELECTION CRITERIA: Randomised controlled trials (RCTs) or quasi-RCTs comparing a surgical treatment of DSD in adults suffering from neurogenic bladder dysfunction, with no treatment, placebo, non-surgical treatment, or other surgical treatment, alone or in combination. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data. MAIN RESULTS: We included five trials (total of 199 participants, average age of 40 years). The neurological diseases causing DSD were traumatic spinal cord injury (SCI), multiple sclerosis (MS), or congenital malformations.One trial compared placement of sphincteric stent prosthesis with sphincterotomy. For urodynamic measurements, results for postvoid residual urine volume (PVR) and cystometric bladder capacity were inconclusive and consistent with benefit of either sphincteric stent prosthesis or sphincterotomy at three, six, 12, and 24 months. Results for maximum detrusor pressure (Pdet.max) were also inconclusive at three, six, and 12 months; however, after two years, the Pdet.max after sphincterotomy was lower than after stent placement (mean difference (MD) -30 cmH2O, 95% confidence interval (CI) 8.99 to 51.01).Four trials considered botulinum A toxin (BTX-A) injection in the EUS, either alone or in combination with other treatments. The comparators included oral baclofen, oral alpha blocker, lidocaine, and placebo. The BTX-A trials all differed in protocols, and therefore we did not undertake meta-analysis. A single 100 units transperineal BTX-A injection (Botox®) in patients with MS resulted in higher voided urine volumes (MD 69 mL, 95% CI 11.87 to 126.13), lower pre-micturition detrusor pressure (MD -10 cmH2O, 95% CI -17.62 to -2.38), and lower Pdet.max (MD -14 cmH2O, 95% CI -25.32 to -2.68) after 30 days, compared to placebo injection. Results for PVR using catheterisation, basal detrusor pressure, maximal bladder capacity, maximal urinary flow, bladder compliance at functional bladder capacity, maximal urethral pressure, and closure urethral pressure at 30 days were inconclusive and consistent with benefit of either BTX-A injection or placebo injections. In participants with SCI, treatment with 200 units of Chinese manufactured BTX-A injected at eight different sites resulted in better bladder compliance (MD 7.5 mL/cmH2O, 95% CI -10.74 to -4.26) than participants who received the same injections with the addition of oral baclofen. Results for maximum uroflow rate, maximal cystometric capacity, and volume per voiding were inconclusive and consistent with benefit of either BTX-A injection or BTX-A injection with the addition of oral baclofen. However, the poor quality of reporting in this trial caused us to question the relevance of bladder compliance as an adequate outcome measure.In participants with DSD due to traumatic SCI, MS, or congenital malformation, the results for PVRs after one day were inconclusive and consistent with benefit of either a single 100 units transperineal BTX-A (Botox®) injection or lidocaine injection. However, after seven and 30 days of BTX-A injection, PVRs were lower (MD -163 and -158 mL, 95% CI -308.65 to -17.35 and 95% CI -277.57 to -39.03, respectively) compared to participants who received lidocaine injections. Results at one month for Pdet.max on voiding, EUS activity in electromyography, and maximal urethral pressure were inconclusive and consistent with benefit of either BTX-A or lidocaine injections.Finally, one small trial consisting of five men with SCI compared weekly BTX-A injections with normal saline as placebo. The placebo had no effect on DSD in the two participants allocated to the placebo treatment. Their urodynamic parameters were unchanged from baseline values until subsequent injections with BTX-A once a week for three weeks. These subsequent injections resulted in similar responses to those of the three participants who were allocated to the BTX-A treatment. Unfortunately, the report presented no data on placebo treatment.Only the trial that compared sphincterotomy with stent placement reported outcome measures renal function and urologic complications related to DSD. Results for renal function at 12 and 24 months, and urologic complications related to DSD at three, six, 12, and 24 months were inconclusive and consistent with benefit of either sphincteric stent prosthesis or sphincterotomy.Adverse effects reported were haematuria due to the cystoscopic injection and muscle weakness, of which the latter may be related to the BTX-A dose used.All trials had some methodological shortcomings, so insufficient information was available to permit judgement of risk of bias. At least half of the trials had an unclear risk of selection bias and reporting bias. One trial had a high risk of attrition bias, and another trial had a high risk of reporting bias. AUTHORS' CONCLUSIONS: Results from small studies with a high risk of bias have identified evidence of limited quality that intraurethral BTX-A injections improve some urodynamic measures after 30 days in the treatment of functional bladder outlet obstruction in adults with neurogenic bladder dysfunction. The necessity of reinjection of BTX-A is a significant drawback; a sphincterotomy might therefore be a more effective treatment option for lowering bladder pressure in the long-term.However, because of the limited availability of eligible trials, this review was unable to provide robust evidence in favour of any of the surgical treatment options. More RCTs are needed, measuring improvement on quality of life, and on other types of surgical treatment options for DSD since these are lacking. Future RCTs assessing the effectiveness of BTX-A injections also need to address the uncertainty about the optimal dose and mode of injection for this specific type of urological condition.

Validation of the Pelvic Floor Distress Inventory (PFDI-20) and Pelvic Floor Impact Questionnaire (PFIQ-7) in a Dutch population.

INTRODUCTION AND HYPOTHESIS: The objective of this study was to validate the Pelvic Floor Distress Inventory (PFDI-20) and Pelvic Floor Impact Questionnaire (PFIQ-7) in Dutch women. METHODS: Patients with pelvic floor dysfunction completed the Dutch questionnaires at (1) inclusion to evaluate internal consistency, (2) 1 week later to assess test-retest reliability, and (3) 6 months later to assess responsiveness and interpretability of change. To assess validity, floor and ceiling effects and construct validity were tested. A population-based sample (reference group) completed the questionnaires once. RESULTS: Data of 111 patients and 283 reference group participants were analyzed. Internal consistency of baseline scores in patient and reference groups was moderate (Cronbach's alpha 0.52-0.60) to adequate in the PFDI-20 (Cronbach's alpha 0.71-0.84) and adequate in the PFIQ-7 (Cronbach's alpha 0.88-0.94). Both measures presented adequate test-retest reliability (intraclass correlation coefficient 0.79-0.91) and adequate responsiveness (area under the receiver-operating characteristic curve both 0.77). Interpretability was adequate for PFDI-20 and acceptable for PFIQ-7 with a clinically relevant minimally important change of -23 and -29 points, respectively. At baseline, the scales of the PFIQ-7 showed floor effects (44-55 %) in patients, though the PFIQ-7 summary score did not. No ceiling effects were observed. Construct validity was adequate with all predefined hypotheses confirmed regarding subgroup discrimination using pooled patient and reference group baseline data. CONCLUSIONS: For assessing distress and health-related quality of life of pelvic floor dysfunction, the Dutch PFDI-20 and PFIQ-7 are reliable and valid in the general Dutch population, and also responsive and interpretable among tertiary care-seeking women.

Urodynamic effects of volume-adjustable balloons for treatment of postprostatectomy urinary incontinence.

OBJECTIVE: To evaluate the urodynamic changes in patients treated with Adjustable Continence Therapy for men (ProACT) for postprostatectomy incontinence and to explore the clinical and urodynamic preimplantation parameters as predictors of clinical outcome. MATERIALS AND METHODS: Patients underwent urodynamic studies before and after ProACT implantation. ProACT was considered successful if patients used none or 1 dry precautionary pad and nonsuccessful if the patient reported ≥1 wet pad/d. The pre- and postimplantation assessments were retrospectively compared within and between the success and nonsuccess groups. Multivariate logistic regression analysis was performed to investigate the association between the preimplantation variables and the clinical outcomes of ProACT implantation. RESULTS: A total of 49 patients were included, 37 with successful and 12 with nonsuccessful clinical outcome. Postimplantation urodynamic studies were performed a median of 9 months after ProACT implantation. In the successfully treated patients, maximum free flow rate, bladder contractility index, maximum of bladder contractility parameter W, and bladder voiding efficiency were significantly lower after implantation. The detrusor pressure at maximum flow rate, postvoid residual urine volume, and bladder outlet obstruction index were significantly higher. A longer duration of urinary incontinence, the use of >5 pads daily, and a smaller cystometric bladder capacity were all independently associated with nonsuccessful clinical outcome after ProACT implantation. CONCLUSION: ProACT implantation with successful clinical outcome resulted in greater urethral resistance during voiding and reduced bladder contraction strength. A longer duration of incontinence, the use of >5 pads daily, and a smaller cystometric bladder capacity were independent predictors of unsuccessful clinical outcomes, suggesting ProACT implantation should be considered sooner, rather than later, after conservative treatment of postprostatectomy incontinence has failed.

Low folate in seminal plasma is associated with increased sperm DNA damage.

OBJECTIVE: To determine associations between vitamin B status, homocysteine (tHcy), semen parameters, and sperm DNA damage. DESIGN: Observational study. SETTING: A tertiary referral fertility clinic. PATIENT(S): Two hundred fifty-one men of couples undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) treatment, with subgroups of fertile (n = 70) and subfertile men (n = 63) defined according to semen concentration and proven fertility. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): The DNA fragmentation index (DFI) as marker of sperm DNA damage determined using the sperm chromatin structure assay (SCSA), and semen parameters assessed according to World Health Organization criteria; tHcy, folate, cobalamin, and pyridoxine concentrations determined in seminal plasma and blood. RESULT(S): In the total group of fertile and subfertile men, all biomarkers in blood were statistically significantly correlated with those in seminal plasma. No correlation was found between the biomarkers in blood and the semen parameters. In seminal plasma, both tHcy and cobalamin positively correlated with sperm count. Folate, cobalamin, and pyridoxine were inversely correlated with ejaculate volume. In fertile men, seminal plasma folate showed an inverse correlation with the DNA fragmentation index. CONCLUSION(S): Low concentrations of folate in seminal plasma may be detrimental for sperm DNA stability.