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Impact Questionnaire (impact + questionnaire)
Kinds of Impact Questionnaire Selected AbstractsA Double-Blind Comparison of OnabotulinumtoxinA (BOTOX®) and Topiramate (TOPAMAX®) for the Prophylactic Treatment of Chronic Migraine: A Pilot StudyHEADACHE, Issue 10 2009Ninan T. Mathew MD Background., There is a need for effective prophylactic therapy for chronic migraine (CM) that has minimal side effects. Objective., To compare the efficacy and safety of onabotulinumtoxinA (BOTOX®, Allergan, Inc., Irvine, CA) and topiramate (TOPAMAX®, Ortho-McNeil, Titusville, NJ) prophylactic treatment in patients with CM. Methods., In this single-center, double-blind trial, patients with CM received either onabotulinumtoxinA, maximum 200 units (U) at baseline and month 3 (100 U fixed-site and 100 U follow-the-pain), plus an oral placebo, or topiramate, 4-week titration to 100 mg/day with option for additional 4-week titration to 200 mg/day, plus placebo saline injections. OnabotulinumtoxinA or placebo saline injection was administered at baseline and month 3 only, while topiramate oral treatment or oral placebo was continued through the end of the study. The primary endpoint was treatment responder rate assessed using Physician Global Assessment 9-point scale (+4 = clearance of signs and symptoms and ,4 = very marked worsening [about 100% worse]). Secondary endpoints included the change from baseline in the number of headache (HA)/migraine days per month (HA diary), and HA disability measured using Headache Impact Test (HIT-6), HA diary, Migraine Disability Assessment (MIDAS) questionnaire, and Migraine Impact Questionnaire (MIQ). The overall study duration was approximately 10.5 months, which included a 4-week screening period and a 2-week optional final safety visit. Follow-up visits for assessments occurred at months 1, 3, 6, and 9. Adverse events (AEs) were documented. Results., Of 60 patients randomized to treatment (mean age, 36.8 ± 10.3 years; 90% female), 36 completed the study at the end of the 9 months of active treatment (onabotulinumtoxinA, 19/30 [63.3%]; topiramate, 17/30 [56.7%]). In the topiramate group, 7/29 (24.1%) discontinued study because of treatment-related AEs vs 2/26 (7.7%) in the onabotulinumtoxinA group. Between 68% and 83% of patients for both onabotulinumtoxinA and topiramate groups reported at least a slight (25%) improvement in migraine; response to treatment was assessed using Physician Global Assessment at months 1, 3, 6, and 9. Most patients in both groups reported moderate to marked improvements at all time points. No significant between-group differences were observed, except for marked improvement at month 9 (onabotulinumtoxinA, 27.3% vs topiramate, 60.9%, P = .0234, chi-square). In both groups, HA/migraine days decreased and MIDAS and HIT-6 scores improved. Patient-reported quality of life measures assessed using MIQ after treatment with onabotulinumtoxinA paralleled those seen after treatment with topiramate in most respects. At month 9, 40.9% and 42.9% of patients in the onabotulinumtoxinA and topiramate groups, respectively, reported ,50% reduction in HA/migraine days. Forty-one treatment-related AEs were reported in 18 onabotulinumtoxinA-treated patients vs 87 in 25 topiramate-treated patients, and 2.7% of patients in the onabotulinumtoxinA group and 24.1% of patients in the topiramate group reported AEs that required permanent discontinuation of study treatment. Conclusions., OnabotulinumtoxinA and topiramate demonstrated similar efficacy in the prophylactic treatment of CM. Patients receiving onabotulinumtoxinA had fewer AEs and discontinuations. [source] The development and validation of a Nocturnal Gastro-oesophageal Reflux Disease Symptom Severity and Impact Questionnaire for adultsALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 4 2010B. M. Spiegel Aliment Pharmacol Ther 2010; 32: 591,602 Summary Background, Current questionnaires for assessing gastro-oesophageal reflux disease (GERD) symptoms are limited in their ability to capture nocturnal symptoms. Aim, To develop and validate an instrument, the Nocturnal Gastro-oesophageal Reflux Disease Symptom Severity and Impact Questionnaire (N-GSSIQ), to assess severity and impact of nocturnal GERD symptoms. Methods, Two focus groups and 16 cognitive debriefing interviews were conducted among GERD patients to identify key issues about nocturnal symptoms. A draft instrument was tested in 196 patients at 11 clinics in the US to evaluate psychometric properties. Exploratory factor and item response theory analyses were conducted to finalize items and subscales. Internal consistency reliability, reproducibility and construct validity were examined. Results, Mean age was 45 (s.d. = 13.8) years; 76% were female and 68% were Caucasian. Patient-rated severity was mild,moderate for 69% of participants; 48% reported symptoms on two to three nights the past week. The final questionnaire includes 20 items and three subscales: Nocturnal GERD Symptoms, Morning Impact of Nocturnal GERD and Concern about Nocturnal GERD. The subscales demonstrated internal consistency reliability (Cronbach's alpha 0.84,0.94) and were significantly correlated with similar measures and disease severity (0.41,0.81; P < 0.0001). Conclusion, The results support the reliability and validity of the N-GSSIQ as a measure of severity, morning impact and concern about nocturnal GERD. [source] Urodynamics, the supine empty bladder stress test, and incontinence severity,,§NEUROUROLOGY AND URODYNAMICS, Issue 7 2010Charles W. Nager Abstract Aims Determine whether urodynamic measures of urethral function [(valsalva leak point pressure (VLPP), maximum urethral closure pressure (MUCP), functional urethral length (FUL)] and the results of the supine empty bladder stress test (SEBST) correlate with each other and with subjective and objective measures of urinary incontinence (UI). Methods Data were collected preoperatively from subjects enrolled in a multicenter surgical trial of mid-urethral slings. Subjective measures included questionnaire scores from the Medical Epidemiological and Social Aspects of Aging Questionnaire, Urogenital Distress Inventory, and Incontinence Impact Questionnaire. Objective measures included a 24-hr pad weight test, incontinence episode frequency on a 3-day voiding diary, and a SEBST. Results Five hundred ninety-seven women enrolled. Three hundred seventy-two women had valid VLPP values; 539 had valid MUCP/FUL values. Subjective measures of severity had weak to moderate correlation with each other (r,=,0.25,0.43) and with objective measures of severity (r,=,,0.06 to 0.45). VLPP and MUCP had moderate correlation with each other (r,=,0.36, ,<,0.001). Urodynamic measures of urethral function had little or no correlation with subjective or objective measures of severity. Subjects with a positive SEBST had more subjective and objective severity measures compared to the negative SEBST group, but they did not have significantly different VLPP and MUCP values. Conclusions VLPP and MUCP have moderate correlation with each other, but each had little or no correlation with subjective or objective measures of severity or with the results of the SEBST. This data suggests that the urodynamic measures of urethral function are not related to subjective or objective measures of UI severity. Neurourol. Urodynam. 29:1306,1311, 2010. © 2010 Wiley-Liss, Inc. [source] Impact of urodynamic based incontinence diagnosis on quality of life in women,,NEUROUROLOGY AND URODYNAMICS, Issue 3 2009Alexandra L. Haessler Abstract Aims To characterize the effect of urodynamic diagnosis on degree of incontinence related bother and health related quality of life in a large, multi-ethnic population of women. Methods Effects of multichannel urodynamic diagnosis, urethral competency, and other patient characteristics on abbreviated Urogenital Distress Inventory (UDI6) and Incontinence Impact Questionnaire (IIQ7) composite scores were analyzed retrospectively. Results Six hundred eleven patients were included. Mean UDI6 and IIQ7 scores were significantly higher among patients with mixed incontinence, detrusor overactivity, urinary stress incontinence with overactive bladder, and negative studies compared to those with stress incontinence without OAB. The relative composite UDI6 and IIQ7 mean scores did not significantly differ between the mixed incontinence, detrusor overactivity, stress incontinence with OAB and negative study groups. UDI6 and IIQ7 scores were significantly higher among stress incontinent patients with intrinsic sphincter deficiency, but similar among mixed incontinent patients with intrinsic sphincter deficiency. Conclusion Urodynamic diagnoses of detrusor overactivity, mixed incontinence, and stress incontinence with overactive bladder are associated with significantly worse incontinence related bother and health related quality of life when compared to those with stress incontinence without OAB. These conditions appear to have similar degree of impact on incontinence related bother and quality of life. Patients presenting with symptoms of incontinence can suffer a similar compromise in quality of life despite a negative MCUD study. Neurourol. Urodynam. 28:183,187, 2009. © 2008 Wiley-Liss, Inc. [source] Patient reported and anatomical outcomes after surgery for pelvic organ prolapse,,NEUROUROLOGY AND URODYNAMICS, Issue 3 2009Ahmed S. El-Azab Abstract Aim Primary aim was to modify Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ) to assess pelvic organ prolapse (POP) in Arabic Muslim women. Secondary aim was to compare functional and anatomical outcomes of POP repair. Methods Questionnaire. A characteristic (prayer) was added to PFIQ. Linguistic validation of questionnaires was then done. Twenty cases were enrolled in a pilot study to test internal consistency and reliability. Subsequent study. Prospective study included women with symptomatic POP,,,stage II. History, examination by POP-Q, and administration of PFDI and PFIQ, were done before and 6 months after surgery. Results Questionnaire. Internal consistency of added question was good (Cronbach ,,=,0.78). Test,retest reliability of individual PFIQ items was variable. Subsequent Study. Between September 2004 and February 2007, 78 consecutive women were included. Cystocele, rectocele, and no site predominated in 74.4%, 17.9% and 7.7% of cases, respectively. Preoperatively 19.2%, 15.4% and 47.4% reported stress, urge, and mixed incontinence, respectively. Overall and individual urinary symptoms scores improved significantly after surgery. There were significant improvements in individual symptoms of constipation, splint to defecate and losing not well formed stools. Low self-esteem was most negative impact of prolapse on quality of life (QoL) followed by prayer. After surgery 90% of subjects had anatomical cure. After surgery, QoL issues are significantly related to anatomic location of prolapse as determined by POP-Q. Conclusions Modified PFIQ and PFDI are suitable to assess POP among Muslim women. Postoperatively, many prolapse-related symptoms and QoL significantly improve after surgery on the short term with an anatomic cure rate of 90%. Neurourol. Urodynam. 28:219,224, 2009. © 2008 Wiley-Liss, Inc. [source] Are there differences between women with urge predominant and stress predominant mixed urinary incontinence?,NEUROUROLOGY AND URODYNAMICS, Issue 2 2007Jack B. Lewis Abstract Objective We sought to determine if there are differences in clinical and urodynamic parameters between women with urge predominant and those with stress predominant mixed urinary incontinence (MUI). Methods Charts of 99 female patients with complaints of MUI were reviewed. Patients were divided into two groups based on the subjective predominance of either stress incontinence (MSUI) or urge incontinence (MUUI). All patients completed a subjective evaluation including an AUA Symptom Index, Urogenital Distress Inventory (UDI-6), and Incontinence Impact Questionnaire (IIQ-7). Objective non-invasive measures included physical exam, 48-hr voiding diary, and a 24-hr pad test. Videourodynamics studies (VUDS), performed in all patients, were reviewed and the presence and characteristics of detrusor overactivity (DO) and stress incontinence were noted. Results There were no significant differences between groups with respect to symptom scores. MUUI patients had significantly higher pad usage, and lower maximum and average voided volumes than MSUI patients. They were also more likely to have lower urodynamic bladder capacities and demonstrable DO (70% vs. 26%) on VUDS with contractions occurring at lower bladder volumes and with higher amplitude. MSUI patients were more likely to have demonstrable SUI on physical examination (63% vs. 16%) and on VUDS (100% vs. 61%). Conclusions There do appear to be differences in clinical and urodynamic parameters between patients with stress predominant and urge predominant MUI. These may help to determine which component of the mixed incontinence is more problematic. Neurourol. Urodynam. 26:204,207, 2007. © 2006 Wiley-Liss, Inc. [source] Transobturator tape (TOT): Two years follow-up,NEUROUROLOGY AND URODYNAMICS, Issue 1 2007Saad Juma Abstract Aims The aim of this study is to report the functional results, patient satisfaction, and morbidity of the Transobturator tape procedure (TOT) in the treatment of stress incontinence (SUI). Methods One hundred and thirty patients were prospectively evaluated with history, physical examination, quality of life questionnaire including Incontinence Impact Questionnaire (IIQ), urogenital distress inventory (UDI), and analog global satisfaction scale (GSS), and urodynamic studies. Results One hundred and seventeen patients (90%) had history of SUI, and 78 (60%) had urge incontinence. Pads/day (PPD) used was 2.48,±,2.42, and the score of IIQ 16.13,±,7.86, UDI 10.95,±,3.4, and GSS 1.41,±,1.67. All patients underwent TOT using the ObTapeÔ. Hospital stay was 0.84,±,0.76 days and catheter duration was 1.42,±,2.08 days. At a follow-up of 16.85,±, 4.68 months, 13 patients (10%) have recurrent SUI, 21 (16.15%) persistent urge incontinence, and 1 (1.92%) de novo urge incontinence. The mean PPD is 0.15,±,0.56, IIQ 1.47,±,5.14, UDI 3.28,±,3.09, and GSS 8.29,±,1.64. Two patients (1.52%) developed urethral obstruction, five (3.84%) had vaginal extrusion of the tape, and two (1.52%) had intra-operative bladder perforation. Conclusions These results demonstrate the safety and efficacy of the TOT. The short hospitalization and catheterization, low incidence of de novo urge incontinence and obstructive voiding offers a distinct advantage over existing techniques. No significant difference in outcome between patients with VLPP ,60 cm H2O, and patients with VLPP >60 cm H2O was observed. Neurourol. Urodynam. © 2006 Wiley-Liss, Inc. [source] Measuring health-related quality of life in women with urogenital dysfunction: The urogenital distress inventory and incontinence impact questionnaire revisitedNEUROUROLOGY AND URODYNAMICS, Issue 2 2003C. Huub van der Vaart Abstract Aims Symptoms of urogenital dysfunction are known to negatively affect health-related quality of life in women. To assess effectiveness of treatment, it is currently recommended to include measurements of quality of life in outcome analysis. One of the questionnaires that is commonly used is the combination of the Urogenital Distress Inventory (UDI) and Incontinence Impact Questionnaire (IIQ). Unfortunately, the validity of the UDI and IIQ has only been tested in highly selected subgroups of female patients. Therefore, it is unclear whether this questionnaire is suitable for use in populations with different characteristics. Methods We analyzed the scale construction and validity of the UDI and IIQ in a random sample of 2,042 women, aged 20,70 years old and a clinical sample of 196 women. Results Our results show that the UDI can be divided into five subscales, namely discomfort/pain, urinary incontinence, overactive bladder, genital prolapse, and obstructive micturition. The internal consistency (Cronbach's alpha) ranged between 0.74 and 0.82. In addition to the original four subscales of the IIQ (mobility, physical, social, and emotional functioning), we identified a fifth subscale with four items about embarrassment. Internal consistency of these subscales ranged between 0.83 and 0.93. In addition to the internal consistency, we tested the criterion and construct validity of these new subscale division. Conclusions We found these subscales to be reliable and of clinical use. It is recommended to use the revised UDI and IIQ in outcome analysis of treatments for urogenital symptoms in women. Neurourol. Urodynam. 22:97,104, 2003. © 2003 Wiley-Liss, Inc. [source] Urinary incontinence symptom scores and urodynamic diagnosesNEUROUROLOGY AND URODYNAMICS, Issue 1 2002Mary P. FitzGerald Abstract The aim of this study was to determine whether scores on two validated urinary incontinence symptom scales predicted eventual urodynamic diagnoses. Two hundred ninety-three patients undergoing multi-channel urodynamic testing rated their symptoms of urinary incontinence and/or pelvic organ prolapse (POP), using the Incontinence Impact Questionnaire, the Urogenital Distress Inventory, and an obstructive symptom subscale from the long form of the Incontinence Impact Questionnaire. Among the 202 (69%) patients without advance-stage POP, increasing scores on scale items related to stress and urge incontinence predicted increasing frequency of the diagnoses of genuine stress incontinence (GSI) and detrusor instability, respectively. Among the 91 (31%) patients with advance-stage POP, there was no association. Among all patients with GSI, the presence of intrinsic sphincter deficiency could not be predicted by responses to the symptom scales. Scores on the symptom scales were inadequate predictors of eventual urodynamic diagnoses, especially among women with advance-stage POP. Neurourol. Urodynam. 21:30,35, 2002. © 2002 Wiley-Liss, Inc. [source] The Effects Of Tizanidine HCL (Zanaflex®) In Patients With FibromyalgiaPAIN MEDICINE, Issue 2 2000Article first published online: 25 DEC 200 David McLain, MD, Brookwood Medical Center, Birmingham, AL This open-label, single-center, dose-finding study of Zanaflex (tizanidine hydrochloride) in 43 patients diagnosed with fibromyalgia showed some effectiveness in reducing pain and other symptoms of this syndrome. Fibromyalgia is a common syndrome characterized by chronic musculoskeletal pain in all 4 quadrants and pain in 18 identified tender points. Effects on fatigue, pain, sleep, and tender points were assessed before and during treatment. Starting doses of 2 mg/day were increased to 4 mg/day after 5 days and increased further as tolerated. Most patients stayed at 4 mg/day or 8 mg/day, and the highest dosage achieved was 12 mg/day. After the initial visit, 6 patients discontinued Zanaflex because of side effects (headaches in 3, hallucinations in 1, hypotension in 1, asthenia in 1), and 11 did not return for a follow-up visit. Results are presented for the remaining 26 patients (25 females; average age 50 years (range, 36,64 years); 25 Caucasian, 1 African-American; 9 on disability or applying for it; all stable on one or more of the following concomitant medications: narcotic analgesics 15%, antidepressants 65%, NSAIDs 46%). On average, at the first follow-up visit (average time 7.8 weeks), patients showed reduction in tender points and improvement on global assessment (GA) scores, Fibromyalgia Impact Questionnaire (FIQ) results, and visual assessment (VAS) scores for fatigue, pain, and sleep. The results for patients still working or retired were better than those for patients on disability or applying for it. Of the 26 patients in this ongoing study, 14 have had second follow-up visits (average time 13.3 weeks). Of these, 2 discontinued the drug at the second follow-up visit. Six of these patients responded especially well to long-term treatment (average age 51 years; range 46,60 years; 5 females; 1 on disability or applying for it) and showed the following averaged results: global assessment improved by 47%, FIQ by 35%, VAS-fatigue by 48%, VAS-pain by 40%, VAS-sleep by 37%, and tender points by 18%. Zanaflex appears to be effective in improving overall functioning, reducing pain and fatigue, improving sleep, and reducing the number of painful tender points in some patients with fibromyalgia, especially in those who are not on disability or applying for it. [source] Site-specific Effects of Transcranial Direct Current Stimulation on Sleep and Pain in Fibromyalgia: A Randomized, Sham-controlled StudyPAIN PRACTICE, Issue 4 2007Suely Roizenblatt MD ,,Abstract Objective: To investigate whether active anodal transcranial direct current stimulation (tDCS) (of dorsolateral prefrontal cortex [DLPFC] and primary motor cortex [M1]) as compared to sham treatment is associated with changes in sleep structure in fibromyalgia. Methods: Thirty-two patients were randomized to receive sham stimulation or active tDCS with the anode centered over M1 or DLPFC (2 mA, 20 minutes for five consecutive days). A blinded evaluator rated the clinical symptoms of fibromyalgia. All-night polysomnography was performed before and after five consecutive sessions of tDCS. Results: Anodal tDCS had an effect on sleep and pain that was specific to the site of stimulation: such as that M1 and DLPFC treatments induced opposite effects on sleep and pain, whereas sham stimulation induced no significant sleep or pain changes. Specifically, whereas M1 treatment increased sleep efficiency (by 11.8%, P = 0.004) and decreased arousals (by 35.0%, P = 0.001), DLPFC stimulation was associated with a decrease in sleep efficiency (by 7.5%, P = 0.02), an increase in rapid eye movement (REM) and sleep latency (by 47.7%, P = 0.0002, and 133.4%, P = 0.02, respectively). In addition, a decrease in REM latency and increase in sleep efficiency were associated with an improvement in fibromyalgia symptoms (as indexed by the Fibromyalgia Impact Questionnaire). Finally, patients with higher body mass index had the worse sleep outcome as indexed by sleep efficiency changes after M1 stimulation. Interpretation: Our findings suggest that one possible mechanism to explain the therapeutic effects of tDCS in fibromyalgia is via sleep modulation that is specific to modulation of primary M1 activity.,, [source] Short-term Impact of Tension-free Vaginal Tape Obturator Procedure on Sexual Function in Women with Stress Urinary IncontinenceTHE JOURNAL OF SEXUAL MEDICINE, Issue 4pt1 2010Hui-Hsuan Lau MD ABSTRACT Introduction., The tension-free vaginal tape obturator (TVT-O) procedure is one of the most commonly used anti-incontinence surgeries, but little is known about its impact on sexual function. Aim., To evaluate sexual function after the TVT-O procedure at 6 months postoperatively. Methods., Fifty-six sexually active women who underwent the TVT-O procedure for severe stress urinary incontinence (SUI) were evaluated using the short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) before and 6 months after surgery. The perception of incontinence-related quality-of-life were also evaluated by the short form of the Urogenital Distress Inventory (UDI-6) and the Incontinence Impact Questionnaire (IIQ-7) to assess the effect of surgery on incontinence. Main Outcome Measures., Total score and score for each PISQ-12 item. Results., The mean total PISQ-12 score did not differ significantly before (24.0 ± 12.2) and after (23.0 ± 13.2) (P = 0.194) the TVT-O procedure. Scores for individual items on the PISQ-12 varied, with incontinence-related items improving but others, such as the frequency of achieving orgasm deteriorating for some women. The scores of UDI-6 and IIQ-7 were significantly improved by 6-month follow-up, indicating that the operation successfully resolved the incontinence. Conclusion., Despite successful amelioration of SUI by the TVT-O procedure, sexual function does not necessarily improve in the first 6 months after surgery. Lau H-H, Su T-H, Su C-H, Lee M-Y, and Sun FJ. Short-term Impact of tension-free vaginal tape obturator procedure on sexual function in women with stress urinary incontinence. J Sex Med 2010;7:1578,1584. [source] ORIGINAL RESEARCH,SURGERY: Short Term Impact on Female Sexual Function of Pelvic Floor Reconstruction with the Prolift ProcedureTHE JOURNAL OF SEXUAL MEDICINE, Issue 11 2009Tsung-Hsien Su MD ABSTRACT Introduction., The Prolift system is an effective and safe procedure using mesh reinforcement for vaginal reconstruction of pelvic organ prolapse (POP), but its effect on sexual function is unclear. Aim., To evaluate the impact of transvaginal pelvic reconstruction with Prolift on female sexual function at 6 months post-operatively. Methods., Thirty-three sexually active women who underwent Prolift mesh pelvic floor reconstruction for symptomatic POP were evaluated before and 6 months after surgery. Their sexual function was assessed by using the short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) before and after surgery. The quality of life was also evaluated with the short forms of the Urogenital Distress Inventory (UDI-6) and the Incontinence Impact Questionnaire (IIQ-7) as a control for efficacy of the procedure. The Pelvic Organ Prolapse Quantification system was used to evaluate the degree of prolapse. Main Outcome Measures., PISQ-12 scores at 6 months post-operatively. Results., The total PISQ-12 score decreased from 29.5 ± 9.0 to 19.3 ± 14.7 (P < 0.001), indicating worsening of sexual function 6 months post-operatively. The behavioral, physical, and partner-related domains of PISQ-12 were each significantly reduced (5.2 ± 3.7 vs. 2.9 ± 3.7, P = 0.016; 15.4 ± 4.7 vs. 10.4 ± 8.6, P = 0.001; 8.9 ± 3.8 vs. 6.4 ± 5.5, P = 0.01, respectively). UDI-6 and IIQ-7 scores were significantly improved at the 6-month follow-up, as was anatomic recovery. Of the 33 subjects, 24 (73%) had worse sexual function 6 months after the procedure. Conclusion., The Prolift procedure provided an effective anatomic cure of POP, but it had an adverse effect on sexual function at 6 months after surgery. Su TH, Lau HH, Huang WC, Chen SS, Lin TY, Hsieh CH, and Yeh CY. Short term impact on female sexual function of pelvic floor reconstruction with the Prolift procedure. J Sex Med 2009;6:3201,3207. [source] Evaluation of the efficacy and safety of terguride in patients with fibromyalgia syndrome: Results of a twelve-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study,ARTHRITIS & RHEUMATISM, Issue 1 2010Oliver Distler Objective To assess the efficacy and safety of terguride, a partial dopamine agonist, in patients with fibromyalgia syndrome (FMS). Methods In a 12-week, multicenter, double-blind, placebo-controlled, parallel-group study, 99 patients were randomized at a ratio of 2 to 1 to receive terguride or placebo. Over 21 days, the dosage was titrated to a maximum daily dose of 3 mg of terguride or placebo, and this fixed dosage was continued over 9 weeks. The primary efficacy variable was the intensity of pain (100-mm visual analog scale). Secondary efficacy variables included the Fibromyalgia Impact Questionnaire (FIQ) score, the tender point score (TPS), and the Hamilton Depression Scale (HDS) score. During the study, patients were evaluated for the presence of cervical spine stenosis by magnetic resonance imaging (MRI). Results No significant differences in the change in pain intensity, FIQ score, TPS, or HDS score between baseline and 12 weeks were observed in the terguride group as compared with the placebo group. Cervical spine stenosis was detected in 22% of the patients. Only patients with cervical spine stenosis responded to terguride treatment. FIQ scores improved significantly (per-protocol analysis), and pain intensity, the TPS score, and the HDS score showed a trend toward improvement in the terguride group as compared with the placebo group. Terguride treatment was safe. Only those adverse events already known to be side effects of terguride were observed. Premature termination of the study in patients receiving terguride (26%) occurred predominantly during up-titration and in the absence of comedication for treatment of nausea. Conclusion Terguride treatment did not improve pain, the FIQ score, the TPS, or the HDS score in the total study population. However, a subgroup of patients with cervical spine stenosis seemed to benefit from terguride treatment. [source] Association of adrenergic receptor gene polymorphisms with different fibromyalgia syndrome domainsARTHRITIS & RHEUMATISM, Issue 7 2009Gilberto Vargas-Alarcón Objective Fibromyalgia (FM) patients have signs of relentless sympathetic hyperactivity associated with hyporeactivity to stress. Adrenergic receptors (ARs) are parts of the sympathetic nervous system that are fundamental for maintenance of homeostasis. We undertook this study to correlate ,-AR and ,-AR gene polymorphisms with the presence of FM and with different domains of the FM syndrome as measured by the Fibromyalgia Impact Questionnaire (FIQ). Methods We studied 78 Mexican FM patients and 48 age-matched controls as well as 78 Spanish FM patients and 71 controls. All subjects studied were women. Single-nucleotide polymorphisms (SNPs) of ,1A -AR (rs574584, rs1383914, rs1048101, and rs573542), ,2 -AR (rs1042713 and rs1042714), and ,3 -AR (rs4994) were analyzed by 5, exonuclease TaqMan polymerase chain reaction. Polymorphic haplotypes were constructed after linkage disequilibrium analysis. Results The ,2 -AR AC haplotype was a risk factor for the presence of FM. This haplotype had an increased frequency in Mexican patients compared with Mexican controls (42.1% versus 30.5%; P = 0.04). Similarly, 50.4% of Spanish patients had this haplotype compared with 40.0% of Spanish controls (P = 0.05). In Spanish patients, the ,1A -AR SNP rs1383914 was associated with the presence of FM (P = 0.01), and the ,1A -AR SNP rs1048101 was linked with FIQ disability (P = 0.02). Mexican patients with the rs574584 GG genotype presented the highest FIQ score compared with Mexican patients with other genotypes (P = 0.01), and in Mexicans SNP rs574584 was associated with FIQ morning stiffness (P = 0.04) and with FIQ tiredness upon awakening (P = 0.02). Conclusion AR gene polymorphisms are related to the risk of developing FM and are also linked to different domains of the FM syndrome. [source] Sodium oxybate relieves pain and improves function in fibromyalgia syndrome: A randomized, double-blind, placebo-controlled, multicenter clinical trial,ARTHRITIS & RHEUMATISM, Issue 1 2009I. Jon Russell Objective To evaluate the safety and efficacy of sodium oxybate for management of the symptoms of fibromyalgia syndrome (FMS). Methods Patients with FMS (according to the American College of Rheumatology 1990 criteria) were randomized, after discontinuing their prestudy medications for FMS, to receive 4.5 gm or 6 gm of sodium oxybate or matching placebo once per night for 8 weeks. The primary outcome variable (POV) was a composite score for changes from baseline in 3 coprimary self-report measures: patient's pain rating (in daily electronic diaries) on a visual analog scale (PVAS), the Fibromyalgia Impact Questionnaire (FIQ) score, and the Patient Global Impression of Change (PGI-C). A beneficial response rate for the POV composite score was defined as ,20% improvement in the PVAS and FIQ scores plus a rating of "much better" or "very much better" on the PGI-C. Secondary measures included subjective sleep outcomes (on the Jenkins Scale for Sleep) and quality-of-life measures. The analyses were based on an intent-to-treat (ITT) population. Results The ITT population included 188 patients with FMS, 78% of whom completed the trial. Significant benefit was observed with both dosages of sodium oxybate, according to changes in the POV and subjective sleep quality. Improvements in the PVAS score were significantly correlated with sleep outcomes. Sodium oxybate was well tolerated overall; dose-related nausea (,28% of patients) and dizziness (,18% of patients) tended to resolve with continued therapy. Conclusion Sodium oxybate therapy was well tolerated and significantly improved the symptoms of FMS. Further study of sodium oxybate as a novel therapeutic option for FMS is warranted. [source] A six-month randomized controlled trial of exercise and pyridostigmine in the treatment of fibromyalgiaARTHRITIS & RHEUMATISM, Issue 2 2008K. D. Jones Objective A subset of fibromyalgia (FM) patients have a dysfunctional hypothalamic,pituitary,insulin-like growth factor 1 (IGF-1) axis, as evidenced by low serum levels of IGF-1 and a reduced growth hormone (GH) response to physiologic stimuli. There is evidence that pyridostigmine (PYD) improves the acute response of GH to exercise in FM patients. The purpose of this study was to evaluate the clinical effectiveness of 6 months of PYD and group exercise on FM symptoms. Methods FM patients were randomized to 1 of the following 4 groups: PYD plus exercise, PYD plus diet recall but no exercise, placebo plus exercise, and placebo plus diet recall but no exercise. The primary outcome measures were the visual analog scale (VAS) score for pain, tender point count, and total myalgic score. Secondary outcome measures were the total score on the Fibromyalgia Impact Questionnaire (FIQ) and FIQ VAS scores for individual symptoms (fatigue, poor sleep, stiffness, and anxiety), as well as quality of life (QOL) and physical fitness (lower body strength/endurance, upper and lower body flexibility, balance, and time on the treadmill). Results A total of 165 FM patients completed baseline measurements; 154 (93.3%) completed the study. The combination of PYD and exercise did not improve pain scores. PYD groups showed a significant improvement in sleep and anxiety in those who completed the study and in QOL in those who complied with the therapeutic regimen as compared with the placebo groups. Compared with the nonexercise groups, the 2 exercise groups demonstrated improvement in fatigue and fitness. PYD was generally well tolerated. Conclusion Neither the combination of PYD plus supervised exercise nor either treatment alone yielded improvement in most FM symptoms. However, PYD did improve anxiety and sleep, and exercise improved fatigue and fitness. We speculate that PYD may have improved vagal tone, thus benefiting sleep and anxiety; this notion warrants further study. [source] Comparison of TVT and TVT-O in patients with stress urinary incontinence: Short-term cure rates and factors influencing the outcome.AUSTRALIAN AND NEW ZEALAND JOURNAL OF OBSTETRICS AND GYNAECOLOGY, Issue 1 2009A prospective randomised study Background: Recently, mid-urethral slings have been commonly used in treatment of patients with stress urinary incontinence (SUI). Aims: To investigate tension-free vaginal tape (TVT) and tension-free obturator tape (TVT-O) for surgical treatment of SUI for cure rates (primary endpoint), complications and factors influencing cure rate (secondary endpoints). Methods: One-hundred and sixty-four patients were included in the study (n = 81 for TVT, n = 83 for TVT-O). The cure rates, complications, preoperative and postoperative urodynamic evaluation, Q-tip test, the Turkish version of Incontinence Impact Questionnaire (IIQ-7) and Urogenital Distress Inventory (UDI-6) scores were recorded. At three and 12 months, the patients were evaluated regarding outcome measures. Results: The cure rates were similar in TVT and TVT-O groups, 88.9% versus 86.7% respectively. Mean operative time was significantly shorter in TVT-O group (P = 0.001). The cure rate was significantly higher in both groups in patients with urethral hypermobility when compared with those with no hypermobility (P = 0.001). Conclusions: The TVT and TVT-O procedures appear to be equally effective for the treatment of SUI. Also, urethral hypermobility seems to be a factor influencing cure rate of mid-urethral slings. [source] Atopic dermatitis: quality of life of young Italian children and their families and correlation with severity scorePEDIATRIC ALLERGY AND IMMUNOLOGY, Issue 3 2007Giampaolo Ricci The aim of this study was to determine the ways in which atopic dermatitis (AD) affects the lives of young Italian children and their families, in terms of quality of life, and correlate it with AD severity and the perception of severity as estimated by the family. The parents of 45 children aged 3,84 months affected by AD were asked to complete two validated questionnaires after clinical examination. The first questionnaire was about the child's quality of life (Infants' Dermatitis Quality of Life Index); the second regarded the family's quality of life (Dermatitis Family Impact questionnaire). In a further question parents were asked to estimate the severity of the disease of the child. Children's quality of life appeared slightly-moderately altered (mean score 10.2) compared with the value of a control group (3.3), and itching, sleep problems and the influence of the disease on the child's mood were the cause of greatest discomfort for the child. Family quality of life appeared moderately altered (mean score 11) compared with the value of the control group (7.4). The greatest problem was the disturbed sleep of the family members. Other important problems were the economic cost for the management of the disease and the tiredness and irritability caused by the disease in parents. Analysis of the responses confirms the incorrect estimation of the severity of the disease perceived by the family. In our opinion, the two questionnaires may be useful in clinical practice to understand better the difficulties suffered by a family with a child affected by AD. They also provide data that may help to improve the clinical approach for the child and the family, and to assess the degree of under-/overestimation of the disease by the family. [source] Validation of the short forms of the incontinence impact questionnaire (IIQ-7) and the urogenital distress inventory (UDI-6) in a Turkish population,NEUROUROLOGY AND URODYNAMICS, Issue 1 2007Cetin Cam Abstract Aim To validate the Turkish versions of the IIQ-7 and UDI-6 for use in Turkish-speaking populations. Methods After establishing the test-retest reliability and internal consistency in a pilot study, 302 patients were enrolled in the study and general and subscale scores of the questionnaires were calculated. All participants underwent an urodynamic assessment. Results Both instruments showed a high internal consistency (Cronbach's alpha for the IIQ-7 and UDI-6 was 0.87 and 0.74, respectively) and test-retest reliability (Spearman's rho was 0.99 for both of the scales (P,<,0.001). 55.6% of the participants showed urodynamic abnormality and/or leakage. 39.7% had urodynamic stress incontinence (USI) and 15.9% had detrussor overactivity (DOA),±,USI. The mean scores of each IIQ-7 and UDI-6 were significantly higher in the USI, and DOA,±,USI groups compared with normal women. Women with DOA,±,USI scored highest in the IIQ-7 and UDI-6. The irritative subscale scores of the 1st and 2nd items of the UDI-6 were significantly higher in the DOA,±,USI group. The stress subscale scores of 3rd and 4th items of UDI-6 were significantly higher in the USI group. Women with postvoid residual (PVR) urine values greater than 50 ml had significantly higher obstructive subscale scores compared to the ones who had less residual volumes. Conclusions The Turkish translated versions of the IIQ-7 and UDI-6 are reliable, consistent and valid instruments for assessing symptom severity and the impact on QOL in Turkish speaking women with urinary incontinence. Neurourol. Urodynam. © 2006 Wiley-Liss, Inc. [source] Measuring health-related quality of life in women with urogenital dysfunction: The urogenital distress inventory and incontinence impact questionnaire revisitedNEUROUROLOGY AND URODYNAMICS, Issue 2 2003C. Huub van der Vaart Abstract Aims Symptoms of urogenital dysfunction are known to negatively affect health-related quality of life in women. To assess effectiveness of treatment, it is currently recommended to include measurements of quality of life in outcome analysis. One of the questionnaires that is commonly used is the combination of the Urogenital Distress Inventory (UDI) and Incontinence Impact Questionnaire (IIQ). Unfortunately, the validity of the UDI and IIQ has only been tested in highly selected subgroups of female patients. Therefore, it is unclear whether this questionnaire is suitable for use in populations with different characteristics. Methods We analyzed the scale construction and validity of the UDI and IIQ in a random sample of 2,042 women, aged 20,70 years old and a clinical sample of 196 women. Results Our results show that the UDI can be divided into five subscales, namely discomfort/pain, urinary incontinence, overactive bladder, genital prolapse, and obstructive micturition. The internal consistency (Cronbach's alpha) ranged between 0.74 and 0.82. In addition to the original four subscales of the IIQ (mobility, physical, social, and emotional functioning), we identified a fifth subscale with four items about embarrassment. Internal consistency of these subscales ranged between 0.83 and 0.93. In addition to the internal consistency, we tested the criterion and construct validity of these new subscale division. Conclusions We found these subscales to be reliable and of clinical use. It is recommended to use the revised UDI and IIQ in outcome analysis of treatments for urogenital symptoms in women. Neurourol. Urodynam. 22:97,104, 2003. © 2003 Wiley-Liss, Inc. [source] A longitudinal study over 5 to 10 years of clinical outcomes in women with idiopathic detrusor overactivityBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 2 2008AR Morris Objective, To evaluate the long-term clinical outcome in women with idiopathic detrusor overactivity (IDO) and to identify significant prognostic factors. Design, Longitudinal study incorporating retrospective case note review and a postal questionnaire. Setting, Tertiary referral urogynaecology clinic in Australia. Population, Women with a sole urodynamic diagnosis of IDO. Methods, Audit of urodynamic records and case notes. Postal questionnaire incorporating validated disease-specific quality-of-life (QoL) instruments. Main outcome measure, Subjective assessment of overall improvement on a 4-point scale followed by scoring of short forms of the urogenital distress inventory and incontinence impact questionnaire. Results, One hundred and thirty two women were identified following examination of 1975 consecutive records with 76 (67%) returning questionnaires. Median follow up was 8 years (6,9), and the duration of symptoms was 13 years (9,18). Improvement was achieved in 25 (35%) women. Disease symptoms fluctuated in severity and QoL were worse in nonresponders to therapy (P < 0.0001). Urge incontinence at presentation was associated with treatment failure (P= 0.001) as was nocturia (P= 0.04), but urodynamic variables were not associated with outcome. Only 3 of 46 (6.5%) women not responding to therapy thought that their symptoms would improve with time. Conclusions, IDO seldom resolves and fluctuates in severity. Individual response is unpredictable, although the presence of urge incontinence is associated with a significantly worse prognosis. [source] Long-term outcome of tension-free vaginal tape for treating stress incontinence in women with neuropathic bladdersBJU INTERNATIONAL, Issue 6 2010Ahmad Abdul-Rahman Study Type , Therapy (case series) Level of Evidence 4 OBJECTIVE To evaluate the long-term safety and efficacy of the tension-free vaginal tape (TVT) for the treatment of stress urinary incontinence (SUI) in women with neuropathic bladder dysfunction. PATIENTS AND METHODS Twelve women (mean age 53.3 years, range 41,80) with neuropathic bladder dysfunction and SUI confirmed by video-cystometrography (VCMG) were treated with a TVT in one institution by an expert neuro-urologist between November 1997 and December 2000. The patient's notes, clinical annual follow-up and VCMG after the procedure, and the incontinence impact questionnaire (IIQ) forms (Urinary Distress Inventory, and IIQ-7) were assessed during the long-term clinical follow-up for SUI, in addition to a health-related quality of life assessment. The cure of SUI was defined as no loss of urine on physical exercise, confirmed VCMG after the procedure, and by clinical assessment. RESULTS The mean (range) follow-up was 10 (8.5,12) years. Nine patients were using clean intermittent self-catheterization before the insertion of TVT and continued to do so afterward. At 10 years of follow-up, one patient had died (with failed TVT initially), and two were lost to follow-up at 5 years after surgery, but up to 5 years they did not complain of UI and VCMG did not show SUI. The remaining seven of the nine patients were completely dry, and two improved and were satisfied with using one or two pads/day. Two patients showed neurogenic detrusor overactivity confirmed on VCMG, with no evidence of SUI. One patient needed a transient urethral catheter for urinary retention after surgery, one had a bladder injury that required leaving the catheter for 5 days, but no urethral erosions were reported during the follow-up. CONCLUSIONS In women with neuropathic bladder dysfunction secondary to a variety of spinal cord pathologies, and who have SUI necessitating a definitive intervention, insertion of TVT should be considered a desirable treatment, with very good long-term outcomes. [source] | ||||||||||||||||||||||