Innovations in pharmacovigilance studies of medicines in older people.

Pharmacovigilance is defined by the World Health Organization as "the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem". Pharmacovigilance studies are critical for detecting and assessing adverse events of medicines that may not have been observed in clinical trials. This activity is especially important in older people who are often excluded from clinical trials as they have multiple chronic conditions and use multiple medicines for longer durations than the clinical trials. In this narrative review we describe innovative methods in pharmacovigilance studies of medicines in older people that leverage the increasing availability of digital health technologies, electronic health records and real-world health data to identify and quantify medication related harms in older people.

Consumers' knowledge and experiences of adverse drug reaction reporting in Australia: a national survey.

This study aimed to investigate the current knowledge and experiences of consumers in Australia on adverse drug reaction (ADR) reporting and their reasons for reporting or not reporting ADRs, with a focus on the use of digital tools for ADR reporting. METHODS: A cross-sectional online survey was conducted among adults who had taken medicine in Australia. A structured questionnaire with multiple choice or Likert scale responses with an option for participants to provide free-text responses and pretested for face validity was used. Consumer characteristics, knowledge, and ADR reporting practices were analyzed using descriptive statistics and the chi-square test or Fisher's exact test. RESULTS: A total of 544 survey responses were included in the analysis. The majority of respondents were women (68%), and 22% were aged between 65 and 74 years. Fifty-eight percent (n = 317) of respondents knew that they could report ADRs to either the Therapeutic Goods Administration (TGA), state or territory government health department, or healthcare professionals. Three-quarters (n = 405) of respondents stated that they had experienced an ADR; of these, 36% reported an ADR to either the TGA, state or territory government health department, or healthcare professionals. Among those who reported ADRs, 58% were unaware that they could use digital tools to report ADRs. The main reason for not reporting was that they did not think the ADR was serious enough to report (39%). CONCLUSION: Over half of consumers knew that they could report ADR; however, improved consumer awareness about using digital tools for ADR reporting and increased ADR reporting is needed.

Non-invasive parameters of autonomic function using beat-to-beat cardiovascular variations and arterial stiffness in hypertensive individuals: a systematic review.

PURPOSE: Non-invasive, beat-to-beat variations in physiological indices provide an opportunity for more accessible assessment of autonomic dysfunction. The potential association between the changes in these parameters and arterial stiffness in hypertension remains poorly understood. This systematic review aims to investigate the association between non-invasive indicators of autonomic function based on beat-to-beat cardiovascular signals with arterial stiffness in individuals with hypertension. METHODS: Four electronic databases were searched from inception to June 2022. Studies that investigated non-invasive parameters of arterial stiffness and autonomic function using beat-to-beat cardiovascular signals over a period of > 5min were included. Study quality was assessed using the STROBE criteria. Two authors screened the titles, abstracts, and full texts independently. RESULTS: Nineteen studies met the inclusion criteria. A comprehensive overview of experimental design for assessing autonomic function in terms of baroreflex sensitivity and beat-to-beat cardiovascular variabilities, as well as arterial stiffness, was presented. Alterations in non-invasive indicators of autonomic function, which included baroreflex sensitivity, beat-to-beat cardiovascular variabilities and hemodynamic changes in response to autonomic challenges, as well as arterial stiffness, were identified in individuals with hypertension. A mixed result was found in terms of the association between non-invasive quantitative autonomic indices and arterial stiffness in hypertensive individuals. Nine out of 12 studies which quantified baroreflex sensitivity revealed a significant association with arterial stiffness parameters. Three studies estimated beat-to-beat heart rate variability and only one study reported a significant relationship with arterial stiffness indices. Three out of five studies which studied beat-to-beat blood pressure variability showed a significant association with arterial structural changes. One study revealed that hemodynamic changes in response to autonomic challenges were significantly correlated with arterial stiffness parameters. CONCLUSIONS: The current review demonstrated alteration in autonomic function, which encompasses both the sympathetic and parasympathetic modulation of sinus node function and vasomotor tone (derived from beat-to-beat cardiovascular signals) in hypertension, and a significant association between some of these parameters with arterial stiffness. By employing non-invasive measurements to monitor changes in autonomic function and arterial remodeling in individuals with hypertension, we would be able to enhance our ability to identify individuals at high risk of cardiovascular disease. Understanding the intricate relationships among these cardiovascular variability measures and arterial stiffness could contribute toward better individualized treatment for hypertension in the future. SYSTEMATIC REVIEW REGISTRATION: PROSPERO ID: CRD42022336703. Date of registration: 12/06/2022.

What is impacting clinical pharmacists' participation in an interprofessional ward round: a thematic analysis of a national survey.

The ward round (WR) is an important opportunity for interprofessional interaction and communication enabling optimal patient care. Pharmacists' participation in the interprofessional WR can reduce adverse drug events and improve medication appropriateness and communication. WR participation by clinical pharmacists in Australia is currently limited. This study aims to explore what is impacting clinical pharmacists' participation in WRs in Australian hospitals. A self-administered, anonymous national survey of Australian clinical pharmacists was conducted. This study describes the outcomes from qualitative questions which were analyzed thematically in NVivo-2020 according to Braun and Clarke's techniques. Five themes were constructed: "Clinical pharmacy service structure", "Ward round structure", "Pharmacist's capabilities", "Culture" and "Value". A culture supportive of pharmacist's contribution with a consistent WR structure and flexible delivery of clinical pharmacy services enabled pharmacists' participation in WR. Being physically "absent" from the WR due to workload, workflow, and self-perception of the need for extensive clinical knowledge can limit opportunities for pharmacists to proactively contribute to medicines decision-making with physicians to improve patient care outcomes. Bidirectional communication between the interprofessional team and the pharmacist, where there is a co-construction of each individual's role in the WR facilitates consistent and inter-dependent collaborations for effective medication management.

Association between mental illness and blood pressure variability: a systematic review.

BACKGROUND: Mental illness represents a major global burden of disease worldwide. It has been hypothesised that individuals with mental illness have greater blood pressure fluctuations that lead to increased cardiovascular risk and target organ damage. This systematic review aims to (i) investigate the association between mental illness and blood pressure variability (BPV) and (ii) describe methods of BPV measurements and analysis which may affect pattern and degree of variability. METHODS: Four electronic databases were searched from inception until 2020. The quality assessment was performed using STROBE criteria. Studies were included if they investigated BPV (including either frequency or time domain analysis) in individuals with mental illness (particularly anxiety/generalised anxiety disorder, depression/major depressive disorder, panic disorder and hostility) and without hypertension. Two authors independently screened titles, abstracts and full texts. A third author resolved any disagreements. RESULTS: Twelve studies met the inclusion criteria. Three studies measured short-term BPV, two measured long-term BPV and seven measured ultra-short-term BPV. All studies related to short-term BPV using ambulatory and home blood pressure monitoring found a higher BPV in individuals with depression or panic disorder. The two studies measuring long-term BPV were limited to the older population and found mixed results. Mental illness is significantly associated with an increased BPV in younger and middle-aged adults. All studies of ultra-short-term BPV using standard cardiac autonomic assessment; non-invasive continuous finger blood pressure and heart rate signals found significant association between BPV and mental illness. A mixed result related to degree of tilt during tilt assessment and between controlled and spontaneous breathing were observed in patients with psychological state. CONCLUSIONS: Current review found that people with mental illness is significantly associated with an increased BPV regardless of age. Since mental illness can contribute to the deterioration of autonomic function (HRV, BPV), early therapeutic intervention in mental illness may prevent diseases associated with autonomic dysregulation and reduce the likelihood of negative cardiac outcomes. Therefore, these findings may have important implications for patients' future physical health and well-being, highlighting the need for comprehensive cardiovascular risk reduction.

Psychological status and physical performance are independently associated with autonomic function.

BACKGROUND: Falls among older adults have become a global concern. While previous studies have established associations between autonomic function indicator; heart rate variability (HRV) and blood pressure variability (BPV) with fall recurrence, as well as physical inactivity and psychological disorders as risk factors for falls, the influence of physical activity and psychological status on autonomic dysfunction observed among older fallers has not been adequately investigated. The aim of this study was to evaluate the relationship between psychological disorder and physical performance on the autonomic nervous system (ANS) in older fallers. We hypothesised that older fallers have poorer autonomic function, greater dependency on others and were associated with psychological disorders. Furthermore, we hypothesised that both physical performance and psychological status can contribute to the worsening of the autonomic function among the elderly. METHODS: In this cross-sectional survey, adults aged ≥ 60 years were recruited. Continuous non-invasive BP was monitored over 5 min of supine and 3 min of standing. Psychological status was assessed in terms of depression, anxiety, stress, and concern about falling, while functional status was measured using time-up-and-go, functional reach, handgrip and Lawton's Instrumental Activities of Daily Life (IADL) scale. RESULTS: A total of 62 participants were recruited consisting of 37 fallers and 25 non-fallers. Multivariate analysis revealed that Lawton IADL was independently associated with systolic blood pressure variability (SBPV) and diastolic blood pressure variability (DBPV) during both supine (SBPV: r2 = 0.080, p = 0.025; DBPV: r2 = 0.064, p = 0.046) and standing (SBPV: r2 = 0.112, p = 0.008; DBPV: r2 = 0.105, p = 0.011), while anxiety score was independently associated with SBPV and DBPV during standing (SBPV: r2 = 0.112, p = 0.009; DBPV: r2 = 0.105, p = 0.011) as compared to the other parameters. CONCLUSION: Our findings suggest that fallers had poorer ANS, greater dependence in IADLs, and were more anxious. IADL dependency and anxiety were the most predictive of autonomic dysfunction, and can be used in practice to identify poor autonomic function for the prevention of falls and cardiovascular diseases among older adults.

Effect of an ongoing pharmacist service to reduce medicine-induced deterioration and adverse reactions in aged-care facilities (nursing homes): a multicentre, randomised controlled trial (the ReMInDAR trial).

OBJECTIVE: To assess the effectiveness of a pharmacist-led intervention using validated tools to reduce medicine-induced deterioration and adverse reactions. DESIGN AND SETTING: Multicenter, open-label parallel randomised controlled trial involving 39 Australian aged-care facilities. PARTICIPANTS: Residents on ≥4 medicines or ≥1 anticholinergic or sedative medicine. INTERVENTION: Pharmacist-led intervention using validated tools to detect signs and symptoms of medicine-induced deterioration which occurred every 8 weeks over 12 months. COMPARATOR: Usual care (Residential Medication Management Review) provided by accredited pharmacists. OUTCOMES: Primary outcome was change in Frailty Index at 12 months. Secondary outcomes included changes in cognition, 24-hour movement behaviour by accelerometry, grip strength, weight, adverse events and quality of life. RESULTS: 248 persons (median age 87 years) completed the study; 120 in the interventionand, 128 in control arms. In total 575 pharmacist, sessions were undertaken in the intervention arm. There was no statistically significant difference for change in frailty between groups (mean difference: 0.009, 95% CI: -0.028, 0.009, P = 0.320). A significant difference for cognition was observed, with a mean difference of 1.36 point change at 12 months (95% CI: 0.01, 2.72, P = 0.048). Changes in 24-hour movement behaviour, grip strength, adverse events and quality of life were not significantly different between groups. Point estimates favoured the intervention arm at 12 months for frailty, 24-hour movement behaviour and grip strength. CONCLUSIONS: The use of validated tools by pharmacists to detect signs of medicine-induced deterioration is a model of practice that requires further research, with promising results from this trial, particularly with regards to improved cognition.

Mesh use in urogynaecological procedures between 2005 and 2016: An Australian cohort study.

BACKGROUND: Pelvic organ prolapse (POP) and stress urinary incontinence (SUI) are common conditions. The use of mesh in the surgical treatment of these conditions in Australia is unclear. AIM: To examine the use of mesh in POP and SUI procedures in an Australian national cohort of older women. METHODS: We conducted a population-based cohort study using data from the Australian Government Department of Veterans' Affairs (DVA) database. The cohort consisted of older women who had POP and SUI procedures between 1 July, 2005 and 31 December, 2016. Women who received mesh were identified by matching device billing codes with the Australian Government's Prosthesis List. RESULTS: In total, 3129 women experienced 3472 hospitalisations for POP and SUI procedures, with 74% of the women aged 75 years and older. There were 2276 (66%) hospitalisations with single POP repairs, 608 (18%) with single SUI procedures and 588 (17%) with concomitant POP and SUI procedures. Mesh was used in 23% of single procedures for POP, in 89% of single procedures for SUI and in 90% of concomitant POP and SUI procedures. The use of mesh in POP procedures decreased from a peak of 33% in 2008 down to 8% by 2016, whereas the use of mesh in SUI procedures increased from 77% in 2006 to 91% by 2016. CONCLUSION: Mesh was commonly used in SUI procedures, whereas use of mesh in POP repair was less common and the use decreased rapidly after 2011, when warnings about use of mesh in POP were first issued.

Which outcome measures should be used in stress urinary incontinence trials?

OBJECTIVE: To review measures used in recent randomised controlled trials (RCTs) evaluating stress urinary incontinence (SUI) treatments and to propose the most relevant outcome measure that should be included in future trials. MATERIALS AND METHODS: We identified RCTs for SUI interventions published between January 2015 and July 2017. We listed the objective and subjective outcome measures used in eligible trials in the literature search. Using data from our RCT conducted from 2013 to 2016 evaluating pulsed magnetic stimulation for SUI, we analysed the correlation between all measures. RESULTS: A total of 45 RCTs were included; 28 (62%) involved surgical interventions. The most frequently used objective and subjective measures were the cough stress test and International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), respectively. In all, 24 different validated questionnaires were administered in the 42 studies that used subjective outcome measure. Analyses of measures used in our trial showed that all measures were significantly correlated with each other except for pelvic floor muscle function. The ICIQ-UI SF showed the highest correlation coefficients (0.587-0.733) with all outcome measures. CONCLUSION: The outcome measures used in recent trials were inconsistent. The ICIQ-UI SF had the highest correlation with all measures in our trial; however, further studies evaluating correlation of measures in other patient cohorts are needed to corroborate our present results. We propose the use of ICIQ-UI SF, as the most relevant outcome measure, in future trials evaluating efficacy of SUI interventions.

Effect of Pulsed Magnetic Stimulation on Sexual Function in Couples With Female Stress Urinary Incontinence Partners.

We prospectively evaluated the effects of pulsed magnetic stimulation (PMS) on sexual function of couples with stress urinary incontinence (SUI) partners. Female SUI subjects received 16 or 32 biweekly PMS sessions, depending on treatment response. Prior to, immediately after, and at 6-months posttreatment, couples completed the Golombok Rust Inventory of Sexual Satisfaction (GRISS) questionnaire. Fifty-three (80.3%) of 66 couples completed reassessments. Based on the overall GRISS score, there were significant improvements in sexual function in both female subjects (Mdiff -5.05, SE 1.34, p = 0.001) and their partners (Mdiff -3.42, SE 1.24, p = 0.026). Our findings suggest that PMS improved sexual function of SUI patients and their partners.

Effect of pulsed magnetic stimulation on quality of life of female patients with stress urinary incontinence: an IDEAL-D stage 2b study.

INTRODUCTION AND HYPOTHESIS: We evaluated the effects of pulsed magnetic stimulation (PMS) on overall and different aspects of quality of life (QoL) in female patients with stress urinary incontinence (SUI). METHODS: This study involved 120 female SUI subjects aged ≥21 years old randomized to either active or sham PMS. Treatment involved two PMS sessions per week for 2 months (16 sessions). After 2 months, subjects could opt for 16 additional sessions regardless of initial randomization. The primary response criterion was a 7-point reduction in the total score of the International Consultation on Incontinence Questionnaire-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) questionnaire. Follow-ups were conducted at months 1, 2, 5, 8, and 14. RESULTS: At 2 months, 35 out of 60 (58%) subjects in the active arm and 21 out of 60 (21%) in the sham arm were treatment responders (≥7-point reduction) (p = 0.006). There was a significant difference in changes in the mean ± SE ICIQ-LUTSqol total score between the active and sham arms (Mdiff = -8.74 ± 1.25 vs -4.10 ± 1.08, p = 0.006). At 1-year post-treatment, regardless of number of PMS sessions (16 or 32 sessions), subjects who received active PMS (63 out of 94, 67%) were more likely to be treatment responders compared with subjects who did not receive any active PMS (3 out of 12, 25%; p < 0.001). The impact of PMS treatment was the greatest on the "physical activities" domain. CONCLUSIONS: PMS resulted in significant short- and long-term improvements in overall and various physical, social, and psychological aspects of QoL.

Patients' perception and satisfaction with pulsed magnetic stimulation for treatment of female stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: We evaluated patients' perception and satisfaction with nonsurgical pulsed magnetic stimulation (PMS) for treatment of female stress urinary incontinence (SUI) in a randomized, double-blind, sham-controlled trial. METHODS: Women with SUI (n = 120) were randomized to either active or sham PMS for 8 weeks (twice/week). Patients answered seven questions on their perception and acceptability, each measured on a 5-point Likert scale. Treatment satisfaction was assessed using two parameters: (i) the single-item question "Overall, please rate how satisfied you are with the treatment" and (ii) Patient Global Impression of Improvement (PGI-I). All adverse events were documented. RESULTS: A total of 115 patients completed treatments (active: n = 57, sham: n = 58). There were no significant differences between groups in all parameters regarding perception and acceptability (p > 0.05). In terms of treatment satisfaction, a significantly higher proportion of patients in the active group (n = 47/57, 82.4%) were either mostly or completely satisfied compared with those in the sham group (n = 27/58, 46.6%) ((p = 0.001). Similarly, a statistically significantly higher percentage of patients in the active group (n = 39/57, 68.4%) felt much or very much better compared with patients in the sham group (n = 11/58, 19.0%) as measured using the PGI-I (p < 0.001). Three (5.3%) patients in the active group and five (8.6%) in the sham group experienced adverse events (p = 0.72). Regardless of treatment arms, 109 (94.8%) patients would not consider surgical options even if they required further treatment for their condition. CONCLUSION: PMS was well accepted, well tolerated, and resulted in a high treatment satisfaction among women with SUI.

Reducing hypnotic use in insomnia management among Australian veterans: results from repeated national interventions.

BACKGROUND: The Australian Government Department of Veterans' Affairs (DVA) Veterans' Medicines Advice and Therapeutics Education Services (Veterans' MATES) programme conducted two intervention (March 2009, follow-up intervention June 2012) both of which aimed to reduce hypnotic use among Australian veterans. We evaluated the effectiveness of the interventions, and estimated the associated health consequences. METHODS: Both interventions targeted veterans who had been dispensed hypnotics prior to the intervention. Patient-specific prescriber feedback containing patient details and the volume of hypnotics dispensed, along with tailored educational information, was mailed to general practitioners. Veterans, pharmacists and directors of care in residential aged care facilities were mailed tailored educational information. Interrupted time-series and segmented regression modelling were used to determine the effect of the two interventions on the rate of hypnotics dispensing. The cumulative patient-months of hypnotic treatment avoided as a result of the interventions was calculated. We estimated improvements in health consequences of as a result of hypnotic treatment avoided based on the results of cohort studies in the same population identifying the association between hypnotic and sedative use on the outcomes of falls, and confusion. RESULTS: After the first Veterans' MATES intervention in March 2009, hypnotic use declined by 0.2% each month, when compared to the baseline level (p = 0.006). The intervention effect was attenuated after one year, and use of hypnotics was found to increase by 0.2% per month after March 2010. Following the second intervention in June 2012, there was a further significant decline in use of 0.18% each month over the 12 months of follow up (p = 0.049). The cumulative effect of both interventions resulted in 20,850 fewer patient-months of treatment with hypnotics. This cumulative reduction in hypnotic use was estimated to lead to a minimum of 1 fewer hospital admissions for acute confusion and 7 fewer hospital admissions due to falls. CONCLUSIONS: The Veterans' MATES insomnia interventions which involved multiple stakeholders were effective in reducing hypnotic use among older Australians. Repetition of key messages led to sustained practice change.

Pulsed Magnetic Stimulation for Stress Urinary Incontinence: 1-Year Followup Results.

PURPOSE: Despite significant differences in success rates between surgical and nonsurgical treatments for female stress urinary incontinence, a few cross-sectional surveys showed that most patients still prefer the latter. We evaluated the efficacy of the under studied nonsurgical treatment using pulsed magnetic stimulation for female stress urinary incontinence. MATERIALS AND METHODS: This randomized, double-blind, sham controlled study was performed in 120 female subjects at least 21 years old with stress urinary incontinence. Treatment involved pulsed magnetic stimulation for 2 sessions per week for 2 months (16 sessions). After 2 months, subjects could opt for 16 additional sessions regardless of initial randomization. The primary response criterion was a 5-point reduction in the ICIQ-UI SF (International Consultation on Incontinence Questionnaire for Urinary Incontinence-Short Form) score. Key secondary response criteria included objective and subjective cure, supplemented by other secondary criteria. Followups were performed at months 1, 2, 5, 8 and 14. RESULTS: At 2 months 45 of 60 subjects (75%) in the active arm vs 13 of 60 (21.7%) in the sham arm were treatment responders (p <0.001). After 2 months 24 subjects (40%) in the active arm and 41 (68%) in the sham arm elected additional active pulsed magnetic stimulation. At 14 months, subjects who received 32 sessions of active pulsed magnetic stimulation had the highest percentage of treatment responders (18 of 24 or 75.0%), followed by those who received 16 sessions (26 of 36 or 72.2% and 28 of 41 or 68.3%) and those who did not receive any active pulsed magnetic stimulation (4 of 19 or 21.1%) (p <0.001). CONCLUSIONS: The encouraging long-term response rates show that pulsed magnetic stimulation is an attractive nonsurgical alternative for patients who do not want to undergo surgery.

Validity, reliability, and responsiveness of the ICIQ-UI SF and ICIQ-LUTSqol in the Malaysian population.

AIMS: To enable the use of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) and ICIQ-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) in Southeast Asia, we translated and subsequently evaluated their validity (content and discriminant validity), reliability (internal consistency and test-retest reliability), and responsiveness in female patients with stress urinary incontinence. METHODS: Permission was obtained to translate the English versions into Malay and subsequently validate them, and to validate the existing Chinese versions. The translated questionnaires were taken for pilot testing. Validation was carried out for the face/content and discriminant validity. Reliability was assessed for test-retest and internal consistency using Cronbach's alpha and intraclass correlation coefficient respectively. The responsiveness was calculated via effect size and standardized response mean. RESULTS: Ten patients were recruited for the pilot testing. The English and Chinese versions had "substantial" or "almost perfect" agreement as measured by weighted Kappa. 284 participants (139 patients with stress urinary incontinence and 145 healthy volunteers) were included in the subsequent phases. The ICIQ-UI SF and ICIQ-LUTSqol had good discriminant validity. The ICIQ-UI SF had moderate internal consistency although the ICIQ-LUTSqol had good internal consistency. Both questionnaires had high test-retest reliability. Responsiveness was established with a moderate to large effect size and a standardized response mean. CONCLUSIONS: The English, Chinese, and Malay versions each proved to be valid and reliable in our Malaysian population, thereby enabling more cross-cultural research in this region. Neurourol. Neurourol. Urodynam. 36:438-442, 2017. © 2015 Wiley Periodicals, Inc.

Validity and Reliability of the Golombok Rust Inventory of Sexual Satisfaction in Couples with Incontinent Partners.

There is currently no published information on the validity and reliability of the Golombok Rust Inventory of Sexual Satisfaction in the Asian population, specifically in patients with stress urinary incontinence, which limits its use in this region. Our study aimed to evaluate the psychometric properties of this questionnaire in the Malaysian population. Ten couples were recruited for the pilot testing. The agreement between the English and Chinese or Malay versions were tested using the intraclass correlation coefficients, with results of more than 0.80 for all subscales and overall scores indicating good agreement. Sixty-six couples were included in the subsequent phase. The following data are presented in the order of English, Chinese, and Malay. Cronbach's alphas for the male total score were 0.82, 0.88, and 0.95. For the female total score, Cronbach's alphas were 0.76, 0.78, and 0.88. Intraclass correlation coefficients for the male total score were 0.93, 0.94, and 0.99, while intraclass correlation coefficients for the female total score were 0.89, 0.86, and 0.88. In conclusion, the English, Chinese, and Malay versions each proved to be valid and reliable in our Malaysian population.

Effect of Stress Urinary Incontinence on the Sexual Function of Couples and the Quality of Life of Patients.

PURPOSE: Studies of the effects of stress urinary incontinence on the sexual function of couples are scarce. We prospectively evaluated couple sexual function and the relationship between sexual function and quality of life. We also compared quality of life in females with vs without stress urinary incontinence. MATERIALS AND METHODS: Sexually active females at least 21 years old with or without stress urinary incontinence and their partners were recruited for study. To assess sexual function the couples completed GRISS (Golombok Rust Inventory of Sexual Satisfaction) and a 1-item question on overall sexual experience, "Over the past 4 weeks, how satisfied have you been with your overall sexual life?" Additionally, females completed ICIQ-LUTSqol (International Consultation on Incontinence Questionnaire-Lower Urinary Tract Symptoms Quality of Life) to assess quality of life. RESULTS: For sexual function assessment 66 of 134 couples with (49.3%) and 95 of 176 without (54.0%) stress urinary incontinence were recruited. Females with stress urinary incontinence had lower overall sexual function, lower frequency of sexual intercourse, less satisfaction (each p <0.001) and higher avoidance behavior (p = 0.026). Partners of females with stress urinary incontinence had more problems with erectile dysfunction (p = 0.027), less satisfaction (p = 0.006) and lower frequency of sexual intercourse (p = 0.001) but no difference in overall GRISS score (p = 0.093). Couples with stress urinary incontinence had poorer overall sexual experience (p <0.05). Females with stress urinary incontinence had poorer quality of life than those without stress urinary incontinence (120 of 134, response rate 89.6% vs 145 of 176, response rate 82.4%, p <0.001). Sexual function and quality of life did not significantly correlate (r = 0.001, p = 0.997). CONCLUSIONS: Stress urinary incontinence in females is negatively associated not only with female quality of life and sexual function but also with partner sexual function.

Efficacy of electromagnetic therapy for urinary incontinence: A systematic review.

AIMS: To review whether patients with urinary incontinence (UI) treated with magnetic stimulation (MS) have a higher continence rate compared to sham. METHODS: Computerized search of electronic databases was performed using the keywords magnetic stimulation therapy and urinary incontinence. Inclusion criteria were randomized, blinded and sham-controlled. RESULTS: Eight studies involving 494 patients were included (285 patients received active MS and 209 patients received sham MS). Sample size ranged from 20 to 151 participants. Three studies were on stress UI, two studies on urgency UI, two studies on mixed UI and one study on overactive bladder. The primary outcome (cure) was not reported since only one study reported this outcome. Meta-analysis of the secondary outcome (improvement) showed patients who received active treatment were 2.3 times more likely to experience improved continence compared to sham treatment (95% confidence interval: 1.60-3.29; P < 0.001), but was subject to bias due to varying inclusion criteria, poor reporting and variable time points. There were conflicting results in the treatment effect on quality of life (QOL). Twenty out of 494 patients (5%) experienced mild side effects. The longest follow up period was six months. CONCLUSIONS: There is no firm evidence to support the benefits of using MS in the management of UI, although short-term outcomes suggests that MS improves UI symptoms in women. The applicability of MS as a treatment option for UI remains uncertain until larger, high-quality trials with longer follow-up periods using comparable and relevant outcomes are conducted.