Responsiveness of the Golombok Rust Inventory of Sexual Satisfaction in couples with incontinent partners.

OBJECTIVE: In order for a measure to reliably evaluate treatment efficacy, it is important that the measure used has adequate responsiveness. However, the responsiveness of the Golombok Rust Inventory of Sexual Satisfaction (GRISS) questionnaire, a highly recommended questionnaire by the International Consultation of Incontinence to assess sexual function in patients with incontinence, has not been established. To enable the use of GRISS to measure change in sexual function following incontinence treatment, we evaluated the short- and long-term responsiveness of the GRISS in couples with female stress urinary incontinence partners. STUDY DESIGN: Forty-eight couples with female stress urinary incontinence partners were included in the study. The GRISS, a 28-item multidimensional measure, comprises two sets of questionnaires to assess sexual function in both male and female partners. Responsiveness was investigated using data from our recent randomized controlled trials evaluating efficacy of pulsed magnetic stimulation for treatment of female patients with stress urinary incontinence. Effect size index and standardized response mean were used to measure responsiveness of the English and Chinese versions of GRISS. RESULTS: For short-term responsiveness, the overall female and male GRISS scores had effect sizes and standardized response means ranging from 0.60 to 0.83 and 0.44 to 0.78 respectively. For long-term responsiveness, the overall female and male GRISS scores had effect sizes and standardized response means ranging from 0.59 to 0.77 and 0.48 to 0.79 respectively. CONCLUSION: In conclusion, the English and Chinese versions of GRISS had adequate responsiveness for use in couples with incontinent partners. The GRISS can be a useful measure to detect change in sexual function of couples following treatment of females with stress urinary incontinence.

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 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.

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.

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.

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.

Magnetic stimulation for stress urinary incontinence: study protocol for a randomized controlled trial.

BACKGROUND: There is currently a lack of randomized, sham-controlled trials that are adequately powered, using validated outcomes, to allow for firm recommendations on the use of magnetic stimulation for stress urinary incontinence. We report a protocol of a multicenter, randomized, double-blind, sham-controlled parallel-group trial to evaluate the efficacy of magnetic stimulation for stress urinary incontinence. METHODS/DESIGN: One hundred twenty subjects with stress urinary incontinence will be randomized in a 1:1 allocation to either active or sham magnetic stimulation using computer-generated, permuted blocks of variable sizes. Subjects will receive 2 sessions of magnetic stimulation per week for 8 weeks (16 sessions total). The primary outcome is the improvement in severity of involuntary urine loss based on the International Consultation on Incontinence Questionnaire for Urinary Incontinence Short Form at the end of treatment sessions compared with baseline. Secondary outcomes include cure, stress urinary incontinence-related symptoms (incontinence episode frequency, urine loss in 1-hour pad test, pelvic floor muscle strength) and health-related quality of life (Patient Global Impression of Improvement, International Consultation on Incontinence Questionnaire-Lower Urinary Tract Symptoms Quality of Life and EQ-5D). The safety of magnetic stimulation will also be assessed. Besides evaluation of clinical treatment effectiveness, cost-effectiveness analysis using patient-reported outcomes will be performed. DISCUSSION: This trial is designed to provide pending outcome information on this non-invasive treatment option. We intend to acknowledge the existing flaws in previous clinical trials and determine conclusively whether magnetic stimulation is effective for stress urinary incontinence. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01924728. Date of Registration: 14 August 2013.

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.

Acupuncture and immune function in chronic prostatitis/chronic pelvic pain syndrome: a randomized, controlled study.

OBJECTIVE: The immune system has been implicated as one mechanism underlying the benefits of acupuncture therapy. Evidence suggests that acupuncture can ameliorate symptoms of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), but the association between clinical response and the immune system has not been investigated. DESIGN/SETTING: We investigated 12 CP/CPPS patients participating in a prospective randomized clinical trial comparing acupuncture versus sham acupuncture for effects on cellular immunity. Blood samples were taken before the first needling and after the last of 20 treatment sessions (week 10). Patients also completed questionnaires examining their CP/CPPS symptoms and mood status at the baseline and end of study visits. RESULTS: At the end of study 8 of 12 participants (67%) were classified as treatment responders, four participants each from the acupuncture and sham groups. The acupuncture group averaged a 5% increase in natural killer cell levels compared to corresponding sham (-13%; p=0.03). Similarly, patients randomized to acupuncture reported a reduction in other white blood cell parameters examined, supporting the possibility that immunity might be important in the pathophysiology of CP/CPPS. CONCLUSIONS: The specific effect of acupuncture on CP/CPPS remains unclear. Further research is warranted to examine the mechanisms by which acupuncture therapy may improve clinical symptoms in patients with CP/CPPS. TRIAL REGISTRATION: ClinicalTrials.gov number, NCT00260637).

Validation of a sham acupuncture procedure in a randomised, controlled clinical trial of chronic pelvic pain treatment.

BACKGROUND: Acupuncture is an attractive treatment option for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) that has proved refractory to conventional medical treatments. Unfortunately, it is difficult to determine the benefit of acupuncture because few studies have employed controls or had physiological outcome measures. OBJECTIVE: To determine the feasibility of a sham, or minimally invasive, acupuncture as a control for studies evaluating the efficacy of acupuncture treatment for chronic pelvic pain. METHODS: Participants were recruited from a double-blind randomised trial comparing acupuncture with a sham procedure for patients with CP/CPPS. Acupuncture or sham procedures were performed over a 10-week period. Sham acupuncture involved placement of short needles at sites 0.5 cm away from true acupuncture points (CV1, CV4, SP6 and SP9). Participants were asked to determine their procedure allocation at the end of treatment. A total of 35 participants also agreed to have blood analyses for cortisol, ß-endorphin and leucine-enkephalin. RESULTS: Thirty-five (78%) of the 45 participants randomised to the sham treatment thought they had received acupuncture compared with 27 (61%) of the 44 participants randomised to acupuncture (p=0.11). Biochemical data showed no differences between the groups immediately after treatment. Thirty-two (73%) of 44 acupuncture participants met the predefined clinical response criterion compared with 21 (47%) of 45 sham acupuncture participants (p=0.017, relative risk 1.81, 95% CI 1.3 to 3.1). At the end of the study, ß-endorphin and leucine-enkephalin levels were both higher in the acupuncture group (p<0.01). CONCLUSIONS: Minimally penetrating acupuncture was found to be a valid sham control and may prove useful for evaluating the efficacy of acupuncture for other conditions.

Acupuncture versus sham acupuncture for chronic prostatitis/chronic pelvic pain.

BACKGROUND: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) afflicts 2%-10% of adult men. Available therapies offer little or no proven benefit. Because acupuncture represents an attractive "natural" therapy, we compared the efficacy of acupuncture to sham acupuncture for CP/CPPS. METHODS: Participants met US National Institutes of Health (NIH) consensus criteria for CP/CPPS, were aged > or = 20 years old, and had a total score > or = 15 on the NIH Chronic Prostatitis Symptom Index (NIH-CPSI) and symptoms for at least 3 of the preceding 6 months. They were randomized 1:1 to acupuncture or sham acupuncture. Treatment consisted of twice-weekly 30-minute sessions for 10 weeks (20 sessions total) without needle stimulation, herbs, or adjuvants. The primary response criterion was a 6-point decrease from baseline to week 10 in NIH-CPSI total score (range 0-43). RESULTS: Thirty-two (73%) of 44 participants responded in the acupuncture group compared with 21 (47%) of 45 sham group participants (relative risk 1.81, 95% confidence interval, 1.3-3.1, P = .02). Long-term responses 24 weeks after completing therapy without additional treatment occurred in 14 (32%) of 44 acupuncture group participants and in 6 (13%) of 45 sham group participants (relative risk 2.39, 95% confidence interval, 1.0-5.6, P = .04). CONCLUSIONS: After 10 weeks of treatment, acupuncture proved almost twice as likely as sham treatment to improve CP/CPPS symptoms. Participants receiving acupuncture were 2.4-fold more likely to experience long-term benefit than were participants receiving sham acupuncture.