The effect of pelvic floor muscle training in men with benign prostatic hyperplasia and overactive bladder.

BACKGROUND: Men with overactive bladder (OAB) and benign prostatic hyperplasia (BPH), will have deterioration in the quality of life. OBJECTIVE: The aim of this study was to evaluate the effect of combining pelvic floor muscle training with the urgency suppression technique (PFMT-st) and silodosin in comparison with silodosin in men with benign prostatic hyperplasia (BPH) and overactive bladder (OAB) after 12 weeks of treatment. PATIENTS AND METHODS: A total of 158 patients were randomized into two groups. The control group received oral silodosin at a daily dose of 8 mg. The experimental group was administered PFMT-st and silodosin. The evaluation methods included the number of voids and intensity of urgencies over 24 h using a micturition diary, the International Prostate Symptom Score (IPSS), the Overactive Bladder Questionnaire (OAB-q), and the patient global impression of improvement (PGI-I). RESULTS: 142 of 172 (86.6%) men were assessed (70 in the control group, 72 in the experimental group). The significant changes were in favor of the experimental group (p < 0.001) in the number of voids per 24 h (- 1.95 ± 1.94 vs. - 0.90 ± 1.44), the OAB-q symptom score (- 14.25 ± 10.05 vs. - 9.28 ± 10.60), the intensity of urgencies (- 0.97 ± 0.53 vs. 0.24 ± 0.57), the IPSS (- 4.59 ± 3.00 vs. - 2.30 ± 3.63), and in the PGI-I (2.24 ± 0.79 vs. 3.60 ± 0.92). CONCLUSIONS: The addition of PFMT-st to silodosin treatment significantly improved OAB in men with BPH. This is the first study to confirm that PFMT-st should be the first-choice treatment for OAB in BPH.

Prevalence of diastasis m. rectus abdominis and pelvic floor muscle dysfunction in postpartum women.

OBJECTIVE: The aim of this study was to determine the prevalence of Diastasis of the rectus abdominis muscles (DRAM) and pelvic floor muscle dysfunction (PFMD) in postpartum women. Design: The observational prospective study. MATERIAL: 150 of 180 women (83.3 %) from 6 weeks to 6 months postpartum, with a mean age of 33.1 years. METHODS: For diastasis examination, inter recti distance (IRD) was measured by a linear 2D ultrasound probe, 4.5 cm above the navel, in its area and 4.5 cm below the navel when lying on the back at rest and under a load test. The degree of DRAM was classified into four grades. Urinary leakage symptoms were assessed by the International Incontinence Consultation Questionnaire (ICIQ - UI SF). RESULTS: The first degree of diastasis during the load test was 38.1 % above the navel, 36.4 % in the navel area, and 23.7 % below the navel. The second degree of diastasis with load was 28.8 % above the navel, 21.2 % in the navel area, and 10.2 % below the navel. PFMD showed 31.3 % of women with mild symptoms of SUI, 32.2 % of women with grade 1 cystocele. CONCLUSION: The average IRD distance at rest and during the load test confirmed the first grade of DRAM out of four degrees of severity. Moderate and medium DRAM occurred according to location in an average of one-third of the cases. The highest percentage of DRAM was above the navel, and the lowest percentage below the navel. PFMD was detected in an average of one-third of cases. It is important to monitor these parameters with a view to improving the quality of life index in the future (Tab. 5, Ref. 22).

A randomised interventional parallel study to evaluate the effect of different frequencies of pelvic floor muscle exercises with core stabilisation using three-dimensional ultrasound: the PELSTAB study.

INTRODUCTION AND HYPOTHESIS: The primary objective was to compare high- and low-frequency pelvic floor muscle training (PFMT) with the impact on urinary incontinence episode frequency over 1 week (IEF/week). The secondary objective was to compare the two groups with regard to pelvic floor muscle function, morphometry, incontinence quality of life, and patient global impression. METHODS: This was a randomised parallel controlled study. The setting was regional gynaecological and urological outpatient clinics. The subjects consisted of a sample of 86 women with stress urinary incontinence (SUI). Group A underwent high-frequency PFMT and group B underwent low-frequency PFMT for 12 weeks. We recorded the IEF/week. The International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) was used. Pelvic floor muscle function was evaluated using a perineometer. Pelvic floor muscle morphometry was evaluated with 3D/4D ultrasound. The Urinary Incontinence Quality of Life Scale (I-QoL) was used. RESULTS: Significant differences between group A and B after treatment (p<0.001) were noted in favour of group A in IEF/week (group A 10.2±7.0/2.3±3.0 vs group B 9.3±4.7/6.3±4.9), in the ICIQ-UI SF (group A 9.7±3.0/3.7 ± 3.6 vs group B 9.9±3.2/9.4±3.4). Significant differences between groups A and B after treatment were noted in favour of group A for pelvic floor muscle function in terms of maximal voluntary contraction and its duration, and also for pelvic floor muscle morphometry in terms of a reduction of the hiatal area during rest, contraction, and the Valsalva manoeuvre. CONCLUSIONS: High-frequency PFMT for 12 weeks significantly decreased IEF/week in comparison with low-frequency PFMT. In the high-frequency exercise group, women had significantly better pelvic floor muscle function, morphometry and quality of life than the low-frequency exercise group.

Comparative Risk Analysis of Low Back Pain among Professional Football, Ice Hockey, and Floorball Athletes.

BACKGROUND Low back pain (LBP) is a common concern among professional athletes, potentially hindering performance and career longevity. However, comparative assessments of LBP prevalence and severity across various sports remain scarce. This study aimed to evaluate the factors associated with LBP in 388 professional athletes, including football, ice hockey, and floorball players. MATERIAL AND METHODS Conducted from June 2021 to September 2022, this cross-sectional study incorporated 388 athletes from national elite clubs, including football (n=148), ice hockey (n=179), and floorball (n=61). The Oswestry Disability Index (ODI), comprising sections like pain intensity, self-care, lifting, walking, sitting, standing, sleeping, sexual life, social life, and traveling, was employed to evaluate spinal pain and disability. RESULTS The study found no significant disparities in the LBP assessment among the groups. The relative risk (OR) of LBP and disability varied among the sports: football players displayed a lower risk (OR=0.49; 95% CI 0.32-0.74, P≤0.001), while ice hockey players had a higher risk (OR=2.18; 95% CI 1.45-3.29, P≤0.001) compared to the others. In contrast, the risk for floorball players (OR=0.82; 95% CI 0.47-1.41) did not significantly deviate from that of the other two sports. CONCLUSIONS LBP prevalence stood at 42.6% for football players, 60.1% for ice hockey players, and 49.2% for floorball players. Among these, ice hockey players exhibited a 2.18-fold increased risk of developing LBP and associated disability when compared to their football and floorball counterparts.

Pelvic floor muscle training, the risk of falls and urgency urinary incontinence in older women.

PURPOSE: The primary aim of the work was to evaluate the effect of physical training and pelvic floor muscle training combined with dual tasks (PFMT-DT) in older women on urgency urinary incontinence (UUI). The secondary aim of the work was to evaluate the impact of interventions on static and dynamic balance, risk of falls and fear of falls. SAMPLE: The research sample consisted of 88 older women with UUI, with a mean age of 75 ± 4.3 years. They were randomly divided into two groups: the experimental (n = 40) and control (n = 40) groups. METHODS: The duration of the intervention was 12 weeks. Both groups underwent physical training three times a week for 30 minutes. In addition, the experimental group received pelvic floor muscle training in different positions and with dual cognitive tasks two times a week for 30 minutes. We used The International Consultation on Incontinence Questionnaire (ICIQ-UI SF), the modified Voiding Diary, and the Overactive Bladder Questionnaire(OAB-q). The risk of falls were assessed according to Tinetti's Performance Oriented Mobility Assessment. Fear of falls was assessed by the Falls Efficacy Scale. RESULTS: After the treatment, significant differences between groups were recorded in favor of the experimental group in the daytime frequency of voiding (7.6 to 5.3), in nycturia (2.1 to 0.7), in UUI (1.8 to 1.0), OAB-q SS (40.8 to 17.6) and OAB-q HR (61.2 to 83.8) (p ≤ 0.001), with large effect size (ES), as well as in the Tinetti balance and gait and in the fall risk assessment (19.2 to 23.2) (p ≤ 0.001), also with a large ES. For fear of falls, significant differences were noted (80.0 to 71.5) (p ≤ 0.05), with a small ES in favor of the experimental group. CONCLUSION: The PFMT-DT proved to be an effective intervention in improving the symptoms of OAB and UUI. We were able to significantly reduce the risk of falls according to POMA by about 21% (19.2 ± 2.7 to 23.20 ± 3.25%) in older women with UUI.

A randomized, intervention parallel multicentre study to evaluate duloxetine and innovative pelvic floor muscle training in women with uncomplicated stress urinary incontinence-the DULOXING study.

INTRODUCTION AND HYPOTHESIS: The aim of our study was to evaluate the effect of a combination of innovative pelvic floor muscle training (iPFMT) and duloxetine compared with the use of duloxetine alone on women with stress urinary incontinence (SUI) after 12 weeks of treatment. METHODS: We conducted a parallel multicentre study with randomized intervention in 45 national urological outpatient clinics. Patients with an enrolment ratio of 1:1 were divided into the experimental and control groups. The following were used for evaluation: incontinence episode frequency (IEF)/week, the International Consultation on Incontinence Questionnaire (ICIQ-SF), the Urinary Incontinence Quality of Life Scale (I-QoL) and the Patient Global Impression of Improvement (PGI-I). The experimental group received oral treatment with duloxetine (a daily dose of 40 mg BID) and innovative pelvic floor muscle training (iPFMT). The control group received only oral treatment with duloxetine at a daily dose of 40 mg BID. RESULTS: The number of women who were evaluated was 158. The control group comprised 79 women with an average age of 56.8 ± 13.8 years and the experimental group comprised 79 women with an average age of 53.4 ± 11.9 years. There were no significant differences in pre-treatment parameters. For the intent-to-treat analysis after 12 weeks' treatment, significant differences were observed between the experimental vs. control group (p < 0.001) for the following variables: IEF/week decrease (66.7% vs. 50.0%); ICIQ-UI SF decrease (8.3 ± 3.8 vs. 9.7 ± 4.2); PGI-I (70.8% vs. 65.6%); I-QoL score increase (19.3% vs. 6.6%). CONCLUSION: The addition of iPFMT to duloxetine treatment improves SUI syndrome in women compared with duloxetine treatment alone. REGISTRATION: Clinical Trials.gov NCT04140253.

Effect of an exercise programme for reducing abdominal fat on overactive bladder symptoms in young overweight women.

INTRODUCTION AND HYPOTHESIS: The effect of exercise in relation to overweight and overactive bladder (OAB) in young women has not been sufficiently supported by studies. The objective of our study was to reduce symptoms of OAB through a 3-month exercise programme in young overweight women with OAB. The sample consisted of 70 women (mean age 26.7 ± 4.8 years), 36 being treated and 34 in the control group. METHODS: We used a body composition analyser with the assessment of skeletal muscle mass (SMM) (kg), body fat mass (BFM) (kg), body fat percentage (BFP) (%), visceral fat area (VFA) (cm²/level) and the waist/hip circumference index (WHR). OAB symptoms were evaluated using a voiding diary, the overactive bladder questionnaire (OAB-q) and the Patient Perception of Intensity of Urgency Scale (PPIUS). The intervention was a programme for the reduction of abdominal fat (PRAF), with elements of aerobic training, strengthening of the abdominal muscles and stretching. RESULTS: In the OAB symptoms assessed through the voiding diary (number of voidings per 24 h, nocturia, mean voided volume) as well as in the OAB-q and PPIUS scales after training, significant differences were reported in favour of the treatment group [number of voidings per 24 h: treatment vs. control group, baseline 9.1 ± 0.3 vs. 8.6 ± 0.3, final 6.9 ± 0.2 vs. 8.1 ± 0.2, p < 0.0001; mean voided volume per 24 h (ml): treatment vs. control group, baseline 154.2 ± 9.1 vs. 162.2 ± 9.3, final 201.3 ± 9.3 vs. 164.1 ± 9.6, p < 0.0001] with a large effect size (ES). In the body composition analysis after training, significant differences were also reported in favour of the treatment group in the reduction of body mass index (BMI), BFP and VFA (p < 0.0001), with a large ES. CONCLUSIONS: Body composition analysis confirmed a reduction of BMI, body weight, body fat percentage, visceral abdominal fat, the WHR index and waist circumference in favour of the treatment group after the 12-week PRAF exercise programme. A reduction in OAB symptoms was also objectively confirmed following the PRAF exercise programme.

Prevalence and risk of sport types to stress urinary incontinence in sportswomen: A cross-sectional study.

OBJECTIVE: The objective of our study was to investigate the prevalence and risk of developing stress urinary incontinence (SUI) in each type of high-intensity sport, and the associated impact on quality of life in sportswomen. METHODS: This cross-sectional study was conducted between March and November 2016. The study included 278 sportswomen. The basic inclusion criteria were being nulliparous and engaging in high-intensity physical activity. The exclusion criteria were childbirth, surgical treatment of gynecological and urological illnesses and urinary tract infection. For evaluation were used: The International Physical Activity Questionnaire (IPAQ), The International Consultation on Incontinence Questionnaire Urinary Incontinence (ICIQ-UISF), the Overactive Bladder Questionnaire (OAB-q), the Urinary Incontinence Quality of Life Scale (I-QOL). RESULTS: The highest percentage of SUI was found in athletes (23.8%), followed by volleyball players (19.6%). We found that cumulative metabolic equivalent (MET) did not affect SUI, but the type of sport did. The risk of SUI was highest in volleyball sportswomen (odds ratio[OR] = 2.16,95% confidence interval[CI] = 0.96-4.89, P < 0.05) and athletes (OR = 2.56,95%CI = 0.87-7.51, P = 0.08). As assessed by the I- QOL, SUI in people who participated in fitness and athletics (e.g., basketball, volleyball and handball) had a negative impact on quality of life including behavior, psychosocial impacts and social embarrassment score. CONCLUSION: Volleyball players have a 116% chance of getting SUI compared to women who play other types of sports that were analyzed as part of this study. Healthcare professionals should inform the population of sportswomen with risk factors for SUI in order to implement preventive physiotherapy for strengthening pelvic floor muscles.

Prevalence of Urinary Incontinence in Females Performing High-Impact Exercises.

The aim of this cross-sectional study was to monitor the prevalence of symptoms of stress (SUI) and mixed urinary incontinence (MUI) in sportswomen performing high-impact exercises. A further objective was to compare the symptoms of urinary incontinence (UI) and quality of life in sportswomen. We used the International Consultation on Incontinence Questionnaire (ICIQ-SF), the Overactive Bladder Questionnaire (OAB-q), the Urinary Incontinence Quality of Life Scale (I-QOL) and the International Physical Activity Questionnaire (IPAQ), short version. The group consisted of 503 sportswomen with a mean age of 21.1±3.6. The response rate was 71.15%. ICIQ-SF results confirmed mild difficulties with urine leakage in 72 (14.3%) sportswomen. Urinary leakage was not noted in 431 (85.7%) sportswomen. The OAB-q and I-QOL showed a significant difference, with pronounced symptoms of UUI and worse QOL in the group of sportswomen with urine leakage (p<0.000). The I-QOL recorded significantly worse parameters in the group of sportswomen with urine leakage (p<0.000). Prevalence of SUI was found in 68 (13.52%), and MUI was found in 4 (0.80%) sportswomen. Every seventh sportswoman (14.3%) in the study group had reported problems with UI when practising high-impact sporting activities, with a negative impact on QOL.

Relationships between balance control and cognitive functions, gait speed, and activities of daily living.

PURPOSE: The purpose of this study was to examine the relationship between balance control and cognitive functions, gait speed, and activities of daily living. SAMPLE: In all, 80 elderly participants with mild cognitive impairment (mean age 67.07 ± 4.3 years) were randomly allocated into the experimental group (n = 40) or the control group (n = 40). METHODS: Balance control was evaluated by the Balance Evaluation Systems Test (BESTest). Cognitive functions were evaluated by the Trail Making Test and the Nine Hole Peg Test. Gait speed was assessed by the Up and Go test with and without dual task. For evaluation of activities of daily living (ADL), the BADLS test was used. The experimental group underwent CogniPlus 20 training sessions twice a week. Both groups had 30 min of physical training daily for 10 weeks. RESULTS: After training, there were five significant correlations found in the experimental group (balance control and visuomotor coordination, psychomotor speed, gait speed with and without cognitive tasks, and activities of daily living). In the control group, one significant correlation was found between balance control and gait speed. CONCLUSION: The cognitive-motor training performed for 10 weeks confirmed more significant relationships between balance control, cognitive functions, gait speed, and activities of daily living, when compared with motor intervention alone.

Prevalence of lower limb pain and disability in football, hockey, and floorball players.

BACKGROUND: Currently there are not enough studies that compared frequent types of collective sports with regard to the prevalence of pain and disability of the lower limb. OBJECTIVE: To determine the prevalence of lower limb pain and disability in team sports players. METHODS: 388 athletes with average age 27.26 ± 4.69, from sports clubs at the national level were included in the study. The Oxford Hip Score was used to determine the prevalence of hip pain. The International Knee Documentation Committee was used to determine the prevalence of knee pain. The Foot and Ankle Disability Index was used to determine the prevalence of ankle pain. RESULTS: Hockey players had a prevalence of hip pain of 97.2% and a 14.3 times higher risk of developing hip pain compared with football and floorball players. Floorball players had a 81.9% prevalence of knee pain, with a 3.8 times higher the risk of knee pain compared with football and hockey. Floorball players had a 62.3% prevalence of ankle pain and a 1.8 times higher the risk of developing ankle pain compared with football and hockey players. CONCLUSIONS: The highest percentage of knee 81.9% and ankle 62.3% pain, as well as the greatest risk of pain, was found among floorball players. Hockey players had the highest prevalence (97.2%) and risk of developing hip pain.

Quality of life and quality of education among physiotherapy students in Europe.

Background: The study of physiotherapy is challenging and can affect the students' well-being and quality of life. The aim of this study was to describe and compare factors that could affect well-being among students across Europe. Methods: In this descriptive cross-sectional study using an online questionnaire survey, students of bachelor's physiotherapy programs from 23 European faculties, from 8 countries, were interviewed on mental health and stress burden, sleep quality, dietary habits, and physical activity. Results: Although 75% of students rated their quality of life positively and 47% were satisfied with their mental health, 65% showed higher levels of stress and 51% described impaired sleep quality. The minimum physical activity of 150 min weekly was described by 79% of students, within which 67% engaged in strengthening twice a week. Students with a higher stress load/worse psychological health also showed worse sleep quality and lower amount of physical activity, women were significantly worse off. In terms of physical activity and sleep quality, students from Finland and Kosovo achieved the best results, while students from Italy, Greece, and Portugal achieved the worst. Students from Italy indicated the greatest dissatisfaction with the organisation of the study system and communication with teachers, while in Kosovo students rated the communication and study organisation the highest. All students had a problem with adhering to nutritional habits. Students from Italy and Spain, with the lowest body mass indexes and weight averages, were closest to the nutrition recommendations. Conclusion: We demonstrated that physiotherapy students are burdened with stress, suffer from sleep disorders, and do not follow the recommendations regarding nutrition nor physical activity. There are significant differences between universities and countries in some aspects.

Corrigendum: Quality of life and quality of education among physiotherapy students in Europe.

[This corrects the article DOI: 10.3389/fmed.2024.1344028.].

Predictive Value of Pelvic Floor Muscle Morphometry Using 3D/4D Ultrasound in Relation to the Success of Pelvic Floor Muscle Training in Women with Stress Urinary Incontinence.

The aim of our study was to establish the predictive value of pelvic floor muscle morphometry using 3D/4D ultrasound in relation to the success of pelvic floor muscle training (PFMT) for 12 weeks in women with stress urinary incontinence (SUI). A total of 86 women with SUI from regional gynaecological and urological outpatient clinics were enrolled on this cross-sectional study. SUI symptoms were assessed by the International Consultation on Incontinence Questionnaire (ICIQ-UI SF). Pelvic floor muscle function was evaluated using a perineometer. Pelvic floor muscle morphometry (PFMM) was evaluated by the size of the urogenital hiatus (HA in cm2) at rest (R), at contraction (C) and during the Valsalva manoeuvre, i.e., a strong push (V), by 3D/4D USG. The intervention was PFMT for 12 weeks. After PFMT, we noted significant improvement in SUI symptoms, pelvic floor muscle function and morphometry. Moderately significant (0.001) negative correlations were confirmed between the total ICIQ-UI SF score and strength (-0.236 **) and endurance (-0.326 **) of the maximal voluntary contraction (MvC), the number of MvC lasting 3 s (-0.406 **) and 1 s (-0.338 **). Moderately significant (0.001) positive correlations were confirmed between the total ICIQ-UI SF score and R (r = 0.453 **), C (r = 0.533 **) and V (r = 0.442 **). The predictive value of PFMM reached a positive prediction of a decrease with an ICIQ-UI SF score below 8. HA during V was most strongly associated with SUI reduction, with an area under the curve (AUC) of 0.87 (p ≤ 0.001), a positive predictive value of 83.3%, a negative predictive value of 75.0%, sensitivity of 78.9% and specificity of 80.0%. The predictive values of pelvic floor muscle morphometry using 3D/4D USG confirmed the success of PFMT in women with SUI.

Evaluation of Silodosin and Pelvic Floor Muscle Training in Men with Benign Prostatic Hyperplasia and Overactive Bladder (Silodosing) Study Protocol (Spirit Compliant).

The aim of our study will be to evaluate the effect of combining pelvic floor muscle training (PFMT) with the urgency-suppression technique and silodosin in comparison with silodosin alone in men with Benign Prostatic Hyperplasia (BPH) and Overactive Bladder (OAB) after 12 weeks of treatment. The primary outcome will be a change in the number of voidings and intensity of urgencies over 24 h using a micturition diary, and the secondary outcomes will be a change in lower urinary tract symptoms, a change in incontinence quality of life, a change in patients' global impression of improvement, and a lower incidence of adverse events. A randomized intervention parallel multicenter study will be conducted in collaboration with 45 urological clinics at the national level. Patients will be assigned at a 1:1 ratio to the experimental and control groups using simple randomization according to odd and even patient sequence numbers in each ambulatory clinic. The experimental group will receive oral silodosin at a daily dose of 8 mg once daily and pelvic floor muscle training (PFMT) 5 times a week for 20-30 min a day, for 12 weeks. The control group will receive oral treatment with silodosin at a daily dose of 8 mg once daily for 12 weeks. The study protocol presents the starting points and design of a randomized, interventional, parallel, multicenter study looking at the effect of a combination of silodosin and PFMT versus silodosin treatment in men with BPH and OAB.

Influence of sports groups on the risk of stress urinary incontinence in sportswomen.

OBJECTIVES: To evaluate sports groups on the risk of stress urinary incontinence (SUI) in sportswomen and its impact on their quality of life. STUDY DESIGN: Cross-sectional study. The group consisted of 249 sportswomen with a mean age of 22.18 ± 6.11 years. We used the International Physical Activity Questionnaire (IPAQ), the International Consultation on Incontinence Questionnaire (ICIQ-UI), the Overactive Bladder Questionnaire (OAB-q) and the Quality of Life Assessment Questionnaire Concerning Urinary Incontinence (Contilife) were used for evaluation. We divided the sports into the following six groups: 1. Functional mobilization sports (FMS); 2. Strength sports (SS); 3. Aesthetic-coordination and sensory-concentration sports (ACS); 4. Heuristic-individual and martial arts (HIS + MAS); 5. Heuristic-collective sports with a hockey stick (HCS-A); and 6. Heuristic-collective sports with a ball (HCS-B). RESULTS: The symptoms of SUI according to the ICIQ-UI SF were 1.80 ± 2.93. The estimate of the relative risk (OR) of developing SUI was most significant in the FMS group (OR = 1.96, 95% CI: 1.04-3.68; p < 0.03). Other sports groups did not pose a significant relative risk of developing SUI and had a lower incidence of SUI. In SS was OR = 0.77, in EKS, OR = 0.69, in (HIS + BS), OR = 1.26, in (HKS-A) was OR = 0.63, in (HKS-B) was OR = 1.02. There were no significant differences between the groups in the overall score of the Contilife, which assesses quality of life. CONCLUSION: The Functional mobilization sports group had a 1.96 times higher risk of SUI compared to that in other sports groups.

Impact of innovative pelvic floor muscle training on quality-adjusted life years (QALYs) in women with stress urinary incontinence treated by duloxetine.

OBJECTIVES: The aim of this study was to measure the impact of innovative pelvic floor muscle training (iPFMT) on Quality-Adjusted Life Years (QALYs) in women with stress urinary incontinence (SUI) treated by duloxetine. STUDY DESIGN: This analysis is part of the DULOXING study conducted between February 2019 and 2020. The control group received oral duloxetine treatment (40 mg BID), and the experimental group received oral duloxetine treatment (40 mg BID) and iPFMT with lumbopelvic stabilization. SUI was analysed at baseline and in the final period according to the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). The QALYs gained were calculated by multiplying life expectancy (LE) by a weighting factor (QALYs = LE * WF). RESULTS: The study included 158 women, of whom 129 were fully analysed (81.6%). The mean life expectancy was 26.3 ± 11.8 years for the control group and 29.0 ± 11.7 years for the experimental group. The mean baseline ICIQ-UI SF scores were 15.2 ± 1.7 vs 15.1 ± 1.5, and the final ICIQ-UI SF scores were 9.8 ± 4.2 vs 8.3 ± 3.8, in the control vs the experimental group, respectively (p < 0.05). The mean baseline WF was 0.27 ± 0.08 vs 0.28 ± 0.07, and the final WF was 0.53 ± 0.20 vs 0.60 ± 0.18, in the control vs the experimental group, respectively (p < 0.05). Before treatment, the number of QALYs during life expectancy in the control vs the experimental group was 7.53 ± 4.24 vs 8.30 ± 4.01. The number of QALYs during life expectancy in control vs the experimental group increased following treatment: 15.03 ± 7.63 vs 17.90 ± 7.86 (p < 0.05). CONCLUSIONS: Combination treatment with duloxetine and iPFMT statistically significantly increased the number of QALYs and reduced the degree of urinary incontinence in women with stress urinary incontinence.

Evaluation of duloxetine and innovative pelvic floor muscle training in women with stress urinary incontinence (DULOXING): Study protocol clinical trial (SPIRIT Compliant).

INTRODUCTION: There is a lack of published studies about the combination of duloxetine and pelvic floor muscle training (PFMT) in women with stress urinary incontinence (SUI). The aim of our work will be to evaluate the effect of this intervention by assessing whether there is a change in the incontinence episode frequency (IEF), Incontinence Quality of Life (I-QoL), Patient Global Impression of Improvement score (PGI-I) and mean time between voids (MTBV). Combined therapy with duloxetine and PFMT will be compared to duloxetine treatment alone with respect to its efficacy and side effects. METHODS: This study will be a randomized intervention, parallel, multicenter study in collaboration with 45 urological outpatient clinics at the national level. Patients will be assigned in a 1:1 ratio to the experimental and control groups using simple randomization according to odd and even numbers assigned sequentially to the patients at each clinic. The experimental intervention will be 12 weeks. The experimental group will receive oral treatment with duloxetine at a daily dose of 2 × 40 mg and will be required to perform innovative PFMT. The control group will receive the same oral duloxetine treatment (2 × 40 mg a day) but will not perform PMFT. Data will be collected from both groups before intervention and after the 12-week intervention is completed. DISCUSSION: The study protocol presents the starting points, design and randomization of an interventional multicenter study to monitor the effect of the combination of duloxetine with innovative PFMT compared to duloxetine treatment alone in women with SUI. This study may provide evidence of the efficacy of this combined treatment for SUI and highlight benefits associated with active approaches to treatment through exercise. REGISTRATION: This study was retrospectively registered in the ClinicalTrials.go NCT04140253. Protocol version 1.0. date 11.1.2019.

A randomized interventional parallel study to evaluate the effect of pelvic floor muscle training with stabilization exercises of high and low intensity in women with stress urinary incontinence: The PELSTAB study.

INTRODUCTION: The effect of different intensities of pelvic floor muscle training (PFMT) assessed by 2D/3D ultrasound (USG) have not been sufficiently monitored in the literature. The objective of the study will be to evaluate the effect of this intervention by assessing the change in incontinence episode frequency, hiatal area (HA) and hiatal diameter by 2D/3D USG and quality of life over 12 weeks of treatment. METHODS: Using a randomized interventional parallel study, patients will be assigned to groups A and B using simple software randomization according to odd and even patient sequence numbers. The following methods will be used for evaluation: change in incontinence episode frequency, power and endurance of pelvic floor muscles assessed by perineometer (in cmH2O), HA (in cm) during contraction, Valsalva manoeuvre assessed by 3D USG, hiatal diameter assessed by 2D USG, the Incontinence Quality of Life scale (I-QoL) and the Patient Global Impression of Improvement score (PGI-I). INTERVENTIONS: Group A, high-intensity PFMT 5 times a week for 30 minutes per day. Group B, low-intensity PFMT twice a week for 15 minutes per day. The duration of the intervention will be 12 weeks. DISCUSSION: The study protocol presents the starting points, design, and methods of the PELSTAB Study. We expect that, after 12 weeks of high-intensity PFMT, women with stress urinary incontinence will have significantly less incontinence episode frequency, better reduction of HA during contraction and Valsalva manoeuvre, higher power and endurance of pelvic floor muscles and better quality of life compared to the group with low-intensity PFMT. REGISTRATION: This study was registered in the ClinicalTrials.govNCT04340323.