Vol 19 No 1 January-February 2022 138 A Prospective Study to Investigate the Effect of Fesoterodine Treatment on Quality of Life, Anxiety, and Depression in Urge-Type Urinary Incontinence Arif Aksak1, Güzin Çakmak1*, Zeynel Abidin Öztürk1 Purpose: Urinary incontinence (UI) is a fundamental health problem, can occur at any age but is especially common in older women. Depression and anxiety are also considerable problems for the elderly. UI is one of the geriatric syndromes that are thought to be related to depression and quality of life (QOL). Materials and methods: This prospective study was conducted for a period of 2 months from February 2020 to April 2020. Women who applied to the outpatient clinic of geriatrics with UI symptoms were taken into the study. The type of UI was determined by using the 3 Incontinence Questions (3IQ). Only patients with urge incontinence were included in the study. Patients were evaluated for QOL, anxiety, depression, disability, and geriatric syn- dromes before and after treatment. Data analysis was done by using SPSS version 22. Results: The study population was 42 women; the mean age was 69.7 +/- 4.3 years. QoL, anxiety, and depression symptoms, and ADL were revealed to be improved after treatment. ICIQ-SF, I-QOL, and HADs scores were as- sociated with UI treatment when evaluated with one-way MANOVA (F [4, 79] =3.25, p = 0.00, Wilk's p = 0.859, partial η2=0.14). Conclusion: UI is a common problem in the elderly. Patients usually hesitate to tell this complaint to even doctors. That situation affects their physical and psychological condition negatively. In this study, we reached that anticho- linergic treatment (fesoterodine) improved ADL, QoL, and psychological symptoms. Those findings represented us that proper treatment of UI is critical for healthy aging. Keywords: anxiety, depression, quality-of-life, urinary incontinence, urge-type INTRODUCTION Urinary incontinence (UI) is defined as “the com-plaint of involuntary loss (leakage) of urine” by the International Continence Society(1). It is a prev- alent problem in the elderly, as it increases with age and affects about 35% and 22% of older women and men, respectively (2). UI in women is typically related to dysfunction of the bladder or pelvic floor muscles, with such dysfunction usually begin to occur during pregnancy or childbirth, or at the time of menopause(3). There are two main subtypes of UI: stress incontinence and urgency incontinence. According to the Interna- tional Urogynecological Association (IUGA) and the International Continence Society (ICS) definitions, stress incontinence is the urinary leakage associated with coughing, sneezing, or physical exertion. In con- trast, urgency incontinence is the urinary leakage asso- ciated with a sudden compelling desire to void that is difficult to defer(1). The most commonly seen subtype of UI in elderly patients is mixed incontinence, which is characterized by the combination of symptoms of these two subtypes(4). The diagnosis of UI is missed in 80% of cases due to patients' difficulties in expressing the complaint(5). Con- tinence is one of the most critical factors that can con- tribute to physical and mental health, quality of life, and people's well-being in all life stages, especially in old age(6). It has been widely documented that UI is more prevalent in an older woman and cause a low quality of 1Gaziantep University, Faculty of Medicine, Department of Internal Medicine, 27100 Sahinbey, Gaziantep, Turkey. *Correspondence: Gaziantep University, Faculty of Medicine, Department of Internal Medicine, Division of Geriatric Medicine, 27100 Sahinbey, Gaziantep, Turkey. Phone : 0090 342 341 66 89. Received May 2021 & Accepted October 2021 life (QOL) and severe complications(1). Dermatological problems fall, psychological problems, impaired sexual performance, and social isolation are complications that cause decreased QOL in patients with UI(2,7). In this study, we aimed to evaluate QOL, depression, and anxiety levels of patients diagnosed with UI. We also compared the pre-treatment and post-treatment sta- tus of the UI patients in terms of these parameters. MATERIALS AND METHODS Participants This prospective study was carried out for a period of three months from February 2020 to April 2020. Pa- tients consulted at the outpatient clinic of geriatrics with urge UI symptoms were included in the study. All of the patients were women and ≥ 65 years old. The study was approved by the Gaziantep University Local Research Ethics Committee. All participants gave informed con- sent. Exclusion criteria Patients below 65 are diagnosed with UI other than urge type, diabetes mellitus, urinary infection, urinary pro- lapsus, atrophic urethritis and vaginitis, mental retarda- tion, and mobility restriction were excluded from the study. Patients who were using diuretics or on dialysis programs were excluded too. Evaluation of participants Patients who were diagnosed with urge UI were eval- FEMALE UROLOGY Urology Journal/Vol 19 No. 1/ January-February 2022/ pp. 69-74. [DOI: 10.22037/uj.v18i.6834] uated. Their chronic diseases, drugs, fall history, and complaints about UI were recorded. Comprehensive geriatric assessment (CGA), frailty, and sarcopenia assessment were done on all patients. Validated scales were used for evaluation of the quality of life (QOL), depression, and anxiety. The same evaluation was done after three months of UI treatment. Evaluation of pa- tients took approximately 30 minutes. UI treatment Patients were treated with 4 mg fesoterodine. Fesotero- dine is a competitive muscarinic cholinergic receptor antagonist with muscle relaxant and urinary antispas- modic properties. Fesoterodine binds and inhibits mus- carinic receptors on the bladder detrusor muscle, there- by preventing bladder contractions or spasms caused by acetylcholine. This resulted in the relaxation of bladder smooth muscle and increased bladder capacity, in addi- tion to a reduction in involuntary muscle contractions and involuntary loss of urine. Evaluation of urinary incontinence Patients were evaluated for urinary incontinence by International Consultation on Incontinence Question- naire-Short Form (ICIQ-SF)(8) and 3 Incontinence Questions (3IQ)(9). The ICIQ-SF questionnaire ques- tioned the frequency, amount, type, and effects of uri- nary incontinence on daily life are and scoring between 0-21 values is made. The Turkish validity and reliability study of the ICIQ-SF test was performed by Çetinel et al(10). Evaluation of quality of life (QOL) Patients were evaluated for quality of life by the Incon- tinence Quality of Life Scale. (I-QOL). The I-QOL contains three subscales. These are avoidance and limiting behaviors, psychosocial im- pact, social embarrassment. This scale consists of 22 items; all items are evaluated in a five-category Lik- ert-type scale with values ranging from 1(extremely) to 5 (not at all). A mean score for each subscale is calculat- ed as well as a total score for all 22 items. The scores are then transformed into a 'Scale score' ranging from 100 points for ease of interpretation(11). The Turkish validity and reliability study of the I-QOL test was performed by Eyigor et al(12). Evaluation of anxiety and depression Patients were evaluated for anxiety and depression by The Hospital Anxiety and Depression Scale (HADS). The HADS questionnaire consists of 14 questions, 7 for depression, and 7 for anxiety. Each question has four possible answers. Furthermore, it is calculated between 0-3 points according to the Likert scale. Cut-off values for anxiety and depression are considered 8-10 mild, 11-14 moderate, and 15-21 severe(13). The validity and reliability study of the HADS test was performed by Aydemir et al(14). Comprehensive geriatric assessment: The cognitive evaluation was done by the standard- ized form of mini-mental state examination (MMSE) (15), assessment of daily living abilities (ADL) by Katz index(16), instrumental activities of daily living (IADL) by Lawton Brody, and nutritional assessment by mini nutritional assessment test-short form(17). In MMSE, patients were evaluated for six different areas: orientation, registration, attention, calculation, language, and recall. Patients whose scores were ≤ 24 were accepted for the presence of dementia(15). Katz index of ADL evaluated patients for personal hygiene, continence, dressing, feeding, and ambulating. Scores were between intervals of 0 and 6; higher scores mean higher independence(16). Lawton Brody index was used for evaluating IADL like house cleaning, doing the laundry, marketing, managing medications, cooking, communicating with others, using transportation, and doing financial management; higher scores mean high- er independence(18). MNA-SF scores ≤ 7 indicate mal- Fesoterodine treatment in urge-type urinary incontinence-Aksak et al. Scales and tests N mean (±SE) (CI:95% ) ADL* 42 4.86 0.07 IADL* 42 5.6 0.32 sMMT* 42 25.57 0.76 MNA-SF* 42 11.52 0.32 FRAIL* 42 2.67 0.19 SARC-F* 42 3.12 0.29 Handgrip strength (kg) 42 22.86 0.45 SMM* (kg) 42 44.87 1 SMMI* (kg/m2) 42 19.57 0.5 Gait speed (m/s) 42 0.69 0.03 ICIQ-SF* 42 13.14 0.63 I-QOL* 42 65.4 3.02 HADS-A* 42 10.17 0.63 HADS-D* 42 8.93 0.62 Table 1. Scores of scales and tests used in the study. ADL*: Activities of daily living sMMT*: Standardized mini mental test MNA-SF*: Mini nutritional assessment test short-form FRAIL*: Fatigue, resistance, ambulation, illness, and loss of weight SARC-F*: Strength, assistance walking, rise from a chair, climb stairs, and falls SMM*: Skeletal muscle mass SMMI*: Skeletal muscle mass index ICIQ-SF*: International Consultation on Incontinence Questionnaire-Short Form I-QOL*: Incontinence Quality of Life Scale HADS-A*: The Hospital Anxiety and Depression Scale- Anxiety HADS-D*: The Hospital Anxiety and Depression Scale- Depression SE: standard error Female Urology 70 Vol 19 No 1 January-February 2022 138 nutrition(17). Assessment for sarcopenia For defining sarcopenia, muscle strength, mass, and physical performances were assessed. SARC-F (strength, assistance walking, rising from a chair, climb stairs, and falls) test was used to select cases to evalu- ate muscle strength(19). The handgrip test was performed if the patient had point ≥ 4 from SARC-F to diagnose probable sarcopenia. The handgrip test was performed by using a hand dynamometer with the dominant hand(20). For females < 16 kg (kilograms), for males < 27 kg was accepted as probable sarcopenic. A bio- impedance test was carried out on probable sarcopenic patients to assess skeletal muscle mass. Sarcopenia was diagnosed by skeletal muscle mass index. In this study, we used skeletal muscle mass index (SMMI) adjusted to height. SMMI was calculated by dividing skeletal muscle mass by the square of height(21). We evaluated gait speed with a four-meter gait speed test to diagnose severe sarcopenia(22) Assessment of frailty We performed a frailty assessment by the FRAIL scale. The FRAIL scale includes five parameters: Fatigue, re- sistance, ambulation, illness, and loss of weight. Frail scale scores range from 0–5 (best to worst). Scores 3-5 were considered frail (3–5), 1-2 pre-frail, and 0 robust(23). Statistical analysis The variables were analyzed for their distribution nor- mality using the Kolmogorov–Smirnov and Shapiro Wilk test. ICIQ, OAB V8, and HADS A variables were disturbed normally (p > 0,05), and other variables were not disturbed normally. The independent sample t-test was used for the comparison of two groups for normally distributed data. Wilcoxon tests were used for the com- parison of two groups for not normally disturbed data. Numerical variables were denoted as mean ± standard error. The IBM SPSS for Windows, version 22.0 (IBM Corp., Armonk, NY, USA) was used for statistical anal- ysis. RESULTS Forty-two female patients who were followed up and treated in the geriatric outpatient clinic due to the diag- nosis of urge UI were included in the study. The mean age of them was 69.7 ± 4.3 (minimum 65 years old, maximum 74 years old). The average body mass index (BMI) of the patients was 33.50 ± 1. Seven-point-one percent of them were nor- mal weight (n = 3), 26.1% were overweight (n = 11), 52.6% were obese(22), and 14.2% were morbid obese (n = 6). All our participants had at least one chronic disease. The average number of medicine that patients used was 3.6 ± 0.6. Polypharmacy was present in 23.8% of the patients Educational status, marital status, social status, place of residence, smoking and/or alcohol consumption, driv- ing and physical exercise status of the patients were not associated with ICI Q-SF, IQOL, HADS-A and HADS-D scores(p > 0.05). Number of pregnancies, number of normal vaginal de- liveries, history of cesarean section, history of abortion and history of induced abortion were also not associated with ICIQ-SF, IQOL, HADS-A and HADS-D scores (p > 0.05). The mean ICIQ-SF scores of the patients were 10.12 ± 0.63, the mean IQOL score was 75.95 ± 3.02, the mean HADS-A score was 7.83 ± 0.63, and the HADS-D score was 6.14 ± 0.63. The first scores of scales and tests used in the study were summarized in Table 1. All these measurements were repeated after three months of treatment and pre-post treatment values were compared. There was a significant improvement in the ADL score after treatment (p = 0.049). There was also a significant upturn in the I-QOL score (p = 0.02). The Katz and I-QOL scores were positively related to UI treatment. The frequency of incontinence and its effects Pre-treatment (n=42) Post-treatment (n=42) p= SARC-F* 3.12 ± 0.29 3.07 ± 0.17 0.91 Handgrip strength (kg) 22.86 ± 0.45 25.52 ± 0.6 0.82 SMM* (kg) 44.87 ± 1 44.68 ± 1.3 0.89 SMMI* (kg/m²) 19.57 ±0.5 19.28 ± 0.65 0.64 Gait speed (m/s) 0.69 ± 0.03 0.70 ± 0.04 0.76 ADL* 4.86 ± 0.07 5.12 ± 0.09 0.049* sMMT 25.57 ± 0.76 27.07 ± 0.8 0.1 MNA-SF* 11.52 ± 0.31 12.17 ± 0.27 0.12 ICIQ-SF* 13.14 ± 0.63 10.12 ± 0.57 0.005* I-QOL* 65.40 ± 3.02 75.95 ± 3.5 0.02* HADS- A* 10.17 ± 0.63 7.83 ± 0.68 0.022* HADS- D* 8.93 ± 0.62 6.14 ± 0.72 0.013* FRAIL* 2.67 ± 0.19 2.24 ± 0.24 0.09 Table 2. Comparison of pre-post treatment scores of scales and tests. ADL*: Activities of daily living sMMT*: Standardized mini mental test MNA-SF*: Mini nutritional assessment test short-form FRAIL*: Fatigue, resistance, ambulation, illness, and loss of weight SARC-F*: Strength, assistance walking, rise from a chair, climb stairs, and falls SMM*: Skeletal muscle mass SMMI*: Skeletal muscle mass index ICIQ-SF*: International Consultation on Incontinence Questionnaire-Short Form I-QOL*: Incontinence Quality of Life Scale HADS-A*: The Hospital Anxiety and Depression Scale- Anxiety HADS-D*: The Hospital Anxiety and Depression Scale- Depression Fesoterodine treatment in urge-type urinary incontinence-Aksak et al. Vol 19 No 1 January-February 2022 71 on daily life significantly improved with urinary incon- tinence treatment (p = 0.005). Improvement in anxiety (p = 0.022) and depression (p = 0.013) after treatment was revealed too. HADS-A and HADS-D scores were significantly decreased after treatment. ICIQ-SF and HADS scores were negatively related to UI treatment. ICIQ-SF, I-QOL and HADS scores were correlated with UI treatment when evaluated with one-way MANOVA (F [4, 79] = 3.25, p = 0.00, Wilk's Λ = 0.859, partial η2 = 0.14). A comparison of pre-post treatment values was summarized in table 2. ADL and I-QOL scores were positively correlated with treatment status (r=0.292, p = 0.007; r = 0.232, p = 0.02). ICIQ-SF, HADS-A and HADS-D scores were negatively correlated with treat- ment status (r = -0.304, p = 0.006; r = -0.279, p = 0.022; r = -0.349, p = 0.002). Patients were also evaluated for anticholinergic-related side effects. Anticholinergic side effects were not ob- served in 25 (59.5%) of the patients. Dry mouth was ob- served in 10 patients (23.8%), constipation in 4 patients (9.5%), and tachycardia in 3 patients (7.1%). There was no significant correlation between the development of anticholinergic-related dry mouth, constipation and tachycardia and I-QOL scores (p = 0.746, 0.072, 0.146). DISCUSSION Urinary incontinence is one of the most common geri- atric syndromes in the elderly. Patients generally hesi- tate to tell this complaint even to doctors. This situation could negatively affect the physical and psychological status of the patients. In this study, we revealed im- provements in patients' activities of daily life, frequen- cy of incontinence and its effects on daily life, quality of life, and psychological status after 3 months of UI treatment. After the treatment, an increase in Katz score and I-QOL score and a decrease in ICIQ-SF score were found. Regarding I-QOL, a significantly good result was found in all scales (limitation of behavior, psycho- social influence, social isolation) after treatment. The relationship between UI and depression was inves- tigated in several studies. Felde et al. revealed that UI was a risk factor for both depression and anxiety with a dose-dependent trend (Felde et al. 2015). In that study, 16263 women over 20 years of age were followed for 10 years. Mild anxiety was detected in one of ten pa- tients with urinary incontinence, and moderate or se- vere anxiety was detected in one of twenty patients. A significant relationship between UI and mild depression development was also found. Lai et al. showed that 27.5 % of overactive bladder (OAB) patients had depression in their study. They also reported OAB patients with depression had more severe incontinence symptoms (ICIQ-UI) and more impact on quality of life compared to OAB patients without depression(24). The relationship between UI, psychological problems, and quality of life could be explained by the patient's necessity to plan every detail in life due to UI and their fear to perform physical activities. This, in turn, can lead to feelings of loss of control and distress and can reduce the quality of life. The causal relationship between UI and anxiety/depres- sion can be explained by serotonergic and sympathetic pathways. Serotonergic pathways play a role in the regu- lation of both depression and continence functions. Ser- otonin inhibits the voiding reflex pathway and increases the tonus of the urethral sphincter. Serotonin levels are low in clinically depressed individuals. Therefore, ser- otonin reuptake inhibitors may have positive effects in the treatment of stress-type urinary incontinence(25). In many studies investigating the relationship between IU and depression, the distinction between inconti- nence types has not been made(26). However, there are also studies analyzing the subject by distinguishing the types of urinary incontinence from each other, such as our study. Walters and colleagues found no differences in psychological tests between women with detrusor in- stability and genuine stress incontinence(27). Converse- ly, Lee et al. concluded that women with urinary in- continence have more depression and stress than those who do not. The situation is similar for those women with both stress UI and urge UI as well as those with mixt UI(28). The relationship between UI and quality of life (QoL) was also investigated in several studies. Saboia et al. concluded that mixed urinary incontinence decreased the quality of life more than stress urinary incontinence and urinary incontinence(29). In the study of Nygaard et al., it was shown that urinary incontinence negatively affects the quality of life and is more common in obese women(30). Pizzol et al. concluded that the presence of urinary incontinence negatively affects the quality of life in their meta-analysis. It was also observed that studies supporting this result were mostly performed using the SF-36 and Incontinence Impact Questionnaire (IIQ-7)(31). Different from them, in our study, quality of life was evaluated with I-QOL. In the study of Ptak et al., it was revealed that pelvic floor muscle exercises positively affect the life quality of women with stress UI(32). Another study analyzing the effect of urge uri- nary incontinence treatment on quality of life has not been found in the literature. In this study, we evaluated the change in the quality of life, anxiety, and depression in patients who had received three months of fesoterodine treatment for urge UI. Our study is the first study that evaluated the change in the quality of life, anxiety, and depression status of patients before and after treatment for urge urinary incontinence by an anticholinergic drug. The major strengths of our study are that it is a prospective study and similar studies showing the effects of urge UI treatment on quality of life, anxiety, and depression were not present. In our study, an improvement was also observed in the SARC-F, MNA-SF, sMMT, and FRAIL scores after treatment. However, these were not statistically signifi- cant. Large-scale studies with more patients are needed to explain these relationships. Some limitations of the study should be mentioned. The number of patients included in the study is small and the degree of urinary incontinence has not been ful- ly investigated (eg by ped test). Another limitation is that the study was conducted three months after the UI treatment. Improvements in other parameters could be seen with longer follow-up. The absence of an untreat- ed control group is major limitation of the study. The reason we designed the study in this way was our ethi- cal reservations about depriving some patients of treat- ment. Therefore, we preferred to make the comparison between the pre- and post-treatment conditions of the patients, not with a control group that did not receive treatment. Fesoterodine treatment in urge-type urinary incontinence-Aksak et al. Female Urology 72 Vol 19 No 1 January-February 2022 138 CONCLUSIONS Urinary incontinence is a geriatric syndrome that is common in the elderly. This situation can be skipped in many patients because patients generally hesitate to tell healthcare professionals about this complaint. The negative effects of urinary incontinence on quality of life and the increase in anxiety and depression can be attributed to many reasons. The first of these is so- cial isolation that occurs with urinary incontinence. The quality of life of the individual, who moves away from his daily activities and social environment, decreases significantly. Anxiety and depression are inevitable. 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Review Article Bacterial Pathogens and Their Antimicrobial Resistance Patterns of Inanimate Surfaces and Equipment in Ethiopia : A Systematic Review and Meta- analysis. 2021;2021. Fesoterodine treatment in urge-type urinary incontinence-Aksak et al. Female Urology 74