A Prospective Study of the Quality of Life of Patients With Stress Incontinence Before and After a Transobturator Tape (TOT) Procedure

Maciej Zalewski Wroclaw Medical University: Uniwersytet Medyczny im Piastow Slaskich we Wroclawiu Gabriela Kołodyńska (  kolodynska.gabriella@gmail.com ) Akademia Wychowania Fizycznego we Wroclawiu https://orcid.org/0000-0001-7921-7058 Anna Mucha Wroclaw University of Environmental and Life Sciences: Uniwersytet Przyrodniczy we Wroclawiu Waldemar Andrzejewski University School of Physical Education in Wrocław: Akademia Wychowania Fizycznego we Wroclawiu


Introduction
Urinary incontinence is a serious social problem. The precise number of patients affected by this condition is unknown, which results from the facts that various de nitions of this disorder have been adopted and classi cation systems are not uniform. As the latest data show, urinary incontinence affects as many as 17-60% of the female population, making it one of the most common chronic diseases (Minassian et al., 2003). Estimates suggest that the number of patients is even larger, but that patients do not report their complaints due to embarrassment and a common belief that incontinence is a natural phenomenon associated with aging. The average incidence of this condition is 27.6% for women, and 10.5% for men (Meyer, 2017). The most frequent type is stress incontinence, which constitutes as many as 50% of all incontinence cases among women (Moroni et al., 2016).
Urinary incontinence is de ned as involuntary leakage of urine through the urethra due to dysfunction of the closure mechanism of the bladder. In stress incontinence, this is typically induced by a sudden increase in the intra-abdominal pressure (IAP) (Syan, Brucker, 2016). Other symptoms include enuresis (i.e., urination without the urge), a lack of change in the frequency of micturition compared with the period preceding the disease, and the subsiding of symptoms during sleep. The etiopathogenesis of this condition has been attributed to factors disturbing the transfer of intra-abdominal pressure to the junction between the urethra and the bladder, and to the proximal urethra (Kołodyńska et al., 2019). The latest reports indicate that latent urinary incontinence is also extremely common. This is estimated to affect 36-80% of patients with pelvic oor prolapse (Szafranowska, Rogowski, 2018) it is associated with urethral exion or pressure, potentially leading to micturition disorders. These cause closure of the urethral lumen, and consequently the lack of immediate compression of the bladder, which can trigger urine leakage through the urethra. The symptoms of urinary incontinence in this group of patients thus only occur after surgical reconstruction of the pelvic oor. Currently, reports describing simultaneous surgery for pelvic organ prolapse and urinary incontinence suggest contradictory results. Performing these two procedures at the same time entails a higher number of complications (Khullar et al., 2017).
There is no consensus on management of this group of patients. It is, however, certain that the scope of the operation should be decided on with a patient after an interview and physical examination, and after she has been informed of all therapeutic options. Improving the quality of the patient's life should be given priority (Svenningsen et al., 2012).
A de nition of quality of life was proposed by the World Health Organization in 1994; it states that QoL is the individual perception of one's own position in life with regard to cultural conditions and the system of values. Factors that have an immediate effect on QoL include somatic health, interpersonal contact, and the community features that are essential for a particular person (Kukielczak, 2012). It is signi cant that physicians do not currently focus exclusively on extending patients' lives but, also on improving the quality of life. Modern medicine aspires to retrieve patients' QoL from before the disease. Hence, there is increasing interest in the assessment of the QoL of people affected by various diseases (Jankowska-Polańska, Polański 2014).
At present, not only strictly medical goals, but also nonmedical goals, constitute crucial elements of the therapeutic process; these latter include improving patients' well-being and functioning in the physical and social spheres. QoL research is part of a holistic approach (Socha et al., 2011). In medicine, both subjective and objective types of QoL assessment should be performed. Subjective assessment of QoL can be based on questions addressed to patients. Nevertheless, this assessment depends on patients' mental state, likes and dislikes, system of values, personality traits, and so on. Objective QoL assessment, on the other hand, is usually performed using standardized questionnaires. These are valuable, repeatable instruments that measure patients' QoL and the effectiveness of treatment (Dudzińska et al., 2011).
The aim of this study was to assess QoL in patients with stress incontinence before and after stress incontinence surgery using the TOT method. All patients gave their informed written consent to take part in the study prior to entering the project. All participants completed the IIQ-7 and I-QoL questionnaires twice: once upon admission to the ward and twelve months after surgery. Patients were quali ed for the study on the basis of the inclusion and exclusion criteria.
The inclusion criteria were: stage II and stage III stress incontinence con rmed by ultrasound scan and interview; not taking hormone replacement therapy (HRT) before or after the surgical procedure; informed written consent of the patient to take part in the project.
The exclusion criteria were: women with overactive bladders (OAB) or mixed urinary incontinence (MUI); women with urinary tract stulas; women with congenital or acquired defects of the urethra or bladder; women with urinary tract infections; women taking medicines contributing to an overactive bladder.
All patients quali ed to the project underwent the TOT suburethral sling procedure, which decreases urethral hypermobility and consequently eliminates or reduces the number of involuntary urine leakage episodes caused by physical effort. The TOT procedure, proposed by Delorme in 2001, is considered the gold standard in the surgical treatment of stress incontinence, due to its high effectiveness and the small percentage of complications. We used this method because it is as effective as the tension-free vaginal tape approach, but takes half the time (

Measures
1. Incontinence Impact Questionnaire (IIQ-7) is used to assess the quality of life of women with urinary incontinence. The IIQ-7 questionnaire is an abridged version of the IIQ questionnaire, which contains 30 questions. All 7 questions in the IIQ-7 questionnaire concern the impact of urinary incontinence on patients' lives. The questions relate to the ability to do household activities, physical activity, entertainment, travel, leisure and mental health. Each question was rated on a scale of 0 to 3, where 0not at all, 1 -a little, 2 -medium, 3 -very. The average score obtained is calculated (Chang et al., 2019). Only the questions answered are taken into account. The average, which ranges from 0 to 3, is multiplied

Statistical analysis
Statistical analysis was performed using R Project (R Core Team, 2019). The statistical signi cance of the impact of surgery on the QoL of the patients was veri ed. For this purpose, the results of the IIQ-7 and I-QOL questionnaires were used; the patients were asked to complete these prior to surgery and twelve months after the surgery. Categorical variables were compared with Fisher's exact test. The statistical signi cance of the differences in the scores within each group was tested using the Wilcoxon test for paired samples. The statistical tests were carried out with a signi cance level of p = 0.05.

Results
The project involved 57 women with a diagnosis of stage II and stage III stress incontinence. The mean age of the patients was 70.28 years and the range was 61-87 years. Analysis of the results obtained from the IIQ-7 questionnaire shows that the operation did not signi cantly affect the improvement of the quality of life of the respondents (Table 1). A detailed analysis of the results of the IIQ-7 questionnaire shows that after surgery, the majority of patients have decreased the frustration felt earlier due to urinary incontinence symptoms (question 7). In addition, after surgery, patients began to undertake physical and recreational activities more often (question 2). The answers obtained in question 1 show that the performed operation also signi cantly increased the patients' ability to perform home tasks ( Table 2). Data are presented as median (range) and mean (standard deviation). n denotes size of each group.
Given p-value is for the t -test.  In most cases, the I-QOL results also con rmed that the patients' QoL improved after surgery. Statistically signi cant changes were observed in three questionnaire domains-namely, avoidance/limiting behavior, psychosocial impact, and social embarrassment ( Table 3). The majority of statistically signi cant changes were found in the avoidance/limiting behavior domain (Table 4). A statistically signi cant change was also observed in the psychosocial impact and social embarrassment domains, though not in all questions (Tables 5 and 6). This may result from the fact that, even prior to surgery, the patients claimed that QoL in these domains was not as important for them as in the avoidance/limiting behavior domain.

Discussion
The main purpose of this study was to assess the quality of patients' lives before and after stress The effect of urinary incontinence on mental health has been examined by Goldacre et al., who provided evidence that women with urinary incontinence are more prone to depression and self-mutilation. Women with advanced symptoms of urinary incontinence suffered from severe depression three times as often as those with mild incontinence. Moreover, the relationship between urinary incontinence and anxiety symptoms is also higher in this group of patients. This problem has a signi cant impact on women's social life, especially in the case of older patients. Women with pelvic organ prolapse feel humiliated and embarrassed, which frequently leads to withdrawal from family and social life. Some researchers have emphasized that depression and urinary incontinence might an epidemiology and etiology (Goldacre et al., 2007). Oh and Ku reached the conclusion that there is a strong correlation between urinary incontinence and mental disorders. Although urinary incontinence is not directly linked to death, it causes anxiety, depression, and dissatisfaction with life, which can lead to suicide attempts. The rate of depression in this group of patients is similar to that observed in patients with diabetes, cardiac conditions, and other chronic diseases (Oh, Ku, 2006).
Both this study and those cited above show how important it is to assess the QoL in patients with stress incontinence. Effective treatment not only improves patients' physical well-being by eliminating an anatomical defect, but also positively affects mental health. The results presented here show that healthcare professionals should not only provide surgical treatment but also assess and promote patients' QoL and mental health. It therefore seems necessary to carry out further research in order to develop strategies for the prevention, early diagnosis, and treatment of patients with stress incontinence.

Conclusions
1. Surgical treatment of stress incontinence by the TOT method relieves the majority of patients of bothersome symptoms and improves their QoL.