¹ Division of Obstetrics & Gynecology, Sari Imam Khomeini hospital, faculty of Medicine, Mazandaran university of Medical sciences;

² Faculty of Medicine, Tabriz university of medical sciences;

³ Shahid Sadoughi University of Medical Science, Yazd, Iran

⁴ Medical Student

Corresponding Author: Mojgan Karimi-Zarchi, Shahid Sadouhi University of Medical Science, Yazd, Iran. E-mail: drkarimi2001@yahoo.com.

	ABSTRACT
	INTRODUCTION
	MATERIALS AND METHODS
	RESULTS
	DISCUSSION
	CONCLUSION
	REFERENCES

	ABSTRACT

Introduction: Stress urinary incontinence (SUI) in women had high prevalence and has a negative impact on their quality of life. Surgery is the most effective way to treat this problem. So, this study designed to compare the efficacy of transobturator tape (TOT) versus anterior colporraphy (APR) in stress incontinence patients. Methods: We designed a prospective cohort study. On base of inclusion and exclusion criteria, we had 65 patients (33 patients in TOT group, 32 patients in APR group) were randomly enrolled in this study. Patients data before surgery, 2 months, 6 months and 18 months after surgery were collected and asked them to complete incontinence quality of life questionnaires (IQOL). We used SPSS 18 for data analysis. Results: Mean surgery time in TOT group was significantly less than APR group (P<0.0001). Quality of life at 6 and 18 months after surgery was significantly better in TOT group (P<0.05). Number of incontinence patients at 2, 6 and 18 months after surgery (P<0.01), incontinence during activity at 18 months after surgery (P=0.031), severity of urinary incontinence at 6 months and 18 months after surgery (P<0.001) were significantly lower in TOT group. Complications after surgery was not different between 2 groups (P=0.78). However, 21 cases in TOT group (63.6%) and 9 cases in APR group (28.1%) complained of pain after surgery (P=0.004). The mean of hospitalization was not statistically significant difference (P=0.54). Finally, 23 patients in TOT group (63.9%) and 13 patients in APR group (36.1%) had urinary incontinence within one last month (OR:3.36, 95%, CL: 1,20-9.36, P=0.018). Furthermore, 25 patients in TOT group (61%) and 16 patients in APR group (39%) had more than 90% improvement in their quality of life (OR: 3.12, 95% CL: 1.08-8.97, P=0.031). Conclusion: The results of this study showed that the TOT techniques more efficient than the APR technique. This technique has more success rate, higher satisfaction of patients and can significantly improve patient’s quality of life.

	INTRODUCTION

   Urinary incontinence affects more than a quarter of women aged 30-60. Stress urinary incontinence involves about 77% of total incontinences (1). This problem is one of the most common anxiety situations affecting women of all ages and affecting their quality of life. Stress urinary incontinence is a complaint of involuntary leakage following increased pressure, coughing, sneezing, or activity, which is usually due to weak pelvic floor muscle or sphincter (2). The colporraphy technique or anterior vaginal repair was first described by Kelly and Howard in 1914, and it was used as the first standard approach to treatment of stress incontinence by the middle of the twentieth century (3, 4). Anatomical correction of anterior vaginal defects and improving the function of endopelvic connective tissue generally resolves protrusions and pressure symptoms, and in cases where urinary dysfunction is associated with a defect in time and no synchronous neuropathy, it usually improves the urinary excretion. The problem with most of the anterior colporraphy techniques is that these techniques lose their efficiency over time. In most studies in which anterior colporraphic techniques have been used for stress incontinence, the long-term success rate has been reported at only 35-65%, and this number is unacceptably low for most scholars (4). The Trans obturator tape (TOT) is a method first described in 2001 by Delmore and was modified by Deleval in 2003. In this method, the tape passes through the obturator space below the urethra and thus the pelvic cavity is interrupted. This method is used to treat stress uric incontinency and modifies the anatomic mobility of the urethra and the bladder neck. The purpose of this method was to prevent the damage to the bladder, bowel and large vessels caused by retro pubic techniques (2). Currently available data on this technique is limited; In one of the reports, there were no cases of bladder perforation in 71 operations involving the first Trans obturator surgeries, and in 68 patients who had been examined 6 to 12 weeks after surgery, 64 recovered completely and in 4 cases relative improvement was observed (4). However, the Trans obturator surgery procedure is not uncomplicated; Urethra and bladder injury, rupture of the tape, urinary dysfunction, groin pain, abscess formation, and protrusion of mesh from the vagina are complications of the TOT. Regarding the prevalence of anterior colporraphy method for the treatment of cystocel and urinary symptoms simultaneously, and sometimes the correction of urinary symptoms through this method, it was decided to investigate newer methods of treatment for SUI, and the rate symptoms relief in these two methods as well as the magnitude of complications and surgical morbidity are compared and their success rate is studied.

	MATERIALS AND METHODS

   This research is a prospective cohort study and has been conducted on 66 women with SUI who referred to the genecology clinic of Imam Khomeini Hospital in Sari, Iran from December 2011 to January 2012. Patients with diseases such as diabetes, dementia, urgency urinary incontinence, pelvic prolapse of more than grade II, previous history of urinary incontinence operation, untreated urinary tract infection, chronic pulmonary disease, neurological disorders, vascular insufficiency, and mixed incontinence, were excluded. Patients were divided to 2 equal subgroups randomly in which the first group was subject to TOT method and second group were treated by anterior colporraphy (APR) surgery method and the surgery was performed by a trained and experienced surgeon. The data were collected using a comprehensive standard questionnaire (including age, parity, BMI, history of previous surgery, menopause, hormone therapy, nachturia, smoking, previous hysterectomy and the presence of urgency urine incontinence), which was completed by the patients. After the completion of surgery, the duration of hospitalization, the complications of the procedure, including bleeding of the vessels, bladder rupture, rectal rupture, neurological damage, hematoma, postoperative urinary retention, and infection of the injection site were compared in both groups. In this study, radiological methods such as ultrasound and urodynamic measurements were not used and the main criteria of improvement was measured by a questionnaire, clinical examination and patient satisfaction. Then, the patients were followed up short-term and long-term; 2 months, 6 months and 18 months after surgery by questionnaires. We used Incontinence Quality of Life Questionnaire (IQOL) in our practice because its validity and reliability has been proven in the study of urinary incontinence in Iran by Dr. Nojomi et al. (5) The data were analyzed by SPSS 18 software and P value< 0.05 was considered statistically significant. Chi-square and fisher tests for comparison of qualitative data and T-test for quantitative data were used.

	RESULTS

   65 women were in this study, of which 32 patients were in the APR group and 33 patients in the TOT group. The results of the comparison of the primary characteristics of the patients in the two groups are shown in the Table 1. Among them, only BMI difference in the two groups was statistically significant (P=0.026), which was due to the presence of two high-BMI patients in the TOT group.

   In the Q.TIP test, all patients in the study had an increased urethral stimulation. The results of the stress test were positive for 33 patients of TOT group (100%) and 32 patients of APR (100%), respectively, and there was no significant difference between the two groups. Urine analyses of all patients were normal and all urine cultures were negative. None of cases had have a history of smoking, hysterectomy nor SUI operation. In the gynecologic examination, the most common finding in the TOT and APR groups were rectocele with cystocele in 13 patients (39.4%) and 17 patients (53.1%) in each group, respectively; which isn’t statistically significant between two groups (P=0.26). Due to the accompanying perinorraphy surgeries in some patients in both groups, comparison between the mean duration of surgery was excluded from the study. I-QOL questionnaire showed that there was no statistically significant difference in patients’ quality of life between groups before surgery (P>0.05). The number of patients who had improved 2 months after the surgery was higher in the TOT group than in the APR; however, the quality of life assessment of patients with the help of the I-QOL questionnaire showed that, there is no significant statistical difference between the groups, two months after surgery (P=0.90). However, 6 months and 18 months post-surgery, the quality of life of patients undergoing TOT surgery was significantly better than the ARP group (P=0.010, P=0.001, respectively). The average of I-QOL score, the number of incontinences and the number of visits by each group are shown in the Table 2.

   Surgical complications were seen in one patient (2.9%) from the TOT group (erythema and ecchymosis) and 4 patients (6.2%) from the APR group (bleeding and urinary retention); there were fewer complications in the TOT group, but there was no significant difference between them (P=0.78). The probability of pain was 4.47 times higher in TOT group patients (P=0.004, OR: 4.47, 95%CL: 1.56-12.74). None of the complications of dyspareunia, vaginal erosion, and vaginal mesh protrusion were observed in the TOT group. The severity of incontinence by the each groups studied is presented in the Table 3.

   The mean time of hospitalization in the TOT group was 2.03 ± 0.17 days and in ARP group 2 days, which was not significantly different between the groups (P=0.54). In the 18th month after surgery, 25 patients in the TOT group (75.7%) and 22 patients with APR group (50%) mentioned improving the quality of life which is 90% higher comparing to the start of the study. The quality of life of patients in the TOT group was significantly improved compared to the APR group, and the chances of improving the quality of life in these patients were 3.12 times higher than that of the APR group (P=0.031, OR: 3.12, 95%CL: 1.08-8,97). Also, all patients in the TOT group, had I-QOL score more than 80, while only 17 patients (53.1%) of APR group had the same score, showing significant statistical differences between the two groups (P<0.0001). At the end of the study, 25 patients (75.9%) in the TOT group and 13 patients in the APR group mentioned the absence of urinary incontinence during the last month of the study. The success rate of TOT surgical technique was significantly better than APR method and the chance of recovery by TOT surgery was 3.36 times higher than APR surgical methods (OR: 3.36, 95%CL: 1.20-9.36, P=0.018). Despite the fact that BMI in patients of TOT group was higher than APR group, and BMI is one of the reasons for the failure of surgical procedures in the stress urinary incontinence, however, the results of treatment in the TOT group were significantly better than APR group.

	DISCUSSION

   SUI is defined as urinary leakage when trying, activity, or coughing, sneezing, and laughing(6, 7). The prevalence of this complication in women with multiple pregnancies with vaginal delivery is more often seen in middle age (8-10). The prevalence of this complication in women is estimated to be between 4% and 35% (11, 12); and associated with negative effects on the quality of life, their physical, psychological and social activity (13, 14). In this type of incontinence, as in the case of mixed incontinence, the type of surgical intervention is the most effective treatment, and so far different surgical procedures have been used in abdominal, vaginal or both methods for these patients (15). The purpose of the present study was to compare the results of two methods of surgical Trans -obturator tape with anterior colporraphy in stress urine incontinence. Anterior reconstructive procedure is used in SUI with the aim of correcting urethral hypermobility (16). In the present study, although the duration of hospitalization of the APR statistically, was the same as that of TOT, and even the patients in this method had less pain, but the APR method was associated with a lower life quality of life; also this surgical procedure had a higher incidence of incontinence, incontinence during activity and more incontinence intensity. In a Cochrane review article that reviewed the effect of this surgical method on incontinence, 10 clinical trials were reviewed which included a survey of 385 women, compared with the retro pubic suspension method, APR with a failure rate of 2 fold in the first year (29% vs. 14% in 6 studies), between one year to 5 years (38% vs. 17% in 6 studies) and more than 5 years (38% vs. 21% in 4 studies) that matches our study because here the rate of APR failure was almost twice as high as the TOT method (16, 17). Considering the poor results of our study, it seems that APR surgery has not had a proper advantage so it is better not be used as an initial treatment for SUI. The TOT surgical procedure was designed with the aim of minimizing the risk of intestinal complications and pelvic vessel structure (17). In the present study, this was also evident, and only one case was observed. However, it was said that the possibility of pain in the groin area in TOT method is more than other methods, which is proportional to the results of our study(18-20). The percentage of recovery in this study was 69.7% in TOT test which is in line with the study of Hsiao et al. (78.3%) and Oh et al. (72.3%) (21, 22); although the results of the studies by Zargham et al. and study by Barber et al. is closer to our study (23, 24). At the end of the study, 75% of the patients in the TOT group mentioned more than 90% of their quality of life from the time they entered the study to 18 months after surgery, which was similar to that of Oh et al., although in the study, patients were followed up for 6 months (22). In the study of Ghanbari et al. in Iran, the mean IQOL score before and after TOT were 23 ± 10 and 71 ± 18.4 respectively (25), which was 22.96 ± 10.87 and 95.38 ± 7.58 in our study, respectively.

	CONCLUSION

   In conclusion, the results of this study showed that TOT method is more effective than APR and has a higher success rate and higher satisfaction rate and can significantly improve patient’s quality of life. The present study on Iranian patients suggests that this method is more effective than APR. Given that APR surgery in many developing countries, including our country, is still one of the most common methods for SUI, and with consideration of extensive studies carried out in this area, it is recommended that, This method can be replaced by other valid methods, including TOT surgeries, and this will not be achieved except by providing appropriate education for specialized residents in universities and patient insurance(26-28) .In the end, it is suggested that in the future a study to compare the TOT method with APR surgery should be designed and implemented so that it is possible to check the duration of the operation and the amount of bleeding. Also a longer follow-up of patients in future studies and the conduct of a study of TOT with urodynamic measurements is recommended.

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