ORIGINAL PAPERS. Comparison of Transobturator Tape and Mini-Sling Tissue Fixation in Female Patients Who Had Stress Urinary Incontinence

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1 ORIGINAL PAPERS Adv Clin Ex Med 215, 24, 5, DOI: /acem/516 Coyright by Wroclaw Medical University ISSN Kursat Zengin 1, A, C E, Mustafa Kara 2, C F, Serhat Tanik 1, A, C, Memduh N. Sertcelik 3, A, E, Asir Eraslan3, A, B Comarison of Transobturator Tae and Mini-Sling Tissue Fixation in Female Patients Who Had Stress Urinary Incontinence 1 Deartment of Urology, Bozok University Medical Faculty, Yozgat, Turkey 2 Deartment of Obstetrics and Gynecology, Bozok University Medical Faculty, Yozgat, Turkey ³ Deartment of Urology, Diskai Training and Research Hosital, Ankara, Turkey A research concet and design; B collection and/or assembly of data; C data analysis and interretation; D writing the article; E critical revision of the article; F final aroval of article Abstract Background. Urinary incontinence is a significant medico-social roblem and its incidence increases u to 7% in the ostmenoausal eriod. Objectives. We aimed to comare the efficacy and safety of transobturator adjustable tae (TOT) and mini sling in female urinary incontinence. Material and Methods. A total of 69 atients were included in the study. Single surgeon alied TOT (n = 56 with ISD) or 13 mini sling (n = 13 with ISD). Patients were considered to have ISD identified by a Valsalva leak oint ressure (VLPP) measurement < 6 cm H 2 O with a volume of 15 ml in the bladder or by a maximum urethral closure ressure (MUCP) measurement < 2 cm H 2 O with a volume of 2 ml in the bladder. The mean follow- -u eriod was 25 months for and 24 months for mini sling grou ( =.72). Results. The cough test was negative in 48 of (86%) and 11 of mini sling grou (84.6%). ICIQ-SF scores for the median value decreased from 14 (11 21) reoeratively to 3 ( 9) ostoeratively ( <.5) in the, and 15 (12 23) reoeratively to 4 ( 1) ostoeratively ( <.5) in the mini sling grou. The difference in the decrease of the score between two grous was not statistically significant ( =.42). There was not any significant comlication to note. The mean hosital stay for was 2.1 days (1 5), and 1.4 days (1 3) for mini sling grou ( =.12). Oeration time was was significantly lower in mini-sling grou than (11.6 vs. 18.4, <.1). Conclusion. Both TOT and mini-sling rocedures are successful and safe rocedures in the treatment of female stress urinary incontinence with ISD (Adv Clin Ex Med 215, 24, 5, ). Key words: urinary incontinence, TOT, mini sling, cystocele. Stress Urinary Incontinence Stress urinary incontinence (SUI) is determined as leakage of urine with any activity like laughing, coughing, and exercise. U to 3% of women exerience symtoms of urinary incontinence during their lifetimes [1, 2]. Laaroscoic Burch colosusension has been described by Vancaillie et al. and acceted as the gold standard for SUI [3]. Petros et al. reorted the first intravaginal suburethral slingolasty oeration [4]. In 1996, Ulmsten et al. erformed midurethral retroubic sling named TVT and since then, treatment modalities have been dramatically changed [5]. Although TVT is less invasive than Burch oeration, some comlications such as vascular, bladder, and small bowel injuries are reorted [6, 7]. A midurethral aroach was erformed via transobturator route (TOT) by Delorme [8]. The comlications seen in TVT were decreased with TOT. However, TOT found to be useless to treat intrinsic shincter deficiency (ISD). Also, other comlications which are secific to TOT like obturator nerve injury and bladder damage are increased. A current multicentric study

2 852 K. Zengin et al. demonstrated that there was no difference between TOT and TVT in terms of efficacy [9]. Postoerative quality of life was similar in both grous. In 25, a mini-sling tissue fixation oeration (TFS) has been introduced by Petros et al. for treatment of SUI [1]. Retroubic or obturator sace was not used in this rocedure and a cystoscoy was also not needed. Besides, there is minimal ostoerative ain with a mini-sling. There are few studies comaring TOT with mini-sling oerations. We aimed to comare the efficacy and comlication rates of TOT and mini-sling rocedures. Material and Methods A total 69 atients with SUI who were lanned for TOT or mini-sling oerations were enrolled to this study. Inclusion criteria were SUI with VLPP < 6, and being unresonsive to conservative management. Exclusion criteria were overflow incontinence, history of genitourinary surgery and genital rolasus. An informed consent form was obtained from all atients and the study was aroved by an ethical committee. The reoerative evaluation included history, hysical examination, voiding diary, cough test, ICIQ-SF questionnaire (Turkish version), cystoscoy, and urodynamic examination [11]. Patients were considered to have ISD identified by a Valsalva leak oint ressure (VLPP) measurement < 6 cm H 2 O with a volume of 15 ml in the bladder or by a maximum urethral closure ressure (MUCP) measurement < 2 cm H 2 O with a volume of 2 ml in the bladder. All oerations were erformed between October 21 and December 212 by the same surgeon under sinal anesthesia. The atients were examined at 3, 6 and 12 months after the surgery and later annually. The rimary endoint of the study was to detect objective cure rate, subjective cure rate, and failure rate through 2-year following SUI surgery. Objective cure was described as having a negative cough stress ad test (CSPT) and measuring a bladder volume of 15 cc or greater. Subjective cure was described when the CSPT was ositive but bladder volume is less than 15 cc. The oeration was acceted as failure, if incontinence continued. The secondary endoint was to determine the oeration time and ostoerative comlications. Patients were followed u to 26 months. Surgical Technique Women were laced in a dorsal lithotomy osition with legs fixed in stirrus. Sinal anesthesia was used in all cases. TOT was erformed by using standard outside-in method. A monofilament Fig. 1. The monofilament tae used in TOT oeration tae (Safyre T, Promedon, Argentina) was utilized (Fig. 1). The tae was inserted in this method starting in the groin, following the obturator foramen and laced in the eriurethral sace reared by the surgeon. The mini-sling oeration was erformed as described by Petros et al. [8]. An adjustable sling (TFS Surgical, Adelaide, Australia) was used for the mini-sling oeration. Statistical Analysis Shairo-Wilk s and Levene s tests were used to test the normality and variance homogeneity of the data. Values are exressed as frequencies and ercentages, mean ± standard deviation or median and 25 th 75 th ercentiles. To comare arametric continuous variables, Student s t-test was used; to comare nonarametric continuous variables, the Mann-Whitney U-test was used. Categorical data was comared by Chi-square distribution. Statistical analyses were erformed using the statistical ackage SPSS, v. 15. (SPSS Inc., Chicago IL, USA); a value of <.5 was used to define statistical significance. Results Sixty nine women were included into the study. Age, body mass index (BMI), arity, duration of SUI, hormon relacement theray (HRT) status, and birth attern were similar in both grous (Table 1). Mean hosital stay was shorter in mini-sling grou (1.4 day) than (2.1 day) but, the difference was not statistically significant ( <.12). Oeration time was significantly lower in mini-sling grou than (11.6 vs. 18.4, <.1). In both grous, there were no bladder injury or wound infection. Two atients in TOT grou reorted urinary retention (Table 2). ICIQ-SF scores for the median value decreased from 14 (11 21) reoeratively to 3 ( 9) ostoeratively ( <.5) in the, and 15 (12 23) reoeratively to 4 ( 1) ostoeratively ( <.5) in the mini sling grou (Table 3).

3 TOT and Mini-Sling in SUI 853 Table 1. Characteristics of the atients Age (year) 6.2 ± ± BMI 31.2 ± ± Parity 3.1 ± ± Duration of SUI (year) 7.51 ± ± Using HRT (%) 18 (32.1) 4 (3.7).31 Birth attern vaginal (%) non-vaginal (%) 38 (67.8) 18 (32.2) 8 (61.5) 5 (38.5).57 BMI body mass index, HRT hormone relacement theray. Table 2. Oerative data and ostoerative comlications Oerative data mean hosital stay (day) oeration time (min) bladder injury wound infection urinary retention (%) 2.1 ± ± (3.5%) 1.4 ± ± n/a n/a.56 Cure rate (%) objective cure rate (%) subjective cure rate (%) failure rate (%) 85.7% 5.3% 9% 84.6% 7.7% 7.7% min minute, n/a not alicable. Table 3. Mean ICIQ-SF values of the atients ICIQ-SF value reoerative ostoerative 14 ± ± ± ± Table 4. Patients cure rates according to the oerations Objective cure rate (%) 48 (85.7) 11 (84.6).5 Subjective cure rate (%) 3 (5.3) 1 (7.7).48 Failure (%) 5 (9) 1 (7.7).69 The difference in the decrease of the scores between two grous was not statistically significant ( =.42). The objective cure rate, subjective cure rate and failure rate in were 85.7%, 5.3%, and 9%, resectively. The objective cure rate, subjective cure rate and failure rate in mini-sling grou were 84.6%, 7.7%, and 7.7%, resectively (Table 4). However, there was no statistically

4 854 K. Zengin et al. significant difference between the two grous according to the atients cure rate. There was no significant comlication to note in the mini-sling grou. The two urinary retention atients seen in which were recovered with three days long catheterization. Discussion In this study, we aimed to comare the efficacy and safety of transobturator adjustable tae (TOT) and mini-sling in female SUI with intrinsic shincter deficiency (ISD). Our study has shown that both TOT and mini-sling rocedures are successful and safe rocedures in the treatment of female SUI with ISD. There were no significant differences between grous by means of comlications and hosital stay. In our study, study grous were homogenous. Inclusion and exclusion criteria heled to maintain the equivalence of the grous. The atient oulation was similar. All the cases were erformed under sinal anesthesia with a non-stretch tae. The oeration was carried out by the same surgeon. Preoerative and ostoerative evaluation was achieved by another erson. Our study suggests that the cure rate was similar at the end of a 2-year follow-u in TOT and mini-sling grous 85.7% vs. 84.6%, resectively. Our results were in contradiction with the study of Sivaslioglu et al. [12]. They reorted with their 3-year follow-u study that TFS was suerior than TOT in terms of objective cure rate (9% vs. 84%) but the difference was not statistically significant. Two years later, the same authors ublished their 5-year follow-u data [13]. At the end of five years, they demonstrated that the objective cure rate were 83% and 75% in TFS and s, resectively. Moreover, this difference was found to be significant ( =.29). Although a lot of theories have been introduced, there is conflict about the real mechanism of SUI. Hammock theory is the most recognized one and based on distal urethral closure. According to this theory, distal urethra is closed like a vaginal hammock to suort the continence during straining [14]. TOT is a tension free sling rocedure and, since it is first described in 21 by Delorme, thousands of oerations have been achieved all over the world. The most acceted benefits of TOT were not to ass retroubic area like transvaginal tae rocedure (TVT), and have a low urge incontinence rate [15]. As well as these advantages, TOT is related with some ossible comlications. The comlications such as bladder injury, vascular injury are due to blind needle assage. Performing a mini sling oeration is somehow easier than TOT. Oliveira et al. also mentioned that oerative technique is simlier [16]. There is no reort about life threatening comlications of mini-sling. Although, the oeration time was shorter for the mini-sling grou in our study, there was no statistically significant difference between the two grous by means of comlications. In our study, both TOT and mini-sling oerations were found to be equally effective for the treatment of SUI. In site of the equivalent efficacy, mini-sling is romising, because of a shorter oeration time. Hence, mini-sling oeration was first introduced in 25, large randomized controlled trials comaring TOT and mini-sling are required. References [1] Senturk S, Kara M: Risk factors and revalence of urinary incontinence in ostmenoausal women living in Turkey. Clin Ex Obstet Gynecol 212, 39, [2] Findik RB, Unluer AN, Sahin E, Bozkurt OF, Karakaya J, Unsal A: Urinary incontinence in women and its relation with regnancy, mode of delivery, connective tissue disease and other factors. Adv Clin Ex Med 212, 21, [3] Vancaillie TG, Schuessler W: Laaroscoic bladderneck susension. J Laaroendosc Surg 1991, 1, [4] Petros P, Ulmsten U: An integral theory of female urinary incontinence: exerimental and clinical considerations. Acta Obstet Gynaecol Scand Sul 199, 153, [5] Ulmsten U, Henriksson L, Johnson P, Varhos G: An ambulatory surgical roce-dure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 1996, 7, [6] Ostergard DR: The eochs and ethics of incontinence surgery: is the direction forward or backwards? Int Urogynecol J 22, 13, 1 3. [7] Brodowska A, Starczewski A, Brodowski J, Laszczyńska M, Nawrocka-Rutkowska J, Marciniak A: The results of surgical treatment urinary stress incontinence of Burch and TVT methods indeendent of osition of elvic organ. Pol Merkur Lekarski 29, 27, [8] Delorme E: Transobturator urethral susension: mini-invasive rocedure in the treatment of stress urinary incontinence in women. Prog Urol 21, 11, [9] Richter HE, Albo ME, Zyczynski HM, Kenton K, Norton PA, Sirls LT: Retroubic versus transobturator midurethral slings for stress incontinence. N Engl J Med 21, 362, [1] Petros PE and Richardson PA: Midurethral Tissue Fixation System sling-a micromethod, for cure of stress incontinence-reliminary reort. Aust N Z J Obstet Gynaecol 25, 45,

5 TOT and Mini-Sling in SUI 855 [11] Cetinel B, Ozkan B, Can G: The validation study of ICIQ-SF Turkish version. Turk Urol J 24, 3, [12] Sivaslioglu AA, Unlubilgin E, Aydogmus S, Celen E, and Dolen I: A rosective randomized controlled trial of the transobturator tae and tissue fixation system mini-sling in 8 atient with stress urinary incontinence-3 year results. Pelvierineology 21, 29, [13] Sivaslioglu AA, Unlubilgin E, Aydogmus S, Keskin L, and Dolen I: A Prosective Randomized Controlled Trial of the Transobturator Tae and Tissue Fixation Mini-Sling in Patients with Stress Urinary Incontinence: 5-Year Results. J Urol 212, 188, [14] DeLancey JO: Structural suort of the urethra as it relates to stress urinary incontinence: the hammock hyothesis. Am J Obstet Gynecol 1994, 17, [15] Magon N, Chora SV: Transobturator Tae in Treatment of Stress Urinary Incontinence: It is Time for a New Gold Standard. N Am J Med 212, 4, [16] Oliveira R, Silva C, Dinis P, Cruz F: Suburethral single incision slings in the treatment of female stress urinary incontinence: what is the evidence for using them in 21? Arch Es Urol 211, 64, Address for corresondence: Mustafa Kara Bozok University Medical Faculty Adnan Menderes Boulevard No Yozgat Turkey Tel: Conflict of interest: None declared Received: Revised: Acceted:

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