Comparison of three different midurethral sling operations using urodynamic evaluation

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1 r l a Re s e a r c h Comarison of three different midurethral sling oerations using urodynamic evaluation g i O in Üç farklı midüretral sling oerasyonunun ürodinamik inceleme kullanılarak karşılaştırılması Comarison of midurethral slings Vehbi Yavuz Tokgoz 1, Omer Tarik Yalcın 2 1 Deartment of Obstetrics and Gynecology, Giresun University, Gıresun, 2 Deartment of Obstetrics and Gynecology, Eskisehir Osmangazi University, Eskisehir, Turkey Present study was carried in Eskisehir Osmangazi University, Deartment of Obstetrics and Gynecology and the manuscrit has not been ublished elsewhere. Öz Amaç: Stress üriner inkontinansı olan hastalarda modifiye midüretral sling, tension-free vajinal tae ve transobturator tae oerasyonlarının ürodinamik inceleme ile etkinliklerininin karşılaştırılması amaçlanmıştır. Gereç ve Yöntem: Stres üriner inkontinansı olan ve 2003 ile 2012 yılları arasında midüretral sling oerasyonu olan 65 hasta çalışmaya dahil edildi. Preoeratif ve ostoeratif ürodinamik değerlendirmeler analiz edildi. Sistometri oerasyonları kür oranlarını satamak için kullanıldı. Valsalva kaçak noktası basıncı, objektif kür oranlarını değerlendirmek ve karşılaştırmak için belirlendi. Bulgular: Oerasyon tileri arasında belirgin farklılık satanamamıştır. Objektif kür oranları; modifiye midüretral sling, tension-free vajinal tae ve transobturator tae için sırasıyla %83.3, %88.9 ve %91.3 olarak satanmıştır. Tension-free vajinal tae, intrinsik sfinkterik yetmezlikte diğer oerasyon tilerine göre daha etkin bulunmuştur. Valsalva kaçak noktası basıncı oerasynların başarısını göstermek için kullanılmıştır. Basınç değerlerine göre, stres üriner inkontinans hastalarında objektif olarak tam kür veya iyileşme sağlandı. Sadece 8 hastada ostoeratif valsalva sonrası kaçak tesit edildi, bu hastalarda da reoeratif düzeylere göre valsalva kaçak noktası basınçları daha yüksek değerlerde satandı. Tartışma: Midüretral sling oerasyonlarının etkinlikleri grular arasında farklı bulunmadı. Valsalva kaçak noktası basıncı objektif kür oranlarını belirlemek için önemli bir arametredir. Modifiye midüretral sling tekniği karşılaştırılabilir başarı oranı ile daha ekonomik bir yöntem olarak gözükmektedir. Anahtar Kelimeler Modifiye Midüretral Sling; Stres Üriner İnkontinans; Tension-Free Vajinal Tae; Transobturator Tae; Valsalva Kaçak Noktası Basıncı Abstract Aim: To use urodynamic evaluation to comare the effectiveness of modified midurethral sling, tension-free vaginal tae, and transobturator tae in the treatment of stress urinary incontinence. Material and Method: A total of 65 atients with stress urinary incontinence underwent midurethral sling oerations between 2003 and Preoerative and ostoerative urodynamic evaluation data were analysed. Cystometry was used to determine the cure rates of oerations. Valsalva leak oint ressure was obtained to assess and comare the objective cure rates. Results: No significant differences were noted between different oeration tyes. Objective cure rates of rocedures were established as 83.3%, 88.9%, and 91.3% for modified midurethral sling, tension-free vaginal tae, and transobturator tae, resectively. Tensionfree vaginal tae was more effective in intrinsic shincteric deficiency than other oeration tyes. Valsalva leak oint ressure showed the effectiveness of the oerations. According to ressure values, stress urinary incontinence were cured or imroved in atients objectively. Only 8 atients had ositive Valsalva leak oint ressure ostoeratively and the mean of ostoerative Valsalva leak oint ressure values was higher than that of reoerative levels. Discussion: Effectiveness of midurethral sling oerations did not differ between grous. Valsalva leak oint ressure is an imortant marker to determine objective cure rates. Modified midurethral sling techniques are more economical with comarable success rates. Keywords Modified Midurethral Sling; Stress Urinary Incontinence; Tension-Free Vaginal Tae; Transobturator Tae; Valsalva Leak Point DOI: /JCAM.5045 Received: Acceted: Printed: J Clin Anal Med 2017;8(sul 4): Corresonding Author: Vehbi Yavuz Tokgoz, Deartment of Obstetrics and Gynecology, Giresun University School of Medicine, Giresun, Turkey. GSM: mdtokgoz@hotmail.com 336 I Journal of Clinical and Analytical Medicine

2 Comarison of midurethral slings Introduction Urinary incontinence (UI) is defined as the comlaint of any involuntary leakage of urine [1]. Stress urinary incontinence (SUI), which mainly occurs during hysical activity due to the urethral shincteric insufficiency, may affect u to 60% of women with UI in a ure or mixed form accomanied by detrusor overactivity (D [2-4]. The mainstay of the treatment of SUI has been imroving urethral sufficiency using a variety of tyes of oerations. Minimally invasive midurethral sling oerations develoed in recent decades, including tension-free vaginal tae () and transobturator tae (), have had high success and low comlication rates and have been acceted as gold standard rocedures for SUI [5-9]. However, the high cost of the sling devices and meshes is a significant burden for effective treatment of SUI in develoing countries with limited healthcare sources. In resonse, many modified techniques have been develoed to reduce the cost without decreasing the success [10]. In the literature there are only a few studies that comare to ubovaginal sling and to ubovaginal sling [11]. Additionally, there are no more studies about synthetic ubovaginal sling rocedures. The aim of our study is to comare cure rates, efficacy rates, and comlication rates among atients who underwent,, and modified midurethral sling oerations for anti-incontinence surgery. Material and Method The study oulation consisted of atients who underwent midurethral sling oerations for stress urinary incontinence (SUI) and mixed urinary incontinence (MUI) between Aril 2003 and Aril The study was aroved by the Ethics Review Board and conducted in Eskisehir Osmangazi University, Deartment of Obstetrics and Gynecology. Eigthy-six atients were evaluated retrosectively. Urogynecological evaluation and urodynamic studies were erformed reoeratively for all atients. Twenty-one atients who did not come to their follow-us and whose medical information couldn t be gained or had missing data were excluded from the study oulation. We assessed age, number of arity, and tye of delivery (sontaneous vaginal or caesarean section) as demograhic arameters. Urodynamic studies (cystometry), which were routine rocedure for SUI oerations in our clinic, were erformed on all atients reoeratively. Urine testing and culture were obtained before the urodynamic test. Postvoiding residual volume (PVR) was assessed before starting the urodynamic testing by sterile catheterization. Maximum bladder caacity, maximum vesical ressure, VLPP (valsalva leak oint ressure), and maximum detrusor ressure were evaluated by the urodynamic test and were recorded with a comuter rogram. VLPP was obtained with the subject seated when the total infused volume reached 200 ml by asking the atient to erform a Valsalva maneuver until urine loss was directly observed. We retrosectively analysed the data obtained from these recordings. According to atients comlaints and urodynamic test results we categorized them into two grous: SUI and MUI. We diagnosed the SUI by confirmation of ositive stress test during the urodynamic test. For atients who had MUI and who had no resonse to any medications, we recommended and erformed surgery for SUI. We erformed three different oeration tyes during the study eriod. Modified midurethral sling (MMUS) oerations were erformed using the abdominovaginal route with synthetic mersilene mesh. In this technique, first an fannenstiel incision was erformed and a trocar was directed to-to-bottom to the vaginal incision. Then synthetic mersilene mesh was fixed to the trocar and ulled out by the trocar from the abdominal incision. After that, sutures of the mesh were adjusted and then tied. The second oeration tye was. In this technique we used the bottom-to-to technique (from the vaginal incision to ubic bone). The third oeration tye was. We erformed an inside-to-outside technique named -O and develoed by de Leval, hereafter referred to as. All of the oerations were erformed by a single exerienced surgeon. Intraoerative comlications were identified. Patients who had mesh erosion were recorded. Patients were invited to the hosital with a telehone call asking them to come for evaluation. They were informed about this study and informed consent was obtained. Present comlaints, articularly those related to stress urinary incontinence, were questioned as resent or absent. Urodynamic tests were erformed to detect objective cure rates. Before the urodynamic tests, PVR was established by sterile catheterization. As with the reoerative rocedure, test data was recorded with a comuter rogram. After these evaluations subjective cure rates and objective cure rates were determined. The absence of involuntary urine leakage was designated subjective cure and negative stress test and no VLPP in the urodynamic test was designated objective cure. Statistical analysis was erformed to comare oeration tyes and to detect differences between reoerative and ostoerative data. Statistical analysis was conducted using SPSS version One-way ANOVA, Indeendent Samles Kruskal- Wallis Test, Pearson Chi-Square Test, Paired-samle t-test, and Related-samles Wilcoxon Test were used. A value <0.05 was considered statistically significant. Results We evaluated 65 atients; modified midurethral sling (MMUS),, and oerations were erformed for 24, 18, and 23 atients, resectively. Demograhic characteristics of atients and reoerative urodynamic results were assessed (Table 1). In the reoerative diagnoses of atients, 28 atients (43.1%) had ure stress urinary incontinence and 37 atients (56.9%) had mixed urinary incontinence. One bladder erforation was seen as an intraoerative comlication; it occurred during the MMUS rocedure. Among all atients, the rate of bladder erforation was evaluated as 1.5% but for the MMUS rocedure this rate was evaluated as 4.1%. Bladder erforation was determined intraoeratively by cystoscoy. The atient was followed with 168 hours of bladder catheterization. After catheterization there was no roblem and the atient was discharged from hosital. We did not see any major comlications, such as major vessel and nerve injury, other than the bladder erforation. Follow-u duration of our atients was in a wide range, from 11 Journal of Clinical and Analytical Medicine I 337

3 Comarison of midurethral slings Table 1. Demograhic characteristics and reoerative Urodynamic results of atients MMUS (n=24) (n=18) months to 114 months. Mean evaluation durations in ostoerative eriod were 76.04, 46.11, and months for MMUS,, and resectively (>0.05). We did not determine any statistical significance for VLPP values ostoeratively. There were only 8 cases that had ositive VLPP ostoeratively so the statistical analysis was not alicable for VLPP. Preoerative and ostoerative urodynamic test results were evaluated. When we comared maximum vesical ressure and maximum detrusor ressure between reoerative and ostoerative urodynamic tests, we determined that the values of both arameters decreased after the oerations and these decreases were statistically significant (<0.05). In the analysis of VLPP values, the mean of ostoerative values was higher than that of reoerative values and this was statistically significant (<0.05). Eight atients had VLPP ostoeratively. We determined that significant imrovement and satisfaction were obtained ostoeratively for most of these 8 atients. VLPP, a arameter for objective diagnosis of stress urinary incontinence, was used to detect resonse of the treatment ostoeratively. Preoerative and ostoerative mean values of VLPP were comared between oeration tyes (Table 2). Among ostoerative urodynamic evaluation of 13 atients who had <60 cm H2O ressure of VLPP reoeratively, 11 of them (84.6%) had no VLPP and only 2 had ositive VLPP (15.4%) ostoeratively. These two atients had higher VLPP levels than their reoerative levels; the increase in VLPP may demonstrate the effectiveness of oerations so we determined these results as imrovement. We established imrovement in atients who had cm H2O ressure of VLPP and >100 cm H2O ressure of VLPP with (n=23) Age (years) 52.04± ± ±12.12 >0.05 Parity (numbers) 3.75± ± ±1.60 >0.05 Number of SVD 3.82± ± ±1.64 >0.05 Caacity of bladder (ml) Vesical Detrusor ressure ± ± ± ± ± ± ± ± ± PVR (ml) 16.45± ± ± VLPP 72.61± ± ± , Oneway ANOVA Test Indeendent Samles Kruskal-Wallis Test Values are given as mean ±SD, MMUS, modified midurethral sling PVR, Postvoiding residual volume SD, Standard deviation SVD, sontaneous vaginal delivery, tension-free vaginal tae, transobturator tae VLPP, valsalva leak oint ressure a rate of 84.6% and 92.3%, resectively. We comared the classification of ostoerative VLPP values and we did not find any significant differences between oeration tyes (>0.05) (Table 3). Evaluation of ostoerative VLPP values are significant and imortant in terms of objective cure assessment. Comarative analysis of oeration tyes showed that objective cure rates were 83.3%, 88.9%, and 91.3% for MMUS,, and resectively (Table 3). In the follow-u rocess 3 atients exerienced mesh erosion. The rate of erosion was 4.6% among all atients; 8.3% (n=2) in the MMUS grou; 0% (n=0) in the grou; and 4.3% (n=1) in the grou. When we comared rate of mesh erosion between oeration tyes, there was no statistical significance (>0.05). Discussion We comared sling oerations for atients with SUI or MUI and evaluated subjective and objective cure rates. We found that subjective cure rates for MMUS,, and were 79.1%, 94.4%, and 91.4% resectively. Objective cure rates for MMUS,, and were 83.3%, 88.9%, and 91.3% resectively. We did not determine any significant differences between oeration tyes in terms of objective and subjective cure rates. There are several studies that comare the effectiveness of sling oerations. In the Cochrane meta-analysis that evaluated cure rates of and, cure rates were reorted as 73% for both oerations [12]. In a randomized study, Richter et al. showed no significant differences for objective cure rates between and oerations (-77.7% vs -80.8%) [13]. Hung et al. comared and ubovaginal sling with synthetic mesh, finding 91.3% and 93% imrovement in and ubovaginal sling with synthethic mesh, resectively [14]. We determined objective cure rates using urodynamic evaluation (cystometry). Urodynamic evaluation rovides some data to detect the stress comonent of urinary incontinence. In articular, VLPP values give more information to clinicians in understanding of ISD (intrinsic shincteric deficiency). Although there are some differences among atients, most clinicians Table 2. Comarison of reoerative and ostoerative urodynamic outcomes according to oeration tyes Bladder Caacity (ml) Vesical VLPP Detrusor PVR (ml) MMUS (n=24) (n=18) (n=23) Preoerative ± ± ± Postoerative ± ± ±79.25 Preoerative 19.20± ± ± Postoerative 17.20± ± ±6.81 Preoerative 71.00± ± ± Postoerative ± ± ±2.82 Preoerative 13.75± ± ± Postoerative 14.54± ± ±7.10 Preoerative 16.45± ± ± Postoerative 11.95± ± ±18.02 Paired Samles t-test, Related-Samles Wilcoxon Test, statistical significant was not evaluated Values are given as mean ±SD, MMUS, modified midurethral sling PVR, Postvoiding residual volume SD, Standard deviation, tension-free vaginal tae, transobturator tae VLPP, valsalva leak oint ressure I Journal of Clinical and Analytical Medicine

4 Comarison of midurethral slings Table 3. Postoerative VLPP and Objective Cure rates between oeration tyes Postoerative VLPP (cm H2 MMUS Absent 20 (83.3) 16 (88.9) 21 (91.3) <60 0 (0) 0 (0) 0 (0) (4.2) 1 (5.6) 0 (0) >100 3 (12.5) 1 (5.6) 2 (8.7) think that a VLPP value below 60 cmh2o confirms the diagnosis of ISD [15]. We classified VLPP values according to the ressure levels and comared ostoerative findings between oeration tyes. When we evaluated the atients who had VLPP values below 60 cm H2O, a comlete cure was obtained in 84.6% of atients. Higher ressure values of VLPP (>100 cm H2 raised the success rate to 92.3% in the resent study. Similarly, Young et al. found significant differences between atients according to whether they had ISD and they showed significantly higher cure rates in the no-isd grou (<0.001) [16]. Another study indicated that low VLPP values (<60 cm H2 may be an indeendent marker for treatment failure [17]. Rechberger et al. showed that low VLPP levels lead to oor treatment resonse in oerations but not in oerations [18]. The success rates of our study for ISD atients was 100% in the grou and 75% in the grou. Similar to our study, Kim et al. established that the success rate of was significantly higher than for in atients who had ISD (, 95.2% vs, 82.7%) [19]. They showed risk factors of treatment failure and found that is the only risk factor associated with treatment failure after 12 months follow-u. Therefore is considered the referred method in atients with ISD because it is a more obstructive technique than [20]. Contrary to these studies, some authors have concluded that is comarable to in ISD [13,21]. Another study which comared ubovaginal sling,, and observed similar comlication rates among oerations for ISD; however, cure rates for were lower (34.9%) than for (87%) and ubovaginal sling (87.3%) [22]. When we evaluated the objective cure rates of atients according to VLPP values, we did not find any significant differences between oeration tyes (MMUS,, and ; 83.3%, 88.9%, and 91.3% resectively) (=0.834). In several studies, similar cure rates were reorted but in the resent study we determined higher objective cure rates than in other studies. Some studies that aroved VLPP values as objective criteria showed lower cure rates comared to our study [13,23]. The most imortant comlication of midurethral sling oerations is bladder erforation. It is also the most common comlication of at a rate of % [24-27]. In a study that comared and ubovaginal sling with synthetic mesh, the rate of bladder erforation was 4.3% in atients and 0% in ubovaginal sling atients (=0.287) [14]. Castillo-Pino et al. found that bladder injuries occurred in the grou at a rate of 5.5% and no bladder erforation was shown in the grou (=0.14) [23]. In our study, one bladder injury occurred, Objective Cure Rate 20(83.3) 16 (88.9) 21 (91.3) >0.05 Pearson Chi-Square Test MMUS, modified midurethral sling, tension-free vaginal tae, transobturator tae VLPP, valsalva leak oint ressure and it was in the MMUS grou. The rate of bladder injury was 4.1% in the MMUS grou and there was no bladder comlication in the and grous. Another imortant comlication is mesh erosion, which develos in the late ostoerative eriod. A meta-analysis by Novara et al. did not find any significant differences between and with regard to mesh erosion [28]. Abouassaly et al. found that mesh erosion occurred at a rate of 0.4% and 1.4% in and oerations, resectively [26]. Some researchers think that the hammock-shaed structure of creates more contact area than the U-shaed structure of, leading to increased inflammation and erosion rates in oerations [29]. In the resent study, we established mesh erosions in 3 atients, 2 of them in the MMUS grou (8.3%) and the other one in the grou. There was no mesh erosion in the grou. These rates are high comared to the literature, but may be exlained by the small samle size. According to the cost-effectiveness analysis of our study, and oerations have higher costs because they use secial materials. Only rolene or mersilene mesh is required for modified sling oerations and this decreases the oeration cost. Average costs of and currently are $ (USD), whereas the cost of mesh for modified sling oerations is aroximately $ As we have seen, modified sling oerations have significantly lower materials costs than and oerations. In one study, the cure rate was determined as 81.3% for ubovaginal sling oerations with olyroylene mesh, and their low cost was also established [30]. ElSheemy et al. comared surgeon-tailored modified technique (STM) with original -O [31]. There was no significant difference in cure rates between oeration tyes (=0.654), but surgical cost decreased significantly from $500 to $10. They also found MUI and urgency imrovement similar to our study. Polyroylene self-tailored mesh has been used by many surgeons and costs of surgery have decreased significantly [32-34]. When -O (with STM) was comared to in one study, it was reorted that cure rates did not show any significant difference, while surgical costs were significantly reduced by the STM method [35]. The surgeon-tailored mesh method has an advantage in develoing countries with few financial resources and it may be considered as a low-cost alternative for treating SUI atients. We erformed MMUS oerations as a cost-effective method with similar cure rates comared to and. Our study has several limitations. Firstly, this study is not a randomized controlled study. Non-random atient selection method is the main limitation. Heterogenous study grous with SUI and MUI is another limitation of our study. Follow-u duration is in a wide range and it is variable in our study. Objective questionnaires were not used to determine subjective cure rates in the resent study. However, the strengths of our study include that it is single exerienced surgeon data and VLPP is used to detect the objective cure rate of oerations. There are few studies using single surgeon data and VLPP is not commonly used to demonstrate the objective cure rates of oerations. In conclusion, the subjective and objective cure rates of atients treated with MMUS,, and were similar and there was no statistically significant differences. VLPP rovides a quantitative comonent of urodynamic evaluation that is useful in SUI Journal of Clinical and Analytical Medicine I 339

5 Comarison of midurethral slings atients and esecially for ISD. Modified sling oerations may be referred in some situations instead of or because of low costs. Further rosective randomized controlled trials are required to confirm our results. Cometing interests The authors declare that they have no cometing interests. References 1. Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U et al. The standardisation of terminology in lower urinary tract function: reort from the standardisation sub-committee of the International Continence Society. Urology 2003;61(1): Norton P, Brubaker L. Urinary incontinence in women. Lancet 2006;367(9504): Hunskaar S, Lose G, Sykes D, Voss S. The revalence of urinary incontinence in women in four Euroean countries. BJU Int 2004;93(3): Hunskaar S, Burgio K, Diokno A, Herzog AR, Hjalmas K, Laitan MC. Eidemiology and natural history of urinary incontinence in women. Urology 2003;62(4 Sul 1): Dainer M, Hall CD, Choe J, Bhatia NN. 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An inexensive modified transobturator vaginal tae inside-out rocedure for the surgical treatment of female stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 2009;20(11): Chen X, Tong X, Jiang M, Li H, Qiu J, Shao L et al. A modified inexensive transobturator vaginal tae inside-out rocedure versus tension-free vaginal tae for the treatment of SUI: a rosective comarative study. Arch Gynecol Obstet 2011;284(6): How to cite this article: Tokgoz VY, Yalcın OT. Comarison of Three Different Midurethral Sling Oerations Using Urodynamic Evaluation. J Clin Anal Med 2017;8(sul 4): I Journal of Clinical and Analytical Medicine