Short-term Effects of TVT-O Operations at AUH from

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1 Short-term Effects of TVT-O Operations at AUH from Navn: Stine Broch Mortensen Studienummer: Vejleder: Susanne Axelsen, Contents Resume... 2 Introduction... 3 Methods... 4 Study population and period... 4 Data... 4 Statistics... 5 Approvals... 5 Results... 5 Postoperative complications... 6 Improvement... 7 Follow-up compared to non-follow-up... 8 Discussion... 9 References /10

2 Resume Introduktion: Stressinkontinens er en lidelse, der rammer mange kvinder. Efter konservative behandlingsmetoder er mid-uretral slynge første kirurgiske valg. Der er udviklet flere forskelige typer bl.a. The Transobturator Vaginal Tape Inside-Out (TVT-O) procedure. I Danmark indrapporteres alle urogynækologiske operationer til en landsdækkende database, DugaBasen. Ved hjælp af data fra Dugabasen undersøges effekten og eventuelle bivirkninger ved TVT-O operation. Metode: Udtræk af data fra DugaBasen med operationskoden KLEG10A fra år De, der manglede follow-up, blev kontaktet pr telefon med henblik på udfyldelse af manglende spørgsmål. Der blev foretaget statistisk analyse af komplikationer og patienternes sammenligning af tilstanden før og efter operation. Resultat: 63 patienter blev inkluderet i analysen. 23,8% oplevede komplikationer efter operationen, hovedsagelig vandladningsproblemer, smerter og urininfektion. 81% syntes at deres tilstand var meget bedre efter operation, og i alt svarede 96,8% at deres tilstand var forbedret. Der var signifikant forskel på, hvor meget symptomerne generede patienterne før og efter operationen. Konklusion: Kvinder, der TVT-O opereret for stressinkontinens på Afdeling for Kvindesygdomme og Fødsler på Århus Universitetshospital, oplever generelt en god subjektiv forbedring af tilstanden. Dog kræves et grundigere follow-up arbejde og en større mængde operationer for at differentiere mellem hvem, der oplever komplikationer, og graden af forbedring. 2/10

3 Introduction Urinary incontinence (UI) is a condition that affects many women. The overall prevalence of urinary incontinence in women is estimated to be between 10% and 40% 1, and increasing with age. 7 In Denmark the prevalence is 16%, however only estimated in one study. 2 Of the different forms of urinary incontinence stress urinary incontinence (SUI) is the most common type. The other types are urgency urinary incontinence and mixed urinary incontinence. SUI accounts for at least 50% of cases of urinary incontinence in women. 1 SUI is the involuntary loss of urine that occurs with physical exertion (e.g. sporting activities), or on sneezing or coughing. 1 According to the European Association of Urology guidelines midurethral slings (MUS) are the first line surgical offers for female SUI after failure of conservative measures 3 such as pelvic floor muscle training. 1 Different types of MUS operations exist. The first, the retropubic route, was described by Ulmsten et al. in 1996, using a transvaginal retropubic insertion of a tape under the midurethra 4 The Transobturator Vaginal Tape Inside-Out (TVT-O), was first described by de Leval in Instead of a retropubic approach, the tape was placed outward through the obturator foramen from a suburethral incision in the anterior vaginal wall. 5 Adverse events vary between the different types of MUS operations. A newly published review concludes that groin pain is seen more often following TVT-O compared to the retropubic route, whereas everse advents as bladder perforation and postoperative voiding dysfunction happen less frequently following TVT-O. 1 In Denmark all surgeries for urinary incontinence is reported to a nationwide database. This database, The Danish Urogynaecological Database (DugaBase), was established in 2006, and it is mandatory by law for all public and private departments to report all surgical activity to the database. 6 The DugaBase was established to monitor, ensure and improve the quality of urogynaecological surgery. 7 In 2010 the registration was nearly complete with a 93.2% registration for public hospitals, and the agreement between the DugaBase and medical records was at least 90% for selected variables, such as surgical procedure code, use of antibiotic prophylaxis, height, weight and smoking. 6 The database includes patient reported subjective measurements on the outcome of the surgery. 7 3/10

4 The aim of this study is to evaluate the patient-reported short-term effects and possible adverse events of TVT-O operations at the Department (Dept.) of Gynecology and Obstetrics at Aarhus University Hospital from Methods Study population and period Women undergoing TVT-O surgery for urinary incontinence at the Dept. of Gynecology and Obstetrics at Aarhus University Hospital from the years 2014 and Only women with all parts of the DugaBase completed were included in the analysis. Data Data was collected from the DugaBase regarding information on all TVT-O operations (code KLEG10A) performed at the Dept. of Gynecology and Obstetrics at Aarhus University Hospital from the years The DugaBase consists of several parts: 1. Information on referral diagnosis and date. 2. A self-administered patient questionnaire prior to the first preoperative doctors exam. The questionnaire contains questions based on the validated International Consultation on Incontinence Questionnaire (ICIQ) on symptoms and disease-specific quality of life, translated to Danish Questions completed by the gynecologist. This includes preoperative examination with baseline information on patient characteristics. 4. Information about the surgical procedure. 5. Follow-up data containing the same questions as before surgery including possible complications and a patient reported comparison to the condition prior to surgery. Patients were given the possibility to answer improved very much, improved much, improved slightly, no change, worsened slightly, worsened much and worsened considerably. The follow-up part is usually completed by a telephone interview conducted by a nurse 3-6 months after surgery. Patients missing the follow-up part were telephoned at the beginning of this study. 4/10

5 Statistics Adverse events were divided into groups by the author based on the type of complication. The patient characteristic between the group with no complications and the ones with complication were analyzed using 2-sample t-test for continuous variables and chi-square test for categorical variables. How the patients compared their condition to prior to surgery was used as measurement for subjective satisfaction. Due to a limited number of patients statistical analysis was only performed between the three levels of improving (very much, much and slightly). Here, patient characteristics were compared using One-way ANOVA for various variables and Chi-square test for categorical variables. Paired t-test was used to analyze the botherscore before and after surgery. Pre-surgery characteristics and symptom load between the ones with follow-up and those without were also compared, using the same tests as for complications. A p-value less than 0.05 was considered significant. Approvals The study was approved by the Danish Data Protection Agency ( ). No further approval was necessary as this was a register-based study. Results From January 2014 to December 2015, 91 operations were registered in the DugaBase. From these, 38 were missing the follow-up part of the registration. For two patients the questionnaire could be completed using information from their medical file. The remaining 36 patients were contacted by telephone, and 8 completed the questionnaire by this contact. In total, 63 patients were included in this analysis (fig. 1). The follow-up time varied from 17 to 975 days. (fig. 2) 5/10

6 Number of patients Days from surgery to follow-up Figure 1: Flow-chart Figure 2: Days from surgery to the follow-up questionnaire was completed. Postoperative complications Postoperative complications were reported by 23.8% (15) of the patients. The complications were divided into groups (fig. 3). Six patients reported urinary problems, such as micturition problems, postoperative de novo onset of urge-symptoms and incomplete emptying. Four patients reported pain in the groin and leg, some short-term and some persistent. Two patients had urinary infection needing antibiotics. One patient experienced strong bleeding one day postoperatively. One had the sling operatively removed due to perforation of the bladder. One needed observation for deep vein thrombosis (DVT) (the location and whether the patient actually had a DVT was unclear in the data). There was no significant difference in the baseline characteristics age (P = 0.941), BMI (P = 0.477), smoking (P = 0.224) and previous UI surgery (P = 0.292) between patients with and without complications. Though 23.8 % experienced complications postoperative, only 4,8% (3) of the patients needed reoperation. The patient with bladder perforation was reoperated and with no complications and good effect the second time. One needed the sling loosened due to micturition problems, and one needed it tightened due to weight. 6/10

7 Number of patients Others Bleeding Infection Bladder perferation 2 Postoperative complications 1 4 Pain 6 Urinary problems Figure 3: Distribution of complications divided into categories. Improvement Before surgery all patients but one leaked during physical activity and/or when coughing or sneezing. Besides that, patients leaked before reaching the toilet and after using the toilet. A few leaked during sleep, some for no reason and three leaked continuously throughout the day. One patient answered no to all possibilities, making it uncertain what the indication for surgery was, unless it is due to a false entering of data to the database. After TVT-O operation 60.3% (38) of the patients answered that they no longer leaked urine (Fig. 4). Number of patients Never Before reaching the toilet Choughing and sneezing Times of leaking 2 1 During sleep 56 9 Physical activity After using the toilet For no reason Continuously Before TVT-O After TVT-O Figure 4: Comparison of situations patients leaked from before to after surgery 7/10

8 81% (51) of all patients answered that their condition improved very much after surgery, 8% (5) improved much and slightly and only 3.2% (2) reported no change or worsening of their symptoms. Overall, 96.8 % (61) of the patients benefitted from TVT-O operation. Baseline characteristics between the categories improved very much, improved much and improved slightly did not differ significantly. (Table 1) Improved very much Improved much Improved slightly P-value Number 51 (81%) 5 (8%) 5 (8%) BMI kg/m 2, mean Age, years, mean Smoking never former yes Previous UI surgery yes no don t know Table 1: Comparison of baseline patient characteristics prior to surgery according to how much their condition improved. Both pre- and postoperatively the patients were asked how much on a visual analog scale from 0 to 10 they were bothered by their UI. The difference before and after surgery was significant (95% Cl 6.03; , p = < 0.001) Follow-up compared to non-follow-up Comparing the women with completed follow-up questionnaire to the women lost for follow-up there was no difference in any of the baseline characteristics (age, BMI, smoking and previous UI surgery). On the botherscore question before the operation, there was a none-significant difference of 0.11 (95% Cl ; , p = 0.841) between the two groups. 8/10

9 Discussion This study shows that women undergoing TVT-O surgery for SUI at the Dept. of Gynecology and Obstetrics at Aarhus University Hospital experience an overall improvement of symptoms. Subjectively the women felt significantly less bothered by their symptoms postoperatively and though 23.8% experienced some sort of complications due to surgery, 96.8% still felt that their condition improved postoperatively % even state that they no longer have any episodes of leaking. In other studies, subjective satisfaction was at a level of 91.7 % 8, 88 % 9 and 91.4 % 10. But comparison can be difficult as different studies uses different measurements for subjective improvement. The complications patients experienced in this study are similar to the complications described in other studies 8, 9, 1. These studies together conclude that the main complications to TVT-O surgery are urinary problems (mainly de novo overactive bladder symptoms), urinary infection and groin pain. This study also has weaknesses. 28 of the 91 (30.8%) patients operated in this period were lost for follow-up. Although there was no difference found in baseline characteristics or the extent of their subjective symptoms some selection bias cannot be ruled out. The follow-up time is another problem. The follow-up part of the DugaBase is meant to be conducted 3-6 months after surgery. In this study the follow-up period various between 17 and 975 days. This might bias the outcome, because it is likely that the same patient would give slightly different answers and ratings depending on how many months after surgery, they are questioned. The largest uncertainty concerns the categorizing of the adverse events. In the DugaBase complications are answered with a yes or no and then a line of free-text. The information about the different complications is very depended on the interviewer and how they interpret the patients answers, and how much information they decide to type into the database. For a more precise examination on complications a thorough interview or review of medical journals would be necessary. Since only one person stated that their condition was worsened since surgery, it was not possible to detect difference between those benefitting from surgery and those who did not. No difference was detected between the different levels of improvement, which was not unexpected. 9/10

10 In conclusion, this study shows a high subjective improvement among women undergoing TVT-O operation at the Dept. of Gynecology and Obstetrics at Aarhus University Hospital. To detect some differences between patients experiencing complications and patients who do not, as well as a difference between patients experiencing a higher subjective satisfaction rate than others, a more thorough follow-up would be necessary, including a longer period of operations. References 1 A.A. Ford, L. Rogerson, J.D. Cody, J. Ogah (2015) Mid-urethral sling operations for stress urinary incontinence in women. Cochrane Database Syst Rev (7) CD Møller LA, Lose G, Jørgensen T (2000) The prevalence and bothersomeness of lower urinary tract symptoms in women years of age. Acta Obstet Gynecol Scand 79: Malcolm GL et al (2012) EAU Guidelines on Surgical Treatment of Urinary Incontinence. Eur Urol 62: Ulmsten U, Henriksson L, Johnson P, Varhos G (1996) An ambula- tory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J 7: de Leval J (2003) (2003) Novel surgical technique for the treatment of female stress urinary incontinence: transbturator vaginal tape inside-out. Eur Urol 44: Guldberg R, Brostrøm S, Hansen JK et al (2012) The Danish Urogynaecological Database: establisment, completenes and validation. Int Urogynecol J 23: Guldberg R, Kesmodel US et al (2012) Patient reported outcome measures in women undergoing surgery for urinary inkontinence and pelvic organ prolaps in Denmark, Laurikainen E, Valpas A et al (2014) Five-year results of a randomized trial comparing retropubic and transobturator midurethral slings for stress incontinence. Eur Urol 65: Aigmüller T, Tammaa A, Tamussino K et al (2014) Retropubic vs. transobturator tension-free vaginal tape for female stress urinary incontinence: 3-months results of randomized trial. Int. Urogynecol J 25: Serati M, Bauer R, Cornu JN et al (2012) TVT-O for the treatment of pure urodynamic stress incontinence: Effiacy, adverse events, and prognostic factors at 5 year follow-up. Eur. Urol. 63: /10