Tension-Free Vaginal Taping in Pakistani Women with Stress Urinary Incontinence

Transcription

1 ORIGINAL ARTICLE Tension-Free Vaginal Taping in Pakistani Women with Stress Urinary Incontinence Ayesha Saleem ABSTRACT Objective: To evaluate the effectiveness and determine the peroperative and postoperative complications of tension-free vaginal tape (TVT) sling for urinary stress incontinence (USI) and contributing factors to complications. Study Design: Descriptive study. Place and Duration of Study: Kidney Centre Postgraduate Institute, Karachi, from January 2009 to December Methodology: One hundred consecutive patients underwent TVT as per Ulmsten Technique for urinary stress incontinence and patients were followed for 3 years. The subjective cure rate and improvement rate was based on the international consultation on incontinence questionnaire for evaluating female lower urinary tract symptoms (ICIQ - FLUS). The subjective cure was defined as the statement of the woman not experiencing any loss of urine upon physical stress and improvement rate was defined as occasional leakage during stress. Results: Patients at 1- and 3-year up follow-up showed subjective cure rate and improvement rate of 98% and 2%, and 95% and 5%, respectively. Mean operative time was 32 minutes. UTI was the commonest complication observed in 7 (7%) patients. Women with voiding dysfunction preoperatively had 9-fold odds of difficulty postoperatively (0<0.001). There was a significant association of preoperative symptoms of overactive bladder (OAB) with the same postoperative symptoms (p<0.0001). Preoperative hysterectomy had a significant (p< 0.005) fold odds of intraoperative bladder perforation. Conclusion: Tension-free vaginal tape sling is an efficacious and secure surgical procedure for the treatment of urinary stress incontinence. Bladder perforation, voiding dysfunction, supra-pubic discomfort and UTI are the commonest complications. Risk factors for perforation include preoperative hysterectomy. Pre-existing voiding dysfunction and UTI lead to persistent similar postoperative problems. Key Words: Bladder perforation. Complication. Contributing risk factors. Urinary stress incontinence. Tension-free vaginal tape sling operation. INTRODUCTION Among the female population, incontinence of urine varies 23-45%. 1 Significant symptoms of urinary incontinence found in about 7%, of which 50% are urinary stress incontinence (USI). 2 USI is defined as an unintentional urinary leakage from the urethra, during physical activity such as coughing, sneezing, laughing or excercise. 3 Until recently, the criterion treatment modality of female urinary stress incontinence (USI) was Burch coloposuspension. 4 Tension-free vaginal tape (TVT) sling procedure has been proved to be a better option with considerably less complications and as efficient as Burch colposupsension. 5 It is the least invasive procedure and has long-term objective success rate. 6 Inspite of the high success rate, it is pertinent to consider the safety of TVT sling procedure in relation to the injury of bowel, major blood vessels, bladder and urethra as well postoperative voiding dysfunctions. 7,8 The Kidney Centre, Postgraduate Training Institute, Karachi. Correspondence: Dr. Ayesha Saleem, Consultant Urologist, The Kidney Centre, Postgraduate Training Institute, Rafiqui Shaheed Road, Karachi. femaleurologistasaleem.urology@yahoo.com Received: January 09, 2016; Accepted: June 17, The complications associated with TVT procedures, include (3.5-6%) frequency of perforation of bladder, significant blood loss ( %), retention of urine requiring catheterization for >24 hours (4-49%), urinary tract infection ( %), and pyrexia >38 C ( %). 9,10 Still very limited data is available from Pakistan where TVT is not a frequently performed procedure. The objective of the this study was to evaluate the effectiveness and complications of TVT sling operation as well as identifying the factors contributing to complications in Pakistani women. METHODOLOGY One hundred patients, who had TVT procedure performed by the same surgeon from January 2009 to December 2010 at Kidney Centre, Postgraduate Institute, Karachi, were recruited into the study. Hospital Ethical Review Committee granted the ethical clearance. Patients who had the urinary volume of 300 ml in bladder, with a positive cough test (CST) performed in a semi-lithotomy position, were inducted. Women with recurrent and persistent infections of urinary tract, pelvic organ prolapse, urge incontinence and having history of anti-incontinence procedure, were excluded. Operative definitions were adopted from the latest International Urogyn-ecological Association (IUGA/ 362 Journal of the College of Physicians and Surgeons Pakistan 2017, Vol. 27 (6):

2 Tension-free vaginal taping in Pakistani women with stress urinary incontinence International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. 11 Patients were evaluated preoperatively consisting of standardized urogynecological history, physical examinations, erect stress test (EST), cough stress test (CST), blood sugar, urinalysis, culture, ultrasound postvoid residual, and uroflowmetry. EST was performed with a urinary volume of 300 ml of urine, the patient standing over a sheet and coughing vigorously 10 times. Ultrasound used as diagnostic modality to confirm bladder volume. The CST was performed with the patient lying supine and coughing vigorously for up to three times. Urinary leakage during coughing was defined as a positive cough stress test, and absence of urinary leakage as negative test. Uro-dynamics study was not performed in present study to keep the study simpler and costeffective. The TVT operations were accomplished under general or spinal anesthesia, according to the previously described procedure. 12 Duration of patient stay in hospital, voiding status upon discharge from hospital, number of catheterization days, presence of voiding difficulty, presence of fever 37.5 C, supra-pubic pain, need for tape loosening, and readmission were recorded. The perioperative period was defined as < 4 weeks from the date of surgery. Patients were evaluated at 1st week, 1st month, 6th month, 1, 2 and 3 years follow-up postoperatively. Standardized urogynecological history was taken. Physical examination, EST, CST, pad test, blood sugar, urinalysis, culture, ultrasound for post-void residual volume and uroflowmetry were performed on each follow-up visit. Voiding difficulty was defined as post-void urine volume of greater than 150 ml on bladder ultrasound scan. Postoperative complication, like supra-pubic pain, tape erosion, voiding difficulty, need for tape division or loosening, infection, newly-developed urgency and urge urinary incontinence after the procedure, were categorized according to onset-time into 2 weeks to < 6 months, 1-year, 2-year and 3-year postoperatively. The parameters recorded were patient's age, BMI, menopausal status, clinical conclusion, clinical symptoms at presentation, physical examination, medical and surgical history, duration of surgery, type of anesthesia, intraoperative complications, including hematoma formation, urethral injury, bladder perforation, vascular injury, and haemorrhage. Amount of bleeding during surgery was estimated from the surgical sponge saturation and suction tallies by the responsible surgical team. IUGA recommendations were used for outcome measures. 13 Objective Silhouetted cure was no urinary leakage during CST. 1 Subjective cure was defined as the statement of the woman, upon physical stress having no experience of urinary leakage. 1 Population characteristics and outcome of the procedures were analyzed and described with simple descriptive statistics. Continuous variables were evaluated as mean (standard deviation) values. Categorical variables were presented in terms of their population. For previous pelvic surgery (hysterectomy and LSCS), logistic regression analysis was performed. Logistic regression was also used to determine whether urinary tract infection before TVT sling procedure led to postoperative urinary tract infection, preoperative-voiding dysfunction to postoperative voiding dysfunction, preoperative OAB to postoperative OAB. Paired t-test was used to arbitrate the efficacy of the procedure. Patient's subjective and objective assessments were made at 1 month, 1 year, 2 years and 3 years, and compared the subjective and objective symptoms pre- and post-tvt for determination of the efficacy of procedure. RESULTS One hundred consecutive patients, who had TVT procedure performed by the same surgeon from January 2009 to December 2010 and completed 3 years follow-up, were analyzed. Patients characteristics, operative details are given in Table I. The CST and EST were positive in all 100 (100%) patients. Further evaluation showed 73 (73%) patients had a pad test of >20 g, while 27 (27%) had a pad test between gm. Bladder perforation occurred in 03 patients (3%), all patients had history of hysterectomy. There was no injury of urethra, nerve or bowel, or laceration of the vaginal wall. Three out of 100 (3%) had blood loss of ml; 1 pint of blood was transfused to each. Table I: Patients characteristics and operative details. Parameters N=100 Mean ± SD or n(%) Mean age (years) 48.2 ±10.4 Body mass index, kg/m ±3.9 Parity Nulliparous 00 (00%) Para 3 46 (46%) Para 4 35 (35%) Para >5 19 (19%) Mode of delivery SVD (spontaneous vaginal delivery) 69 (69%) LSCS (caesarian delivery) 31 (31%) Pre-menopausal status 33 (33%) Post-menopausal status 67 (67%) Previous hysterectomy 11 (11%) Types of anesthesia: General anesthesia 63 (63%) Spinal anesthesia 27 (27%) Duration of TVT in minutes 32 (25-40) Journal of the College of Physicians and Surgeons Pakistan 2017, Vol. 27 (6):

3 Ayesha Saleem The average length of stay of patient was 2.5 (2-3.5 days). The average duration of catheterization was 1.38 (1-7 days); 3 patients had voiding difficulty with a residual urine value >150 ml. Two patients (2%) developed temperature of >37.5 C 24 hours after surgery, and both settled within 24 hours. None of the patient had urinary tract infection at that time. Seven patients (07%) developed UTI ten days after surgery. Voiding difficulty and voiding dysfunction (OAB) occurred in 3% and 5%, respectively. There was no clinical hematomas observed. Out of the seven patients with postoperative UTI, 4 had UTI prior to the procedure which was treated successfully before TVT. Postoperative complications are elaborated in Table II. Five of the patients (05%) had supra-pubic pain. Four out of 5 patients (4%) had pain for short term period, which was resolved with the use of non-steroidal antiinflammatory analgesics in two months time. In one patient, pain persisted for 1 year, none of the patient had pain at second and third year. None of the patient had tape erosion within a follow-up of 3 years. Three out of 100 (3%) patients had voiding difficulty for 1 week. Postoperatively, (24 hours after catheter removal), 3 had residual volume PVR greater than 150 ml and required catheterization for one week. After one week of catheterization, they were able to pass urine without catheter with a post-void residual less than 30 ml. Voiding dysfunction (symptoms of frequency, nocturia and/or urgency) occurred in 5 patients. All the patients with symptoms of OAB were cured within 6-8 weeks of treatment with anti-cholinergic agents. At 6 follow-ups, none were symptomatic, while 1 (1%) and 4 (4%) patients developed symptoms at 2 and 3 years, respectively. At 2 weeks, de-novo urge incontinence occurred in 2% patients, while none had urge incontinence at follow-up of 6 months, 1, 2 and 3 years. Table III showed logistic regression model predicting postoperative complications. Women with voiding dysfunction preoperatively had 9-fold odds of difficulty postoperatively (p<0.0001). There was an association of preoperative symptoms of OAB with postoperative symptoms of OAB (p<0.0001). Preoperative hysterectomy was significantly associated (p< ) with a fold odds of intraoperative bladder perforation. Preoperative history of UTI had a fold odds of postoperative UTI within two week (p<0.0001). The subjective cure rate and improvement rate was 98%, 2%, and 95%, 5%, 8.2% at 1 and 3 years, respectively. The objective cure rate and improvement rate by CST and EST was 99%, 1%, and 95%, 5% at 1 month and 3 years, respectively. Table II: Postoperative complications N=100 (%). Types of 2 weeks to 1 year 2 years 3 years complications < 6 months N=100 N=100 N=100 N=100 Pain 5 (5%) 1 (1%) 0 0 Erosion Voiding difficulty 3 (3%) Voiding dysfunction 5 (5%) 0 1 (1%) 4 (4%) De-novo urge incontinence 2 (2%) UTI 7 (7%) 3 (3%) 5 (5%) 0 (0%) Tape loosening Tape division Voiding dysfunction (frequency, nocturia,urgency) Table III: Showed logistic regression model predicting postoperative complications. Logistic regression model predicting bladder perforation Characteristics B WALD EXP (B)/OR p- value Previous LSCS < Previous hysterectomy < Logistic regression model predicting postoperative voiding dysfuntion Characteristics B WALD EXP (B)/OR p-value Preoperative voiding dysfunction < Logistic regression model predicting postoperative symptoms of OAB Characteristics B WALD EXP (B)/OR p- value Preoperative symptoms of OAB < Logistic regression model predicting postoperative UTI Characteristics B WALD EXP (B)/OR p-value Preoperative UTI < DISCUSSION The quality of laxity characterized the surrounding ligaments of the mid-urethra due to the trauma of muscles of pelvic floor, bladder neck, and urethra. This trauma, which may occur during the delivery or operation, results in USI. This theory explained an important factor to cure urinary stress incontinence (USI) that is the recreation of an artificial support to midurethra and to reinforce pubo-urethral ligaments. 14 TVT sling operation technique, introduced in 1996, has produced a significant change and improvement in the management of USI surgically. Ulmsten and Petros, first described the integral theory of urethral closure mechanism. The goal of TVT sling operation is to provide support to the middle urethra with the reconstruction of the defects of pubourethral ligaments and also to recreate a vaginal hammock and support of paraurethral tissues for the middle urethra. 15 CST is as reliable as urodynamic study for objective measurement of SUI. 12 European Association Urology 2016 guidelines recommended that in a patient with absent past history of lower urinary tract and either pure USI or stress predominant mixed incontinence, performing uro-dynamics does not improve surgical outcome. 16 Considering the above facts, the authors did not perform uro-dynamic in these patients to keep the study simpler and cost-effective. 364 Journal of the College of Physicians and Surgeons Pakistan 2017, Vol. 27 (6):

4 Tension-free vaginal taping in Pakistani women with stress urinary incontinence The short-term objective cure rate shown by CST 17 and EST as well as subjective cure rates are marginally better than international literature, i.e. 99% of these patients had cure rate objectively at 1 month and 1 year; while at second and third year, it was found to be 98% 95%, respectively. The overall subjective cure rate was 98% after 1 month and after 1 year; while it decreased to 96 and 95% after 2 and 3 years of the procedure. Ninety-nine of our patients were very satisfied, while one of the patient was not very satisfied, because of occasional leakage. Laurikainen et al. reported cure rate objectively and subjectively as 84.7% and 94.2%, respectively 18 ; while Maliheh et al. showed objective and subjective cure rate 83.9% and 81%, respectively. 19 In a series by Costantini et al., 20 the patient achieved 75% cure rate on subjective and objective assessments. In this series of 100 patients, operative time of TVT sling operation was 32 minutes (25-40 minutes); while length of patient in hospital was 2.5 (2-3.5) days. Operative time of ±7.40 minutes and 1.56 ±0.51 days duration of stay in hospital as reported by Maliheh et al. 19 During surgery, there was uncomplicated bladder perforation in 3 of our patients (3%), which is consistent with other reports of 2-6%. 21,22 Three patients required blood transfusion; with blood loss between , drop in haemoglobin was 1 mg/dl, preoperative haemoglobin was 10 mg/dl. Ingrid et al. reported blood loss requiring transfusion in 0.5%. 23 In the study by Annetta et al., blood transfusion required in 3% patients. 24 There was no report of clinical hematoma or tape erosion in our study, while recent studies suggested clinical hematoma 1-4% patients, 23,24 and tape erosion, to 1% patients. After 1-2 months, short-term and 1 year (long-term), supra-pubic discomfort was observed in 5 (5%) and 1 patients, respectively in this series, while previous studies showed short-term discomfort in 5.9%. 22 In this data, short-term urge incontinence developed after the procedure in two patients (2%). Giovanni et al. reported newly developed urge incontinence in 10% patients. 22 After surgery, the short-term (1-3 months) urgency was present in 30 patients (15%), which substantially decreased to 5%, after 1 year of procedure in another study. 23 Voiding difficulties after TVT were reported in 5.4%. 25 In the current study, 3% patients had voiding difficulty. UTI was the most commonly reported symptom in this study, i.e. 7%. Laurikainen et al., Giovvanei et al. and Ingrid et al. reported that 21.3%, 9.3% and 3.1%, in their series had postoperative UTI. 18,22,23 In this study, previous hysterectomy was identified to be associated with bladder perforation. There was an association between postoperative voiding dysfunction and voiding difficulty and UTI with same symptoms preoperatively, as reported by Ingrid et al. 23 This study has a limitation as it is a retrospective review of case sheet. The strength of this study is that all procedures were peformed by the same surgeon, limiting the operator bias. CONCLUSION The present study showed that TVT is an effective surgical treatment for USI with minimal complications in Pakistani women. It provides an evidence based frequency of complication, which may help the surgeon to counsel the patient a potential increased risk of bladder perforation when the patient had previous hysterectomy. Preoperative voiding difficulty, voiding dysfunction, and UTI are also likely to continue postoperatively. REFERENCES 1. Paul A, Kerry A, Nikki G, Jenny D. The international consultation on incontinence modular questionnaire. J Urol 2006; 175: Wang Y, Li F, Wang Q, Yang S, Cai X, Chen Y. 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5 Ayesha Saleem 12. Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J 1996; 7: Gohniem G, Stanford E, Kenton K, Achtari C, Goldberg R, Mascarenhas T, et al. Evaluation and outcome measures in the treatment of female stress urinary incontinence international urogynaecological association (IUGA) guidelines for research and clinical practice. Int Urogynecol J pelvic Floor Dysfunct 2008; 19: Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten et al. The standardization of terminology of lower urinary tract function:report from standardization sub-committee of the international continence society. Neurourol Urodyn 2002; 21: Nilsson CG, Kuuva N, Falconer C, Rezapour M, Ulmsten U. Long term results of the tension-free Vaginal tape (TVT) procedure for surgical treatment of female stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 2001; 12:S5-S Nambier AK. The role of urodynamics in the evaluation of urinary incontinence: The European Association of Urology Recommendations in Eur Urol 2016; 71: Wall LL, Wiskind AK, Taylor PA. Simple bladder filling with a cough stress test compared with subtracted cystometry for the diagnosis of urinary incontinence. Am J obstet Gynecol 1994; 171: Laurikainen E, Valpas A, Aukee P, Kivela A, Rinne K, Takala T. Five years results of a randomized trial comparing retropubic and transobturator mid-urethral sling for stress incontinence. Eur Urol 2014; 65: Maliheh KS, Hamid RR, Mohammnad R DM, Zhila S. Tension vaginal tape versus transobtrutor tape for the treatment of stress urinary incontence. Urol Sci 2014; 125: Costantini E, Lazzeri M, Zucchi M, Di Bias M, Porena M. Long term efficacy of transobtrutor and retropubic mid-urethral sling for stress urinary incontinence single-centre update from a non-randomized controlled trial. Eur Urol 2014; 66: Ogah J, Cody DJ, Rogerson L. Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in women: a short cochrane review. Neurol Urodyn 2011; 30: Giovanni AT, Coastintino DC, Cormen F, Annamaria F, Carmine N. Medium-term and long-term outcomes following placement of midurethral slings for stress urinary incontinence: a systematic review and metaanalysis. Int. Urogynecol J 2015; 26: Ingrid K, Maysoon E, Tyler W, Stephen W, Tom M, Sue R. Complications of the tension-free vaginal tape procedure for stress urinary incontinence. Int Urogynecol J 2010; 21: Annetta M, Madsen A, Sherif A, El- Nasher, Joshua L, Woelk J, et al. A cohort study comparing a single-incision mini-sling with a retropubic midurethral sling. Int Urogynecol J 2014; 25: Karin G, Susy S. Incidence and treatment of postoperative voiding dysfunction after tension-free vaginal tape procedure. Int Urogynecol J 2015, 25: Journal of the College of Physicians and Surgeons Pakistan 2017, Vol. 27 (6):