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doi:10.1111/jog.12410
J. Obstet. Gynaecol. Res. Vol. 40, No. 6: 1764–1769, June 2014
Results of tension-free vaginal tape for recurrent stress urinary incontinence after unsuccessful transobturator tape surgery Abdulmuttalip Simsek1, Faruk Ozgor1, Sinan Levent Kirecci2, Mehmet Fatih Akbulut1, Erkan Sonmezay1, Bahar Yuksel3, Onur Kucuktopcu1 and Zafer Gokhan Gurbuz1 1
Department of Urology, Haseki Research and Training Hospital, 2Department of Urology, Sisli Etfal Research and Training Hospital, and 3Department of Obstetrics and Gynecology, School of Medicine, Istanbul University, Istanbul, Turkey
Abstract Aim: The aim of this study was to evaluate cure rate and mid-term results of tension-free vaginal tape for recurrent stress urinary incontinence after failed transobturator tape surgery. Material and Methods: Between January 2006 and December 2011, 42 women were enrolled in this study. Patient characteristics and operating parameters were recorded, and any complications were noted. All patients were followed up for at least 24 months after the second surgery. The Incontinence Impact Questionnaire and the Urinary Distress Inventory were used to identify satisfaction level. Results: The mean age of the patients was 49.07 ± 8.6 years, and median period between transobturator surgery and the tension-free vaginal tape procedure was 12.8 (range 9.2–17.8) months. The cure rate was 83.3% and 76.2% at the first- and second-year follow-up visits, respectively. Intraoperative complications were transient and slight. Bladder injury in five patients and subcutaneous hematoma above the pubis in two patients were the most serious complications, but they were managed conservatively. We found the scores of the Incontinence Impact Questionnaire and Urinary Distress Inventory to be significantly lower at follow-up, compared to the preoperative assessment. De novo urgency was the most common complaint at follow-up and occurred in 11.9% of the women. Conclusions: We suggest that tension-free vaginal tape is a feasible surgical option for recurrent stress urinary incontinence. Further studies with larger patient numbers and longer follow-up periods are needed to support this finding. Key words: recurrent urinary incontinence, suburethral sling, tension-free vaginal tape, transobturator tape, urinary incontinence.
Introduction Stress urinary incontinence is the involuntary leakage of urine due to increased abdominal pressure, without detrusor muscle contraction.1 Although SUI is not a life-threatening disease, its relation with depression, embarrassment, loss of confidence, and deterioration
of social life is well known. These factors also inhibit women from consulting with their physicians.2 Although the exact incidence of the condition is unknown, approximately 4% of women will face SUI surgery in their lives.3 Traditional surgery, which has been practical in the past, included the Burch colposuspension and the
Received: September 25 2013. Accepted: January 21 2014. Reprint request to: Dr Abdulmuttalip Simsek, Department of Urology, Haseki Training and Research Hospital, Millet Cad. No: 11, 34000, Fatih, Istanbul, Turkey. Email: [email protected]
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TVT for recurrent SUI
Marshall–Marchetti–Krantz procedures. However, they are not as popular now, with the midurethral sling procedure gaining popularity over the last 2 decades.4,5 Transobturator tape (TOT) and tension-free vaginal tape (TVT) are minimally invasive and effective procedures for SUI, although TOT is preferred due to its lower complication rate.6 Despite its high success rate, the number of patients who need a second surgery for SUI has increased. Instead, a periurethral bulking method, open colposuspension, and repeating sling technique have been recommended; however, there is still insufficient knowledge about the best method for managing SUI after an unsuccessful TOT procedure.7–9 In this study, we attempted to analyze the use of TVT after unsuccessful TOT. Both the short- and mid-term outcomes of the TVT procedure have been evaluated.
Methods From January 2006 to December 2011, 42 patients were diagnosed with either recurrent SUI or mixed incontinence with predominant SUI symptoms; they were followed up in three urogynecologic centers (Vakif Gureba Research and Training Hospital, Sultanciftligi Lutfiye Nuri Burat State Hospital and Haseki Research and Training Hospital). Full histories and a bladder diary were requested from all patients, who then underwent a physical examination, a stress test, and a Q-tip test. Urine analysis and culture, as well as urinary ultrasonography for post-voiding residue, were performed. Filling cystometry, abdominal leak-point pressure, and uroflowmetry were evaluated in the urodynamic assessment, which all patients underwent before the TVT procedure. Urethral hypermobility was defined as a Q-tip test result > 300, and intrinsic sphincter deficiency (ISD) was defined as maximal urethral closure pressure (MUCP) of 20 cm H2O or less. The 1-h pad-weighing test was used to define SUI as a loss of 1 g of urine in 1 h, as recommended by the EAU 2012 Guidelines on Urinary Incontinence.10 Severity of the disease was determined with the Incontinence Impact Questionnaire (IIQ-7) and the Urinary Distress Inventory (UDI-6). Conservative and surgical treatment options were explained so that the patient and surgeon determined the best modality together. However, those patients with a neurogenic bladder, overactive bladder, gynecologic malignancies, immobile urethra, or bleeding diathesis were excluded from the study. All procedures were performed by one of three experienced surgeons, with every patient having epidural
anesthesia at the time of TVT placement.11,12 The first sling was not removed except in two cases: these patients had a voiding dysfunction, so the mesh was partially removed. A second tape was placed (with as little tension as possible) beneath the posterior wall of the urethra, and with the cough stress test (with 250– 300 mL in the bladder), a cystoscopy was carried out to verify the absence of bladder injury. Demographic characteristics of patients, including age, body mass index (BMI), comorbidities, and number of pregnancies, were recorded preoperatively. The duration of the operation, estimated blood loss, days hospitalized, and perioperative and postoperative complications were registered as well. At 1- and 2-year postoperative follow-ups, patients were evaluated by physical examination, a Q-tip test, and ultrasonography; in addition, the UDI-6 and IIQ-7 questionnaires were repeated.13 Objective cure rates were determined by 1-h pad-weighing tests, and complete dryness or significant reduction of any episode of involuntary urine leakage.
Statistical analysis Data analysis was performed using spss 13.0 for Windows. Changes in the IIQ-7, UDI-6, Q-tip test, and Qmax after the TVT were analyzed with the Wilcoxon signed-rank test. A two-tailed P-value < 0.05 was considered to indicate statistical significance.
Results The mean age of the 42 patients was 49.07 ± 8.6 years. All women completed the 12- and 24-month followups, while the mean follow-up period was 33.2 (range 26.1–37.2) months. BMI was over 30 kg/m2 in seven patients (16.6%), although the most common comorbidities were hypertension (11.9%) and diabetes mellitus (14.3%). Patient characteristics and physical examination findings are listed in Table 1. The median time between the TOT and TVT procedure was 12.8 (range 9.2–17.8) months. All procedures were performed under spinal anesthesia, and the mean operation time was 35.8 ± 10.6 min. The median estimated blood loss was 68.4 cc, and none of the patients required a blood transfusion. There were no lethal intraoperative complications. Bladder injury occurred in four patients (9.5%), but they recovered after catheterization for 14 days. In two patients, subcutaneous hematoma was observed above the pubis; both patients were treated conservatively. The most common postoperative complaints were pain
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and difficulty voiding. Three women (3/42, 7.14%) suffered postoperative voiding difficulties: two patients presented with mild urinary retention (250–300 mL residual urine), and were treated with repeated urethral catheterizations for 2 weeks. Following this, ultrasonic measurements clearly showed that this issue had been resolved. Women with severe retention problems underwent catheterization for 4 weeks; however, the retention problem was not resolved, and the tape was cut at the midline. At the 12- and 24-month follow-ups, the cure rates were 83.3% and 76.2%, respectively. Intrinsic sphincter Table 1 Demographic characteristics of patients Characteristics
Mean ± SD or %
Age (years) BMI (kg/m2) Pregnancy HT DM Smoking Prolapsus Nocturia PVR (mL) IIQ-7 UDI-6 Q-tip Test Urethral hypermobility Intrinsic sphincter deficiency Mixed incontinence
49.1 ± 8.6 27.4 ± 1.9 3.4 ± 1.3 5 (11.9%) 6 (14.4%) 17 (40.5%) 5 (11.9%) 7 (16.6%) 19.2 ± 12.8 17.2 ± 2.9 11.6 ± 1.7 61.2 ± 13.8 24 (57.1%) 11 (26.2%) 7 (16.6%)
BMI, body mass index; DM, diabetes mellitus; HT, hypertension; IIQ-7, Incontinence Impact Questionnaire; PVR, post-void residual volume; UDI-6, Urinary Distress Inventory.
deficiency was seen in 11 patients, but five of them (45.4%) improved after a 24-month follow-up (Table 2). All women completed the IIQ-7 and UDI-6 questionnaires. The symptom scores were lower at follow-up, compared to the preoperative assessments (P < 0.001) (Table 2, Fig. 1). The efficacy of the procedures was assessed by physical examination and a cough stress test in the supine and standing positions, with a relatively full bladder (250–300 mL). Physical exam revealed significant improvement in 35 and 32 patients at the 12- and 24-month follow-ups, respectively. De novo urgency developed in seven patients, and four of them had worsening urge symptoms. Pelvic floor exercises were suggested and an antimuscarinic agent was used to reduce symptoms.
Discussion Since the TOT sling’s introduction to urology practice,14 it has been a safe and reasonable procedure for SUI. The surgeon places polypropylene mesh between the obturator foramen to suspend the urethra, which prevents the trocar from invading the retropubic area; it also minimizes potential complications, such as bowel or bladder injuries.14 Despite high cure rates, almost 10% of patients have recurrent or persistent symptoms after surgery.15 There is no definitive reason for this, but several risk factors are associated with unsuccessful TOT.16 Recurrence is related to increasing age and BMI, diabetes mellitus, and intrinsic sphincter deficiency. Misplacement of the tape, the surgeon’s
Table 2 Changes in parameters before and after TVT surgery and the relation between bladder types and surgical outcomes Outcomes and bladder types
Before TVT operation
Surgical success Surgical failure IIQ-7 UDI-6 Q-tip test (degree) PVR (mL) Qmax (mL/s) Success group ISD MI UH Failure group ISD MI UH
17.2 ± 2.9 11.6 ± 1.7 61.2 ± 13.8 19.2 ± 12.8 20.8 ± 2.8
One year later
Two years later
83.5% 16.5% 2.8 ± 1.2 1.9 ± 0.43 21.7 ± 13.7 25.6 ± 20.1 22.1 ± 3.8 35 women 7 (20%) 5 (14%) 23 (66%) 7 women 4 (57%) 2 (29%) 1 (14%)
76.2% 23.8% 4.6 ± 2.1 2.3 ± 0.7 26.8 ± 11.2 24.9 ± 19.7 21.6 ± 1.9 32 women 5 (16%) 4 (13%) 23 (72%) 10 women 6 (60%) 3 (30%) 1 (10%)
P
0.001 0.001 0.001 0.08 0.13
IIQ, Incontinence Impact Questionnaire; ISD, intrinsic sphincter deficiency; MI, mixed incontinence; PVR, post-void residual volume; Qmax, Maximum flow rate; TVT, tension-free vaginal tape; UDI, urogenital distress inventory; UH, urethral hypermobility.
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17.2
18 16 14 12
11.6
10 8
6 4
4.6 2.8
2
1.9
2.3
0 IIQ-7 UDI-6
Figure 1 Preoperative and postoperative Incontinence Impact Questionnaire (IIQ-7) and the Urinary Distress Inventory (UDI-6) in patients with stress urinary incontinence. , Preoperative. , 1-year follow-up. , 2-year follow-up.
level of experience, and prior incontinence surgery also affect success rates.17–20 Management of recurrent or persistent SUI after unsuccessful TOT surgery remains a challenge. Selection of the appropriate remedy depends on the type of incontinence, the patient’s expectations, the general condition of the patient, and the surgeon’s experience. Some physicians suggest behavioral therapy, pelvicfloor exercises, or use of anticholinergic drugs.21,22 Bulking agents have also been injected into the periurethral area without any serious complications, but longterm results were unfavorable. Selection of the appropriate agent is another concern.22 Nithara et al. reported unsatisfactory results for colpocystourethropexy for recurrent incontinence after unsuccessful TOT procedures. In addition, open surgeries take more time, involve painful postoperative periods, as well as scarring at the incision.23 Artificial urinary sphincters are useful in selected cases.24 The placement of a second suburethral sling has been reported to treat recurrent or persistent SUI. Stav et al. found that TVT had a higher cure rate than did TOT. Unfortunately, secondary sling placement is associated with less patient satisfaction and a lower objective cure rate than primary procedures.25 Lee et al. analyzed 29 patients with failed incontinence surgery.
The cure rate was higher in the TVT group than in the TOT group, but the difference was not clinically significant.26 If intrinsic sphincter deficiency is determined during physical exam or urodynamic evaluation following TOT surgery, we believe that TVT would be more likely to help these patients. The TVT retropubic sling may be much more appropriate to treat persistent incontinence given its more acute retropubic angle, which may be more obstructive than the TOT, so that it creates a greater degree of obstruction to the urethra. Our findings are consistent with those of Moore et al.27 Ala-Nissila reported no significant differences in complications between patients with or without incontinence surgery.28 Bladder injury and subcutaneous hematoma above the os pubis were the most serious complications in our study, but these were managed conservatively. There were no urethral injuries, and the first sling was left in place to avoid wide dissection of the periurethral area. This was done because the slings can create fibrosis, and the border between the vagina and the urethra is unpredictable. Verbrugge et al. reported the results of retention of two vaginal mesh implants after TVT.29 The rate of voiding difficulty was 11.9%, and yet all were temporary and slight. Liapis et al. performed transurethral resection of the tape 3 weeks after the initial operation to assist voiding.30 In our study, de novo urgency rate was 16.6%, which was slightly lower than previously reported.16 Incontinence-related quality of life is measured with UDI-6 and IIQ-7,31 as they can be validated in the Turkish population.13 Vassallo et al. similarly used them to assess the outcome of TVT, and confirmed a significant improvement in quality of life.32 Another large study evaluated quality of life in women who underwent TVT, with a 2-year follow-up. Postoperatively, UDI-6 and IIQ-7 were shown to be effective, so the authors concluded that the TVT procedure significantly improved health-related issues.33 In this study, there were benefits in postoperative scores with each assessment tool. We concluded that TVT surgery, after unsuccessful TOT, improved quality of life at the first- and second-year follow-ups. This study has some limitations. First, there was no control group. Second, the TVT procedures were performed by different surgeons, which may have affected the results. In addition, 14 patients were referred to our clinic after unsuccessful TOT surgery at other hospitals, so that it was impossible to know their medical history or have complete results about the initial physical examination. The strengths of this study are obvious in its prospective nature. We also noted that a
© 2014 The Authors Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology
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large number of patients were followed-up mid-term with validated questionnaires. Subsequently, follow-up assessments were performed by the same physician for all women, in order to prevent interpersonal bias. In our experience, the TVT procedure is a feasible, effective option for failed TOT. Recurrent or persistent SUI after a TOT procedure may be treated with TVT, which increases the MUCP and reduces urethral hypermobility. De novo urgency was slightly higher, but almost all complications were nonlethal and acceptable. Additional larger studies with mid-term follow-up are needed to clarify the effectiveness of TVT after failed TOT.
Disclosure None of the authors has anything to disclose.
References 1. Kim S, Son JH, Kim HS, Ko JS, Kim JC. Tape shortening for recurrent stress urinary incontinence after transobturator sling: 3-year follow-up results. Int Neurourol J 2010; 14: 164– 169. 2. Minassian VA, Devore E, Hagan K, Grodstein F. Severity of urinary incontinence and effect on quality of life in women by incontinence type. Obstet Gynecol 2013; 121: 1083–1090. 3. Barber MD, Kleeman S, Karram M et al. Risk factors associated with failure 1 year after retropubic and transobturator midurethral slings. Am J Obstet Gynecol 2008; 199: 666.e1– 666.e7. 4. Novara G, Artibani W, Barber MD et al. Updated systematic review and meta-analysis of the comparative data on colposuspensions, pubovaginal slings, and midurethral tapes in the surgical treatment of female stress urinary incontinence. Eur Urol 2010; 58: 218–238. 5. Latthe PM, Foon R, Toozs-Hobson P. Transobturator and retropubic tape procedures in stress urinary incontinence: A systemic review and meta-analysis of effectiveness and complications. BJOG 2007; 114: 522–531. 6. Delorme E, Droupy S, de Tayrac R, Delmas V. Transobturator tape (Uratape): A new minimally-invasive procedure to treat female urinary incontinence. Eur Urol 2004; 45: 203–207. 7. Lee HN, Lee YS, Han JY, Jeong JY, Choo MS, Lee KS. Transurethral injection of bulking agent for treatment of failed mid-urethral sling procedures. Int Urogynecol J 2010; 21: 1479–1483. 8. Mischinger J, Amend B, Reisenauer C et al. Different surgical approaches for stress urinary incontinence in women. Minerva Ginecol 2013; 65: 21–28. 9. Meyer F, Hermieu JF, Boyd A et al. Repeat mid-urethral sling for recurrent female stress urinary incontinence. Int Urogynecol J 2013; 24: 817–822. 10. Lucas MG, Bosch JLHR, Cruz FR et al. EAU Guidelines on Urinary Incontinence 2012, p. 23.
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11. Ulmsten U. An introduction to the tension free vaginal tape (TVT) – A new surgical procedure for treatment of female urinary incontinence. Int Urogynecol J 2001; 12: 3–4. 12. Ulmsten U, Johnson P, Rezapour M. A three-year follow up of tension free vaginal tape for surgical treatment of female stress urinary incontinence. BJOG 1999; 106: 345–350. 13. Cam C, Karateke A, Sakallı M. Validation of the short forms of Incontinence Impact Questionnaire (IIQ-7) and Urogenital Distress Inventory (UDI-6) in a Turkish population. Neurourol Urodyn 2006; 26: 129–133. 14. Delorme E. Transobturator urethral suspension: Miniinvasive procedure in the treatment of stress urinary incontinence in women. Prog Urol 2001; 11: 1306–1313. 15. Abdel-Fattah M, Ramsay I, Pringle S et al. Randomised prospective single-blinded study comparing ‘inside-out’ versus ‘outside-in’ transobturator tapes in the management of urodynamic stress incontinence: 1-year outcomes from the E-TOT study. BJOG 2010; 117: 870–878. 16. Sabadell J, Poza JL, Esgueva A et al. Usefulness of retropubic tape for recurrent stress incontinence after transobturator tape failure. Int Urogynecol J 2011; 22: 1543–1547. 17. Poza JL, Pla F, Sabadell J, Sánchez-Iglesias JL, Martínez-Gómez X, Xercavins J. Trans-obturator suburethral tape for female stress incontinence: A cohort of 254 women with 1-year to 2-year follow-up. Acta Obstet Gynecol Scand 2008; 87: 232–239. 18. Giberti C, Gallo F, Cortese P, Schenone M. Transobturator tape for treatment of female stress urinary incontinence: Objective and subjective results after a mean follow-up of two years. Urology 2007; 69: 703–707. 19. Guerette NL, Bena JF, Davila GW. Transobturator slings for stress incontinence: Using urodynamic parameters to predict outcomes. Int Urogynecol J 2008; 19: 97–102. 20. Gilchrist AS, Rovner ES. Sling location in women with recurrent stress urinary incontinence following midurethral sling. Urology 2012; 79: 76–79. 21. Labrie J, Fischer K, van der Vaart CH. Health-related quality of life. The effect of pelvic floor muscle training and midurethral sling surgery: A systematic review. Int Urogynecol J 2012; 23: 1155–1162. 22. Villet R, Ercoli A, Atallah D, Hoffmann P, Salet-Lizee D. Second tension free vaginal tape procedure and mesh retensioning: Two possibilities of treatment of recurrentpersistent genuine stress urinary incontinence after a primary tension free vaginal tape procedure. Int Urogynecol J 2002; 13: 377–379. 23. Nitahara KS, Aboseif S, Tanagho EA. Long-term results of colpocystourethropexy for persistent or recurrent stress urinary incontinence. J Urol 1999; 162: 138–141. 24. Nam SB, Bae JH, Lee JG. Surgical considerations for recurrent stress urinary incontinence after the midurethral sling procedure: Redo midurethral sling and shortening of the tape. Korean. J Urol 2007; 48: 527–535. 25. Stav K, Dwyer PL, Rosamilla A et al. Repeat synthetic mid urethral sling procedure for women with recurrent stress urinary incontinence. J Urol 2010; 183: 241–246. 26. Lee KS, Doo CK, Han DH, Jung BJ, Han J, Choo M. Outcomes following repeat mid urethral synthetic sling after failure of the initial sling procedure: Rediscovery of the tension-free vaginal tape procedure. J Urol 2007; 178: 1370–1374.
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27. Moore RD, Gamble K, Miklos JR. Tension free vaginal tape sling for recurrent stress incontinence after transobturator tape sling failure. Int Urolgynecol J 2007; 18: 309–313. 28. Ala-Nissilä S, Haarala M, Mäkinen J. Tension-free vaginal tape – a suitable procedure for patients with recurrent stress urinary incontinence. Acta Obstet Gynecol 2010; 89: 210–216. 29. Verbrugghe A, De Ridder D, Van der Aa F. A repeat midurethral sling as valuable treatment for persistent or recurrent stress urinary incontinence. Int Urogynecol J 2013; 24: 999– 1004. 30. Liapis A, Bakas P, Creatsas G. Tension-free vaginal tape in the management of recurrent urodynamic stress incontinence after previous failed midurethral tape. Eur Urol 2009; 55: 1450–1458.
31. Uebersax JS, Wyman JF, Shumaker SA, McClish DK, Fantl JA. Short forms to assess life quality and symptom distress for urinary incontinence in women: The Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program for Women Research Group. Neurourol Urodyn 1995; 14: 131–139. 32. Vassallo BJ, Kleeman SD, Segal JL, Walsh P, Karram MM. Tension-free vaginal tape: A quality-of-life assessment. Obstet Gynecol 2002; 100: 518–524. 33. Tomoe H, Kondo A, Takei M, Nakata M, Toma H, Tensionfree Vaginal Tape Trial Group. Quality of life assessments in women operated on by tension-free vaginal tape (TVT). Int Urogynecol J 2005; 16: 114–118. discussion 108.
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J. Obstet. Gynaecol. Res. Vol. 40, No. 6: 1764–1769, June 2014
Results of tension-free vaginal tape for recurrent stress urinary incontinence after unsuccessful transobturator tape surgery Abdulmuttalip Simsek1, Faruk Ozgor1, Sinan Levent Kirecci2, Mehmet Fatih Akbulut1, Erkan Sonmezay1, Bahar Yuksel3, Onur Kucuktopcu1 and Zafer Gokhan Gurbuz1 1
Department of Urology, Haseki Research and Training Hospital, 2Department of Urology, Sisli Etfal Research and Training Hospital, and 3Department of Obstetrics and Gynecology, School of Medicine, Istanbul University, Istanbul, Turkey
Abstract Aim: The aim of this study was to evaluate cure rate and mid-term results of tension-free vaginal tape for recurrent stress urinary incontinence after failed transobturator tape surgery. Material and Methods: Between January 2006 and December 2011, 42 women were enrolled in this study. Patient characteristics and operating parameters were recorded, and any complications were noted. All patients were followed up for at least 24 months after the second surgery. The Incontinence Impact Questionnaire and the Urinary Distress Inventory were used to identify satisfaction level. Results: The mean age of the patients was 49.07 ± 8.6 years, and median period between transobturator surgery and the tension-free vaginal tape procedure was 12.8 (range 9.2–17.8) months. The cure rate was 83.3% and 76.2% at the first- and second-year follow-up visits, respectively. Intraoperative complications were transient and slight. Bladder injury in five patients and subcutaneous hematoma above the pubis in two patients were the most serious complications, but they were managed conservatively. We found the scores of the Incontinence Impact Questionnaire and Urinary Distress Inventory to be significantly lower at follow-up, compared to the preoperative assessment. De novo urgency was the most common complaint at follow-up and occurred in 11.9% of the women. Conclusions: We suggest that tension-free vaginal tape is a feasible surgical option for recurrent stress urinary incontinence. Further studies with larger patient numbers and longer follow-up periods are needed to support this finding. Key words: recurrent urinary incontinence, suburethral sling, tension-free vaginal tape, transobturator tape, urinary incontinence.
Introduction Stress urinary incontinence is the involuntary leakage of urine due to increased abdominal pressure, without detrusor muscle contraction.1 Although SUI is not a life-threatening disease, its relation with depression, embarrassment, loss of confidence, and deterioration
of social life is well known. These factors also inhibit women from consulting with their physicians.2 Although the exact incidence of the condition is unknown, approximately 4% of women will face SUI surgery in their lives.3 Traditional surgery, which has been practical in the past, included the Burch colposuspension and the
Received: September 25 2013. Accepted: January 21 2014. Reprint request to: Dr Abdulmuttalip Simsek, Department of Urology, Haseki Training and Research Hospital, Millet Cad. No: 11, 34000, Fatih, Istanbul, Turkey. Email: [email protected]
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© 2014 The Authors Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology
TVT for recurrent SUI
Marshall–Marchetti–Krantz procedures. However, they are not as popular now, with the midurethral sling procedure gaining popularity over the last 2 decades.4,5 Transobturator tape (TOT) and tension-free vaginal tape (TVT) are minimally invasive and effective procedures for SUI, although TOT is preferred due to its lower complication rate.6 Despite its high success rate, the number of patients who need a second surgery for SUI has increased. Instead, a periurethral bulking method, open colposuspension, and repeating sling technique have been recommended; however, there is still insufficient knowledge about the best method for managing SUI after an unsuccessful TOT procedure.7–9 In this study, we attempted to analyze the use of TVT after unsuccessful TOT. Both the short- and mid-term outcomes of the TVT procedure have been evaluated.
Methods From January 2006 to December 2011, 42 patients were diagnosed with either recurrent SUI or mixed incontinence with predominant SUI symptoms; they were followed up in three urogynecologic centers (Vakif Gureba Research and Training Hospital, Sultanciftligi Lutfiye Nuri Burat State Hospital and Haseki Research and Training Hospital). Full histories and a bladder diary were requested from all patients, who then underwent a physical examination, a stress test, and a Q-tip test. Urine analysis and culture, as well as urinary ultrasonography for post-voiding residue, were performed. Filling cystometry, abdominal leak-point pressure, and uroflowmetry were evaluated in the urodynamic assessment, which all patients underwent before the TVT procedure. Urethral hypermobility was defined as a Q-tip test result > 300, and intrinsic sphincter deficiency (ISD) was defined as maximal urethral closure pressure (MUCP) of 20 cm H2O or less. The 1-h pad-weighing test was used to define SUI as a loss of 1 g of urine in 1 h, as recommended by the EAU 2012 Guidelines on Urinary Incontinence.10 Severity of the disease was determined with the Incontinence Impact Questionnaire (IIQ-7) and the Urinary Distress Inventory (UDI-6). Conservative and surgical treatment options were explained so that the patient and surgeon determined the best modality together. However, those patients with a neurogenic bladder, overactive bladder, gynecologic malignancies, immobile urethra, or bleeding diathesis were excluded from the study. All procedures were performed by one of three experienced surgeons, with every patient having epidural
anesthesia at the time of TVT placement.11,12 The first sling was not removed except in two cases: these patients had a voiding dysfunction, so the mesh was partially removed. A second tape was placed (with as little tension as possible) beneath the posterior wall of the urethra, and with the cough stress test (with 250– 300 mL in the bladder), a cystoscopy was carried out to verify the absence of bladder injury. Demographic characteristics of patients, including age, body mass index (BMI), comorbidities, and number of pregnancies, were recorded preoperatively. The duration of the operation, estimated blood loss, days hospitalized, and perioperative and postoperative complications were registered as well. At 1- and 2-year postoperative follow-ups, patients were evaluated by physical examination, a Q-tip test, and ultrasonography; in addition, the UDI-6 and IIQ-7 questionnaires were repeated.13 Objective cure rates were determined by 1-h pad-weighing tests, and complete dryness or significant reduction of any episode of involuntary urine leakage.
Statistical analysis Data analysis was performed using spss 13.0 for Windows. Changes in the IIQ-7, UDI-6, Q-tip test, and Qmax after the TVT were analyzed with the Wilcoxon signed-rank test. A two-tailed P-value < 0.05 was considered to indicate statistical significance.
Results The mean age of the 42 patients was 49.07 ± 8.6 years. All women completed the 12- and 24-month followups, while the mean follow-up period was 33.2 (range 26.1–37.2) months. BMI was over 30 kg/m2 in seven patients (16.6%), although the most common comorbidities were hypertension (11.9%) and diabetes mellitus (14.3%). Patient characteristics and physical examination findings are listed in Table 1. The median time between the TOT and TVT procedure was 12.8 (range 9.2–17.8) months. All procedures were performed under spinal anesthesia, and the mean operation time was 35.8 ± 10.6 min. The median estimated blood loss was 68.4 cc, and none of the patients required a blood transfusion. There were no lethal intraoperative complications. Bladder injury occurred in four patients (9.5%), but they recovered after catheterization for 14 days. In two patients, subcutaneous hematoma was observed above the pubis; both patients were treated conservatively. The most common postoperative complaints were pain
© 2014 The Authors Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology
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and difficulty voiding. Three women (3/42, 7.14%) suffered postoperative voiding difficulties: two patients presented with mild urinary retention (250–300 mL residual urine), and were treated with repeated urethral catheterizations for 2 weeks. Following this, ultrasonic measurements clearly showed that this issue had been resolved. Women with severe retention problems underwent catheterization for 4 weeks; however, the retention problem was not resolved, and the tape was cut at the midline. At the 12- and 24-month follow-ups, the cure rates were 83.3% and 76.2%, respectively. Intrinsic sphincter Table 1 Demographic characteristics of patients Characteristics
Mean ± SD or %
Age (years) BMI (kg/m2) Pregnancy HT DM Smoking Prolapsus Nocturia PVR (mL) IIQ-7 UDI-6 Q-tip Test Urethral hypermobility Intrinsic sphincter deficiency Mixed incontinence
49.1 ± 8.6 27.4 ± 1.9 3.4 ± 1.3 5 (11.9%) 6 (14.4%) 17 (40.5%) 5 (11.9%) 7 (16.6%) 19.2 ± 12.8 17.2 ± 2.9 11.6 ± 1.7 61.2 ± 13.8 24 (57.1%) 11 (26.2%) 7 (16.6%)
BMI, body mass index; DM, diabetes mellitus; HT, hypertension; IIQ-7, Incontinence Impact Questionnaire; PVR, post-void residual volume; UDI-6, Urinary Distress Inventory.
deficiency was seen in 11 patients, but five of them (45.4%) improved after a 24-month follow-up (Table 2). All women completed the IIQ-7 and UDI-6 questionnaires. The symptom scores were lower at follow-up, compared to the preoperative assessments (P < 0.001) (Table 2, Fig. 1). The efficacy of the procedures was assessed by physical examination and a cough stress test in the supine and standing positions, with a relatively full bladder (250–300 mL). Physical exam revealed significant improvement in 35 and 32 patients at the 12- and 24-month follow-ups, respectively. De novo urgency developed in seven patients, and four of them had worsening urge symptoms. Pelvic floor exercises were suggested and an antimuscarinic agent was used to reduce symptoms.
Discussion Since the TOT sling’s introduction to urology practice,14 it has been a safe and reasonable procedure for SUI. The surgeon places polypropylene mesh between the obturator foramen to suspend the urethra, which prevents the trocar from invading the retropubic area; it also minimizes potential complications, such as bowel or bladder injuries.14 Despite high cure rates, almost 10% of patients have recurrent or persistent symptoms after surgery.15 There is no definitive reason for this, but several risk factors are associated with unsuccessful TOT.16 Recurrence is related to increasing age and BMI, diabetes mellitus, and intrinsic sphincter deficiency. Misplacement of the tape, the surgeon’s
Table 2 Changes in parameters before and after TVT surgery and the relation between bladder types and surgical outcomes Outcomes and bladder types
Before TVT operation
Surgical success Surgical failure IIQ-7 UDI-6 Q-tip test (degree) PVR (mL) Qmax (mL/s) Success group ISD MI UH Failure group ISD MI UH
17.2 ± 2.9 11.6 ± 1.7 61.2 ± 13.8 19.2 ± 12.8 20.8 ± 2.8
One year later
Two years later
83.5% 16.5% 2.8 ± 1.2 1.9 ± 0.43 21.7 ± 13.7 25.6 ± 20.1 22.1 ± 3.8 35 women 7 (20%) 5 (14%) 23 (66%) 7 women 4 (57%) 2 (29%) 1 (14%)
76.2% 23.8% 4.6 ± 2.1 2.3 ± 0.7 26.8 ± 11.2 24.9 ± 19.7 21.6 ± 1.9 32 women 5 (16%) 4 (13%) 23 (72%) 10 women 6 (60%) 3 (30%) 1 (10%)
P
0.001 0.001 0.001 0.08 0.13
IIQ, Incontinence Impact Questionnaire; ISD, intrinsic sphincter deficiency; MI, mixed incontinence; PVR, post-void residual volume; Qmax, Maximum flow rate; TVT, tension-free vaginal tape; UDI, urogenital distress inventory; UH, urethral hypermobility.
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TVT for recurrent SUI
17.2
18 16 14 12
11.6
10 8
6 4
4.6 2.8
2
1.9
2.3
0 IIQ-7 UDI-6
Figure 1 Preoperative and postoperative Incontinence Impact Questionnaire (IIQ-7) and the Urinary Distress Inventory (UDI-6) in patients with stress urinary incontinence. , Preoperative. , 1-year follow-up. , 2-year follow-up.
level of experience, and prior incontinence surgery also affect success rates.17–20 Management of recurrent or persistent SUI after unsuccessful TOT surgery remains a challenge. Selection of the appropriate remedy depends on the type of incontinence, the patient’s expectations, the general condition of the patient, and the surgeon’s experience. Some physicians suggest behavioral therapy, pelvicfloor exercises, or use of anticholinergic drugs.21,22 Bulking agents have also been injected into the periurethral area without any serious complications, but longterm results were unfavorable. Selection of the appropriate agent is another concern.22 Nithara et al. reported unsatisfactory results for colpocystourethropexy for recurrent incontinence after unsuccessful TOT procedures. In addition, open surgeries take more time, involve painful postoperative periods, as well as scarring at the incision.23 Artificial urinary sphincters are useful in selected cases.24 The placement of a second suburethral sling has been reported to treat recurrent or persistent SUI. Stav et al. found that TVT had a higher cure rate than did TOT. Unfortunately, secondary sling placement is associated with less patient satisfaction and a lower objective cure rate than primary procedures.25 Lee et al. analyzed 29 patients with failed incontinence surgery.
The cure rate was higher in the TVT group than in the TOT group, but the difference was not clinically significant.26 If intrinsic sphincter deficiency is determined during physical exam or urodynamic evaluation following TOT surgery, we believe that TVT would be more likely to help these patients. The TVT retropubic sling may be much more appropriate to treat persistent incontinence given its more acute retropubic angle, which may be more obstructive than the TOT, so that it creates a greater degree of obstruction to the urethra. Our findings are consistent with those of Moore et al.27 Ala-Nissila reported no significant differences in complications between patients with or without incontinence surgery.28 Bladder injury and subcutaneous hematoma above the os pubis were the most serious complications in our study, but these were managed conservatively. There were no urethral injuries, and the first sling was left in place to avoid wide dissection of the periurethral area. This was done because the slings can create fibrosis, and the border between the vagina and the urethra is unpredictable. Verbrugge et al. reported the results of retention of two vaginal mesh implants after TVT.29 The rate of voiding difficulty was 11.9%, and yet all were temporary and slight. Liapis et al. performed transurethral resection of the tape 3 weeks after the initial operation to assist voiding.30 In our study, de novo urgency rate was 16.6%, which was slightly lower than previously reported.16 Incontinence-related quality of life is measured with UDI-6 and IIQ-7,31 as they can be validated in the Turkish population.13 Vassallo et al. similarly used them to assess the outcome of TVT, and confirmed a significant improvement in quality of life.32 Another large study evaluated quality of life in women who underwent TVT, with a 2-year follow-up. Postoperatively, UDI-6 and IIQ-7 were shown to be effective, so the authors concluded that the TVT procedure significantly improved health-related issues.33 In this study, there were benefits in postoperative scores with each assessment tool. We concluded that TVT surgery, after unsuccessful TOT, improved quality of life at the first- and second-year follow-ups. This study has some limitations. First, there was no control group. Second, the TVT procedures were performed by different surgeons, which may have affected the results. In addition, 14 patients were referred to our clinic after unsuccessful TOT surgery at other hospitals, so that it was impossible to know their medical history or have complete results about the initial physical examination. The strengths of this study are obvious in its prospective nature. We also noted that a
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large number of patients were followed-up mid-term with validated questionnaires. Subsequently, follow-up assessments were performed by the same physician for all women, in order to prevent interpersonal bias. In our experience, the TVT procedure is a feasible, effective option for failed TOT. Recurrent or persistent SUI after a TOT procedure may be treated with TVT, which increases the MUCP and reduces urethral hypermobility. De novo urgency was slightly higher, but almost all complications were nonlethal and acceptable. Additional larger studies with mid-term follow-up are needed to clarify the effectiveness of TVT after failed TOT.
Disclosure None of the authors has anything to disclose.
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