Tension-Free Vaginal Tape and Associated Procedures: A Case Control Study

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1 Euroean Urology Euroean Urology 45 (2004) Tension-Free Vaginal Tae and Associated Procedures: A Case Control Study Arash Rafii a, Xavier Paoletti b, François Haab c, Michel Levardon a, Bruno Deval a,* a Service de Gynécologie, Hôital Beaujon, 100 Boulevard du Général Leclerc, Clichy, France b Service de Biostatistics, Hôital Beaujon, Clichy, France c Hôital Tenon, Université Paris VII, Assistance Publique Hôitaux de Paris (AP-HP), Paris, France Acceted 17 October 2003 Published online 6 November 2003 Abstract Objectives: We comare objective and subjective cure rates after tension-free vaginal tae rocedures erformed alone or in conjunction with vaginal rocedures. Methods: One hundred eighty-six women underwent a tension-free vaginal tae rocedure for stress or mixed urinary incontinence. One hundred women treated with tension-free vaginal tae alone (grou 1) were comared with 40 women treated with tension-free vaginal tae and concomitant vaginal hysterectomy (grou 2), and 46 atients treated with tension-free vaginal tae and elvic floor reconstruction (grou 3). Patient outcomes, surgical difficulties and comlications are reorted. Postoerative voiding diaries, standing stress-test results, and atient satisfaction were comared. Results: There were no significant differences among the three grous in terms of age, menoausal status, BMI, revious incontinence surgery, or the tye and degree of incontinence. Parity was significantly higher in the grou treated with tension-free vaginal tae and elvic floor reconstruction ( ¼ 0:04). The overall erioerative comlication rate was 15.6%. Women treated with tension-free vaginal tae and hysterectomy (grou 2), and those treated with tension-free vaginal tae and elvic floor reconstruction (grou 3) had a significantly higher incidence of bladder injury (17.9% and 13%, resectively, versus 5% in grou 1; ¼ 0:05). Estimated blood loss and the frequencies of ostoerative urgency and voiding disorders did differ significantly between women treated with tension-free vaginal tae alone and those who underwent associated rocedures. The mean follow-u time was 24:5 2:6 months. No difference in the objective cure rate was found between the tension-free vaginal tae grou and the other two grous (93% versus 97.5% and 91.1%; ¼ 0:3). No difference in the subjective cure rate was found between the tension-free vaginal tae grou and the grous undergoing associated rocedures (72% versus 72.5% and 68.8%; ¼ 0:4). Conclusion: Pelvic floor defects, benign uterine disorders and stress urinary incontinence can be safely treated with tension-free vaginal tae and vaginal rocedures during the same surgical rocedure. # 2003 Elsevier B.V. All rights reserved. Keywords: Tension-free vaginal tae; Vaginal hysterectomy; Genital rolase 1. Introduction Women undergoing surgical treatment of stress urinary incontinence often require concomitant surgical * Corresonding author. Tel. þ ; Fax: þ address: bruno.deval@bjn.ao-ho-aris.fr (B. Deval). rocedures for benign uterine disorders [1] and elvic relaxation, such as uterine or osthysterectomy vaginal vault rolase, cystocele, rectocele or enterocele [2]. Treatment of genitourinary rolase can unmask occult stress urinary incontinence (SUI) in 36% to 80% of women [3]. The otential advantages of erforming tension-free vaginal taing (TVT) during other elvic surgical rocedures include a shorter total hosital /$ see front matter # 2003 Elsevier B.V. All rights reserved. doi: /j.eururo

2 A. Rafii et al. / Euroean Urology 45 (2004) stay, lower cost, and a reduced risk of anesthesiarelated morbidity. However, the safety of concomitant rocedures, and the efficacy of TVT erformed during other elvic floor reconstructive rocedures, are oorly documented. Two studies addressing this issue have been ublished [4,5]. Partoll analyzed the imact of elvic floor reconstructive surgery on the outcome of TVT in 37 atients [4]. The short-term results (6 months) were good, with 94% of the atients dry; the main ostoerative comlication was urinary retention (43%). Gordon et al. evaluated TVT erformed during rolase reair in 30 women [5]. In this rosective study none of the atients develoed ostoerative symtomatic stress urinary incontinence; ostoerative de novo detrusor instability was diagnosed in four atients (13%); and none of the atients had clinical evidence of bladder outlet obstruction. However, these studies were based on relatively short follow-u. The aims of this study were to document comlications and otential surgical itfalls when TVT is erformed during the same rocedure as reconstructive elvic rocedures, and to determine the mid-term outcome of TVT in this setting. 2. Patients and methods From June 1998 to February 2001, 186 atients with stress incontinence undergoing TVT were enrolled in the Gynecology Deartment of Hôtel-Dieu Hosital in Paris, France. One hundred women underwent TVT alone (grou 1), while 86 women also underwent vaginal hysterectomy (n ¼ 40) (grou 2) or elvic floor reconstruction (n ¼ 46) (grou 3) during the same rocedure. Before TVT, each atient underwent a hysical examination and urodynamic study, and comleted a questionnaire. Incontinence was scored by the atient from 0 to 10 on a visual analogue scale (0 ¼ no incontinence) and the degree of incontinence was assessed using the Ingelman-Sunberg and Ulmsten scale [6]. Physical examination was erformed with the atient in the lithotomy osition, with the chest at 30 degrees and the thighs flexed at 45 degrees. Patients were hydrated one hour before hysical examination. Loss of urine was tested during coughing and stress. The urethral axis and urethrovesical junction mobility were assessed by means of the cotton swab test. Pelvic suort defects were assessed using the half-way system classification described by Baden and Walker [7] with the atient recumbent and straining down, allowing the clinician to grade the defect of each vaginal site under stress. All the rolase atients enrolled in the study had documented objective SUI. Urodynamic techniques, measurements, terms and diagnostic criteria conformed to the recommendations of the International Continence Society [8]. All subjects received intravenous antibacterial rohylaxis (cefazolin, 2 g) at the beginning of surgery. The TVT rocedure, when erformed alone, was carried out according to the authors recommendations, as described by Ulmsten et al. [9] under local, sinal or general anesthesia. General anesthesia was used when sinal anesthesia was contraindicated. When the atient could not roduce an effective cough, the bladder was filled to the caacity at which leakage was first noted on urodynamic testing, and suraubic ressure was alied to elicit urine leakage; the sling was then adjusted until the leaking stoed. Patients included in grous 2 and 3 underwent the associated rocedures before TVT. Vaginal hysterectomy was erformed using the modified Heaney technique. In grou 3, TVT was never used rohylactically. After insertion of the tae, a cystoscoic control was erformed, and a Foley catheter was left in lace for 2 days in case of bladder erforation. A Foley catheter was always inserted for 24 hours for bladder drainage. After removal until a ostoerative residual less than 150 ml, the atients underwent intermittent catheterization. For those who had a bladder injury, the Foley catheter was left for 3 days and the same rotocol as above was alied when it was removed. The incidence of eri- and ostoerative comlications and fever were recorded in all cases, together with analgesic requirements and the length of the ostoerative hosital stay. Postoerative fever was defined as a temerature of at least 38 8C on two consecutive measurements at least 6 hours aart, excluding the first 24 hours. Follow-u visits were scheduled at 1, 6, 12 and 24 months. Patients were considered objectively cured if they had no stress incontinence (as determined by a clinical stress rovocation test and urodynamic examinations) and no urinary retention (as determined by a residual urine volume of 150 ml or more). Subjective cured, imrovement and failure rates were based on the Contilife 28-item questionnaire [10]. Only atients with a follow-u of at least 12 months were included in this analysis. Mean values of continuous variables were comared among the grous with Student s t test, and the w 2 -test or Fisher s exact test was used for categorical variables. When a statistically significant difference among the three grous was found, each individual grou was comared with the TVT-only grou. All test were carried out at the 5% level. 3. Results 3.1. Patient characteristics (Table 1) There were no significant differences among the grous in terms of age, menoausal status, BMI, revious incontinence surgery, or the tye (e.g. ure stress incontinence or stress incontinence associated to urge syndrome) and degree of incontinence. Eighteen atients (9.6%) had reviously undergone incontinence surgery; one atient had undergone two such rocedures. Previous incontinence surgery included 6 oen and 1 laaroscoic Burch rocedures, 3 Pereyra-Raz, 1 ubovaginal sling, 1 TVT and 6 Kelly lications. Urinary incontinence was grade I in 54 atients (28.9%), grade II in 52 atients (28.3%), and grade III in 80 atients (42.8%). The indications for vaginal hysterectomy (grou 2) were abnormal uterine bleeding (n ¼ 11) and chronic elvic ain (n ¼ 29). The atients in grou 3 underwent anterior and osterior colorrhahy (46 atients) or sacrosinous ligament fixation of the vaginal vault (17 atients) in addition to TVT.

3 358 A. Rafii et al. / Euroean Urology 45 (2004) Table 1 Characteristics of women undergoing tension-free vaginal taing alone or concomitantly with other rocedures (TVT and elvic floor reair) Age BMI Parity * 0.04 Mixed incontinence n (%) 35 (35) 8 (20) 11 (23.9) 0.1 Stress incontinence n (%) 65 (65) 32 (80) 35 (76.1) 0.1 Previous incontinence surgery (n, %) 10 (10) 2 (5.1) 6 (13) 0.4 Menoausal status (n, %) 59 (59) 15 (37.5) 26 (56.5) 0.06 Visual analog scale * * < Ingelman-Sundberg and Ulmsten scale Grade I Grade II Grade III * > 0:05: not significant. Preoerative incontinence, measured using the visual analogue scale, was significantly more severe in the TVT-only grou than in the other grous (6:8 2, versus 5:4 2:1and5:1 2:8; < 0:0001). The mean severity score was 6:1 2:4 (range 3 10) Procedures, erioerative comlications and immediate ostoerative outcome (Table 2) Most of the atients in grou 1 had local anesthesia (68%), while the atients in the other two grous usually had sinal or general anesthesia (62.7% and 33.7%, resectively). The mean ( S.D.) oerating times were resectively min, min and 96:1 36 min in grous 1, 2 and 3; there was a significant difference between grou 1 and grous 2 þ 3 ( < 0:05), but not between grous 2 and 3. Perioerative comlications occurred in 29 atients (15.6%), and mainly consisted of bladder injury (n ¼ 18). There was no significant difference in the bladder injury rate according to the revious history of incontinence surgery. There were more bladder injuries in grous 2 þ 3 than in grou 1 ( ¼ 0:05). Seven women (2.7%) had blood loss exceeding 300 ml. Two atients required blood transfusion, one for hemorrhage after vaginal hysterectomy. No difference in the hemorrhage rate was observed among the three grous. The mean durations of bladder catheterization in grous 1, 2 and 3 were 2:4 2:2 days, 3:5 5:7 and 3:8 3:3, resectively (no significant difference). Fifteen atients develoed urinary tract infections, which always resonded to antibiotic theray; the rate of urinary tract infection in the three grous did not differ significantly. The mean hosital stay was significantly shorter in grou 1 (3:8 2:3 Table 2 Peri- and early ostoerative comlications in women who underwent tension-free vaginal taing alone or concomitantly with other rocedures (TVT and elvic reconstructive surgery) Overall oerating time (min) * * <0.05 TVT rocedure oerating time NS Perioerative comlications total (n, %) 7 (7%) 10 (5.1%) 12 (7.5%) 0.2 Blood loss >300 ml 1 (1%) 2 (5%) 4 (8.6%) NS Blood loss <300 ml 1 (1%) 1 (2.5%) 2 (4.3%) NS Blood transfusion 0 2 (5%) 0 NS Bladder injury (n, %) 5 (5%) 7 (17.9%) * 6 (13) * 0.05 Bladder catheterization (days) * Hosital stay (days) * * <0.002 * > 0:05: not significant.

4 A. Rafii et al. / Euroean Urology 45 (2004) Table 3 Postoerative urinary continence of women who underwent tension-free vaginal taing alone or concomitantly with other rocedures (TVT and elvic reconstructive surgery) Bladder self-catheterization (n, %) 7 (7%) 5 (12.5%) 5 (10.8%) 0.5 De novo urge symtoms (n, %) 34 (34%) 6 (15%) 14 (30.4%) 0.09 Postoerative leakage (n, %) 8 (8%) 4 (10%) 6 (13%) 0.9 > 0:05: not significant. Table 4 Functional outcome of women who underwent tension-free vaginal taing alone or concomitantly with other rocedures (TVT and elvic reconstructive surgery) Objective assessment Postoerative VAS Cure 93 (93%) 39 (97.5%) 41 (93.1%) 0.3 Failure 7 (7%) 1 (2.5%) 4 (13.7%) 0.3 Subjective assessment Cured 72 (72%) 29 (72.5%) 31 (67.3) 0.9 Imroved 20 (20%) 10 (25%) 10 (21.7%) Worsened 7 (7%) 1 (2.5%) 5 (10.8%) > 0:05: not significant. days) than in grou 2 and 3 (5:2 2:06 and 6:9 3:4 days) ( < 0:001) Postoerative continence (Table 3) Mean follow-u was 24:5 2:6 months. During this eriod, 29.1% of the atients had urinary urge symtoms, with no difference among the grous. Likewise, voiding difficulties requiring bladder self-catheterization occurred in 30 atients (16.2%) with no difference among the grous, 13 atients had a resolution of their voiding difficulties within a week after surgery. For 17 atients the voiding difficulties lasted longer, 10 of them had a resolution within a month ostoeratively, but desite intermittent self-catheterization there was no imrovement in 7 of the 17 women with ostoerative urinary retention in our series. Sling adjustment was required in 4 cases and sectioning of the trans-vaginal olyroylene tae in 3 cases during the first ostoerative months (3:5 1:4 months). Previous incontinence surgery and the tye of anesthesia did not influence the risk of either dysuria or urge symtoms. Overall, 10.8% of atients comlained of leakage during ostoerative follow-u; the frequency was slightly but not significantly higher in grou 3 than in the other two grous ( ¼ 0:9). No tae rejection and no vaginal wall healing defects occurred. There were no differences among the three grous as regards any of the urinary arameters studied Objective and subjective results (Table 4) The overall objective cure rate was 93.5%, and did not differ among the three grous. The overall subjective cure rate was 71.3% ( < 0:05 versus the objective cure rate), and did not differ among the three grous. The mean reoerative and ostoerative visual analog scores were 6:2 2:4 and 0:9 2:2, resectively, reresenting a significant imrovement ( ¼ 0:0001). A trend towards a lower subjective cure rate was observed among women with mixed versus genuine stress incontinence. No difference in the subjective cure rate was noted according to the Ingelman- Sundberg classification, with grade I to III incontinence in 100 of 141 (70.9%), 10 of 14 (71.4%) and 22 of 31 (70.9%) women in grous 1, 2 and 3, resectively. In the same way, no difference in the subjective cure rate was observed according to reoerative clinical variable such as age, menoausal status, revious incontinence surgery, and the body mass index. Finally, no difference in the subjective cure rate was noted according to maximal urethral closure ressure or to

5 360 A. Rafii et al. / Euroean Urology 45 (2004) additional surgical rocedures erformed during tension-free vaginal taing. 4. Discussion The safety and efficacy of the vaginal aroach to elvic reconstructive surgery and hysterectomy has been extensively documented. Likewise, long-term trials show that TVT is safe and effective [11 14]. It is therefore aealing to erform TVT at the same time as other vaginal rocedures for atients with SUI, although the outcome of such mixed rocedures is oorly documented [4,5]. Our results suggest that TVT can be erformed concomitantly with hysterectomy or elvic floor reconstruction, with good results. In contrast to revious reorts [9,15,16] we observed a high rate of comlications, consisting mainly of bladder injury, voiding difficulties and de novo urge symtoms. The incidence of bladder erforation in our series (9.6%) is comatible with reviously reorted rates of 1% to 23%. In contrast to our revious study [17], we found no difference in the rate of bladder erforation according to the history of incontinence surgery. However, bladder injury was more frequent in atients undergoing concomitant hysterectomy or elvic floor reconstruction than in atients undergoing TVT alone. Therefore it seem reasonable in case of associate surgery to erform the TVT before other associated rocedure, then the risk of bladder erforation is the same as rimary cases. Voiding difficulties develoed ostoeratively in 9.1% of our atients, comared to 3% to 19.1% in revious reorts [9,18]. There are few ublished data on the management of this comlication after TVT. Desite intermittent self-catheterization there was no imrovement in 7 of the 17 women with ostoerative urinary retention in our series. Sling adjustment was required in 4 cases and sectioning of the transvaginal olyroylene tae in 3 cases during the first ostoerative month. This aroach is unique to the TVT rocedure; in other series the average time from sling to urethrolysis is many months [19]. In a national analysis of comlications associated with tension-free vaginal tae, Kuuva and Nilsson found only one case of urinary retention requiring olyroylene tae section, desite a 7.5% incidence of urinary retention lasting u to 4 months [11]. Furthermore, this comlication can occur when the TVT tae slides toward the bladder neck, and this is why we used a new incision after the associated rocedure to lace the TVT. Voiding difficulties were less frequent than that in the study by Partoll (43%) [4], and were not clearly related to the associated rocedures or to revious incontinence surgery. This difference may be exlained by our oerating rotocol. Indeed, the atients undergoing TVT and another rocedure usually had general or loco-regional anesthesia, meaning that we could not adjust the tae according to the effects of coughing; we therefore laced the tae as loosely as ossible to avoid urinary retention. The other chief itfall of TVT that can be assimilated to sling rocedures is the risk of a ostoerative urge syndrome [20]. In our study the rate of de novo ostoerative urge symtoms (28.4%) was higher than in other studies [5,12,21], but few atients comlained of urge urinary incontinence (7.5%). No difference was found among the three grous in this resect. It has been suggested that the occurrence of urge symtoms may be related to over-correction or to the connective tissue reaction to the tae [22]. However, as the number of atients included in the associated-rocedure grous was limited, further studies with more atients may be able to throw light on this question. The rate of ostoerative leakage (9.6%) was similar in the three grous and robably reflects the good objective cure rates. The success of incontinence surgery can be hard to assess, articularly when associated with other elvic surgical rocedures, and subjective cure rates can be biased by the results of the associated rocedures. We first evaluated the objective cure rate by hysical examination and by using a visual analog scale. The follow-u eriod was the same in the three grous, and the overall cure rate was 93%, a figure in keeing with revious reorts. When assessing the subjective cure rate, we tried to avoid bias due to the associated rocedures, with questions secifically addressing the atients satisfaction with their urinary continence. The atients feelings about the outcome of their incontinence surgery were very similar in the three grous. The subjective cure rate, assessed using a visual analog scale and a questionnaire, was 70.9% overall. The difference between the objective and subjective cure rates was statistically significant, contrary to some revious studies in which atient satisfaction was assessed using a visual analog scale alone [11]. The only factor exlaining the difference between the objective and subjective cure rates was de novo urge symtoms. Previous studies have shown a relationshi between the risk of de novo urge symtoms and urethral elevation [23]. In addition to urethral elevation, changes in araurethral collagen metabolism and sclerosis around the olyroylene tae may be involved in the onset of de novo urge symtoms in this setting [22]. Further studies are necessary to confirm the imact of this factor.

6 A. Rafii et al. / Euroean Urology 45 (2004) The statistical ower of our study is robably insufficient to draw firm conclusions, but bladder erforation aeared to be more frequent when TVT was erformed concomitantly with other rocedures, although this had no imact on urologic outcome. Desite its statistical limitation our study may reflect a clinical reality. We do not retend to rove the sueriority of one attitude above another (concomitant rocedure or searate rocedures), as it would be ossible in a randomised controlled trial. In conclusion, elvic floor defects, benign uterine disorders and stress urinary incontinence can be safely treated with tension-free vaginal tae and vaginal rocedures during the same surgical rocedure. References [1] Darai E, Jeffry L, Deval B, Birsan A, Kadoch O, Soriano D. Results of tension-free vaginal tae in atients with or without vaginal hysterectomy. Eur J Obstet Gynecol Rerod Biol 2002;103: [2] Grody MH. Urinary incontinence and concomitant rolase. Clin Obstet Gynecol 1998;41: [3] Roovers JP, van der Bom JG, van der Vaart CH, Schagen van Leeuwen JH, Heintz AP. Abdominal versus vaginal aroach for the management of genital rolase and coexisting stress incontinence. Int Urogynecol J Pelvic Floor Dysfunct 2002;13: [4] Partoll LM. Efficacy of tension-free vaginal tae with other elvic reconstructive surgery. Am J Obstet Gynecol 2002;186: [Discussion ]. [5] Gordon D, Gold RS, Pauzner D, Lessing JB, Groutz A. Combined genitourinary rolase reair and rohylactic tension-free vaginal tae in women with severe rolase and occult stress urinary incontinence: reliminary results. Urology 2001;58: [6] Ingelman-Sundberg A, Ulmsten U. Surgical treatment of female urinary stress incontinence. Contr Gynec Obstet 1983;10:51. [7] Baden WF, Walker TA. Physical diagnosis in the evaluation of vaginal relaxation. Clin Obstet Gynecol 1972;15: [8] Abrams P, Blaivas JG, Stanton SL, Andersen JT. The standardisation of terminology of lower urinary tract function. The International Continence Society Committee on Standardisation of Terminology. Scand J Urol Nehrol Sul 1988;114:5 19. [9] Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical rocedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 1996; 7(2):81 5. [10] Deval B, Jeffry L, Al Najjar F, Soriano D, Darai E. Determinants of atient dissatisfaction after a tension-free vaginal tae rocedure for urinary incontinence. 2002;167(5): [11] Nilsson C, Kuuva N. The tension-free vaginal tae rocedure is successful in the majority of women with indications for surgical treatment of urinary stress incontinence. Br J Obstet Gynaecol 2001; 108(4): [12] Rezaour M, Falconer C, Ulmsten U. Tension-Free vaginal tae (TVT) in stress incontinent women with intrinsic shincter deficiency (ISD) a long-term follow-u. Int Urogynecol J Pelvic Floor Dysfunct 2001;12(Sul 2):S [13] Rezaour M, Ulmsten U. Tension-free vaginal tae (TVT) in women with mixed urinary incontinence a long-term follow-u. Int Urogynecol J Pelvic Floor Dysfunct 2001;12(Sul 2):S [14] Rezaour M, Ulmsten U. Tension-free vaginal tae (TVT) in women with recurrent stress urinary incontinence a long-term follow u. Int Urogynecol J Pelvic Floor Dysfunct 2001;12(Sul 2): S9 11. [15] Ulmsten U, Johnson P, Rezaour M. A three-year follow u of tension free vaginal tae for surgical treatment of female stress urinary incontinence. Br J Obstet Gynaecol 1999;106(4): [16] Wang AC, Lo TS. Tension-free vaginal tae. A minimally invasive solution to stress urinary incontinence in women. J Rerod Med 1998;43(5): [17] Jeffry L, Deval B, Birsan A, Soriano D, Darai E. Objective and subjective cure rates after tension-free vaginal tae for treatment of urinary incontinence. Urology 2001;58(5): [18] Jacquetin B. Use of TVT in surgery for female urinary incontinence. J Gynecol Obstet Biol Rerod 2000;29(3): [19] Nitti VW, Raz S. Obstruction following anti-incontinence rocedures: diagnosis and treatment with transvaginal urethrolysis. J Urol 1994;152:93 8. [20] Klutke JJ, Carlin BI, Klutke CG. The tension-free vaginal tae rocedure: correction of stress incontinence with minimal alteration in roximal urethral mobility. Urology 2000;55(4): [21] Haab F, Sananes S, Amarenco G, Ciofu C, Uzan S, Gattegno B, et al. Results of the tension-free vaginal tae rocedure for the treatment of tye II stress urinary incontinence at a minimum followu of 1 year. J Urol 2001;165(1): [22] Falconer C, Ekman-Ordeberg G, Malmstrom A, Ulmsten U. Clinical outcome and changes in connective tissue metabolism after intravaginal slinglasty in stress incontinent women. Int Urogynecol J Pelvic Floor Dysfunct 1996;7: [23] Leng WW, McGuire EJ. Obstructive uroathy induced bladder dysfunction can be reversible: bladder comliance measures before and after treatment. J Urol 2003;169:563 6.