Prospective randomized trial of TVT and TOT

Arch Gynecol Obstet (2010) 281:279–286DOI 10.1007/s00404-009-1098-9ORIGINAL ARTICLEProspective randomized trial of TVT and TOT as primary treatment for female stress urinary incontinence withor without pelvic organ prolapse in Southeast ChinaFengmei Wang · Yanfeng Song · Huijuan HuangReceived: 22 January 2009 / Accepted: 15 April 2009 / Published online: 30 April 2009© Springer-Verlag 2009AbstractObjective To compare the outcomes of tension- free vaginal tape (TVT) and transobturator tape (TOT) in the treatment of female stress urinary incontinence with or without con-comitant pelvic organ prolapse (POP).Methods One hundred and forty patients with SUI were randomly allocated to TVT (n=70) or TOT (n=70). The objective outcomes were assessed with a stress test, 1-h pad test. Subjective outcomes were assessed with UDI-6/(IIQ-7) questionnaires.Results The surgical outcomes revealed no signi W cant di V erence between TVT and TOT surgical route. Both the subjective and objective cure rates were 91.4% in the TOT group, while 90 and 92.8% in the TVT group, respectively. The results showed the association to pelvic X oor surgical techniques did not diminish a year later. TOT procedure has a shorter operative time for patients without concomi-tant surgery.Conclusion The e Y cacy and safety of TVT procedure were similar to that of TOT procedure for female stress uri-nary incontinence with or without concomitant POP. Keywords Tension-free vaginal tape · Transobturator tape · Stress urinary incontinence · Surgical outcomes IntroductionThe tension-free vaginal tape (TVT) procedure for the treatment of urodynamic stress urinary incontinence in women was reported in 1996 by Ulmsten et al. with an ini-tial 2-year cure rate of 84% [1]. This minimally invasive procedure has been shown to be a safe and e V ective treat-ment for GSI with good long-term results [2]. However, the TVT procedure has been related with various and poten-tially serious complications, such as urine retention, blad-der perforation, vaginal erosion, retropubic hematoma, or abscess and injuries at vessels, nerves, and intestine [3–8].In 2001, Delorme [9] described the transobturator (TOT) access ‘outside–inside’, aiming at the reduction of compli-cations by avoiding entering the space beyond the endopel-vic fascia. In this technique, the tape is inserted through the obturator foramens from outside to inside (in extenso from the thigh folds toward underneath the urethra). Delorme showed that TOT procedure is accompanied with high suc-cess rates and few perioperative complications.The aim of this study is to compare the TOT procedure with the TVT procedure in a randomized clinical trial set-ting and compare their e Y cacy in the treatment of SUI associated with or without pelvic organ prolapse (POP). Materials and methodsPatients, who urodynamically had proven stress urinary incontinence, were recruited for the study between Septem-ber 2003 and December 2007. Seventy patients in TVT group between 42 and 87years of age and 70 patients in TOT group between 37 and 75 were enrolled. Patients with urge incontinence or overactive bladder were excluded (Fig.1). Our study was a single-blind randomized trial andF. Wang · Y. Song (&) · H. HuangDepartment of Obstetrics and Gynecology,Fuzhou General Hospital, 350025 Fuzhou, Fujian, China e-mail: carnation1002@the patients were randomly allocated to either TVT or TOT group. All procedures were performed by Y. F. Song. The patients were not blinded to the operative procedure. Post-operative assessment was done by F.M. Wang, who did not take part in the operations. Y.F. Song was not involved in the follow-up.All patients gave an informed consent, and the study protocol was approved by the ethics committee of our hospital. Preoperative evaluation included clinical history, urinalysis, QoL assessment and clinical examination, uro-dynamic study with cystomanometry urethral pro W le if there was suspicion of sphincter insu Y ciency (severe from of stress incontinence with a Valsalva leak point pressure less than 100cm H2O) and measurement of postvoid residual urine by ultrasound examination. Urodynamic and prolapse quanti W cation methods, de W nitions and units conformed to the standards recommended by the International Conti-nence Society.A positive cough test was a necessary condition for per-forming an incontinence stress surgery. Intrinsic sphincter de W ciency was de W ned as urodynamic stress incontinence with maximum urethral closure pressure <20cm H2O and/ or valsalva leak point pressure <60cm H2O. Also, any pel-vic X oor defect was evaluated according to the POP quanti-W cation (POPQ) staging. In all prolapse cases, a cough test was made after bladder W lling to 200ml reducing prolapse for the diagnosis of occult stress incontinence.The TVT procedures were performed in accordance with the technique by Ulmsten et al. [1]. The patient was positioned in the dorsal lithotomy position. The sites of the suprapubic stab incisions were located along the superior rim of the pubic bone, two W ngerbreadths lateral to themidline, each 0.5–1cm in length. The bladder was drained with a Foley catheter and a 1.5 midline incision was made at the mid-urethra. Metzenbaum scissors were used to dissect under the vaginal epithelium laterally to create a periurethral spaces to the inferior pubic ramus. Once the periurethral spaces were ready, a special prolene tape (Ethi-con, Sommerville, NJ, USA) covered by a plastic sheath was introduced using a two-component needle instrument. The tip of this needle W rst perforates the urogenital dia-phragm and is then moved upwards within the retropubic space (keeping the tip close to the pubic bone). After perfo-ration of the rectus sheath, a small 1-cm incision is made over the needle point in the skin just above the superior rim of the pubic bone. This procedure is then repeated on the other side with the other needle, ensuring that the skin inci-sions are <5cm apart. At this time, cystoscopy was per-formed because of the risk of bladder perforation. The tape is, therefore, placed in a U-form shape around the mid-ure-thra. During this step, a Metzenbaum scissors is placed between the urethra and the tape to prevent an increase in the tension of the tape. The vaginal incision was closed with absorbable suture. The remaining sling mesh is cut at the abdominal skin. The Foley catheter is then replaced in the bladder.The TOT procedures were performed in accordance with the technique by Delorme et al. [9]. The anterior vaginal wall is suspended with two Allis clamps on either side of the midline, 0.5cm proximally to the urethral meatus. A vertical midline incision of the vaginal wall is started at this level and is continued proximally over a 1.5cm distance. Both vaginal mucosal and submucosal tissues are incised. Using scissors, dissection of the para-urethral space is made bilaterally, toward the ischiopubic rami. The lateral margin of the ischiopubic is identi W ed and the index W nger placed in the latero-vaginal fornix and thumb placed in front of the obturator foramen. The external needle entry point is made in the genitofemoral fold by a shallow cutaneous stab incision slightly above a horizontal line passing through the clitoral hood, just under the adductor longus tendon insertion. The semicir-cular, corkscrew-shaped needle of the device is intro-duced through the stab incision, held in the same hand as the side on which the surgeon is working. Once the needle passes through the obturator membrane, it reaches the W ngertip inserted in the para-urethral space. It is then passed around the ischiopubic ramus, while the protecting W nger remains in contact with the needle until it is visual-ized at the suburethral incision. Once this procedure has been completed, the vagina is evaluated for any unwanted perforations. The tape is then connected to the needle tip. Next, with a rotating wrist motion, the tape is guided through the tunnel and exist the skin incision. The same procedure is carried out on the contralateral side. Tension-free adjustment is made to the tape under the mid-urethra. Vaginal closures are made with interrupted absorbable sutures.The urinary catheter was removed 12–24h after surgery. In the patients, who also underwent various other vaginal reconstructive procedure, urinary catheter was removed 24–72h after surgery. The two procedures were performed under local anesthesia supplemented by an intravenous sed-ative, unless the patients were also undergoing vaginal hys-terectomy or pelvic X oor repair. In these cases, they were given spinal anesthesia.In TVT group, 40 patients had isolated urinary inconti-nence, 30 patients had concomitant uterine or vaginal vault prolapse. Patients, who had uterine prolapse, underwent transvaginal hysterectomy, anterior–posterior colporrhaphy (APC) and posterior intravaginal slingplasty reconstructive surgeries, and TVT procedure. The patients who had vagi-nal vault prolapse underwent APC and TVT procedure. Of the 70 patients in TOT group, 48 had isolated urinary incontinence, 22 had concomitant uterine or vaginal vault prolapse. Patients who had uterine prolapse underwent transvaginal hysterectomy, APC and/or posterior IVS reconstructive surgeries and TOT procedure. The patients who had vaginal vault prolapse underwent APC and TOT procedure.Intraoperative and postoperative complications were evaluated. The QoL assessment was carried out preopera-tively and 1year from surgery with the use of the Urogeni-tal Distress Inventory Short Form (UDI-6) and the Incontinence Impact Questionnaire Short Form (IIQ-7) questionnaires. The short form of IIQ-7 and UDI-6 vali-dated by Uebersax et al. [10] consists of seven and six questions, respectively. These questionnaires had been translated into Chinese and validated for female population in China [11]. Subjective outcomes were assessed by the two questionnaires. The cough test, 1-h pad test and urody-namic examination were performed if the patient referred voiding dysfunction. The operations were all conducted by the same gynecologist. A voiding trial as described by Kle-eman et al. [12] was performed on all patients before dis-charge. If patients failed their voiding trial, they were taught to perform intermittent self-catheterization with a Foley catheter. The length of hospital stay was de W ned as number of days between the completion of surgery and hos-pital discharge.Outcome measures were categorized as follows: objec-tive cure was de W ned as no stress incontinence during cough stress test (300cm X uid in the bladder, cough force-fully, visible leakage means a positive test), a 1-h pad test (1-h pad test) of <2g. Patients were considered ‘improved’if they did not leak on the cough stress test, but may have had occasional urine leakage during stress; this occasion leakage did not in X uence their daily activities or requirefurther treatment. Besides, urine weight by the 1-h pad test was decreased by more than 50%. All other cases were reported as objective failures. The patient’s subjective assessment of the outcome of incontinence was classi W ed as cured (UDI-6 and IIQ-7 postoperative <10), improved (UDI-6 and IIQ-7 if postoperative>preoperative) and worsened (UDI-6 and IIQ-7 if postoperative<preoperative). Statistical analysisAll data were recorded using standard forms. We used SPSS 11.5. A P value of less than 0.05 was considered signi W cant.ResultsAll of patients were followed up at the end of 12 months. Thus, we obtained the preoperative and postoperative data from 140 patients. There were no signi W cant di V erences in the preoperative characteristics of patients who under-went TVT or TOT procedure (Table1). We also found that there was no major intraoperative complication in the both TVT and TOT group (Table2). However, the dura-tion of the operation was signi W cantly shorter in the TOT group (12min) compared with the TVT group (21min) for patients without concomitant POP (P=0.012). No perioperative injury to the urethra, nerves, vessel or bowel happened in each group. But a bladder perforation occurred in three patients in TVT group, and one of them had been operated on twice before for urinary inconti-nence. In TOT group, one patient had bladder perforation. With cystoscopy, we withdrew and re-implanted the tape which did not a V ect the e Y ciency. Until the 12-month fol-low-up, we did not W nd any declined e Y ciency of this patient. About 3 patients (4.2%) in the TVT group and 8 (11.4%) in the TOT group complained of postoperative inner thigh or buttock discomfort, but all of these transient symptoms of discomfort disappeared in all patients at 1-month follow-up. After surgery, 8 patients (11.4%) in the TVT group and 6 (8.57%) in the TOT group had short-term voiding di Y culty. With a longer catheter time, all patients voided well following removal of the catheter. Three patients had vaginal tape erosion: one in the TVT group at 1month’s follow-up and two in the TOT group at 3months’ follow-up.Surgical results were similar in both groups. Concomi-tant pelvic reconstructive procedure had no e V ect on the surgical results (Tables3, 4, 5, 6). At the 1-year follow-up, the objective cure rates were 91.4% in the TOT group and 92.8% in the TVT group. In comparison with the complete cure rate, there were no signi W cant di V erences between the TOT group and the TVT group. The objective cure rates for patients with isolated SUI were 95% in the TVT group and 93.75% in the TOT group. For patients with concomitant POP, the cure rates were 90% in the TVT group and 86.36% in the TOT group (Tables3, 4). On subjective Table1Patient characteristics, preoperative clinical, quality of life, and urodynamic parametersValues are given as mean§SDP value denotes the comparison between two groups using two sample t test, chi-squareQmax maximum X ow rate, ALPP abdominal leak point pressure, SUI stress urinary incontinence, UDI-6 Urogenital Distress Inventory Short Form, IIQ-7 Incontinence Impact Questionnaire Short Forma Student’s t testb Chi-square testTVT (n=70)TOT (n=70)PAge (years)60§10.858§11.60.595a Isolated SUI58§11.259§13.50.606a Concomitant pelvicorgan prolapse62§12.361§12.90.612aBody mass index (kg/m2)24§2.424.6§2.60.332a Isolated SUI23§2.722.9§3.10.295a Concomitant pelvicorgan prolapse25§3.123.1§2.50.301aHormone replacementtherapy16 (22.86%)14 (20%)0.832a Previous surgery for SUI 5 (7.14%) 3 (4.29%)0.643b Duration of SUI (years) 4.7§4.6 4.3§3.90.496a Isolated SUI 5.1§4.2 4.7§4.10.398a Concomitant pelvicorgan prolapse3.7§3.1 3.9§3.10.402aPostvoid residualurine (ml)17.9§27.923.7§23.70.967a Isolated SUI18.9§24.321.3§20.10.879a Concomitant pelvicorgan prolapse17.2§25.223.5§24.20.921a Qmax (ml/s)27.6§13.829.8§11.30.413a Isolated SUI30.8§14.932.8§15.30.362a Concomitant pelvicorgan prolapse24.3§11.224.5§11.10.377a ALPP (cm H2O)92.3§41.881.2§43.60.104a Isolated SUI91.4§42.492.4§41.80.314a Concomitant pelvicorgan prolapse89.3§39.282.5§40.10.234a UDI-649§2149§190.699a Isolated SUI52§1748§200.605a Concomitant pelvicorgan prolapse45§2445§210.586a IIQ-740§2840§250.712a Isolated SUI45§2541§260.597a Concomitant pelvicorgan prolapse35§3038§310.801aassessment, the cure rate of TVT group and TOT group was 90 and 91.4%, respectively.The scores of UDI-6 and IIQ-7 were signi W cantly less than the preoperative scores on each scale. These statistical di V erences between pre- and postsurgery with the QoL test were independent of the association of pelvic X oor repair surgery.DiscussionBecause of the pelvic structure, stress incontinence and POP often occur together because of the pelvic structure. POP can a V ect the urethra by pulling and open the posterior urethral wall, thereby causing urethral sphincter inconti-nence by mechanically obstructing the urethra or by dissi-pating the e V ects of abdominal pressure on the urethra. This might be the main cause of the stress incontinence that occurs after correcting POP [13, 14]. Since the introduction in 1996 [1], TVT procedure had become a popular treat-ment for urinary incontinence. With some complications including bowel and major blood vessel injuries, bladder and urethral perforation, and postoperative voiding di Y cul-ties or urgencies, a new surgical technique of mid-urethral prosthetic suspension called the TOT tape was introduced in 2001 [3]. There were large occidental studies reporting that TOT was safer and more e Y cient for the treatment of stress urinary incontinence than TVT, mainly with fewer complications. Thus, it was hypothesized that there would be no di V erence in the outcome between TVT and TOTTable2Intraoperative compli-cations, operation time, catheter time, and length of hospitaliza-tion and postoperative complica-tionsTVT (n=70)TOT (n=70)P Mean operation timein min (range)35.5 (18–80)29.8 (10–80)0.082aIsolated SUI21 (18–30)12 (10–21)0.012a Concomitant pelvicorgan prolapse62 (35–80)65 (30–75)0.324a Cystoscopy performed70/703/70Bladder perforation 3 (4.3%) 1 (1.4%)0.310b Nerves or vessel lesionsor hemorrhage00Mean catheter timein hours (range)34 (12–72)32 (12–72)0.356a Isolated SUI18 (12–24)16 (12–24)0.567a Concomitant pelvicorgan prolapse28 (24–72)30 (24–72)0.348aMean length of hospitalizationin days (range)3.6 (1–6) 3.2 (1–5)0.708a Isolated SUI 1.4 (1–3) 1.5 (1–3)0.712a Concomitant pelvicorgan prolapse4.3 (3–6) 3.9 (3–5)0.612a Infection00Tape division01Postoperative residualvolume (ml)37.3§50.348.4§61.10.643a Isolated SUI33.3§46.142.4§55.60.419a Concomitant pelvicorgan prolapse38.2§48.748.3§58.40.732a Postoperative complicationsPain 3 (4.2%)8 (11.4%)0.116b Short-term voiding di Y culty8 (11.4%) 6 (8.57%)0.317b Frequency430.698 Urgency31 1.320 Leakage of urine whenstraining120.559 Rejection of tape120.559 Overactive bladder140.172P value denotes the comparison between two groups using two-sample t test, chi-squarea Student’s t testb Chi-square testapproach where the safety and e Y cacy were concerned, if we made the optimal prophylactic measures in our country.Meanwhile, we were interested in whether the concomitant surgical procedures would a V ect the di V erences in safety and e Y cacy between TOT procedure and TVT procedure.Therefore, a prospective study was performed to evaluate the postoperative continence situation of those USI women with POP, who underwent anti-incontinence surgery com-bined with reconstructive surgery.In our study, average time of discharge and catheteriza-tion were comparable to the data reported previously [15].Bladder perforation was the only perioperative complica-tion that happened in both TVT group and TOT group. In the TVT procedure, it may occur due to a defect in the W xa-tion of the endopelvic fascia at the level of the arcus tendin-eus of the levator ani muscle. This may give room to the lateral parts of the bladder base to sink into this paravaginal space. The instrument can perforate the bladder base at that point. Pulling back the instrument or removing the tape and transurethral catheter for 24h is su Y cient. In di Y cult cases with known paravaginal defect, we strongly suggest to per-form a cystoscopy. In TOT group, there was only one case of bladder perforation, which hinted us that the periopera-tive cystoscopy might be imperative (particularly in patients who had undergone previous pelvic surgery),although many studies thought that there was no essential-ity of the perioperative cystoscopy as the procedure path-way was more far away from the bladder in the TOT surgery. Other perioperative complications, such as hema-toma and hemorrhea and infection were not found in each group. As the procedure route was closer relative to the obturator canal, a higher frequency of thigh pain was found in TOT group than that in TVT group. But these pains often would not exceed over 1month.A lthough TVT and TOT procedure are commonly applied to treatment female SUI, tape rejection is also a well-reported complication. The vaginal tape erosion rates reported in the literature were 2.2% in the TVT and 3.6% inTable 3Pad-test results at 12months follow-upaP =0.852 the number of patients with isolated SUI whose 1-h pad test of less than 2g in the TVT group vs that in the TOT groupbP =0.400 the number of patients with Concomitant pelvic organ pro-lapse whose 1-h pad test of less than 2g in the TVT group vs that in the TOT group1-h pad test <2g >2gTVTTOT TVT TOT Isolated SUI 38/40a 46/482/402/48Concomitant pelvic organ prolapse28/30b19/222/303/22Table 4Cough test results at 12months follow-upaP =0.801 the number of patients with isolated SUI whose cough test being negative in the TVT group versus that in the TOT group bP =0.685 the number of patients with Concomitant pelvic organ pro-lapse whose cough test being negative in the TVT group versus that in the TOT groupThe cough test Negative PositiveTVTTOT TVT TOT Isolated SUI 38/40a 45/482/403/48Concomitant pelvic organ prolapse27/30b19/223/303/22Table 5Preoperative and 1-year follow-up di V erences in the UDI-6scoresaP <0.05 preoperative versus 1-year follow-up in the TVT group (P =0.014)bP >0.05 preoperative in the TVT group vs preoperative in the TOT group cP >0.05 1-year follow-up in the TVT group versus 1-year follow-up in the TOT group dP <0.05 preoperative versus 1-year follow-up in the TOT group (P =0.008)UDI-6Preoperative 1-year follow-up TVT TOT TVT TOT Total 49§21a 46§20b 15§15c 14§17d Isolated SUI 52§1850§1718§1219§12Concomitant pelvic organ prolapse45§2545§2116§1414§15Table 6Preoperative and 1-year follow-up di V erences in the IIQ-7scoresaP <0.05 preoperative versus 1-year follow-up in the TVT group (P =0.020)bP >0.05 preoperative in the TVT group versus preoperative in the TOT group cP >0.05 1-year follow-up in the TVT group versus 1-year follow-up in the TOT group dP <0.05 preoperative versus 1-year follow-up in the TOT group (P =0.012)UDI-6Preoperative 1-year follow-up TVTTOT TVT TOT Total 40§21a 42§20b 13§12c 10§12d Isolated SUI 45§2341§318§129§11Concomitant pelvic organ prolapse40§2745§2112§1411§15the TOT procedures [14]. In our study, all three patients with tape erosion presented with vaginal tape protrusion. Since all of the protruding vaginal tapes seen in our study were <1cm long and no signs of infection were present, we adopted a more conservative surgical approach to trim o V the extruded portion of the tape, and closed the cleaned vaginal wound over it without tension. All patients recov-ered well and were symptom-free without any evidence of tape rejection recurrence at 12month’s of follow-up.Objective cure rates of stress incontinence surgery are determined by 1-h pad test and cough stress test. As showed in Tables3, 4, there was no signi W cant di V erence in the cure rate between the TVT group and the TOT group. DeTayrac et al. [15] had reported, in a randomized study, a 1-year cure rate of 83.9% with the TVT versus 90.0% with the TOT. Fisher et al. [16] reported a cure rate of 81% with TOT procedure compared with 76% with TVT. In our study, 92.8% with the TVT procedure and 91.4% with the TOT procedure were reported, which were higher than other reports. All these assessments, however, merely re X-ect the continence state at a single moment in time. The patient’s concept of cure was shown to have important in the rate of the outcome of incontinence surgery [17]. With a QoL analysis, we can provide di V erent information over a longer period of time and show the outcome of inconti-nence surgery more sensitively [18]. We chose to assess patients subjectively by asking them to express their satis-faction level via the UDI-6 and the IIQ-7 questionnaires because they are easy to administer and have been appro-priately validated in the Chinese language [11]. In our study, 90% with the TVT procedure and 91.4% with the TOT procedure were reported.We have also attempted in this report to determine if there could be any di V erence in outcome when a pelvic X oor reconstructive surgery was added to a TVT procedure or a TOT procedure. No signi W cant di V erences were found in the patients undergoing TVT procedure or TOT proce-dure. For patients with isolated SUI, an objective cure rate of 95% with the TVT group and 93.75% with the TOT group were reported. The objective cure rates of patients with associated pelvic reconstructive surgery were 90 and 86.36%, respectively. Neither UDI-6 nor IIQ-7 showed any di V erence between groups with and without pelvic repair. There were also no di V erences in the UDI-6 and IIQ-7 pre-operative and postoperative scores in women with pelvic X oor repair or women with just the TOT/TVT procedure.Until now, many reports comparing the e Y cacy and safety of TOT procedure to that of TVT procedure were published. 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