Int Urogynecol J (2014) 25:909–914 DOI 10.1007/s00192-013-2312-7

ORIGINAL ARTICLE

Randomized clinical trial comparing TVT Secur system and trans vaginal obturator tape for the surgical management of stress urinary incontinence Ken Maslow & Chander Gupta & Peter Klippenstein & Lise Girouard

Received: 10 July 2013 / Accepted: 12 December 2013 / Published online: 23 January 2014 # The International Urogynecological Association 2014

Abstract Introduction and hypothesis This prospective randomized study aimed to compare the safety and efficacy of the TVTSecur (TVT-S) with the trans vaginal obturator tape (TVT-O) for the treatment of stress urinary incontinence. Methods We set out to enroll 136 patients in our study. 106 patients with stress urinary incontinence were randomized to either the TVT-S (n=56) or TVT-O (n=50) procedure. Patients were evaluated postoperatively at 2 months and 1 year. Our primary outcome was objective cure measured by the cough test. Secondary outcomes of subjective symptoms, questionnaires, pain scores, complications, and urodynamic studies were also included. Statistical analysis was by Chi-squared, Kruskal–Wallis, Wilcoxon, and Fisher’s exact tests as appropriate. P values of 30 lbs (13.6 kg) Smoker Atrophic vagina Presence of ≤ stage 1 prolapse UDS: MCC (ml) UDS: DO (years) MUCP (cmH2O) USUI (years) Uroflow volume Qmax

0.9, 1.03 18 (36.0) 5 (10.0) 41 (83.7)a 42 (85.7)a 16 (32.7)a 6 (12.0) 0 (0) 17 (34) 9 (18.4)a 10 (20.0) 8 (16.3)a 314.9, 80.4 0 74.8, 26.3a 31 (62) 325.8, 122.3 31.1, 1.6

0.8, 0.92 19 (33.9) 6 (10.9)a 49 (87.5) 40 (74.1)b 21 (37.5) 6 (10.9)a 1 (1.8)a 11 (20)b 9 (17.0)b 11 (19.6) 2 (3.6) 300.2, 80.5b 3.6 84.7, 28.6 38 (69.1)a 334.7, 103.8 31.7, 15.1

PVR initially IIQ-7 UDI-6

8.3, 14.7 42.19, 4.14 47.10, 16.7

7.5, 14.3 50.43, 4.26 52.3, 15.5

(Table 2). Both groups showed improved IIQ-7 scores and UDI-6 scores, but the degree of improvement was not significant (Table 2). The percentage of patients using pads at 1 year appeared to decrease more in the TVT-O than the TVT-S group; however, this did not reach significance (Tables 1, 2). In the initial postoperative period, significantly fewer patients randomized to the TVT-S experienced groin pain (Table 3). The severity of the groin/leg pain was significantly higher in the TVT-O group as were higher postoperative overall pain scores. Groin pain also lasted longer in the TVT-O group (Table 3). Groin discomfort at 1 year persisted in a minority of patients with TVT-O, and none of the patients receiving TVT-S (Table 2). Additionally, dyspareunia at 1 year was present in 14.3 % of those with TVT-O compared with 6.3 % of those with TVT-S (Table 2). Intraoperative blood loss was less with TVT-O as was having few days with vaginal bleeding, although this was

not clinically significant. Post-void residual volumes remained low and urinary maximum flow rates did not change in the two groups prior to and post-surgery at 1 year. Urinary frequency, nocturia, and number of UTIs were the same in both groups at 1 year (Table 2).

Discussion This randomized trial revealed that the TVT-Secur has a higher 1-year positive cough stress test than the TVT-O procedure. Patients also reported more subjective stress urinary incontinence at 1 year after the TVT-S procedure. Since statistical significance was achieved in our interim analysis for our primary objective, our study was terminated early. Hota et al. prematurely terminated their study at 86 participants owing to interim results showing only 45 % cure rate with

Int Urogynecol J (2014) 25:909–914

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Table 2 One-year objective and subjective results for TVT-O and TVT Secur TVT-O (n=50) n (%)

TVT-Secur (n=52) n (%)

p value

SUI (subjective) Pad use Vaginal discomfort Presence of groin discomfort Dyspareunia Vaginal erosion Atrophic vagina Cough test negative Qmax (ml/s)

6 (12.0) 7 (14.9)a 0 (0) 3 (6.0) 6 (14.3)b 0 (0.00)d 17 (34.0) 43 (86.0) 23.9 (9.74)

14 (26.9) 14 (26.9) 1 (1.9) 0 (0.0) 3 (6.3)c 1 (2.1)b 16 (30.8) 33 (63.5) 34.3 (59.9)

0.08 0.22 1.0 0.11 0.29 0.49 0.83 0.01 0.79

PVR (ml) IIQ7 UDI6 Change in IIQ-7 score from initial to final Change in UDI6 score from initial to final

5.9 (20.66) 2.5 (6.88) 8.6 (9.1) 39.69

7.4 (13.9) 9.6 (17.4) 17.6 (18.3) 40.83

0.20 0.02 0.02 0.84

38.5

34.7

0.25

For Qmax, PVR, IIQ7, and UDI-6 numbers are mean (standard deviation) a

3 missing; b 8 missing; c 2 missing; d 1 missing

TVT-S versus a 91 % cure rate using TVT-O, with differences appearing as early as 12 weeks postoperatively [18]. In reviewing the existing literature, several other authors found cure rates similar to those found in our study [19–22]. Most recently, in a similar study, Andrada Hamer et al. compared TVT with TVT-S and found objective 1-year cure rates of 94 % and 71 % respectively [19]. Wang et al. compared TVT, TVT-O, and TVT-S in a three-arm prospective randomized study with 102 participants and found that TVT-S had only a 68 % cure rate compared with 92 % and 94 % for TVTO and TVT respectively [20]. Oliveira et al. compared three groups of 30 patients randomized to the TVT-S, TVT-O, and Mini-Arc, and found 67 %, 83 %, and 87 % cure according to Table 3 Initial postoperative period

Presence of groin pain Groin/leg discomfort score (VAS) Groin pain (days) OR time (min) Vaginal bleeding (days) Blood loss in (g) Pain score (VAS)

TVT-O (n=50) n (%)

TVT-Secur (n=56) n (%)

p value

48 (97.9)a 3.2, 2.2b

27 (50)a 0.8, 1.5a

0.00000001

Randomized clinical trial comparing TVT Secur system and trans vaginal obturator tape for the surgical management of stress urinary incontinence.

This prospective randomized study aimed to compare the safety and efficacy of the TVT-Secur (TVT-S) with the trans vaginal obturator tape (TVT-O) for ...
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