A short-term follow-up comparison of two trans-obturator tape procedures
© Springer-Verlag 2007
Received: 9 June 2006
Accepted: 5 April 2007
Published: 10 July 2007
The objective of the study was to compare the clinical outcomes at the short-term follow-ups of two novel transobturator mid-urethral sling procedures – the transobturator tape (TOT) procedure and the tension-free vaginal tape (TVT)-obturator procedure. The study cohort consisted two groups of 40 women with urodynamically proven stress urinary incontinence (SUI). The patients in one group underwent the TOT procedure, performed according to Delorme (Prog Urol 11:1306–1313, 2001); those in the second group underwent the TVT-obturator operation, performed according to de Leval (Eur Urol 44:724–730, 2003). Intra-operative diagnostic cystoscopy was not performed with either the TVT-obturator or the TOT procedures. The average follow-up was 12 months. The two patient groups were similar in terms of demographic and therapeutic criteria, except for patient age, which was significantly younger in the TVT-obturator group. Previously reported TVT-related operative complications, such as bladder penetration, intra-operative bleeding, field infection and post-operative pelvic floor relaxation, were not observed in patients of either group. Bowel and urethral injuries were also not recorded. The therapeutic failure rates were 10% for the TOT procedure and 5% for the TVT-obturator procedure. Urinary frequency and urgency post-operatively were reported in 25% of the TOT patients and 19% of the TVT-obturator patients, pelvic or vaginal pain affected 10% of the TOT and 5% of the TVT-obturator patients, while post-operative voiding difficulty was experienced by 12.5% of the TOT and 7.5% of the TVT-obturator patients. None of the above-mentioned differences between the two patient groups were of statistical significance. The TVT-obturator and TOT procedures, both minimally invasive, novel, mid-urethral sling procedures, seem to be safe, easy-to-perform and effective in treating female SUI. The patients of both study groups suffered less intra- and post-operative surgical complications than previously been reported in connection with the TVT operation. The TVT-obturator patients had fewer therapeutic failures, less post-operative urinary frequency and urgency, less pelvic pain and less voiding difficulty. All of these findings, however, had no statistical significance; consequently, long-term comparative data collection will be required before solid conclusions can be drawn on the superiority of either of these two operative techniques.
The tension-free vaginal tape (TVT) procedure, first described by Ulmsten et al. in 1996 and based on mid-urethral prolene tape support, is a surgical procedure used for treating female stress urinary incontinence (SUI) [1–6]. Although the procedure is well-established, a number of complications are associated with the TVT operative approach that have drawn the concern of surgeons. These include bladder penetration [2, 3, 6] and post-operative urinary outlet obstruction [2, 3, 6, 8, 10] as well as bowel penetration, intra-operative bleeding, and post-operative infection [2, 3, 6–9]. The latter three complications entail the potential risk of severely harming the health of the patient. Against this background, de Leval  and Delorme  designed novel transobturator mid-urethral sling procedures. Jean de Leval described the TVT-obturator as follows: "while the TVT needle passes through the retropubic area, which is proximal to the neighboring bladder, bowel and blood vessels, the newly reported TVT-Obturator needle route runs through the relatively safe medial compartment of the obturator fossa area" . Delorme developed the transobturator tape (TOT) procedure, in which a skin incision is made at the genitofemoral fold at the level of the clitoris and the tape is inserted through the obturator foramen underneath the urethra. The vaginal wall is then re-approximated with a running Vicryl 2/0 suture .
This study reported here was designed to compare surgeons’ learning curves for these two TOT procedures.
Patients suffering from SUI, diagnosed both clinically and urodynamically, were referred for corrective surgery. The first author performed the TVT-obturator procedures, and the last author performed the TOT procedures. The second and third authors compared the patients’ series for these two different types of procedures. Data were collected by telephone interview based on the Urinary Distress Index (UDI)-6 validated questionnaire. The TVT-obturator operations were carried out according to de Leval  and the TOT procedure was according to Delorme . All of the operated patients were given 1 g Monocef (Cefonicid; Beecham Healthcare) intravenously 1 h prior to surgery  and had an iodine antiseptic prophylactic vaginal wash before commencement of surgery. The mode of anesthesia depended on the patient’s request. Diagnostic cystoscopy was not carried out in either patient group. Therapeutic failures were confirmed by repeat urodynamic studies and treated successfully by TVT. Patients with early post-operative partial outlet obstruction were treated with bladder catheterization for up to 2weeks . All statistical analyses were performed with SPSS ver.10.1.4 (SPSS, Chicago, Ill.). The t-test was used for quantitative variance analysis, while the Fisher’s exact test and the chi-square test were used for categorical variance. All statistical tests were evaluated at the P = 0.05 level of significance.
Patient demographics (NS not significant)
TVT- obturator group
Statistical significance (P value)
Age (years; average and range)
Previous anti-incontinence surgery (n and %)
Previous hysterectomy (n and %)
Cystocele grade 2 and 3
Rectocele grade 2 and 3
Additional operations (No. and %)
A. and P. Colporrhaphy
Background diseasesa (n and %)
Post-operative variables (NS not significant)
TOT group (n= 40)
TVT-obturator group (n = 40)
Statistical significance (P value)
5/3, 2/2, 2/1
UDI-6 (Pts / level)
Since being described by Ulmsten et al. in 1996 , the TVT procedure has become very popular. Common complications of former operations for the treatment of SUI, such as intra-operative blood loss, pelvic and abdominal organ injury, post-operative de-novo Detrusor instability, dyspareunia, and urethral erosion, are rare in the TVT era [1–5]. Prospective randomized multi-center studies that have compared TVT and the former gold standard, the Burch colposuspension, have demonstrated a similar therapeutic impact for both. However, TVT had a higher intra-operative complication rate, while colposuspension had a higher post-operative complication rate and a longer recovery period [14–19]. Among the well-documented typical TVT complications are bladder penetration, intra-operative bleeding, post-operative field infection, and bowel injury [1–3, 5]. De Leval  and Delorme  described novel TVT-related procedures that enable mid-urethral support for the treatment of female SUI without coming into the vicinity of the bladder, the femoral blood vessels, or the bowel. This is achieved by using the obturator fossa, rather than the retropubic space, as a route for the prolene tape. The results of our comparative study are in line with the previously reported efficacy of the TOT and the TVT-obturator procedures in terms of cure and early and late post-operative complication rates . The short-term results for TOT and TVT-obturator surgery include fewer cases of bladder penetration, intra-operative bleeding, and post-operative field infection in comparison to the TVT approach. The therapeutic failure rates, post-operative urinary frequency and urgency, pelvic or vaginal pain, and voiding difficulty that our patients encountered were all slightly more common in patients who underwent the TOT procedure than in those having the TVT-obturator procedure, but those findings had no statistical significance. None of these differences between the two patient groups were of statistical significance. This lack of significant difference between the outcome measures of the two patient groups may be partially due to the relatively short follow-up period for the recently launched TOT and TVT-obturator procedures as well as to the accumulated surgical experience with mid-urethral sling placement following the learning curve period for TVT. However, our study was a short-term one with a subjective nature. A long-term follow-up for objectively measured large-scale studies will be required before solid conclusions can be drawn with regard to advocating TOT placement as the procedure of choice for the treatment of female SUI.
The TOT and TVT-obturator procedures, two novel mid-urethral sling operations for the treatment of female SUI, seem to be effective, easy-to-learn, and safe procedures. Intra-operative diagnostic cystoscopy for ruling out bladder penetration is not required with these surgical approaches. The short-term follow-up results of the present study for TOT and TVT-obturator are comparable: both the TOT and TVT-obturator procedures resulted in fewer intra-operative and post-operative complications than the TVT. Further follow-up is required for the transobturator operation before it can be recommended as primary care of female SUI.
- Ulmsten U, Henriksson L, Johnson P, Varhos G (1996) An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J 7:81–86View ArticleGoogle Scholar
- Olsson I, Kroon U (1999) A three-year post-operative evaluation of tension-free vaginal tape. Gynecol Obstet Invest 48:267–269PubMedView ArticleGoogle Scholar
- Kuuva N, Nilsson CG (2002) A nationwide analysis of complications associated with the tension-free vaginal tape (TVT) procedure. Acta Obstet Gynecol Scand 81:72–77PubMedView ArticleGoogle Scholar
- Paraiso MFR, Muir TW, Sokol AI (2002) Are mid-urethral slings the gold standard surgical treatment for primary genuine stress incontinence? J Am Assoc Gynecol Laparosc 9:405–407PubMedView ArticleGoogle Scholar
- Groutz A, Gordon D, Wolman I, Jaffa AJ, David MP, Lessing JB (2002) Tension-free vaginal tape for stress urinary incontinence: Is there a learning curve? Neurol Urodynam 21:470–472View ArticleGoogle Scholar
- Waetjen LE, Subak LL, Shen H et al (2003) Stress urinary incontinence surgery in the United States. Obstet Gynecol 101:671–676PubMedView ArticleGoogle Scholar
- Neuman M (2003) Low incidence of post-TVT genital prolapse. Int Urogynecol J 14:191–192Google Scholar
- Neuman M (2004) Post tension-free vaginal tape voiding difficulty – prevention and management. J Pelvic Med Surg 10:19–21View ArticleGoogle Scholar
- Neuman M (2004) Transvaginal tape readjustment after unsuccessful tension-free vaginal tape operation. Neurourol Urodynam 23:282–283View ArticleGoogle Scholar
- Neuman M (2002) Infected hematoma following tension-free vaginal tape implantation. J Urol 168:2549PubMedView ArticleGoogle Scholar
- De Leval J (2003) Novel surgical technique for the treatment of female stress urinary incontinence: Transobturator vaginal tape inside-out. Eur Urol 44:724–730PubMedView ArticleGoogle Scholar
- Delorme E (2001) Transobturator urethral suspension: a minimally invasive procedure to treat female stress urinary incontinence. Prog Urol 11:1306–1313Google Scholar
- Neuman M (2007) Prophylactic antibiotics for the TVT procedure. Gynecol Surg (in press)Google Scholar
- Esinler I, Zeyneloglu HB (2004) Routine cystoscopy is not needed in TOT outside-in. Eur Urol 46:675PubMedView ArticleGoogle Scholar
- Neuman M (2006) Transvaginal suture placement for bleeding control with the tension-free vaginal tape procedure. Int Urogynecol 17:176–177Google Scholar
- Liapis A, Bakas P, Creatsas G (2002) Burch colposuspension and tension-free vaginal tape for the management of stress incontinence in women. Eur Urol 41:469–473PubMedView ArticleGoogle Scholar
- Ward KL, Hilton P (2004) United Kingdom and Ireland tension-free vaginal tape Trial group. A prospective multicenter randomized trail of tension-free vaginal tape and colposuspension for primary urodynamic stress incontinence: two-year follow-up. Am J Obstet Gynecol 190:324–331PubMedView ArticleGoogle Scholar
- Grise P, Lobel B, Grall J (2003) Les complications du TVT. Prog Urol 13:144–146PubMedGoogle Scholar
- Cody J, Wyness L, Wallace S et al (2003) Systemic review of the clinical effectiveness and cost-effectiveness of TVT for the treatment of urinary stress incontinence. Health Technol Asssess 7:1–189Google Scholar
- Costa P, Delmas V (2004) Trans-Obturator-tape procedure - “inside out or outside in”: current concept and evidence based. Current Opin Urol 14:313–315View ArticleGoogle Scholar