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Transobturator tape sling for female stress incontinence with polypropylene tape and outside-in procedure: Prospective study with 1 year of minimal follow-up and review of transobturator tape sling
ADULT UROLOGY
TRANSOBTURATOR TAPE SLING FOR FEMALE STRESS INCONTINENCE WITH POLYPROPYLENE TAPE AND OUTSIDE-IN PROCEDURE: PROSPECTIVE STUDY WITH 1 YEAR OF MINIMAL FOLLOW-UP AND REVIEW OF TRANSOBTURATOR TAPE SLING PHILIPPE GRISE, STEPHANE DROUPY, CHRISTIAN SAUSSINE, PHILIPPE BALLANGER, FRANCOIS MONNEINS, JEAN FRANCOIS HERMIEU, GERARD SERMENT, AND PIERRE COSTA
ABSTRACT Objectives. To assess the efficacy and safety of a minimally invasive surgical procedure using a polypropylene transobturator tape to treat female stress urinary incontinence during a minimal follow-up of 1 year and to present a review of this technique. Methods. A total of 206 women with stress urinary incontinence who underwent the transobturator tape procedure in a French multicenter prospective open tracker study, with a minimal follow-up of 1 year (range 12 to 33 months), were assessed. A nonelastic, polypropylene tape was placed under the mid-urethra. The surgical placement technique used a vaginal and transobturator percutaneous approach. Postoperative assessments included clinical examination, cough-stress test (full bladder), uroflowmetry, and postvoid residual urine volume performed after 1, 6, 12, 18, and 24 months. Results. The mean follow-up was 16 months (range 12 to 33). Of the 206 patients, 79.1% were completely cured, 13% improved, and 7% failed. No vascular, nervous system, or digestive perioperative complications were observed; however, 2.4% of the patients had postoperative urinary retention. Conclusions. The results of the present study have confirmed the optimal results in stress incontinence previously reported in short-term studies. These results suggest that the transobturator tape procedure is a valuable alternative to the transvaginal tape procedure, with a low rate of complications. UROLOGY 68: 759–763, 2006. © 2006 Elsevier Inc.
S
tress incontinence is a common condition in women, with a prevalence of 35% for European countries.1 The stress (37%) and mixed (33%) types are the more frequent symptoms of incontinence and surgery may be proposed. Minimal invasive surgery has been widespread for the past 10 From the Department of Urology, Rouen University Hospital, Rouen, France; Department of Urology, Bicêtre Hospital, Le Kremlin-Bicêtre, France; Department of Urology, University Hospital, Strasbourg, France; Department of Urology, Pellegrin Hospital, Bordeaux, France; Department of Urology, Hospital of Gonesse, Gonesse, France; Department of Urology, Bichat Hospital, Paris, France; Department of Urology, Salvator Hospital, Marseille, France; and Department of Urology, Caremeau University Hospital, Nîmes, France Reprint requests: Philippe Grise, M.D., Department of Urology, Rouen University Hospital-Charles Nicolle, 1 rue de Germont, Rouen 76031 Cedex, France. E-mail: [email protected] Submitted: December 26, 2005, accepted (with revisions): April 21, 2006 © 2006 ELSEVIER INC. ALL RIGHTS RESERVED
years, since Petros and Ulmsten2 reported a new concept of mid-urethral support without tension, the tension-free vaginal tape (TVT) technique, with a cure rate of incontinence of more than 80%.3 The TVT procedure has been shown to be equally as effective as open Burch colposuspension.4,5 Most perioperative complications of the TVT procedure have been related to penetration of the retropubic space. Therefore, as an alternative to the TVT sling, the transobturator tape (TOT) outside-in technique has been developed to minimize the blind passage of the needle in the retropubic space by placing the tape between the two obturator foramen. This approach was first described by Delorme6 in 2001 and later confirmed by short-term studies,7,8 with a continence rate approximately similar to that for the retropubic TVT technique. This prospective study presents our results with 1 year of minimal follow-up on the efficacy and 0090-4295/06/$32.00 doi:10.1016/j.urology.2006.04.020 759
TABLE I.
Patient characteristics (n ⴝ 206)
Age at procedure (yr) Menopausal (%) Parity Body mass index Prior surgery for prolapse (%) Hysterectomy (%) Prior surgery for incontinence (%) Pure stress incontinence (%) SUI and urgency (%) Mixed incontinence (%)
58.5 (29–88) 63.6 2.3 (0–9) 26.5 (16.9–48.8) 13.1 32.5 16.5 39.8 22.3 37.9
KEY: SUI ⫽ stress urinary incontinence. Data in parentheses are ranges.
safety of the TOT technique with the same thermally bonded polypropylene tape (OBTAPE, Mentor-Porges, Le Plessis Robinson, France) used for all patients. MATERIAL AND METHODS From November 2002 to September 2004, 206 consecutive patients with proven stress urinary incontinence from eight European centers were enrolled in a prospective open tracker study. They underwent surgery using the TOT outside-in surgical approach. The main criteria for inclusion were visible stress urinary incontinence and urethral hypermobility on physical examination. All the patients were able to void spontaneously without dysuria. No pressure flow study was performed. Evaluations were performed on the 206 patients with a minimal follow-up of 1 year (range 12 to 33 months). The patient characteristics are presented in Table I. All surgeons were experienced in the TVT procedure and attended a hands-on training course for TOT. Their first learning-curve patients were included in this series. The preoperative and postoperative assessments included previous medical history, a urogynecologic examination, urodynamics (urethrocystometry, urethral pressure profile, urine flow measurement), a stress test (cough provocation), a Marshall test, and routine assessment of postoperative efficacy and safety at 1, 6, 12, 18, and 24 months postoperatively. Stress incontinence and urgency was recorded preoperatively and postoperatively by the physician on the study form. The safety assessment results were reported on the case report form. Potential perioperative hazards, including hemorrhage and vaginal or urethral perforation, were recorded. Postoperative hazards, including retention, low stream, frequency, urgency outcome, de novo urgency, pain, erosion, or abnormalities on the vaginal and thigh examination, and other adverse effects, were also recorded. Some patients underwent concomitant surgery (hysterectomy in 1 and prolapse repair in 34). Cure was defined as the absence of a subjective complaint of urine leakage and the absence of leakage on cough stress testing and was reported on the case report form. The patients were considered to have improvement when they reported a decrease in stress incontinence. Other cases were considered treatment failures. The TOT method6 has been previously described. The low elasticity of the thermally bonded polypropylene tape facilitates its precise perioperative adjustment, and no sheath was required. A Foley catheter was inserted at the beginning of the procedure and removed on day 1, after which the postvoid residual urine volume was measured. Implantation was performed under general anesthesia in 129 patients, spinal in 21, and local in 56 patients. All the 760
TABLE II.
Preoperative urodynamic characteristics
Urodynamic findings (n) No bladder overactivity Bladder overactivity Maximum urethral closure pressure (cm H2O) at rest (n) ⬍20 ⱖ20 Missing data Uroflowmetry parameters* Maximal flow rate (mL/s) Voiding time (sec) Postvoid residual urine (mL)
187 19
7 189 10 30.4 ⫾ 12.8 30.8 ⫾ 15.7 16.9 ⫾ 44.8
* Data presented as mean ⫾ standard deviation.
patients had undergone a urodynamic test before surgery. The preoperative urodynamic characteristics of the patients are summarized in Table II. All the data were anonymous and centralized for statistical analysis. The signed-rank Wilcoxon test was used for continuous variables. P ⬍0.05 was considered significant.
RESULTS The mean follow-up was 16 months (range 12 to 33, median 14). The perioperative complications were bladder perforation in 2 patients and vaginal sulcus perforation in 6. No nerve or bowel damage occurred. No significant intraoperative bleeding (more than 200 mL) was observed nor was blood transfusion necessary, but a thigh hematoma occurred. The postoperative obstructive complication rate was 2.4% (5 of 206). The tape was released 10 days after implantation in 1 patient and sectioned at 1.5 and 2 months after implantation in 2 patients who required intermittent self-catheterization. Two additional patients used intermittent self-catheterization for 3 and 5 days. Of the 206 patients, 4 had vaginal erosion (1.5%) situated laterally that occurred at 2, 8, 13, and 25 months after implantation. They were all treated by partial removal. One vaginal erosion at 25 months after implantation led to a deep adductor abscess. The deep adductor abscess was treated by antibiotics and surgery for tape removal. The patient was cured and did not present with any sequelae. Significantly, this patient had previously developed a retropubic abscess after TVT implantation, and the TVT had to be removed. Some patients complained of transitory pain after implantation that was related to the procedure in 15 patients (7.3%), with pain located on the route of the TOT, or to the patient position on the table in 12 patients (ie, thighs were in hyperflexion on the abdomen). All cases of postoperative pain resolved spontaneously, most of them during the UROLOGY 68 (4), 2006
TABLE III.
Cure rate at 12- and 18-month follow-up for all patients (n ⴝ 206) or at 12-month follow-up for subgroup with recurrent incontinence of associated prolapse All Patients
Cured Improved Failed
12-mo Follow-up (n ⴝ 206)
18-mo Follow-up (n ⴝ 60)
Recurrent Incontinence at 12 mo (n ⴝ 34)
Associated Prolapse (n ⴝ 31)
163 (79.1) 27 (13.1) 16 (7.8)
48 (80) 8 (13.3) 4 (6.7)
25 (73.5) 5 (14.7) 4 (11.8)
23 (74) 7 (23) 1 (3)
Data in parentheses are percentages.
first week. Eighteen patients (8.7%) had a urinary tract infection. The continence results are displayed in Table III; a complete cure was obtained in 80% of patients with a minimum of 1 year of follow-up. Sixteen patients were considered to have treatment failure. Of these, 2 patients had recurrent incontinence a few months after sectioning the tape because of obstructive symptoms. Of the 14 other patients, 4 had a history of multiple procedures for incontinence, 8 had a maximal urethral closure pressure of 8 to 29 cm H2O, and no risk factor was observed in the remaining 2 patients. The resolution of urgency in 46 patients with stress urinary incontinence was disappearance in 56.6%, improvement in 13%, unchanged in 15.2%, and worse in 15.2%. For the 78 patients with mixed incontinence, the corresponding values were 53.8%, 26.9%, 15.4%, and 3.9%. Postoperative de novo urgency was reported in 9 patients (10.9%). As regards the remaining patients out of 206, they all have pure stress incontinence as represented in Table I (i.e., 39.8%). Uroflowmetry results were considered only for a single voided volume of 150 mL or greater. The comparison between preoperative and postoperative findings in 91 patients showed a significant decrease in the maximal flow rate (30.4 ⫾ 12.8 versus 29.0 ⫾ 13.3 mL/s, P ⬍0.0001), respectively. No significant change in the voiding time (30.8 ⫾ 15.7 versus 32.3 ⫾ 18.9 seconds) or postvoid residual urine volume (16.9 ⫾ 44 versus 14.3 ⫾ 37.3 mL) was observed. COMMENT The minimally invasive TVT procedure and similar techniques of sling placement have replaced most colposuspensions. The cure rate for stress incontinence reported for TVT has ranged from 84% to 95%, with proven long-term efficacy evaluated at 7 years by Kuva and Nilson.9 To minimize the TVT complications while maintaining the same results for continence, the TOT technique presents a new approach for the route of the tape. Preliminary UROLOGY 68 (4), 2006
results for the TOT procedure7 have confirmed that this procedure is a useful alternative to the TVT procedure. Evaluation on continence in a short-term study8 of 183 patients demonstrated a cure rate greater than 80% after a mean follow-up of 7 months, with a perioperative complication rate as low as 2.2%. However, the reported series of TOT placement have all had a short follow-up period of less than 1 year. The results of the present study have confirmed the high cure rate of stress incontinence, with 80% of patients completely dry after a minimum of 1 year of follow-up. An ongoing evaluation is being conducted for these patients. Our results also appear similar for associated pelvic organ prolapse. The postoperative retention rate after the TOT procedure compares favorably to the 2% to 27% retention rate reported after the TVT procedure.10 –12 A comparative study13 has confirmed a lower incidence of immediate and late bladder outlet obstruction after the TOT procedure. Only a 2.4% transient incomplete retention rate was observed in our series, with no statistically significant changes in voiding time or postvoid residual urine volume. The maximal flow rate decreased slightly from 30.4 to 29.0 mL/s. Few cases of complete retention were reported and all resolved after a few days of self-catheterization7 or by loosening the tape if retention persisted after 1 week.14,15 A more oblique and lateral direction of the tape, reproducing the pelvic hammock support, could explain the less obstructive effect compared with the retropubic suspension. Urinary obstruction in the first days after surgery may be due to edema or pain; however, after 1 week, persistent signs of dysuria or retention require early intervention using the same vaginal incision to release the tape by downward traction and adjust it to the correct position. Urgency with or without leakage disappeared in 56.6% and 53.8% of our patients, respectively. An improvement was also reported9 with TVT procedures. Significantly, the de novo urgency rate in our series was only 10.9% and may have reflected the minor obstructive effect of the TOT. 761
The absence of a retropubic space puncture dramatically limits the risk of severe complications such as reported with TVT, bowel16 and iliac vessel,10 injuries, and the large veins of the Santorini plexus are avoided. Preoperative and immediate postoperative TOT complications were rare. Urethral perforation occurred in 1 patient in a study by Mellier et al.17 during the procedure. It is safer to postpone implantation, unless the lesion is superficial. Hemorrhage18,19 has been reported in 0.8% of patients and has been treated by compression alone. The lateral urethral space punctured below the fascia pelvis is not crossed by vessels. In our series, we did not observe any nerve deficiency but only a transitory thigh pain. Furthermore, Spinosa et al.20 have recently demonstrated that the pathway of the outside-in procedure is distant from the posterior branch of the obturator nerve and the inferior external pudendal artery, which is not the case for the inside-out procedure. The thigh hematoma could have been due to the puncture of a superficial vein. The outcome of a bladder perforation differs between the retropubic space approach and the transobturator procedure. This complication is estimated to occur in 0.8% to 21% of patients undergoing the TVT procedure.10 –12,21 Few cases of bladder perforation have been reported during TOT implantation (2 patients in our series); most occurred when associated with pelvic organ prolapse repair or hysterectomy during the same procedure. Minaglia et al.22 recently published 3 cases of bladder perforation, in which 2 patients had undergone previous prolapse surgery. Nevertheless, the risk of bladder perforation appears to be greatly reduced with the TOT technique, estimated at 0.5% (3 of 604) in the study by Krauth et al.18 When routine cystoscopy was done on 38 patients,23 no perforation was observed. Therefore, cystoscopy can be recommended when previous or concomitant prolapse is present. The more lateral direction of the tape in the TOT procedure is a risk factor for perforation or secondary extrusion on the sulcus vaginalis. Variations in the individual anatomy of the vaginal sulcus depth, as well as vaginal tissue strength, require dissection of the vaginal wall deep enough and below the Halban fascia to minimize the risk of vaginal perioperative perforation or secondary erosion. A perioperative sulcus perforation requires locating a new deeper route for tape insertion and longer postoperative abstinence from sexual intercourse. The outcome of vaginal extrusion should be investigated by a careful vaginal examination during the postoperative consultation. The mean time to appearance was 9 months.24 Although some patients have no symptom, others may present with vaginal discharge, pain 762
(alone or during intercourse), or labia major edema.17,24 Two cases of inguinal abscess24,25 and one of perineal cellulitis26 have also been reported. The risk of an obturator abscess24 is specific to this route. Computed tomography or magnetic resonance imaging of the pelvis27 should be done to assess anatomic modifications when this clinical diagnosis is suspected. Exposure of the tape can be observed directly at vaginal examination, but in some cases it is covered by a granuloma. After tape removal, all reported patients were asymptomatic, and most remained continent. One can excise only the exposed segment of the tape,17 but complete removal24 has been advocated by some investigators for nonwoven tape. Infectious postoperative complications have also been reported for the TVT procedure, with vaginal erosions in 1.2%,28 wound infections in 0.8%,11 2 cases of infected hematoma,29 and 1 case of necrotizing fasciitis.30 The type of biomaterial may be an additional factor. Resistance to infection and tissue integration are better for large-pore synthetic tapes. Nonwoven thermally bonded tape is more exposed than woven polypropylene large-size mesh, such as the TVT, which reinforces the need for routine antiseptic vaginal preoperative preparation and antibiotic prophylaxis. A tape with a silicon-coated short surface facing the urethra has been abandoned8 because of vaginal extrusion and urethral erosion along the silicone surface. The previously reported studies and our present medium-term outcome series have suggested that the TOT sling procedure could be a valuable alternative to the TVT technique in terms of efficacy for stress urinary incontinence and because of its low rate of technique-related complications. The criteria for the respective indications between these two procedures warrant additional consideration, even if the TVT is probably more obstructive and may lead to retropubic injuries. This tracker study is currently ongoing. CONCLUSIONS Our results have demonstrated efficacy and a low complication rate for TOT with 1 year of minimal follow-up. These results add to the evidence that the TOT procedure compares well with the TVT procedure and could be considered a useful alternative. Long-term follow-up with prospective studies and comparisons of different tapes are also warranted. ACKNOWLEDGMENT. To Richard Medeiros, Rouen University Hospital Medical Editor, for his valuable advice in editing the manuscript. UROLOGY 68 (4), 2006
REFERENCES 1. Hunskaar S, Lose G, Sykes D, et al: The prevalence of urinary incontinence in women in four European countries. BJU Int 93: 324 –330, 2004. 2. Petros P, and Ulmsten U: An integral theory and its method for the diagnosis and management of female urinary incontinence. Scand J Urol Nephrol Suppl 153: 3–93, 1993. 3. Ulmsten U, Falconer C, Johnson P, et al: A multicenter study of tension-free vaginal tape (TVT) for surgical treatment of urinary stress incontinence. Int Urogynecol J 9: 210 –213, 1998. 4. Ward K, and Hilton P: A prospective multicenter randomized trial of tension-free vaginal tape and colposuspension for primary urodynamic stress incontinence: two-year follow-up. Am J Obstet Gynecol 190: 324 –331, 2004. 5. Wang AC, and Chen MC: Comparison of tension-free vaginal tape versus modified Burch colposuspension on urethral obstruction: a randomized controlled trial. Neurourol Urodyn 22: 185–190, 2003. 6. Delorme E: La bandelette trans-obturatrice: un procédé mini-invasif pour traiter l’incontinence urinaire d’effort de la femme. Prog Urol 11: 13.6 –13.13, 2001. 7. Delorme E, Droupy S, de Tayrac R, et al: Transobturator Tape (Uratape®): a new minimally-invasive procedure to treat female urinary incontinence. Eur Urol 45: 203–207, 2004. 8. Costa P, Grise P, Droupy S, et al: Surgical treatment of female stress urinary incontinence with a transobturator tape (T.O.T.; Uratape®): short-term results of a prospective multicentric study. Eur Urol 46: 102–107, 2004. 9. Nilsson C-G, Falconer C, and Rezapour M: Seven year follow-up of the tension-free vaginal tape procedure for treatment of urinary incontinence. Obstet Gynecol 104: 1259 – 1262, 2004. 10. Debodinance P, Delporte P, Engrand JB, et al: Tensionfree vaginal tape (TVT) in the treatment of urinary stress incontinence: 3 years experience involving 256 operations. Eur J Obstet Gynecol Reprod Biol 105: 49 –58, 2002. 11. Kuuva N, and Nilson CG: A nationwide analysis of complications associated with the tension-free vaginal tape (TVT) procedure. Acta Obstet Gynecol Scand 81: 72–77, 2002. 12. Levin I, Groutz A, Gold R, et al: Surgical complications and medium-term outcome results of tension-free vaginal tape: a prospective study of 313 consecutive patients. Neurourol Urodyn 23: 7–9, 2004. 13. Ansquer Y, Marcollet A, Yazbeck C, et al: The suburethral sling for female stress urinary incontinence: retropubic or transobturator approach. J Am Assoc Gynecol Laparosc 11: 353–358, 2004. 14. Albouy B, Sambuis C, Andreou A, et al: Can transobturator tape for urinary incontinence cause complete urinary retention? Prog Urol 14: 189 –191, 2004.
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15. Ozel B, Minaglia S, Hurdato E, et al: Treatment of voiding dysfunction after transobturator tape procedure. Urology 64: 1030e9 –1030e10, 2004. 16. Peyrat L, Boutin JM, Bruyere F, et al: Intestinal perforation as a complication of tension-free vaginal tape procedure for incontinence. Eur Urol 39: 709 –715, 2001. 17. Mellier G, Benayed B, Bretones S, et al: Suburethral tape via the obturator route: is the T.O.T. a simplification of the TVT? Urogynecol J Pelvic Floor Dysfunct 15: 227–232, 2004. 18. Krauth JS, Rasoamiaramanana H, Bartela H, et al: Suburethral tape treatment of female urinary incontinence—morbidity assessement of the trans-obturator route and a new tape (I-STOP): a multi-centre experiment involving 602 cases. Eur Urol 47: 102–107, 2005. 19. Spinosa JP, and Dubuis PY: Suburethral sling inserted by the transobturator route in the treatment of female stress urinary incontinence: preliminary results in 117 cases. Eur J Obstet Gynecol Reprod 123: 212–217, 2005. 20. Spinosa JP, Dubuis PY, and Riederer B: Chirurgie de l’incontinence urinaire à l’effort féminine par voie transobturatrice: dehors dedans ou dedans dehors? Etude anatomique comparative. Prog Urol 15: 700 –706, 2005. 21. Tsivian A, Kessler O, Mogutin B, et al: Tape related complications of the tension-free vaginal tape procedure. J Urol 171: 762–764, 2004. 22. Minaglia S, Ozel B, Klutke C, et al: Bladder injury during transobturator sling. Urology 64: 376e1–376e2, 2004. 23. Dargent D, Bretones S, George P, et al: Insertion of a sub-urethral sling through the obturating membrane for treatment of female urinary incontinence. Gynecol Obstet Fertil 30: 576 –582, 2002. 24. Domingo S, Alama P, Ruiz N, et al: Diagnosis, management and prognosis of vaginal erosion after transobturator suburethral tape procedure using a nonwoven thermally bonded polypropylene mesh. J Urol 173: 1627–1630, 2005. 25. Cindolo L, Salzano L, Rota G, et al: Tension-free transobturator approach for female stress urinary incontinence. Minerva Urol Nefrol 56: 89 –98, 2004. 26. Caquant F, Collinet P, Deruelle P, et al: Perineal cellulitis following trans-obturator sub-urethral tape Uratape. Eur Urol 47: 108 –110, 2005. 27. Mahajan ST, Kenton K, Bova DA, et al: Transobturator tape erosion associated with leg pain. Int Urogynecol J Pelvic Floor Dysfunct 17: 66 – 68, 2006. 28. Hammad FT, Kennedy-Smith A, and Robinson RG: Erosions and urinary retention following polypropylene synthetic sling. Eur Urol 47: 641– 647, 2005. 29. Neuman M: Infected hematoma following tension free vaginal tape implantation. J Urol 168: 2549, 2002. 30. Johnson DW, Elhajj M, O’Brien-Best E, et al: Necrotizing fasciitis after tension-free vaginal tape (TVT) placement. Int Urogynecol J 14: 291–293, 2003.
763
TRANSOBTURATOR TAPE SLING FOR FEMALE STRESS INCONTINENCE WITH POLYPROPYLENE TAPE AND OUTSIDE-IN PROCEDURE: PROSPECTIVE STUDY WITH 1 YEAR OF MINIMAL FOLLOW-UP AND REVIEW OF TRANSOBTURATOR TAPE SLING PHILIPPE GRISE, STEPHANE DROUPY, CHRISTIAN SAUSSINE, PHILIPPE BALLANGER, FRANCOIS MONNEINS, JEAN FRANCOIS HERMIEU, GERARD SERMENT, AND PIERRE COSTA
ABSTRACT Objectives. To assess the efficacy and safety of a minimally invasive surgical procedure using a polypropylene transobturator tape to treat female stress urinary incontinence during a minimal follow-up of 1 year and to present a review of this technique. Methods. A total of 206 women with stress urinary incontinence who underwent the transobturator tape procedure in a French multicenter prospective open tracker study, with a minimal follow-up of 1 year (range 12 to 33 months), were assessed. A nonelastic, polypropylene tape was placed under the mid-urethra. The surgical placement technique used a vaginal and transobturator percutaneous approach. Postoperative assessments included clinical examination, cough-stress test (full bladder), uroflowmetry, and postvoid residual urine volume performed after 1, 6, 12, 18, and 24 months. Results. The mean follow-up was 16 months (range 12 to 33). Of the 206 patients, 79.1% were completely cured, 13% improved, and 7% failed. No vascular, nervous system, or digestive perioperative complications were observed; however, 2.4% of the patients had postoperative urinary retention. Conclusions. The results of the present study have confirmed the optimal results in stress incontinence previously reported in short-term studies. These results suggest that the transobturator tape procedure is a valuable alternative to the transvaginal tape procedure, with a low rate of complications. UROLOGY 68: 759–763, 2006. © 2006 Elsevier Inc.
S
tress incontinence is a common condition in women, with a prevalence of 35% for European countries.1 The stress (37%) and mixed (33%) types are the more frequent symptoms of incontinence and surgery may be proposed. Minimal invasive surgery has been widespread for the past 10 From the Department of Urology, Rouen University Hospital, Rouen, France; Department of Urology, Bicêtre Hospital, Le Kremlin-Bicêtre, France; Department of Urology, University Hospital, Strasbourg, France; Department of Urology, Pellegrin Hospital, Bordeaux, France; Department of Urology, Hospital of Gonesse, Gonesse, France; Department of Urology, Bichat Hospital, Paris, France; Department of Urology, Salvator Hospital, Marseille, France; and Department of Urology, Caremeau University Hospital, Nîmes, France Reprint requests: Philippe Grise, M.D., Department of Urology, Rouen University Hospital-Charles Nicolle, 1 rue de Germont, Rouen 76031 Cedex, France. E-mail: [email protected] Submitted: December 26, 2005, accepted (with revisions): April 21, 2006 © 2006 ELSEVIER INC. ALL RIGHTS RESERVED
years, since Petros and Ulmsten2 reported a new concept of mid-urethral support without tension, the tension-free vaginal tape (TVT) technique, with a cure rate of incontinence of more than 80%.3 The TVT procedure has been shown to be equally as effective as open Burch colposuspension.4,5 Most perioperative complications of the TVT procedure have been related to penetration of the retropubic space. Therefore, as an alternative to the TVT sling, the transobturator tape (TOT) outside-in technique has been developed to minimize the blind passage of the needle in the retropubic space by placing the tape between the two obturator foramen. This approach was first described by Delorme6 in 2001 and later confirmed by short-term studies,7,8 with a continence rate approximately similar to that for the retropubic TVT technique. This prospective study presents our results with 1 year of minimal follow-up on the efficacy and 0090-4295/06/$32.00 doi:10.1016/j.urology.2006.04.020 759
TABLE I.
Patient characteristics (n ⴝ 206)
Age at procedure (yr) Menopausal (%) Parity Body mass index Prior surgery for prolapse (%) Hysterectomy (%) Prior surgery for incontinence (%) Pure stress incontinence (%) SUI and urgency (%) Mixed incontinence (%)
58.5 (29–88) 63.6 2.3 (0–9) 26.5 (16.9–48.8) 13.1 32.5 16.5 39.8 22.3 37.9
KEY: SUI ⫽ stress urinary incontinence. Data in parentheses are ranges.
safety of the TOT technique with the same thermally bonded polypropylene tape (OBTAPE, Mentor-Porges, Le Plessis Robinson, France) used for all patients. MATERIAL AND METHODS From November 2002 to September 2004, 206 consecutive patients with proven stress urinary incontinence from eight European centers were enrolled in a prospective open tracker study. They underwent surgery using the TOT outside-in surgical approach. The main criteria for inclusion were visible stress urinary incontinence and urethral hypermobility on physical examination. All the patients were able to void spontaneously without dysuria. No pressure flow study was performed. Evaluations were performed on the 206 patients with a minimal follow-up of 1 year (range 12 to 33 months). The patient characteristics are presented in Table I. All surgeons were experienced in the TVT procedure and attended a hands-on training course for TOT. Their first learning-curve patients were included in this series. The preoperative and postoperative assessments included previous medical history, a urogynecologic examination, urodynamics (urethrocystometry, urethral pressure profile, urine flow measurement), a stress test (cough provocation), a Marshall test, and routine assessment of postoperative efficacy and safety at 1, 6, 12, 18, and 24 months postoperatively. Stress incontinence and urgency was recorded preoperatively and postoperatively by the physician on the study form. The safety assessment results were reported on the case report form. Potential perioperative hazards, including hemorrhage and vaginal or urethral perforation, were recorded. Postoperative hazards, including retention, low stream, frequency, urgency outcome, de novo urgency, pain, erosion, or abnormalities on the vaginal and thigh examination, and other adverse effects, were also recorded. Some patients underwent concomitant surgery (hysterectomy in 1 and prolapse repair in 34). Cure was defined as the absence of a subjective complaint of urine leakage and the absence of leakage on cough stress testing and was reported on the case report form. The patients were considered to have improvement when they reported a decrease in stress incontinence. Other cases were considered treatment failures. The TOT method6 has been previously described. The low elasticity of the thermally bonded polypropylene tape facilitates its precise perioperative adjustment, and no sheath was required. A Foley catheter was inserted at the beginning of the procedure and removed on day 1, after which the postvoid residual urine volume was measured. Implantation was performed under general anesthesia in 129 patients, spinal in 21, and local in 56 patients. All the 760
TABLE II.
Preoperative urodynamic characteristics
Urodynamic findings (n) No bladder overactivity Bladder overactivity Maximum urethral closure pressure (cm H2O) at rest (n) ⬍20 ⱖ20 Missing data Uroflowmetry parameters* Maximal flow rate (mL/s) Voiding time (sec) Postvoid residual urine (mL)
187 19
7 189 10 30.4 ⫾ 12.8 30.8 ⫾ 15.7 16.9 ⫾ 44.8
* Data presented as mean ⫾ standard deviation.
patients had undergone a urodynamic test before surgery. The preoperative urodynamic characteristics of the patients are summarized in Table II. All the data were anonymous and centralized for statistical analysis. The signed-rank Wilcoxon test was used for continuous variables. P ⬍0.05 was considered significant.
RESULTS The mean follow-up was 16 months (range 12 to 33, median 14). The perioperative complications were bladder perforation in 2 patients and vaginal sulcus perforation in 6. No nerve or bowel damage occurred. No significant intraoperative bleeding (more than 200 mL) was observed nor was blood transfusion necessary, but a thigh hematoma occurred. The postoperative obstructive complication rate was 2.4% (5 of 206). The tape was released 10 days after implantation in 1 patient and sectioned at 1.5 and 2 months after implantation in 2 patients who required intermittent self-catheterization. Two additional patients used intermittent self-catheterization for 3 and 5 days. Of the 206 patients, 4 had vaginal erosion (1.5%) situated laterally that occurred at 2, 8, 13, and 25 months after implantation. They were all treated by partial removal. One vaginal erosion at 25 months after implantation led to a deep adductor abscess. The deep adductor abscess was treated by antibiotics and surgery for tape removal. The patient was cured and did not present with any sequelae. Significantly, this patient had previously developed a retropubic abscess after TVT implantation, and the TVT had to be removed. Some patients complained of transitory pain after implantation that was related to the procedure in 15 patients (7.3%), with pain located on the route of the TOT, or to the patient position on the table in 12 patients (ie, thighs were in hyperflexion on the abdomen). All cases of postoperative pain resolved spontaneously, most of them during the UROLOGY 68 (4), 2006
TABLE III.
Cure rate at 12- and 18-month follow-up for all patients (n ⴝ 206) or at 12-month follow-up for subgroup with recurrent incontinence of associated prolapse All Patients
Cured Improved Failed
12-mo Follow-up (n ⴝ 206)
18-mo Follow-up (n ⴝ 60)
Recurrent Incontinence at 12 mo (n ⴝ 34)
Associated Prolapse (n ⴝ 31)
163 (79.1) 27 (13.1) 16 (7.8)
48 (80) 8 (13.3) 4 (6.7)
25 (73.5) 5 (14.7) 4 (11.8)
23 (74) 7 (23) 1 (3)
Data in parentheses are percentages.
first week. Eighteen patients (8.7%) had a urinary tract infection. The continence results are displayed in Table III; a complete cure was obtained in 80% of patients with a minimum of 1 year of follow-up. Sixteen patients were considered to have treatment failure. Of these, 2 patients had recurrent incontinence a few months after sectioning the tape because of obstructive symptoms. Of the 14 other patients, 4 had a history of multiple procedures for incontinence, 8 had a maximal urethral closure pressure of 8 to 29 cm H2O, and no risk factor was observed in the remaining 2 patients. The resolution of urgency in 46 patients with stress urinary incontinence was disappearance in 56.6%, improvement in 13%, unchanged in 15.2%, and worse in 15.2%. For the 78 patients with mixed incontinence, the corresponding values were 53.8%, 26.9%, 15.4%, and 3.9%. Postoperative de novo urgency was reported in 9 patients (10.9%). As regards the remaining patients out of 206, they all have pure stress incontinence as represented in Table I (i.e., 39.8%). Uroflowmetry results were considered only for a single voided volume of 150 mL or greater. The comparison between preoperative and postoperative findings in 91 patients showed a significant decrease in the maximal flow rate (30.4 ⫾ 12.8 versus 29.0 ⫾ 13.3 mL/s, P ⬍0.0001), respectively. No significant change in the voiding time (30.8 ⫾ 15.7 versus 32.3 ⫾ 18.9 seconds) or postvoid residual urine volume (16.9 ⫾ 44 versus 14.3 ⫾ 37.3 mL) was observed. COMMENT The minimally invasive TVT procedure and similar techniques of sling placement have replaced most colposuspensions. The cure rate for stress incontinence reported for TVT has ranged from 84% to 95%, with proven long-term efficacy evaluated at 7 years by Kuva and Nilson.9 To minimize the TVT complications while maintaining the same results for continence, the TOT technique presents a new approach for the route of the tape. Preliminary UROLOGY 68 (4), 2006
results for the TOT procedure7 have confirmed that this procedure is a useful alternative to the TVT procedure. Evaluation on continence in a short-term study8 of 183 patients demonstrated a cure rate greater than 80% after a mean follow-up of 7 months, with a perioperative complication rate as low as 2.2%. However, the reported series of TOT placement have all had a short follow-up period of less than 1 year. The results of the present study have confirmed the high cure rate of stress incontinence, with 80% of patients completely dry after a minimum of 1 year of follow-up. An ongoing evaluation is being conducted for these patients. Our results also appear similar for associated pelvic organ prolapse. The postoperative retention rate after the TOT procedure compares favorably to the 2% to 27% retention rate reported after the TVT procedure.10 –12 A comparative study13 has confirmed a lower incidence of immediate and late bladder outlet obstruction after the TOT procedure. Only a 2.4% transient incomplete retention rate was observed in our series, with no statistically significant changes in voiding time or postvoid residual urine volume. The maximal flow rate decreased slightly from 30.4 to 29.0 mL/s. Few cases of complete retention were reported and all resolved after a few days of self-catheterization7 or by loosening the tape if retention persisted after 1 week.14,15 A more oblique and lateral direction of the tape, reproducing the pelvic hammock support, could explain the less obstructive effect compared with the retropubic suspension. Urinary obstruction in the first days after surgery may be due to edema or pain; however, after 1 week, persistent signs of dysuria or retention require early intervention using the same vaginal incision to release the tape by downward traction and adjust it to the correct position. Urgency with or without leakage disappeared in 56.6% and 53.8% of our patients, respectively. An improvement was also reported9 with TVT procedures. Significantly, the de novo urgency rate in our series was only 10.9% and may have reflected the minor obstructive effect of the TOT. 761
The absence of a retropubic space puncture dramatically limits the risk of severe complications such as reported with TVT, bowel16 and iliac vessel,10 injuries, and the large veins of the Santorini plexus are avoided. Preoperative and immediate postoperative TOT complications were rare. Urethral perforation occurred in 1 patient in a study by Mellier et al.17 during the procedure. It is safer to postpone implantation, unless the lesion is superficial. Hemorrhage18,19 has been reported in 0.8% of patients and has been treated by compression alone. The lateral urethral space punctured below the fascia pelvis is not crossed by vessels. In our series, we did not observe any nerve deficiency but only a transitory thigh pain. Furthermore, Spinosa et al.20 have recently demonstrated that the pathway of the outside-in procedure is distant from the posterior branch of the obturator nerve and the inferior external pudendal artery, which is not the case for the inside-out procedure. The thigh hematoma could have been due to the puncture of a superficial vein. The outcome of a bladder perforation differs between the retropubic space approach and the transobturator procedure. This complication is estimated to occur in 0.8% to 21% of patients undergoing the TVT procedure.10 –12,21 Few cases of bladder perforation have been reported during TOT implantation (2 patients in our series); most occurred when associated with pelvic organ prolapse repair or hysterectomy during the same procedure. Minaglia et al.22 recently published 3 cases of bladder perforation, in which 2 patients had undergone previous prolapse surgery. Nevertheless, the risk of bladder perforation appears to be greatly reduced with the TOT technique, estimated at 0.5% (3 of 604) in the study by Krauth et al.18 When routine cystoscopy was done on 38 patients,23 no perforation was observed. Therefore, cystoscopy can be recommended when previous or concomitant prolapse is present. The more lateral direction of the tape in the TOT procedure is a risk factor for perforation or secondary extrusion on the sulcus vaginalis. Variations in the individual anatomy of the vaginal sulcus depth, as well as vaginal tissue strength, require dissection of the vaginal wall deep enough and below the Halban fascia to minimize the risk of vaginal perioperative perforation or secondary erosion. A perioperative sulcus perforation requires locating a new deeper route for tape insertion and longer postoperative abstinence from sexual intercourse. The outcome of vaginal extrusion should be investigated by a careful vaginal examination during the postoperative consultation. The mean time to appearance was 9 months.24 Although some patients have no symptom, others may present with vaginal discharge, pain 762
(alone or during intercourse), or labia major edema.17,24 Two cases of inguinal abscess24,25 and one of perineal cellulitis26 have also been reported. The risk of an obturator abscess24 is specific to this route. Computed tomography or magnetic resonance imaging of the pelvis27 should be done to assess anatomic modifications when this clinical diagnosis is suspected. Exposure of the tape can be observed directly at vaginal examination, but in some cases it is covered by a granuloma. After tape removal, all reported patients were asymptomatic, and most remained continent. One can excise only the exposed segment of the tape,17 but complete removal24 has been advocated by some investigators for nonwoven tape. Infectious postoperative complications have also been reported for the TVT procedure, with vaginal erosions in 1.2%,28 wound infections in 0.8%,11 2 cases of infected hematoma,29 and 1 case of necrotizing fasciitis.30 The type of biomaterial may be an additional factor. Resistance to infection and tissue integration are better for large-pore synthetic tapes. Nonwoven thermally bonded tape is more exposed than woven polypropylene large-size mesh, such as the TVT, which reinforces the need for routine antiseptic vaginal preoperative preparation and antibiotic prophylaxis. A tape with a silicon-coated short surface facing the urethra has been abandoned8 because of vaginal extrusion and urethral erosion along the silicone surface. The previously reported studies and our present medium-term outcome series have suggested that the TOT sling procedure could be a valuable alternative to the TVT technique in terms of efficacy for stress urinary incontinence and because of its low rate of technique-related complications. The criteria for the respective indications between these two procedures warrant additional consideration, even if the TVT is probably more obstructive and may lead to retropubic injuries. This tracker study is currently ongoing. CONCLUSIONS Our results have demonstrated efficacy and a low complication rate for TOT with 1 year of minimal follow-up. These results add to the evidence that the TOT procedure compares well with the TVT procedure and could be considered a useful alternative. Long-term follow-up with prospective studies and comparisons of different tapes are also warranted. ACKNOWLEDGMENT. To Richard Medeiros, Rouen University Hospital Medical Editor, for his valuable advice in editing the manuscript. UROLOGY 68 (4), 2006
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