Obstetrics & Gynecology Track the topics, authors and articles important to you
HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
QUICK SEARCH:   [advanced]


     

Obstetrics & Gynecology 2001;98:732-736
© 2001 by The American College of Obstetricians and Gynecologists
This Article
Right arrow Abstract Freely available
Right arrow Full Text (PDF)
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Tamussino, K. F.
Right arrow Articles by Riss, P. A.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Tamussino, K. F.
Right arrow Articles by Riss, P. A.

ORIGINAL RESEARCH

Tension-Free Vaginal Tape Operation: Results of the Austrian Registry

Karl F. Tamussino, MD, Engelbert Hanzal, MD, Dieter Kölle, MD, George Ralph, MD and Paul A. Riss, MD for the Austrian Urogynecology Working Group

From the Departments of Obstetrics and Gynecology, Universities of Graz, Vienna, and Innsbruck; and the Departments of Obstetrics and Gynecology, Bruck an der Mur Hospital, Bruck an der Mur, and Mödling Hospital, Mödling, Austria.

Address reprint requests to: Karl Tamussino, MD, Department of Obstetrics and Gynecology, University of Graz, Auenbruggerplatz 14, A-8036 Graz, Austria; E-mail: karl.tamussino @kfunigraz.ac.at.


   ABSTRACT
TOP
ABSTRACT
MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
OBJECTIVE: To assess the use of and perioperative complications associated with the tension-free vaginal tape operation with a central registry.

METHODS: Fifty-five gynecology units completed questionnaires on patients undergoing the tension-free vaginal tape operation. Information was collected on patient, surgical, and postoperative data.

RESULTS: A total of 2795 patients were entered. Overall, 773 patients (28%) had undergone previous surgery for incontinence or prolapse; 1640 (59%) tension-free vaginal tapes were performed as isolated operations, and 1155 (41%) were done in combination with other procedures. The median operating time for tension-free vaginal tapes alone was 30 minutes (range 10–120). Of the isolated tension-free vaginal tapes, 727 (44%) were performed with local, 711 (43%) with regional, and 193 (12%) with general anesthesia. In patients undergoing tension-free vaginal tape only, postoperative bladder drainage was obtained with intermittent catheterization in 389 (24%) patients, an indwelling urethral catheter in 1032 (63%), and a suprapubic catheter in 143 (9%). The bladder perforation rate was 2.7% overall (n = 75) and higher in patients with than in those without previous surgery (4.4% compared with 2.0%, P = .01). There were four bladder perforations (3.3%) among the 120 patients with previous colposuspension. Most patients undergoing tension-free vaginal tape only were able to void the next day (range 0 to over 64). A total of 68 patients (2.4%) required reoperation for reasons related to the tape (39 to loosen, remove, or cut the tape, or to place a suprapubic catheter, 19 for hematoma, one for bowel injury).

CONCLUSION: The tension-free vaginal tape has become a frequently performed operation in Austria. There are considerable variations in clinical practice. The risk of bladder perforation was increased in patients with previous surgery. Severe complications were rare.

Ulmsten and Petros1 and Ulmsten et al2 described the concept of correcting stress urinary incontinence in women by placing a tape of mesh under the midurethra. According to their integral theory of stress urinary incontinence, this restores continence at the level of the pubourethral ligaments,1–3 not at the bladder neck as with most anti-incontinence operations. The original concept has since evolved into what is now known as the tension-free vaginal tape operation. The procedure uses a strip of polypropylene mesh and is commercially available as a kit from the Ethicon (Norderstedt, Germany) company. Local anesthesia can be used. The tape is not sutured in place, and placement is supposed to be without tension. Initial results4–7 and 3-year follow-up reports8,9 suggest success rates comparable with those of established operations.

The tension-free vaginal tape system has quickly gained popularity in Europe and elsewhere despite the absence of completed randomized trials comparing it with standard anti-incontinence operations. To date, over 150,000 tension-free vaginal tape sets have been sold worldwide, with more than 6700 in Austria alone by May 2001. In 1998, the Austrian Working Group for Urogynecology initiated a registry of tension-free vaginal tape procedures with the aim of assessing the use of the operation and complications during surgery and in the immediate postoperative period. We were also interested in how many procedures were performed in the primary setting, how many in patients with a history of surgery for incontinence or pelvic organ prolapse, and whether previous surgery is a risk factor for perioperative complications.


   MATERIALS AND METHODS
TOP
ABSTRACT
 MATERIALS AND METHODS
RESULTS
 DISCUSSION
 REFERENCES
 
All 95 departments of gynecology in Austria were contacted by mail about participating in the registry. A total of 55 units replied affirmatively and entered patients. The centers were asked to complete a single-page questionnaire for every patient undergoing a tension-free vaginal tape procedure. The questionnaire contained items regarding the patient (age, parity, previous gynecologic surgery), the operation (operating time, concomitant procedures, anesthesia, intraoperative complications, and method of postoperative bladder drainage), and the postoperative course (days until spontaneous voiding with residual urine volumes less than 100 mL, postoperative hospital stay, urinary tract infection, reoperations). Patients with a history of simple hysterectomy only were not considered to have had previous surgery for incontinence or pelvic organ prolapse. Differences in proportions between groups were compared with the {chi}2 test.


   RESULTS
TOP
ABSTRACT
 MATERIALS AND METHODS
 RESULTS
DISCUSSION
 REFERENCES
 
Fifty-five centers entered a total of 2795 patients. The median number of patients per center was 27 (range 4–239). Eight centers reported more than 100 patients. The median age of the patients was 60 years (range 28–93). Of these, 2022 (72%) had not undergone surgery for incontinence or pelvic organ prolapse (this included 531 patients who had undergone a simple hysterectomy only), whereas 773 had (Table 1Go). Overall, 1640 tension-free vaginal tape operations (59%) were done as isolated procedures, whereas 1155 (41%) were done in conjunction with other gynecologic procedures (460 with vaginal hysterectomy and colporrhaphy, 121 with simple hysterectomy, 574 with other operations).


View this table:
[in this window]
[in a new window]
  		Table 1. Previous Surgery for Pelvic Organ Prolapse or Incontinence in 2795 Patients Undergoing a Tension-Free Vaginal Tape Operation
 
Table 2Go shows the surgical data. The median operating time for patients undergoing a tension-free vaginal tape operation only was 30 minutes (range 10–120). Regional anesthesia was common, both for patients undergoing an isolated procedure and for those with concomitant procedures. Only 727 (44%) of the isolated tension-free vaginal tape operations were performed with local anesthesia. Similarly, an indwelling urethral catheter was the most frequently used method for postoperative bladder drainage, even for patients undergoing an isolated procedure (63%).


View this table:
[in this window]
[in a new window]
  		Table 2. Surgical Data on 2795 Tension-Free Vaginal Tape Operations
 
There were a total of 75 bladder perforations (2.7%). The perforation rate was higher in patients with previous surgery for pelvic organ prolapse or incontinence than in those without previous surgery (4.4% compared with 2.0%, P = .01, Table 3Go). There were four bladder perforations (3.3%) in the group of 120 patients with a history of colposuspension. The rate of increased intraoperative bleeding was 2.3% overall and similar in women with or without previous surgery.


View this table:
[in this window]
[in a new window]
  		Table 3. Intraoperative Complications in 2795 Patients With or Without Previous Surgery for Pelvic Organ Prolapse or Incontinence
 
Table 4Go shows data on the postoperative course. The median number of days until the residual urine volume was less than 100 mL was one (range 0 to over 64) after tension-free vaginal tape only and three after tension-free vaginal tapes in combination with other operations. The rate of postoperative urinary tract infection was 17% overall (8% among patients with intermittent catheterization, 18% among patients who received an indwelling urethral catheter, and 25% among those who received a suprapubic catheter, P = .01). The median postoperative stay was 3 days in patients undergoing a tension-free vaginal tape only and 7 days in those undergoing a concomitant procedure. One patient with vulvar carcinoma recurrent after radical vulvectomy and radiotherapy died of multiorgan failure 46 days after radical resection of the recurrence with flap closure of the defect and insertion of a tension-free vaginal tape.


View this table:
[in this window]
[in a new window]
  		Table 4. Postoperative Course
 
A total of 74 patients (2.6%) required reoperation in the postoperative period, 68 (2.4%) for reasons related to the tension-free vaginal tape operation (Table 5Go). The most common cause for reoperation was voiding dysfunction (12 tapes loosened, three removed, 15 cut, and nine suprapubic catheters inserted after the initial procedure). Nineteen patients (0.7%) required reoperation for hematoma. The small bowel injury occurred in a 48-kg patient with a previous vaginal hysterectomy and colporrhaphy but no other previous surgery in the lower abdomen. She developed an acute abdomen on the second postoperative day whereupon laparotomy was performed, the tape removed, and a segment of ileum resected. The patient subsequently did well. One patient who underwent a concomitant vaginal hysterectomy (without adnexectomy or prolapse surgery) required percutaneous nephrostomy and later ureteroneocystostomy to relieve ureteral obstruction. The obstruction was considered to result from a suture placed at the vaginal hysterectomy. This complication, a laparotomy for bleeding from an adnexal pedical after hysterectomy, and four reoperations for bleeding from a colpoperineorrhaphy cannot be ascribed to the tension-free vaginal tape operation (Table 5Go).


View this table:
[in this window]
[in a new window]
  		Table 5. Reoperations in 2795 Patients Undergoing a Tension-Free Vaginal Tape Operation
 

   DISCUSSION
TOP
ABSTRACT
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
REFERENCES
 
With 123 units sold in Austria in 1998, 2022 in 1999, and 3279 in 2000, the tension-free vaginal tape has rapidly become a widely performed operation in this country of 8 million people. According to the Ethicon company, more than 150,000 units have been sold worldwide. This advance has been unchecked by the lack of prospective randomized clinical trials comparing the new operation with established anti-incontinence operations such as abdominal colposuspension or suburethral slings. One prospective randomized trial comparing tension-free vaginal tape with colposuspension is underway in the United Kingdom, and preliminary results with a follow-up of 6 months have been presented ( Ward KL, Hilton P, Browning J. A randomized trial of colposuspension and tension-free vaginal tape [TVT] for primary genuine stress incontinence [abstract]. Neurourol Urodyn 2000;19:386–8). The lack of a large database on perioperative complications was an impetus for our study.

The registry also aimed to assess how tension-free vaginal tapes are performed in clinical practice. We found considerable variations, particularly with regard to methods of anesthesia and postoperative bladder drainage. Descriptions by Ulmsten and Petros1 and Ulmsten et al2,5,9 in the original publications emphasized the use of local anesthesia and intermittent catheterization. However, spinal or epidural blocks were the most frequently used methods of anesthesia in our survey, and the rate of indwelling urethral and suprapubic catheters was high, even in the patients who had no concomitant procedures. The two to three times increased rate of urinary tract infection in patients with inwelling catheters compared with those with intermittent catheterization argues for the use of the latter.

The bladder perforation rate in our series was 2.7% overall and significantly higher in patients with previous surgery for prolapse or incontinence. There were no reports of sequelae of bladder perforations in our survey. Adhesions in the retropubic space after colposuspension might be expected to be associated with a high bladder perforation rate, but the 3.3% rate in the 120 patients with a history of colposuspension was not higher than that in patients with a history of other urogynecologic operations. Of the six perforations (3.7%) in a series of 161 operations reported by Nilsson and Kuuva,7 four occurred in patients with previous retropubic surgery or radiotherapy to the pelvis and two in uncomplicated cases. Our bladder perforation rate was lower than the 3.8% in an analysis of 1455 patients from Finland (Kuuva N, Nilsson CG. A nationwide analysis of complications associated with the tension-free vaginal tape [TVT] procedure [abstract]. Neurourol Urodyn 2000; 19:394–5). Perforation rates in other series, some of which included only patients without previous surgery, range from 0%1,2,8 to 9% ( Ward KL et al. Neurourol Urodyn 2000;19:386–8).

The reoperation rate for problems related to the tension-free vaginal tape procedure was 2.4%. Postoperative voiding dysfunction was the most common reason for reoperation. Thirty tapes were loosened, cut, or removed, and nine suprapubic catheters were placed secondarily. Nineteen patients (0.7%) required laparotomy for control of bleeding or evacuation of hematomas because of the tension-free vaginal tape operation. The Finnish series reported three reoperations (0.2%) for hematoma. Injury to vessels in the retropubic space or further laterally is a small but real risk with an operation that involves passing sharp 5-mm needles behind the symphysis. Case reports on bleeding complications in connection with the tension-free vaginal tape operation have begun to appear.10,11 One small bowel injury occurred in our series, and a similar case has been published ( Brink DM. Bowel injury following insertion of tension-free vaginal tape [letter]. S Afr Med J 2000;90: 450–1). Both these patients did well. The death in our series, of a patient who died of multiorgan failure 46 days after radical resection of recurrent vulvar cancer, was probably not caused by the concomitant placement of the tension-free vaginal tape.

The lengthy postoperative stay in our series (5 days overall and 3 days for patients undergoing a tension-free vaginal tape without concomitant procedures) is a result of the health care system in Austria, in which keeping hospital beds filled is still as important as reducing lengths of stay. In a series from Finland,7 103 (80%) of 161 women undergoing tension-free vaginal tape operations without other procedures were released from the hospital on the afternoon of the day of surgery.

A registry such as this has limitations.12 It cannot evaluate the indications for the procedure, how patients were evaluated before surgery, the expertise of the surgeon, medium-term or long-term complications such as pain or detrusor instability, or cure rates for stress incontinence. Nonetheless, our data show that the tension-free vaginal tape has rapidly become a widely performed operation in Austria for women with primary and recurrent stress incontinence and in conjunction with other operations. There are considerable variations in clinical practice, particularly with regard to anesthesia and postoperative bladder drainage, but major complications appear to be rare.


   Footnotes
 
Participating investigators and centers are as follows: P. Riss, I. Geiss, Krankenhaus Mödling; A. Staudach, M. Zajc, Landeskrankenanstalten Salzburg; G. Wagner, Krankenhaus der Barmherzigen Brüder, Vienna; R. Winter, A. Giuliani, K. Tamussino, University of Graz; S. Leodolter, E. Hanzal, O. Preyer, University of Vienna; C. Marth, D. Kölle, University of Innsbruck; R. Pavelka, Krankenhaus Oberwart; C. Gamper, O. Ungerböck, Krankenhaus Wiener Neustadt; L. Boubenizek, Krankenhaus der Barmherzigen Schwestern, Linz; P. Sevelda, Krankenhaus Lainz, Vienna; A. Beck, Hanusch Krankenhaus, Vienna; F. Marberger, Krankenhaus Kirchdorf an der Krems; R. Leikermoser, Krankenhaus der Elisabethinen, Linz; F. Girardi, Krankenhaus der Stadt Baden; F. Brandstetter, St. Josef Krankenhaus, Vienna; G. Trabitsch, D. Spiessberger, Krankenhaus der Schulschwestern St. Franziskus, Grieskirchen; W. Rösslhuber, Krankenhaus Oberndorf; K. Weghaupt, Krankenhaus Amstetten; G. Ralph, B. Baumgartner, Krankenhaus Bruck an der Mur; P. Wagenbichler, Ignaz Semmelweis-Frauenklinik, Vienna; R. Schmid, Krankenhaus Mistelbach; R. Burmucic, Krankenhaus Deutschlandsberg; M. Trockenbacher, Krankenhaus St. Johann in Tirol; P. Stumpner, Krankenhaus Rohrbach; F. Nagl, Krankenhaus Ried im Innkreis; G. Bartussek, Krankenhaus Wolfsberg; P. Klug, Krankenhaus Rottenmann; S. Bosak, Krankenhaus Lilienfeld; A. Bichler, Krankenhaus Bad Ischl; W. Gruber, F. Wierrani, Kaiser-Franz-Josef-Spital, Vienna; W. Grabensberger, Krankenhaus Judenburg; J. Burkl, Krankenhaus Waidhofen an der Thaya; M. Fabsits, Krankenhaus Oberpullendorf; P. Wurm, Krankenhaus Linz; H. Salzer, A. Mirna, A. Tammaa, Wilhelminen-Spital, Vienna; V. Schabus, Krankenhaus Spital an der Drau; T. Golaszewski, Krankenhaus Waidhofen an der Thaya; H. Enzelsberger, R. Heider, Krankenhaus Steyr; P. Lang, E. Gruber-Fröhlich, Krankenhaus der Barmherzigen Brüder, Graz; A. Breinl, Graz; A. Kerak, Krankenhaus Tulln; W. Grünberger, Krankenanstalt Rudolfsstiftung, Vienna; W. Neunteufel, Stadtspital Dornbirn; J. Klobasa, Waldviertlerklinikum Horn; A. Mayer, Krankenanstalt des Göttlichen Heilands, Vienna; H. Stopfer, Krankenhaus Klosterneuburg; S. Szalay, G. Mori, Krankenhaus Klagenfurt; H. Concin, Landeskrankenhaus Bregenz; B. Abendstein, J. Joost, Krankenhaus Hall/Tirol; I. Nürnberger, Landeskrankenhaus Leoben; E. Kermauner, Krankenhaus Hallein; P. Anderl, B. Mitterdorfer, Krankenhaus Lienz; W. Schneider, Krankenhaus Wels; M. Buczkowski, Krankenhaus Reutte; H. Pontasch, Krankenhaus Zell am See; all in Austria.

PII S0029-7844(01)01565-4

Received February 26, 2001. Received in revised form June 18, 2001. Accepted July 5, 2001.


   REFERENCES
TOP
ABSTRACT
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
1. Ulmsten U, Petros P. Intravaginal slingplasty (IVS): An ambulatory surgical procedure for treatment of female urinary incontinence. Scand J Urol Nephrol 1995;29: 75–82.[Medline]

2. Ulmsten U, Henriksen L, Johnson P, Varhos G. An ambulatory surgical procedure for treatment of female urinary incontinence. Int Urogynecol J 1996;7:81–6.

3. Atherton M, Stanton SL. A comparison of bladder neck movement and elevation after tension-free vaginal tape and colposuspension. Brit J Obstet Gynaecol 2000;107: 1366–70.

4. Moran PA, Ward KL, Johnson D, Smirni WE, Hilton P, Bibby J. Tension-free vaginal tape for primary genuine stress incontinence: A two-centre follow-up study. BJU Int 2000;86:39–42.[Medline]

5. Ulmsten U, Falconer C, Johnson P, Jomaa M, Lannér L, Nilsson CG, et al. A multicenter study of tension-free vaginal tape (TVT) for surgical treatment of stress urinary incontinence. Int Urogynecol J 1998;9:210–3.

6. Wang AC, Lo TS. Tension-free vaginal tape. A minimally invasive solution to stress urinary incontinence in women. J Reprod Med 1998;43:429–34.[Medline]

7. Nilsson CG, Kuuva N. The tension-free vaginal tape procedure is successful in the majority of women with indications for surgical treatment of urinary stress incontinence. Br J Obstet Gynaecol 2001;108:414–9.

8. Olsson I, Kroon U. A three-year postoperative evaluation of tension-free vaginal tape. Gynecol Obstet Invest 1999; 48:267–9.[Medline]

9. Ulmsten U, Johnson P, Rezapour M. A three-year follow-up of tension free vaginal tape for surgical treatment of female stress urinary incontinence. Br J Obstet Gynaecol 1999;106:345–50.[Medline]

10. Vierhout ME. Severe hemorrhage complicating tension-free vaginal tape (TVT): A case report. Int Urogynecol J 2001;12:139–40.

11. Zilbert AW, Farrell SA. External iliac artery laceration during tension-free vaginal tape procedure. Int Urogynecol J 2001;12:141–3.

12. Horton R. Surgical research or comic opera: Questions, but few answers. Lancet 1996;347:984–5.[Medline]




This article has been cited by other articles:


Home page
 Obstet GynecolHome page
M. D. Barber, S. Kleeman, M. M. Karram, M. F. R. Paraiso, M. D. Walters, S. Vasavada, and M. Ellerkmann
Transobturator Tape Compared With Tension-Free Vaginal Tape for the Treatment of Stress Urinary Incontinence: A Randomized Controlled Trial
Obstet. Gynecol., March 1, 2008; 111(3): 611 - 621.
[Abstract] [Full Text] [PDF]

Home page
 Obstet GynecolHome page
E. Laurikainen, A. Valpas, A. Kivela, T. Kalliola, K. Rinne, T. Takala, and C. G. Nilsson
Retropubic Compared With Transobturator Tape Placement in Treatment of Urinary Incontinence: A Randomized Controlled Trial
Obstet. Gynecol., January 1, 2007; 109(1): 4 - 11.
[Abstract] [Full Text] [PDF]

Home page
 Obstet GynecolHome page
F. Flock, A. Reich, R. Muche, R. Kreienberg, and F. Reister
Hemorrhagic Complications Associated With Tension-Free Vaginal Tape Procedure
Obstet. Gynecol., November 1, 2004; 104(5): 989 - 994.
[Abstract] [Full Text] [PDF]

Home page
 Obstet GynecolHome page
M. M. Karram, J. L. Segal, B. J. Vassallo, and S. D. Kleeman
Complications and Untoward Effects of the Tension-Free Vaginal Tape Procedure
Obstet. Gynecol., May 1, 2003; 101(5): 929 - 932.
[Abstract] [Full Text] [PDF]

Home page
 Obstet GynecolHome page
T. W. Muir, P. K. Tulikangas, M. F. Paraiso, and M. D. Walters
The Relationship of Tension-Free Vaginal Tape Insertion and the Vascular Anatomy
Obstet. Gynecol., May 1, 2003; 101(5): 933 - 936.
[Abstract] [Full Text] [PDF]

Home page
 Obstet GynecolHome page
M. T. Margolis and C. R. Rardin
Tension-Free Vaginal Tape: Outcomes Among Women With Primary Versus Recurrent Stress Urinary Incontinence
Obstet. Gynecol., April 1, 2003; 101(4): 817 - 818.
[Full Text] [PDF]

Home page
 Obstet GynecolHome page
C. R. Rardin, P. L. Rosenblatt, N. Kohli, J. R. Miklos, M. Heit, and V. R. Lucente
Release of Tension-Free Vaginal Tape for the Treatment of Refractory Postoperative Voiding Dysfunction
Obstet. Gynecol., November 1, 2002; 100(5): 898 - 902.
[Abstract] [Full Text] [PDF]

This Article
Right arrow Abstract Freely available
Right arrow Full Text (PDF)
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Tamussino, K. F.
Right arrow Articles by Riss, P. A.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Tamussino, K. F.
Right arrow Articles by Riss, P. A.

HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS