Aims of Study:
To evaluate therapy-associated morbidity of all patients who underwent a TVT operation by the end of the year 1999.

Methods:
Retrospective questionnaires about number of operations per hospital as well as intraoperative and postoperative complications were sent to every Finnish hospital where TVT operations had been independently performed after the obligatory TVT training period. The information from 38 hospitals was analyzed. One hospital which did not use the standard TVT set and the largest TVT center which functioned as the primary training center were excluded.

Results:
Among the 38 hospitals there were 4 university hospitals, 13 central hospitals and 21 local hospitals. The total amount of TVT operations was 1455 and in 40 cases (2.7%) one or several other operations were performed at the same time. There were 27 cases (1.9%) of intraoperative blood losses over 200 ml: eight patients were managed by a vaginal tamponade and/or manual compression, one arterial bleeding behind the sympfysis required laparotomy and tape removal. There were 56 cases (3.8%) of bladder perforations: (a) forty-eight perforations were detected during the operation, in 40 cases the needle was withdrawn and reinserted more laterally, in five cases the TVT tape was completely or partially removed, in two cases the operation was interrupted, one case was treated only with catheterization; (b) four cases of perforations were detected within a few hours up to four days after the operation, in all of these cases the tape was totally or partially removed and in one case of removal a cystotomy was needed; (c) in four cases of perforations the time of the observation has not been stated, in one of these cases an open exploration of the cavum Retzii was performed and in one case the tape was removed from the bladder by laparotomy, two cases were treated only with catheterization. Only one case (0.1%) of injury on a major vessel (epigastric) was reported and it was treated by ligation. Three cases(0.2%) of various intraoperative complications were reported: (a) an injury of the obturator nerve led to limping and adhesion formation on the Achilles tendon and an adhesiotomy was required; (b) a vaginal haematoma was treated by surgical evacuation; (c) a possible urethra lesion was detected and the procedure was interrupted. There were 34 cases (2.3%) of complete postoperative urinary retentions (range of duration 6 hours - 6 months): (a) in one case the tape had to be cut off; (b) twenty-nine cases were managed by catheterization; (c) one case was spontaneously cured; (d) in three cases the intervention used was not reported. There were 109 cases (7.5%) of minor postoperative voiding difficulties with a residual urine volume more than 100 ml after the first postoperative day (range of duration 48 hours - 4 months): in two cases the tape had to be cut off and 107 cases where treated with conservative methods or spontaneously cured. There were 27 cases (1.9%) of retropubic haematomas (range of size 3-10 centimetres): three cases were punctured, two cases were evacuated by surgery, three cases required blood transfusion. There were 12 cases (0.8%) of wound infections: eight cases were treated with antibiotics, four cases of abscess formations needed drainage. There were 10 cases (0.7%) of defect healings of the vaginal incision: four cases were resuturated, in two cases the tape was partially removed. There were 59 cases (4.1%) of urinary tract infections. No case of tape rejection occurred. The total amount of some other kind of postoperative complications was 33 (2.3%): (a) in 13 cases de novo urge symptoms occurred, the old urge component became worse or there were some kind of voiding discomfort; (b) seven haematomas were found outside the retropubic area; (c) a vesicovaginal fistula was discovered which led to tape removal and fistulectomy; (d) there was one case of urinary retention where a rudimentary kidney and a double ureter system were detected which led to cutting of the tape, ureterolysis and unilateral removal of the rudimentary kidney and the double ureter system; (e) three cases of pain in the region of the gluteal muscle and the thigh occurred, two cases were cured by anti-inflammatory drugs, in one case there was a suspicion of compression on the obturator nerve but a laparoscopic exploration showed no evidence of nerve compression and the pain disappeared after cutting of the tape; (f) there was one case of venous thrombose which was treated with anticoagulants; (g) one seroma formation around the tape which needed drainage was found; (h) there were six cases of various minor complications. All together the majority of complications were mild complications such as minor postoperative voiding difficulties or urinary tract infections and only five cases (0.3%) of major complications requiering laparotomy occurred.

Conclusions:
The TVT procedure is a safe method for the treatment of stress urinary incontinence.