CLINICAL TRIAL
ENGLISH ABSTRACT
JOURNAL ARTICLE
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[Prolene mesh sling in the treatment of stress urinary incontinence. Integral treatment of pelvic floor anomalies. Long-term results].

OBJECTIVES: To evaluate the results of a comprehensive treatment of female stress urinary incontinence combining prolene mesh sling and proper gynaecologic repair depending on the kind of prolapse or pelvic floor dysfunction. To analyse short and long term clinical and urodynamic outcomes, and the effect on quality of life and economics associated with female urinary incontinence.

METHODS: Prospective study including 102 consecutive patients with urinary incontinence; recruitment started in June 1996, ended in March 2002 for this analysis but it continues open currently. History of neurourologic disorders, radiotherapy, oncological diseases, gynaecological diseases and previous surgeries data were recorded in all subjects. History and physical examination were done evaluating urinary symptoms, duration of urinary incontinence, and urinary symptoms oriented examination (incontinence, urgency and urgency-incontinence), as well as gynaecological examination evaluating and grading cystocele, rectocele, uterine prolapse, enterocele and dome prolapse. Complete urodynamics were performed before and after surgery. Surgery was indicated as a complete pelvic floor dysfunction repair including prolene mesh sling in all cases with urinary stress incontinence, hysterectomy or not depending on the existence of prolapse, and anterior/posterior colpoperineorrhaphy with or without mesh. Results on urinary continence, complications and their treatment were evaluated in the postoperative period, on discharge, at 6 months and yearly thereafter.

RESULTS: Average age was 63.8 years (27-82 years, SD 11.2). 39.3% of the patients were over age 70. Mean follow-up was 4.25 years (12-75 months, SD 11.9). The cost of pads for urinary incontinence was 2741.17 Euros per patient (456,117 pesetas). 32.3% of the patients had risk factors for urinary incontinence surgical treatment failure and 18.8% had a leak point pressure below 30 H20 cm. 22.3% cases presented with detrusor instability before surgery. 102 sling procedures, 20 hysterectomies, 26 anterior plasties, 14 posterior plasties, 10 mesh cystocele repair, 1 posterior mesh, and 2 enterocele sacral promontory fixation were performed, accounting a total of 173 surgical procedures during 102 anaesthesia procedures. 9 additional procedures were necessary for the treatment of complications. Stress continence was achieved in 99.01% cases. In half of the patients with preoperative urgency-incontinence it continued during the first postoperative year. 11 cases have postoperative bladder instability, 7 of which had it preoperatively and 4 were de novo.

COMPLICATIONS: 5 cases needed sling section/reconfiguration because of excess tension (non effective sling). 3 cases needed sling tight stretching/reconfiguration because of less than adequate tension. 2 cases of accidental bladder performation were treated with primary closure and urinary diversion. One case of infection-abscess in the mesh left anchoring stitch was drained under local anaesthesia. There were 6 cases of suprapubic, inguinal and rectal pain (8.1%), in all of them it disappeared within 9 months. There were 2 cases of wound infection.

CONCLUSIONS: The prolene mesh sling can offer long term cure for stress urinary incontinence in almost all cases (99.01%), including the complicated ones. 91.1% of the patients underwent one surgical procedure only, and 8.8% required additional procedures. Results stand the test of time with a clinical-urodynamic follow up of 4.25 years. The voiding urgency referred by 81% of the women with large prolapses is associated with demonstrated bladder instability in 63% of the cases. Voiding urgency as well as bladder instability disappeared in all cases but one, being this fact prolapse-correction dependent, so that pelvic prolapse correction plays a decisive role. De novo bladder instability is uncommon (3.9%) and appears randomly in this series.

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