Inside-out Transobturator Vaginal Tape (TVT-O): one-year results of a prospective study

Title
Inside-out transobturator vaginal tape (TVT-O): One-year results of a prospective study

Introduction and Objectives
The aim of this study was to prospectively assess the efficacy of a new surgical technique, the inside-out transobturator vaginal tape (TVT-O), for the treatment of female stress urinary incontinence (SUI).

Study design, materials and methods
From 03/2003 through 10/2003, a TVT-O tape was inserted in 83 consecutive patients with clinical evidence of SUI. Preoperative evaluation included complete history, physical examination, urodynamics, urine analysis, and cystoscopy. None of the patients presented the following exclusion criteria: post-void residual (PVR) >100 cc, detrusor overactivity or acontractility, pregnancy, neurological pathology, active urinary or vaginal infection, age >85 years, negative stress test, and maximum cystometric capacity <300 mL. Post-operative evaluation was carried out using symptom scoring and quality of life (QoL) questionnaires, visual analog scales, physical examination, uroflowmetry, and PVR measurement. Cure was defined as no leakage based on both symptom scale scoring and physical examination. Improvement was defined as ≥50% decrease in symptoms based on the questionnaire’s results.

Results
Mean age of the patients was 61 years. The TVT-O procedure was associated with pelvic organ prolapse cure in 15 patients (18%). Follow-up time was ≥12 months in all women (mean = 13.6); 3 patients were lost to follow-up. No significant blood loss (≥100 cc), vaginal wall, urethral, or bladder perforation was encountered. No hematoma, vaginal or urethral erosion, or neurological complication was observed. No patient complained of persistent pain. At the latest follow-up visit, max flow rate was ≥10 mL/sec and PVR was <100 cc in 90% and 94% patients, respectively. Two patients underwent an immediate tape release procedure while the tape was sectioned in 2 other patients for retention and/or urgency associated with obstruction. Sixty eight patients (85%) were cured of their SUI while 9 patients (11%) were improved. Urgency questionnaire’s results showed that 5 (5/46) patients developed de novo urgency. Twenty and 14 out of the 34 patients with preoperative urge symptoms reported either disappearance or no change of urgency, respectively. Obstruction symptoms appeared or worsened in 3 patients and were unchanged or decreased in all other patients. Analysis of the incontinence visual analog and QoL scale scores showed that the majority of patients reported disappearance of incontinence together with significant improvement of their QoL.

Conclusions

The one-year results of this study suggest that TVT-O is associated with a low incidence of peri- and post-operative complications and high objective and subjective SUI cure rates.