Hypothesis / aims of study
The growth of the elderly population in western countries highlights the importance of studying the long-term outcomes of the various treatments of chronic conditions, including urinary incontinence. The aim of this study is to assess the outcomes in incontinent patients who underwent tension free vaginal tape (TVT) with a 10-year minimum follow-up
Study design, materials and methods
This is a single-center prospective study on women who underwent TVT for stress urinary incontinence (SUI) or stress predominant mixed urinary incontinence. The pre-operative evaluation included: history; urogynaecological examination; cough stress test; urodymamics; Urogenital distress inventory short form (UDI-6) and Incontinence Impact Questionnaire (IIQ) questionnaires for symptoms; the Kings Health Questionnaire (KHQ) for quality of life (QoL). SUI was defined according to ICS standardisation and classified according to the Ingelmann-Sundberg scale. In September. -October 2018 all patients who had undergone TVT before 2008 were recalled for follow-up. Follow-up visits were scheduled for one month, six months, one year, then annually after surgery, with a final visit in September-October 2018. Each visit included a medical history, physical examination, and evaluation of subjective satisfaction.They completed the same pre-op questionnaires and the Patient Global Impression of Improvement (PGI-I).Patient-reported improvement was indicated by the combination of ‘very much improved or much improved’ (score of ≤ 2) on the PGI-I scale and a patient-satisfaction score of ≥8.Objective cure for SUI was defined as the absence of urine leakage during the stress test. Subjective cure was defined by a ‘no-answer’ to question 3 of the UDI-6 questionnaire. We considered voiding dysfunctions to be present when a patient answered affirmatively at least two structured questionnaire questions and also answered ‘moderately’ or ‘greatly’ to question 5 of UDI-6. Repeat urodynamic test were performed when women complained of de novo symptoms and irrespectively at final follow-up. The examinations and interviews were performed by urologists who were not involved in the surgical phase of the study.The primary outcome was the SUI cure rate. Secondary outcomes included improvement in QoL, effect on urinary symptoms and late adverse events. Institutional Review Board Committees approved this study; participants gave informed consent. Statistical analysis: McNemar chi-square test; Fisher’s exact test.
From January 2004 to December 2008, 80 consecutive patients underwent TVT. Sixteen patients were lost to follow-up, so we report data on 64 patients. Mean age was 62.3±10.18; median parity was 2; mean BMI 26.25± 2.57; 41 patients (64%) were menopausal. The figure 1 showed the functional outcomes. At a mean follow-up of 139 months, 47 patients (73.4%) were subjectively cured for SUI. The objective cure rate was 78.9%. Of the 16 failed patients none underwent further SUI surgery. The urgency urinary incontinence appeared de novo in 3.1% of the entire sample. Urgency increased statistically significantly (from 29.6 % to 35.9%), as did urgency urinary incontinence (from 31.2 % to 34.3%). De novo urgency occurred in 6.2% of cases. Voiding symptoms decreased from 18.7% to 7.8%. De novo voiding symptoms appeared in 4.5% of patients.In no patients did we observe a PVR > 50ml. Post-operatively, no urodynamic obstruction was observed using the Blaivas and Groutz nomogram. All domains of the KHQ except general health and sleep saw statistically significant improvements. We had none cases of mesh exposure
Interpretation of results
Our study demonstrates that in the period of ten or more years after TVT surgery, cure rates are lower than in shorter-term studies, however, at 73%, they may still be considered satisfactory. It is difficult to ascertain if a patient dissatisfaction 10 years or more after surgery is due to long-term treatment failure or to general factors like age or another pathology