Hypothesis / aims of study
TVT-O is one of the most popular treatment for urinary incontinence (UI). Its efficacy is well established in patients with genuine stress urinary incontinence (SUI) and in patients with no previous surgical treatments for UI. However, data reporting long-term outcomes of TVT-O for the treatment of mixed urinary incontinence (MUI) or recurrent SUI is scarce.
The aim of this study was to evaluate the efficacy, safety and overall patient satisfaction of the TVT-O technique in long-term follow-up in patients suffering from primary or recurrent SUI or MUI.
Study design, materials and methods
A single-center retrospective study was conducted in Turku University Hospital, Finland. All consecutive women with primary, mixed and recurrent UI treated by TVT-O between August 2004 and October 2011 were included. The TVT-O procedures were performed as originally described by de Leval under local anesthesia. In 2016 the patients were invited to follow-up visit which consisted of a clinical examination, a cough stress test (CST) performed in the same manner as preoperatively, and the post void residual urine volume (PVR) measurement by vaginal ultrasonography. Objective treatment success was a negative cough stress test. Patient satisfaction was assessed by condition specific and general health quality-of-life questionnaires. Urinary Incontinence Severity Score (UISS), a Visual Analog Scale (VAS 0-100), in which 0 represents no urinary problems and 100 unbearable urinary problems and the Detrusor Instability Score (DIS), which is a 10-item questionnaire, with a score of 0-20, to distinguish between stress and urgency incontinence. The Urogenital Distress Inventory - short form (6 items, UDI-6) and the Incontinence Impact Questionnaire-short form (7 items, IIQ-7) were used for condition specific assessment. Quality-of-life (QoL) assessment was carried out with use of the EuroQoL-5D (EQ-5D) questionnaire. Subjective success or patient satisfaction was assessed by asking if the patient was satisfied to the operation: very satisfied, satisfied, partly satisfied, partly unsatisfied, unsatisfied, very unsatisfied. The patient was subjectively cured if she answered to be very satisfied or satisfied to the operation. Data regarding adverse events were collected from the hospital records during the follow-up. Patients with recurrent SUI and those with apparent MUI underwent complete urodynamics.
A mean time from the surgery to the follow-up visit was 9.25 years (111 months, range 64 to 144 months). From the 136 patients initially asked to participate to the study, 118 consented and of these 117 were invited to the follow-up visit. 106 patients were included to the final evaluation. 76 women (72 %) suffered from SUI and 30 (28 %) from MUI before the TVT-O operation. 19 patients (18%), including both SUI and MUI subgroups, were previously operated on due to urinary incontinence. Six of them had had two or more incontinence operations. 40 patients (38 %) underwent complete urodynamics. Fourteen patients (13 %) underwent concomitant surgery, procedures varying from prolapse procedure kolporrafia posterior, kolporrafia anterior, vaginal hysterectomy, laparoscopic adnex procedure to bladder biopsy. Mean age at the surgery was 57 years (range 31 to 80 years) and at the long-term follow-up visit 66 years (range 42 to 88 years).
90 patients (85 %) were objectively cured; 68 (89 %) of the SUI and 22 (73 %) of the MUI patients (p=0.0665). From 19 previously operated patients 14 (74 %) and 76 (87%) of the 87 patients who underwent incontinence surgery for the first-time were objectively cured (P=0.1582). 86 patients (81 %) achieved subjective success; 70 (92 %) of the SUI and sixteen (53 %) of the MUI patients (p< 0.001). Eleven women (58 %) who had repeat surgery and 75 women (86 %) who did not undergo reoperation were subjectively cured (p=0.0084). Of the 106 women 77 (73 %) were subjectively and objectively cured, nine (8 %) achieved subjective but not objective cure and two (2 %) achieved objective but not subjective cure.
At the clinical examination three patients (3 %) were found to have a vaginal tape erosion, which was asymptomatic. Three patients (3%) had PVR over 150 ml the biggest PVR being 212 ml. 17 women (16%) reported groin pain, 13 of them having mild pain. One woman had urinary retention, and the tape was cut three months after the surgery. She remained continent and there were no reoperations because of UI.
De-novo urgency was reported by 22 from 106 patients (21 %) defined as a score > 7 compared to <7 preoperatively in their DIS.
Interpretation of results
The results of TVT-O are still good and it can be considered as a therapeutic alternative also in different subgroups of UI.