Jose D Roman M.D. Braemar Hospital, Hamilton, NEW ZEALAND Subjective outcome of 166 tension-free vaginal tape procedures performed by a single surgeon: The Braemar experience Jose D Roman M.D. Braemar Hospital, Hamilton, NEW ZEALAND

Rationale for this study Tension -free vaginal tape (TVT) procedure for stress urinary incontinence (SUI) success is well documented Need for reporting long-term outcomes (Cochrane Database review 2015) Adverse effects of using vaginal mesh

Material and Methods 1. Ethical approval 2. Inclusion criteria: SUI demonstrated clinically and by urodynamic testing Exclusion criteria: Patients with detrusor overactivity (with or without SUI) demonstrated by urodynamic testing- Previous surgery for SUI- Prophylactic TVT procedure when undergoing a Pelvic Organ Prolapse (POP)repair. 3. Number of patients: 231 TVT procedures 2004-2015 - 166 for the actual study

Material and Methods 4. Pre-operative evaluation Urogynaecological history 24-h voiding diary Urine analysis Pelvic examination in the lithotomy position Cough Stress test Stage of the POP : Baden-Walker system Urodynamic testing (Pessary for patients with significant POP) Questionnaires: Urogenital Distress Inventory (UDI-6) and the Incontinence Impact Questionnaire (IIQ-7)

Material and Methods 5. Operative technique G.A and endotracheal intubation as in-patient all procedures performed by one single surgeon Ulmsten’s Technique, 1995. If anterior colporrhaphy (anterior vaginal repair) needed then a separated incision was performed for the insertion of the sling Routine cystoscopy IDC removed on postop day 1 and the residual bladder volume was calculated (scan) 6. FOLLOW UP Postoperative assessment at 2 weeks- 8 weeks and long-term at the time of this study (questionnaires) SUCCESS: postoperative score greater than the threshold of the minimum important difference (MID) of 11 Points: UDI-6 and 16 points: IIQ-7 when compared to the preoperative score 7. Social Science Statistical Package for analysis

RESULTS CHARACTERISTICS OF THE STUDY GROUP: 166 patients MEAN STANDARD DEVIATION AGE (YEARS) 51.27 9.14 PARITY 2.7 1 BMI (KG/M2) 26.7 4.1 FOLLOW-UP (MONTHS) 58 28.56 PREVIOUS HYSTERECTOMY 37(22.29%) CONCOMITANT POP REPAIR 111(66.87%) LAPAROSCOPIC HYSTERECTOMY AND APICAL REPAIR 53(31.93%) ANTERIOR/POSTERIOR REPAIR 46(27.71%) LAPAROSCOPIC MESH SACROCOLPOPEXY 12(7.23%) BMI : BODY MASS INDEX; POP: PELVIC ORGAN PROLAPSE

FIGURE 1. YEARLY UDI-6 SCORE MEANS BEFORE AND AFTER SURGERY AND THE YEARLY PERCENTAGE OF PATIENTS WHO ACHIEVED A REDUCTION BETWEEN THE PRE AND POSTOPERATIVE SCORE -MID > 11, VERSUS LENGTH OF FOLLOW-UP IN YEARS

FIGURE 2. YEARLY IIQ-7 SCORE MEANS BEFORE AND AFTER SURGERY AND THE YEARLY PERCENTAGE OF PATIENTS WHO ACHIEVED A REDUCTION  BETWEEN THE PRE AND POSTOPERATIVE SCORE - MID > 16, VERSUS LENGTH OF FOLLOW-UP IN YEARS

SUBJECTIVE SUI REPORTED BY THE 166 PATIENTS OF THE SURVEY NUMBER OF PATIENTS PERCENTAGE NO SUI 133 80.1 Mild SUI 23 13.9 Moderate SUI 9 5.4 Severe SUI 1 0.6 SUI: Stress urinary incontinence

SATISFACTION WITH THE TVT PROCEDURE LIKERT SCALE SATISFACTION AVERAGE 0.82 +/- 0.18 (score of 0.75 or more) 133 (83.3%)

FIGURE 3. YEARLY PERCENTAGE OF PATIENTS WHO REPORTED NO SUI AT THE TIME OF THE STUDY - VERSUS – THE LENGTH OF FOLLOW-UP

SURGICAL COMPLICATIONS Intra-operative 1: Vaginal bleeding (8 weeks) 1: Persistent SUI and recurrent cystocele Late Post-operative 1: Recurrent SUI at 4/52 2: Further TVT sling and 1: Referred to Urogynaecologist

Conclusions 1. The TVT procedure in a population in which 67% had a POP repair performed concomitantly was associated with a subjective cure rate of 80% 2. The TVT procedure, with or without concomitant POP repair, was found to be a safe procedure, with a low peri-operative complication rate and a patient-reported satisfaction rate of 83.3% 3. The overall success rate and quality of life effects did not decline significantly within 10 years after TVT surgery

THANK YOU !!