FIVE YEAR LONG TERM OUTCOMES AFTER MINIARC SINGLE INCISION SLING FOR PRIMARY URODYNAMIC STRESS INCONTINENCE
LO1, Y. LIN 2, M. YE 3, R. K. IBRAHIM 4, S. T. CHUA 5;
1Chang Gung Mem. Hosp., Keelung, Taiwan, 2Obstetrics and gynecology, Chang Gung Mem. Hosp., Tao-Yuan, Taiwan, 3Xiamen Chang Gung Mem. Hosp., Xiamen, China, 4Albashir Hosp., Amman, Jordan, 5Cebu Velez Gen. Hosp., Cebu City, Philippines.
Introduction: Single-incision sling (SIS), MiniArc, which has showed a short-term efficacy rates comparable to tension-free vaginal tape/ transobturator tape approach.1 However, there was a lack of long term outcome report.
Objective: The aim of this study was to evaluate the long-term efficacy and safety of MiniArc over 5 years for treatment of primary urodynamic stress incontinence (USI).
Methods: From February 2010-December 2011, patients with clinically confirmed stress urinary incontinence (SUI) and urodynamic stress incontinence without needing concurrent procedures were considered for enrollment. Preoperative evaluation included medical history, physical exam, 72-hour voiding diary, urinalysis and complete urodynamic testing. Subjective assessment used validated questionnaires: UDI-6, IIQ-7, and PISQ-12. USI was defined as the involuntary leakage of urine with stress in the absence of detrusor contraction during filling cystometry. Objective cure of SUI was defined as the absence of demonstrable leakage of urine on provocative filling cystometry and 1-hour pad test weight of <2grams. Subjective cure was based on negative response to UDI-6 Question 3 - no leakage on coughing, sneezing, or laughing. De novo urgency was defined as having an assessment index score of ≥1 on UDI-6 Question 2 and/or urgency symptoms reported in the bladder diary. The MiniArc procedure was performed in standard and with no additional procedure.1 Cystoscopy was performed at the end of surgery. All patients were followed-up after 1 week, 1 month, 3 months, 6 months and annually thereafter. PVR urine measurements, urinalysis, and pelvic examinations were performed during follow-up. Multichannel urodynamics was performed at 1 and 3 years post-operatively. At 5 years, patients were objectively evaluated with a pad test. Validated subjective questionnaires were done on annual follow-ups.
Results: There were 80 patients diagnosed with USI in the study period. Of these 15 were satisfied on conservative treatment and 5 were not willing to join thus only 60 patients were included. Within one year results showed subjective cure of 88.3% and objective cure of 91.7%. After 3 years, 5 patients were lost to follow-up and 3 more on the 5th year. A total of 52 patients were evaluated after 5 years. Subjective cure was seen in 42 patients (80.8%) and objective cure in 44 (84.6%) at the 5th post-operative year. Most patients (58.3%) were noted to be post-menopausal with mean age of 55.7 + 11.3 years old. Most of them were multiparous and overweight with a mean BMI of 25.1 + 3.3 kg/m2. Amongst them 8 (13.3%) had prior pelvic surgeries. The entire operative procedure was short with mean operative time of 23.5 + 7.1 minutes. Intraoperative blood loss was very minimal with a mean of 25.5 + 27.6ml. No major complications were noted post-operatively such as mesh extrusions. Comparing pre and post-operative clinical outcomes, the 1-hour pad test showed statistical improvement at 1, 3 and 5 years follow-up. De novo detrusor overactivity (DO) and detrusor overactivity incontinence (DOI) were noted in 3 patients (5.4%) at 1 and 3 years time but were managed conservatively. None of the patients developed bladder outlet obstruction (BOO). Subjective assessment on the quality of life of patients through the use of questionnaires (UDI-6, IIQ-7, and PISQ-12) at 5 years post-operation was not only well maintained but improved with data showing statistical significant improvement. Throughout 5 years, a stepladder decline in the trend of cure was observed yet cumulative rates were maintained at 80% with objective cure rates being higher then subjective cure rates
Conclusions: Single-incision sling (SIS), MiniArc, maintains its effectiveness and safety in treatment of SUI through 5-years with high objective and subjective cure rates with low incidence of complications.
References: 1. Lo TS, Tan YL, Wu PY, Cortes EFM, Pue LB, Al-kharabsheh AM. Ultrasonography and Clinical Outcomes Following Surgical Anti-Incontinence Procedures (Monarc vs Miniarc). Eur J Obstet Gynecol Reprod Biol. 2014 Nov;182:91-7