Study design, materials and methods
Following institutional review board (IRB) approval, a long-term database of non-neurogenic patients who underwent AVWS for bothersome SUI with early stage anterior compartment prolapse (stage ≤ 2) “Small C” or symptomatic anterior compartment prolapse (stage > 2) “Large C” was reviewed. Any patient with less than 10-year follow-up was excluded. Preoperative evaluation included detailed history, uterine status, pad use, and 3 validated questionnaires [Urogenital Distress Inventory-Short Form (UDI-6), Incontinence Impact Questionnaire-Short Form (IIQ-7), visual analog quality of life score (QoL)]. Additional Pelvic Organ Prolapse Quantification (POP-Q) and voiding cystourethrography (VCUG) data is available for those seen in clinic. Follow-up data was based on clinic visits in EMR or structured telephone interviews for patients not seen in the past 2 years. Telephone interviews used similar validated questionnaires and were conducted by a third party not involved in patient care. Failure was defined as any reoperation for SUI or POP at the last patient encounter (Kaplan-Meier).
Results
Between 1996 and 2008, 161 of 328 patients met study criteria, with follow-up from phone interviews (103) or clinic visits (58). The 167 lost to follow-up patients were deceased (52), mentally disabled (5), or unreachable by telephone (110). Median follow-up was 13.5 years (range: 10-22.1). Type of follow-up (clinic vs. phone) and uterine status (concomitant/prior/no hysterectomy) did not impact reoperation rates. The “Large C” group was older at the time of surgery and had a non-statistically significant higher reoperation rate. Reoperation occurred in 23 women (14%), with sacrocolpopexy (8), anterior colporrhaphy (5), injectable agents (8), or fascial sling placement (2). The Kaplan-Meier 10-year reoperation free survival rate was 87% (95% CI: 80.7-91.3).
No patients in our cohort experienced postoperative blood transfusion, bladder perforation, ureteric injury, or sexual dysfunction. Early complications (urinary retention, wound infection, urinary tract infections) and late complications (infection, pain, UTI) were minimal and each occurred in <2% of our patients.
Interpretation of results
This study reports on the very long-term outcome of AVWS to treat SUI and/or anterior vaginal wall compartment prolapse. At a median follow-up of 13.5 years (range: 10-22.1 years), we observed 86% success rate for SUI and minimal complications, which highlights that this native tissue repair is a safe, effective, and durable repair for patients with SUI and/or POP. The rate of reoperation is equivalent to those of other standard anti-incontinence procedures such as the urethral sling, which has reported 9 year cumulative reoperation rates from a population based analysis of 13% [2].
There are many possible definitions of postoperative failure in the treatment of SUI and/or anterior compartment prolapse. Defining failure as the need for reoperation secondary to recurrent bothersome SUI provides a very definitive data point and it is our experience that those patients who did not pursue reoperation were overall satisfied with their postoperative QoL even if there was mild recurrence of SUI symptoms. For POP recurrence, we used vaginal bulge presence question in our structured interviews which has been validated before [3].
Functional outcomes based on validated questionnaires and QoL scores demonstrated significant improvement after AVWS from baseline preoperative values and these improvements were maintained over time. For the patients with long-term follow-up in clinic, physical exam POP-Q scores showed sustained statistically significant improvement even over 10 years (Aa, Ba: baseline vs. FU p < 0.0001). There was no adverse increase in urge incontinence (UDI-6 Q2) or voiding function (UDI-6 Q5).