G. Willy Davila

An International Urogynecological Association (IUGA) / International Continence Society (ICS) joint terminology and classification of the complications related directly to the insertion of prostheses (meshes, implants, tapes) & grafts in female pelvic floor surgery

Introduction and hypothesisA terminology and standardized classification has yet to be developed for those complications arising directly from the insertion of synthetic (prostheses) and biological (grafts) materials in female pelvic floor surgery.MethodsThis report on the above terminology and classification combines the input of members of the Standardization and Terminology Committees of two International Organizations, the International Urogynecological Association (IUGA) and the International Continence Society (ICS) and a Joint IUGA/ICS Working Group on Complications Terminology, assisted at intervals by many expert external referees. An extensive process of 11 rounds of internal and external review took place with exhaustive examination of each aspect of the terminology and classification. Decision-making was by collective opinion (consensus).ResultsA terminology and classification of complications related directly to the insertion of prostheses and grafts in female pelvic floor surgery has been developed, with the classification based on category (C), time (T) and site (S) classes and divisions, that should encompass all conceivable scenarios for describing insertion complications and healing abnormalities. The CTS code for each complication, involving three (or four) letters and three numerals, is likely to be very suitable for any surgical audit or registry, particularly one that is procedure-specific. Users of the classification have been assisted by case examples, colour charts and online aids (www.icsoffice.org/complication).ConclusionsA consensus-based terminology and classification report for prosthess and grafts complications in female pelvic floor surgery has been produced, aimed at being a significant aid to clinical practice and research.

Comparative efficacy and safety of transdermal oxybutynin and oral tolterodine versus placebo in previously treated patients with urge and mixed urinary incontinence

OBJECTIVES To compare the efficacy and safety of an oxybutynin transdermal delivery system (OXY-TDS) and oral, long-acting tolterodine (TOL-LA) with placebo in previously treated patients with urge or mixed urinary incontinence. METHODS After withdrawal of their current antimuscarinic therapy, 361 adult patients were randomized to 12 weeks of double-blind, double-dummy treatment with twice weekly OXY-TDS 3.9 mg/day, daily TOL-LA 4 mg, or placebo. Evaluations included change from baseline in patient urinary diary symptoms, incontinence-specific quality of life, and safety. RESULTS OXY-TDS 3.9 mg/day and TOL-LA 4 mg/day significantly reduced the number of daily incontinence episodes (median change -3 OXY-TDS and -3 TOL-LA versus -2 placebo; P <0.05), increased the average void volume (median change 24 and 29 mL versus 5.5 mL, P <0.01), and improved quality of life (incontinence impact questionnaire [IIQ] total score, P <0.05; Urogenital Distress Inventory Irritative Symptom subscale, P <0.05) compared with placebo. The most common adverse event for OXY-TDS was localized application site pruritus (14% versus 4% placebo) accompanied by a low incidence of systemic side effects (eg, dry mouth 4.1%). Anticholinergic adverse events occurred with greatest frequency during TOL-LA treatment (dry mouth 7.3% versus 1.7% placebo, P <0.05). CONCLUSIONS OXY-TDS and TOL-LA are effective and comparable treatments for patients with urge and mixed incontinence. OXY-TDS improves systemic safety with regard to anticholinergic side effects. Local skin irritation occurs in some OXY-TDS patients.

Efficacy and Safety of Transdermal Oxybutynin in Patients With Urge and Mixed Urinary Incontinence

PURPOSE We evaluated the efficacy and safety of an oxybutynin transdermal delivery system (TDS) in a general population of patients with overactive bladder and urge or mixed urinary incontinence. MATERIALS AND METHODS Following symptom stabilization or treatment withdrawal 520 adult patients were randomized to 12 weeks of double-blind daily treatment with 1.3, 2.6 or 3.9 mg. oxybutynin TDS or placebo administered twice weekly, followed by a 12-week open-label, dose titration period to assess efficacy and safety further. Evaluations included patient urinary diaries, incontinence specific quality of life and safety. RESULTS A dose of 3.9 mg. daily oxybutynin TDS significantly reduced the number of weekly incontinence episodes (median change -19.0 versus -14.5, p = 0.0165), reduced average daily urinary frequency (mean change -2.3 versus -1.7, p = 0.0457), increased average voided volume (median change 24 versus 6 ml., p = 0.0063) and significantly improved quality of life (Incontinence Impact Questionnaire total score, p = 0.0327) compared with placebo. Average voided volume increased in the daily 2.6 mg. group (19 ml., p = 0.0157) but there were no other significant differences between 1.3 and 2.6 mg. oxybutynin TDS and placebo. The most common adverse event was application site pruritus (oxybutynin TDS 10.8% to 16.8%, placebo 6.1%). Dry mouth incidence was similar in both groups (7.0% versus 8.3%, p not significant). In the open-label period a sustained reduction of nearly 3 incontinence episodes per day was reported for all groups. CONCLUSIONS Doses of 2.6 and 3.9 mg. oxybutynin TDS daily improve overactive bladder symptoms and quality of life, and are well tolerated. Transdermal oxybutynin is an innovative new treatment for overactive bladder.

An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint terminology and classification of the complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery.

A terminology and standardized classification has yet to be developed for those complications arising directly from the insertion of synthetic (prostheses) and biological (grafts) materials in female pelvic floor surgery.

Are There Predictors of Outcome Following Rectovaginal Fistula Repair

BACKGROUND: Rectovaginal fistula is a distressing condition for patients and for physicians who are continuously challenged in providing durable treatment options. The aim of this study is to assess the results of rectovaginal fistula repair and identify predictive factors for poor outcome. METHODS: Retrospective analysis of patients who underwent rectovaginal fistula repair from 1988 to 2008 was performed. &khgr;2 tests and logistical regression analysis were used to study treatment outcomes according to the following fistula characteristics: etiology, size, location, and number of prior attempts at fistula repair. In addition, patient factors such as age, body mass index, smoking history, comorbid condition of diabetes, use of steroid and immunosuppressive medications, number of prior vaginal deliveries, and presence of a diverting stoma were analyzed. RESULTS: A total of 184 procedures were performed in 125 patients. Inflammatory bowel disease was the most common indication for surgery (45.6%), followed by obstetric injury (24%) and surgical trauma (16%). The mean duration of fistula presence was 31.2 months. The procedures performed included endorectal advancement flap (35.3%), gracilis muscle interposition (13.6%), seton placement (13.6%), and transperineal (8.7%) and transvaginal repair (8.1%). The overall success rate per procedure was 60%, with no difference in recurrence rates based on the type of repair. Patients with Crohns disease had more recurrent fistulas (44.2% success per procedure; P < .01), although 78% eventually healed after an average of 1.8 procedures. Patients with obstetric injuries had an 89% success rate after an average of 1.3 procedures per patient, which is similar to the success rate for traumatic fistulas. Pouch vaginal fistulas had a 91% success rate after an average of 1.6 procedures per patient. The overall success rate per patient was 88% after multiple procedures with a mean follow-up of 16.3 months. Age, body mass index, diabetes, use of steroids and immunosuppressive agents, size and location of the fistula, number of vaginal deliveries, time interval between a recurrent episode and subsequent repair, and the presence of fecal diversion did not affect outcomes. The presence of Crohns disease and a smoking history are strongly associated with rectovaginal fistula recurrence (P = .02). CONCLUSIONS: Despite a relatively low initial success rate (60%), most rectovaginal fistulas can be successfully repaired with subsequent operations. Crohns disease and smoking are associated with adverse outcomes.

Levator ani deficiency and pelvic organ prolapse severity.

OBJECTIVE: To estimate whether levator ani deficiency severity is a predictor of clinically significant pelvic organ prolapse (POP) and to determine whether there is a levator ani deficiency threshold above which POP occurs. METHODS: Two-hundred twenty three-dimensional ultrasound scans performed on urogynecologic clinic patients were reviewed, and each levator ani muscle subdivision was individually scored (0=no defect, 1=50% or less defect, 2=more than 50% defect, 3=total absence of the muscle) on each side. A levator ani deficiency score was calculated and categorized as mild (score 0–6), moderate (score 7–12), and severe (score more than 13). Clinically significant prolapse was defined as stage 2 or higher. RESULTS: The mean age was 56.50 (standard deviation ±15.58) and median parity was 2 (range 0–6). A mild positive correlation was demonstrated between levator ani deficiency category and prolapse stage (rs=0.44; P<.001). Score distribution significantly differed by prolapse stage (P<.001). No patients with stage 3 prolapse had a levator ani score less than 6, and no patients with stage 4 prolapse had a levator ani score less than 9. In patients with prolapse, those with moderate levator ani deficiency had 3.2 times the odds of POP compared with patients with a minimal defect; those with severe levator ani deficiency had 6.4 times the odds of prolapse than those with minimal deficiency. CONCLUSIONS: Levator ani deficiency severity is associated with clinically significant prolapse. LEVEL OF EVIDENCE: II

Obliterative LeFort colpocleisis in a large group of elderly women.

OBJECTIVE: To report on anatomical and functional outcomes, patient satisfaction, and associated morbidity and mortality in patients undergoing LeFort colpocleisis. METHODS: This was a retrospective case series of LeFort colpocleisis performed from January 2000 to October 2011. Data obtained from a urogynecologic database included demographics, comorbidities, medications, and urinary and bowel symptoms. Prolapse was quantified using the pelvic organ prolapse quantification (POP-Q) examination. Operative characteristics were recorded. All patients underwent pelvic examination and POP-Q assessment at follow-up visits. Patients also were asked about urinary and bowel symptoms as well as overall satisfaction. All intraoperative and postoperative surgical complications were recorded. RESULTS: Three hundred twenty-five patients underwent LeFort colpocleisis. Fifteen patients were excluded from the analysis because of incomplete data. The mean age was 81.3±5.3 years. Comorbidities were common, with 74.1% of the patients having at least one concomitant medical condition. The procedure was performed under spinal anesthesia in 67%. Additional procedures at the time of colpocleisis included incontinence procedures (79%) and dilation and curettage (46%). Mean follow-up was 45 (range 2–392) weeks. Anatomical success rate was 98.1% and patients were highly satisfied, with 92.9% reported being “cured” or “greatly improved.” Complication and mortality rates were 15.2% and 1.3%, respectively. CONCLUSION: Colpocleisis is an effective and low-risk procedure with high anatomical success rates and patient satisfaction. Associated morbidity and mortality related to the procedure are low. Colpocleisis remains an excellent surgical option for the elderly patient with advanced pelvic organ prolapse. LEVEL OF EVIDENCE: III

Bladder-health diaries: an assessment of 3-day vs 7-day entries.

To assess the reliability of symptom reports in 3‐day vs 7‐day bladder diaries used in clinical trials of patients with overactive bladder (OAB) and to compare those results and related issues with previous reports.

Clinical implications of the biology of grafts: conclusions of the 2005 IUGA Grafts Roundtable

With few exceptions, the current expansion of graft utilization in pelvic reconstructive surgery is not a product of evidence-based medicine. Abdominal sacrocolpopexy and suburethral sling procedures are two situations under which synthetic graft utilization is indicated, based on randomized prospective trials and reported clinical outcomes. Otherwise, indications and contraindications for graft utilization are unclear. Current published data on the biology of synthetic and biologic grafts are limited and overall not very helpful to the reconstructive surgeon who is faced with the selection of a graft for use during a reconstructive procedure. This Roundtable presented the opportunity for a series of basic science researchers to present their data to a group of reconstructive surgeons and provide publishable background information on the various currently available grafts. The occurrence of healing abnormalities after graft implantation is becoming increasingly recognized as a potentially serious problem. To date, definitions and a classification system for healing abnormalities do not exist. Based on the input from basic scientists and experienced surgeons, a simple classification is suggested based on the site of healing abnormality, timing relative to graft implantation, presence of inflammatory changes, and the viscera into which the graft is exposed. Many opportunities for clinical and basic science research exist. As the use of grafts in reconstructive surgery is expanded, surgeons are encouraged to familiarize themselves with currently published data, and determine whether a graft should, or should not be, utilized during a reconstructive procedure, and if so, the type of graft best indicated in each specific clinical situation.

Selection of patients in whom vaginal graft use may be appropriate

Introduction and hypothesisThe recent rapid and widespread adoption of the use of mesh, and mesh-based surgical kits for pelvic organ prolapse (POP) repair surgery has occurred largely unchecked, and is now being subjected to critical analysis and re-evaluation.MethodsThere have been multiple driving forces for this phenomenon, including aggressive marketing by surgical device manufacturing companies, contagious hype among pelvic surgeons and regulatory processes which facilitated relatively rapid marketing of new devices.ResultsPatient-related factors such as indications for mesh use, expected risks and benefits relative to mesh implantation, and appropriately selected outcome measures have been slow to be defined.ConclusionsThis manuscript reviews the currently available literature in the use of grafts and mesh in POP surgery with a focus on identifying situations where graft use may be appropriate for an individual patient. It also identifies specific clinical situations where mesh use may not be recommended.