DEFINING SUCCESS AFTER SURGERY FOR PELVIC ORGAN PROLAPSE

DEFINING SUCCESS AFTER SURGERY FOR PELVIC ORGAN PROLAPSE

484 THE JOURNAL OF UROLOGY® maintained in 28/29 (95.5%) patients. Four patients showed de novo urinary incontinence (3 # stress urinary incontinence...

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484

THE JOURNAL OF UROLOGY®

maintained in 28/29 (95.5%) patients. Four patients showed de novo urinary incontinence (3 # stress urinary incontinence - SUI, and 1 # urgency incontinence -UI). Thirty-nine of 47 patients (82.97%) were satisfied. No one develop pelvic neoplasms. CONCLUSIONS: Long-term follow-up showed that uterus sparing surgery seems to be feasible and safe in women who wants to preserve the integrity of vaginal function and to be satisfied with their self image of body. We should always advise them about the risks of pregnancy and delivery and the need for a long-term follow-up to rule out malignant disease. Source of Funding: None

1356 COMPLICATIONS ASSOCIATED WITH MINIMALLY INVASIVE SURGERY FOR PELVIC ORGAN PROLAPSE (POP) Jeremy B Tonkin*, Jennifer Bepple, Kurt A McCammon, Norfolk, VA INTRODUCTION AND OBJECTIVES: Recently, the US Food and Drug Administration (FDA) issued a warning regarding complications arising from the use of trans-vaginal POP repairs utilizing mesh. The Manufacturer and User Facility Device Experience Database (MAUDE database) is sponsored by the FDA and contains voluntarily reported complications from physicians, facilities, distributors, and manufacturers. This data is not intended to compare rates of adverse events, but is a centralized source for identifying surgical morbidities across the nation. As minimally invasive mesh “kit” repairs have become more common, so have the reported complications. Here we investigate complications arising from several commonly utilized mesh repairs. METHODS: We performed an inquiry using the MAUDE database regarding complications associated with various products used to repair POP using mesh. We searched for “Perigee, Prolift, Apogee, and Avaulta” from 2004 to November 2008. Results were organized by type of complication and product used. RESULTS: Major complications were defined as injury to any organ, bleeding requiring transfusion or return to the operating room, fistula, abscess formation, stroke and death. Minor complications included erosions, pain, hematoma, minor mesh infection, and equipment failure. A total of 275 events were reported. Perigee had 25 minor and 4 major complication reported. Prolift had 122 minor and 33 major complications reported. Avaulta had 41 minor and 22 major complications reported. Apogee had 20 minor and 3 major complication reported. CONCLUSIONS: Significant injury can occur during the repair of pelvic organ prolapse using these minimally invasive techniques. While mesh erosions accounted for a majority of the minor complications, a startling rise in the incidence of major complications was noted. Increased awareness of the responsibility to report or the increase in use of these products in general may be a factor in the rise of reported complications. Certainly, mesh “kit” repairs have been marketed as an easy way to repair POP and as such are increasingly popular. Due to their popularity, they may be marketed to practitioners with varying degrees of comfort in performing trans-vaginal procedures thus leading to increased morbidity. These factors are unclear and future studies should aim to answer these questions so that we may maximize patient safety. Source of Funding: None

1357 SINGLE INSTITUTION EXPERIENCE OF PERI-OPERATIVE AND SHORT-TERM COMPLICATIONS WITH THE PROLIFT REPAIR SYSTEM FOR PELVIC ORGAN PROLAPSE Larry T Sirls*, Pradeep Nagaraju, Fadi Eliya, Kim Killinger, Keith Mullins, Paul Thomas, Kenneth M Peters, Royal Oak, MI INTRODUCTION AND OBJECTIVE: The Gynecare Prolift System uses mesh to correct the anterior, apical and posterior compartments through a vaginal approach. We report our perioperative and short-term complications with the Prolift system. METHODS: We retrospectively reviewed 191 patients who underwent prolapse surgery with the Gynecare Prolift System between

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October 2005 and April 2008 by 3 fellowship trained urologists at William Beaumont Hospital. Peri-operative and short-term complications were evaluated focusing on surgical complications, transfusion, mesh exposure and re-operation for any reason. RESULTS: Mean patient age is 65 +10 years and mean follow up was 18.6 + 9 months. 102 (53%) had anterior or anterior & apical mesh, 26 (14%) posterior mesh only, and 63 (33%) had anterior, apical and posterior mesh. 48 (25%) had concurrent hysterectomy. Mean operative time and length of stay was 118 minutes and 2 days, respectively. 2/191 (1%) had a recognized bladder injury that was repaired and mesh placed. Peri-operative complication rates included 6/183 (3%) patients with post-operative hematoma, 10/190 (5%) patients required transfusion, none requiring intervention. A learning curve was observed with 4/10 transfusions in the first 25% of cases, 4/10 the second 25%, 2/10 in the third 25% and none in the last 25% of patients. 9/183 (5%) had urinary retention requiring prolonged catheterization. 9/183 (5%) patients reported perineal or buttock pain that resolved without intervention. 16 /183 (9%) patients had mesh exposure on physical exam and 9/183 (5%) had recurrent prolapse identified. Secondary operations were required in 29/182 (16%) patients for local mesh excision, obstructed voiding, persistent or de-novo SUI, and recurrent prolapse. Mesh exposure and need for transfusion did not correlate with age, body mass index, grade of prolapse, prior prolapse surgery, prior or concurrent hysterectomy, menopausal status or HRT use. CONCLUSIONS: This study reinforces that the Prolift mesh delivery system for pelvic organ prolapse can be accomplished with acceptable morbidity. Proper patient counseling of complications and reoperation rates need to be emphasized. Medium and long-term data are needed to assess efficacy. Source of Funding: None

1358 DEFINING SUCCESS AFTER SURGERY FOR PELVIC ORGAN PROLAPSE Matthew D Barber*, Cleveland, OH; Pelvic Floor Disorders Network INTRODUCTION AND OBJECTIVES: There is no consensus on how to define success after surgery for pelvic organ prolapse (POP). The objective of this study is to compare success rates after abdominal sacrocolpopexy using different definitions of success and to assess how patients’ subjective assessments of improvement correlate with each definition. METHODS: We created 15 different definitions of surgical success using data from the POPQ examinations, responses to Pelvic Floor Distress Inventory (PFDI) questions regarding vaginal bulging, and data on re-treatment obtained from the 2-year results of the Colpopexy And Urinary Reduction Efforts (CARE) trial, a randomized trial evaluating the effect of Burch colposuspension in stress continent women undergoing abdominal sacrocolpopexy for POP. Subjects rated their overall improvement relative to baseline from “much better” to “much worse” and the success of their treatment from “very successful” to “not at all successful.” We assessed whether the participant’s assessment of overall improvement and rating of treatment success differed between surgical success and failure for each of the definitions studied. RESULTS: 322 CARE women completed the 2-year followup and are included in this analysis. Treatment success varied widely depending upon definition used, from 18.8% to 97.2%. 71% considered their surgery “very successful” and 85% considered themselves “much better” than before surgery. Definitions of success requiring anatomic support of all compartments proximal to the hymen had the lowest treatment success (18.8% to 57.6%). 84% achieved surgical success when it was defined as the absence of prolapse beyond the hymen. Subjective cure (absence of bulge symptoms) occurred in 92.1% while absence of retreatment occurred in 97.2% of subjects. When the absence of bulge symptoms was included in the definition of treatment success, significant improvements in the patients’ subjective assessments of overall improvement were noted between those who met the definition of success and those who did not (p<0.05) while definitions that included

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anatomic data alone demonstrated no such relationship (p>.40) CONCLUSIONS: The definition of success has a substantial effect on the rate of treatment success in POP surgery. The absence of vaginal bulge symptoms postoperatively has a significant relationship with a patient’s assessment of overall improvement, while anatomic success alone does not. Source of Funding: Supported by grants from the NICHD and the NIH Office of Research on Women’s Health (U01 HD41249, U10 HD41250, U10 HD41261, U10 HD41267, U10 HD54136, U10 HD54214, U10 HD54215, and U10 HD54241).

1359 PATIENT SATISFACTION AND SELF-REPORTED OUTCOMES FOLLOWING REPAIR OF VAGINAL PROLAPSE USING TENSIONFREE NON-ABSORBABLE POLYPROPYLENE MESH KITS Joe D Mobley, III*, Pleas Copas, Wesley M White, Frederick A. Klein, Knoxville, TN INTRODUCTION AND OBJECTIVES: The use of vaginal prolapse repair kits by urologists has grown substantially over the past decade as urologists feel increasingly comfortable with this surgical technique. This increase has occurred despite much data on patient tolerance of and clinical outcomes following the procedure. Given this, we present data collected from patient questionnaires regarding their experience following repair of vaginal prolapse via this technique. METHODS: Questionnaires were mailed to 133 patients in our initial series of patients treated for vaginal prolapse utilizing the Gynecare PROLIFT™ system. Patients were queried in regards to their personal satisfaction with the procedure including its affect on sexual function, any adverse effects experienced, and any interventions required after their initial procedure. The primary investigator was blinded to the identity of the patients. This information was compared with a database containing information obtained from office follow-up visits to compare the accuracy of the two sources of information. RESULTS: From June 2005 to July 2006, 133 patients with a mean age of 60.7 years (range 34 - 85 years) underwent vaginal prolapse repair utilizing the PROLIFT™ system. 63 questionnaires (47%) were returned fully completed. 78% of patients reported being mostly or completely satisfied with their procedure and an equal number reported they would have the same procedure performed again for repair of their prolapse. 11% were dissatisfied and a total of 19% reported they would not repeat the same procedure. 16% of patients reported adverse events and 3.2 % reported surgery to address a complication. 67% of patients reported sexual activity since repair of their prolapse and of these 36% report a negative impact on their sexual function. When compared to our data collected from office visits our numbers were similar in regards to adverse events and patients requiring a subsequent procedure. Our clinical success rate overestimated patient satisfaction with the procedure and incompletely described the breadth of patient perceived adverse events. CONCLUSIONS: The majority of patients treated for repair of vaginal prolapse with Gynecare’s PROLIFT™ system were satisfied and would choose to have the surgery performed again. This being said, negative effects of surgery were reported in 19% of patients and new onset dyspareunia remains as a substantial cause of post-operative morbidity. Source of Funding: None

485

Sexual Function/Dysfunction/Andrology: Medical & Non-Surgical Therapy (I) Podium 34 Tuesday, April 28, 2009

8:00 am - 10:00 am

1360 ERECTILE FUNCTION REHABILITATION AFTER RADICAL PROSTATECTOMY: PRACTICE PATTERNS AMONG AUA MEMBERS. Raanan Tal*, Patrick E Teloken, John P. Mulhall, New York, NY INTRODUCTION AND OBJECTIVES: Despite a growing body of evidence in the literature to support erectile function (EF) rehabilitation after radical prostatectomy (RP) there are no AUA guidelines on this subject. This study was undertaken in association with the AUA to explore EF rehabilitation practice patterns of AUA urologists. METHODS: A 36-question instrument was constructed assessing: physician demographics, training and EF rehabilitation practices after RP. AUA members were sent an email by the AUA Office of Education asking them to complete the survey. The data were acquired by the AUA and data analysis was performed by the investigators. RESULTS: 618 urologists completed the survey, 71% were in private practice. 73% practiced general urology, 18% urologic oncology and 4% andrology. 28% considered themselves a specialist in sexual medicine, although only 4% were fellowship-trained. 30% had been in practice for <5 years, and 54% >10 years. 86% perform RP; 77% perform a10 cases per month. 52%, and 44% perform open and robotic surgery, respectively. Rehabilitation practices were: 86% of responders recommend EF rehabilitation, with no significant difference between sexual medicine and urologic oncology specialists (90 vs 91%; p=ns). 43% of respondents rehabilitate all patients, 57% only in selected patients. Patient selection for rehabilitation was considered to dependent upon pre-op EF by 66%, nerve sparing status by 22%, and age by 5%. 11% start rehab immediately after RP, 97% within 4 months. 24%, 45% and 18% cease rehab at <12, 12-18 and 18-24 months respectively. Respondents practicing <10 years recommend rehab more often than those >10 years (90 vs. 82%, p=0.003). 89% of RP surgeons perform rehab vs only 66% who do not perform RP (p<0.0001). 87% of responders prefer PDE5i as their primary rehabilitation strategy followed (in order) by vacuum erection device (VED), intracavernosal injection (ICI) and urethral suppositories. 81% recommend Viagra/Levitra on a regular basis, 30% for daily use, When Cialis is recommended on a regular basis, 23% suggest daily use. 65% recommend VED on a regular basis, 26% for daily use. 46% recommend ICI on a regular basis, 34% recommend 2-3 times weekly. CONCLUSIONS: Among respondents, penile rehabilitation is a common practice. Sexual medicine specialists and RP surgeons are most likely to recommend rehabilitation. The most commonly employed strategy is PDE5i on a regular basis for 12-18 months after RP. Source of Funding: None

1361 NIGHTLY SILDENAFIL IS UNNECESSARY AFTER MINIMALLYINVASIVE NERVE-SPARING RADICAL PROSTATECTOMY: ONDEMAND SILDENAFIL PROVIDES EQUIVALENT RESTORATION OF ERECTILE FUNCTION Christian P Pavlovich*, Lynda Z Mettee, Baltimore, MD; Li-Ming Su, Gainesville, FL; Jonathan P Jarow, Bruce J Trock, Baltimore, MD INTRODUCTION AND OBJECTIVES: Two randomized controlled trials (RCT) of phosphodiesterase-5 inhibitor (PDE5i) use after radical prostatectomy have showed disparate results, one favoring nightly use vs. placebo, the other favoring on-demand vs. nightly dosing. We sought to compare these two rehabilitative regimens after nerve-