Vol. 181, No. 4, Supplement, Tuesday, April 28, 2009 THE JOURNAL OF UROLOGY® 483

6 (UDI6), Pelvic Organ Prolapse Distress Inventory (POPDI), and Colorectal-anal Distress Inventory (CRADI). The Mann-Whitney test was used to compare independent groups; chi-square test was used for nominal variables. Linear regression models were used to determine which variables were associated with CRADI, POPDI, and UDI6 scores.

RESULTS: 330 women, with mean age of 58±16 years and median vaginal parity of 2, met inclusion criteria. 35% had prior hysterectomy, and 18% had prior POP/UI surgery. POP-Q stage included: 57% stage 0/I, 20% stage II, and 23% stage III/IV. Higher CRADI and POPDI scores were associated with prior hysterectomy (P=.02 and P=.03) and prior POP/UI surgery (P=.001 and P=.001). Higher UDI6 scores were only associated with prior POP/UI surgery (P=.001). Comparing stage II and stages III/IV, we did not detect differences in CRADI scores, POPDI scores, or proportion of women with prior hysterectomy or POP/UI surgery, although women with stage II POP had higher UDI6 scores (P<.0005). After adjusting for age, prior POP/UI surgery was independently associated with higher POPDI (P<.0005) and UDI6 scores (P=.007), while stage III/IV POP was independently associated with higher POPDI scores (P=.001), but lower UDI6 scores (P=.007). Only prior POP/UI surgery was independently associated with CRADI scores (P<.0005).

CONCLUSIONS: New urogynecologic patients who have undergone prior POP/UI surgery report more bothersome pelvic floor symptoms independent of prolapse stage or age. This may be due to higher pre-op symptom burden, patient perceptions of “unsuccessful” surgery or other factors that require additional research.

Source of Funding: None

1354A NEW OPERATION FOR VAGINAL PROLAPSE REPAIR USING MESH AND A VAGINAL SUPPORT DEVICE: 1 YEAR ANATOMIC AND FUNCTIONAL RESULTS OF AN INTERNATIONAL, MULTICENTER STUDY.

Halina M Zyczynski*, Pittsburg, PA; Mark Slack, Cambridge, United Kingdom; Christl Reisenauer, Tubingen, Germany; Salil Khandwala, Dearborn, MI; Douglas Van Drie, Grand Rapids, MI; Nicholas Franco, Naples, FL; Tim Sayer, Basingstoke, United Kingdom; Christian Goepel, Halle, Germany; Miles Murphy, Allentown, PA; Anthony R.B. Smith, Manchester, United Kingdom; Marcus P Carey, Melbourne, Australia

INTRODUCTION AND OBJECTIVES: We describe a novel, surgical approach to prolapse repair using a polypropylene mesh, supported by placement of a vaginal support device (VSD) for 3 to 4 weeks during tissue in-growth (GYNECARE PROSIMA™ Pelvic Floor Repair System, Ethicon, Somerville, NJ). This study evaluated anatomic, functional and safety outcomes.

METHODS: Women with symptomatic prolapse (POP-Q Stage II-III) were invited to participate in this prospective, IRB-approved study. Surgery used a trocar-less vaginal approach with mesh inserted into the vesciovaginal and / or rectovaginal planes and extended without fixation over the obturator internus muscles and bilateral sacrospinous ligaments, respectively. The VSD was fitted and secured into the vagina at the end of surgery with planned wear for 3 to 4 weeks. Participants completed a medical history, POP-Q exam, QOL and sexual function surveys and a global impression scale (GIS) at baseline, 6 months and 1 year post-operatively. The primary outcome was anatomic success, defined as POP-Q Stage I at 1 year.

RESULTS: 136 women were included with mean age of 64.3 years (SD 10.5), BMI 28.4 (5.0). 53.7% were Stage II and 46.3% Stage III. 31 (22.8%) had anterior mesh, 33 (24.3%) posterior and 72 (52.9%) combined repairs. 16.9% had concurrent hysterectomies and 33.1% had mid-urethral slings. At 1 year, 102 (76.7%) women had POP-Q stage

I, while in 113 (88.3%), the leading edge of the vaginal wall was at 1cm above the hymen. POP-Q measurements are in the table. Based on GIS, 73.3% patients reported they were “much better” and 15.3% “a little better” at 1 year. All measures of QOL and sexual function improved significantly from baseline (see table). Analysis of safety included 12

additional “run in” cases (n=149). Cystotomy occurred with dissection in 2 cases; there were no rectal injuries. Mesh exposure occurred in 12 patients (8.1%). At baseline, dyspareunia was reported in 13 / 62 (21.0%) sexually active patients; at 1 year, this was reduced to 7.7% (2 persistent, 3 de novo). 3 patients (2.2%) underwent re-intervention for prolapse.

CONCLUSIONS: Prolapse surgery using this mesh repair with VSD resulted in safe, good anatomical and functional outcomes at 1 year.

POP-Q Measures and Functional Outcomes

Baseline: mean (SD) 1 year: mean (SD)

Ba 0.4 (2.0) -1.9 (1.3)*

C -3.9 (3.0) -6.0 (1.7)*

Bp -0.4 (1.9) -2.5 (0.8)*

GH 4.1 (1.1) 3.5 (0.9)*

PB 3.0 (1.0) 3.2 (0.8)*

TVL 8.2 (1.5) 7.5 (1.1)*

PFDI-20 118.9 (57.5) 43.1 (41.1)*

POPDI-6 48.0 (23.5) 12.1 (15.6)*

CRADI-8 29.8 (22.6) 13.1 (14.2)*

UDI-6 41.1 (24.7) 17.8 (19.6)*

PFIQ-7 65.3 (64.7) 14.8 (26.3)*

POPIQ 21.0 (25.3) 2.8 (8.3)*

CRAIQ 16.5 (23.4) 3.7 (8.8)*

UIQ 27.7 (26.0) 9.2 (17.4)*

PISQ-12 26.9 (13.7) 31.4 (12.9)**

*p<0.001; **p=0.029

Source of Funding: Ethicon Women’s Health and Urology

1355LONG-TERM FOLLOW-UP OF UTERUS SPARING SURGERY FOR PELVIC ORGAN PROLAPSE (POP)

Elisabetta Costantini*, Massimo Lazzeri, Alessandro Zucchi, Luigi Mearini, Michele Del Zingaro, Massimo Porena, Perugia, Italy

INTRODUCTION AND OBJECTIVES: At present, concomitant hysterectomy and repair of pelvic support defects is considered the standard option for pelvic organ prolapse (POP) involving the uterus. The few reports on uro-genital prolapse repair associated with uterus preservation generally present short follow-ups and vague outcome measures. Here, we report the long-term follow-up of our experience in uterus sparing surgery, performed at our tertiary Urogynecological Department.

METHODS: Forty-seven patients with symptomatic POP underwent uterus sparing surgery: 40 abdominal hysterocolposacropexy (HSP) and 7 laparoscopic (LHSP). Patients underwent an accurate preoperative evaluation. All patients were followed-up for 1, 3, 6 and 12 months postoperatively and then annually. Outcomes were assessed objectively and subjectively using a symptoms investigation, anatomical/physical examination, patient questionnaires and urodynamic tests. Objective success was defined as the cervix and/or vaginal apex remaining well supported > 6 cm above the hymen plane and no vaginal prolapse greater than or equal to grade 2 at any vaginal site while the patient performed Valsalva’s maneuver. Subjective success was absence of symptoms related to prolapse or incontinence. Patient satisfaction was defined by replies to questions as to whether the patient was satisfied with the operation and would they repeat it.

RESULTS: The mean follow-up was 60.7 months (range of 12-141 months). Anatomical outcome showed anterior compartment prolapse (cystocele) 2 in 6/47 patients (12.76%), while posterior compartment prolapse (rectocele) 2 was present in 4/47 patients (8.51%). However no one required a further surgery to correct the recurrence. Post-operative voiding symptoms persisted in 3/33 (6.38%) patients, post-operative storage symptoms persisted in 6/32 (18.75 %) patients. Two patients reported de novo urgency. Sexual activity was