URINARY RETENTION IS UNCOMMON AFTER COLPOCLEISIS WITH CONCOMITANT MIDURETHRAL SLING

Vol. 179, No. 4, Supplement, Tuesday, May 20, 2008

host tissue was monitored histologically after 4, 8, 12, 28, and 56 days of cell injection. RESULTS: Muscle antigens were expressed homogeneously LQ06&VDIWHUH[SRVXUHWR$=$LQDOO¿YHFXOWXUHSDVVDJHVLQYHVWLJDWHG The anti-smooth muscle antibodies 1A4 and CGA7 and the anti-skeletal muscle MyoD antibody MoAb5.8A identifed 86-97%, 81-100% and 63-100%, respectively of the MSCs. Undifferentiated MSCs in P0 stained positive in 62%, 60%, and 73%, respectively compared to 94%, 100%, and 92%, respectively for MSCs in P1. There was no reactivity with the antibody NOQ7.5.4D in both groups of MSCs. Histology demonstrated ZHOOGH¿QHGFOXVWHUVRIÀXRUHVFHQWFHOOVLQEODGGHUQHFNWLVVXHVIURP four until 56 days after cell injection. CONCLUSIONS: The results stress the potential of human bone marrow-derived MSCs to differentiate into smooth and skeletal PXVFOH FHOOV $Q H[SRVXUH WR $=$ LV QRW QHFHVVDU\ 6XUYLYDO DQG integration of MSCs in bladder tissue for up to eight weeks may lead to ¿QDOGLIIHUHQWLDWLRQLQYLYRDQGIXOO\IXQFWLRQDOPXVFOHFHOOV7KLVPRGHO HPSKDVL]HV WKH XVH RI DXWRORJRXV 06&V IRU D FHOOEDVHG WUHDWPHQW modality of urinary incontinence. Source of Funding:%LR3UR¿OHSURJUDPRIWKH*HUPDQ Federal Ministry of Education and Research (PTJ-BIO 0313619).

1417 THE ADJUSTABLE CONTINENCE THERAPY (ACT) SYSTEM: ONE YEAR RESULTS OF THE NORTH AMERICA ACT CLINICAL STUDY GROUP Ethan I Franke*, Sherif Aboseif, Steven Nash, Joel Slutsky, Neil Baum, Le Mai Tu, Niall Galloway, Peter J Pommerville, Suzette E Sutherland. Los Angeles, CA, Leawood, KS, Kankakee, IL, New Orleans, LA, Fleurimont, QC, Canada, Atlanta, GA, Victoria, BC, Canada, and Plymouth, MN. INTRODUCTION AND OBJECTIVE: Management of stress XULQDU\LQFRQWLQHQFHDVVRFLDWHGZLWKLQWULQVLFVSKLQFWHUGH¿FLHQF\FDQ EHGLI¿FXOW7KH$&7V\VWHPLVDGHYLFHWKDWSURYLGHVEXONDWWKHEODGGHU neck with balloons for urethral coaptation and bladder neck support. :HUHSRUWXSGDWHGRQH\HDUUHVXOWVRQWKHHI¿FDF\VDIHW\DGMXVWDELOLW\ and technical feasibility of the ACT system for treatment of recurrent female SUI. METHODS: Inclusion criteria: female patients with stress urinary incontinence who have failed previous incontinence treatments. Exclusion criteria: insulin dependent diabetes, autoimmune disease, pregnancy, urinary infection, prior pelvic radiotherapy, detrussor dysfunction, untreated bladder pathology, untreated grade 3/4 pelvic prolapse. Baseline and follow-up tests: physical examination, urinalysis, cystourethroscopy, urodynamics, provocative pad weights, 3-day voiding diary, Stamey score, and validated questionnaires. Surgical technique: WKHGHYLFHLVGHOLYHUHGÀXRURVFRSLFDOO\WRWKHXUHWKURYHVLFDOMXQFWLRQWKH EDOORRQV¿OOHGDQGWKHLQMHFWLRQSRUWSODFHGLQWRDVXEFXWDQHRXVSRXFK in the labia majora. Device adjustments: performed percutaneously beginning 6 weeks post-operatively. Complications: all adverse events are reported. RESULTS: 161 subjects have been implanted to date with 1 year of data available on 107 patients. The mean age of implanted patients is 67.8 years (31-94 years). Mean Stamey score improved by •DW\HDULQRISDWLHQWV 6LJQL¿FDQWLPSURYHPHQWLQ the mean Incontinence Quality of Life Questionnaire score was noted at \HDUYHUVXVDWEDVHOLQHS $GGLWLRQDOO\UHGXFWLRQV in the mean Urogenital Distress Inventory (32.7 at 1 year from 61.3 DW EDVHOLQH S  DQG ,QFRQWLQHQFH ,PSDFW 4XHVWLRQQDLUH  DW  \HDU IURP  DW EDVHOLQH S  VFRUHV ZHUH QRWHG 0HDQ provocative pad weight decreased from 49.7 grams at baseline to 11.9 grams at 1 year (p<0.001). The mean number of balloon volume adjustments through 1 year was 2.1 (0-8). Device or procedure related adverse events were reported in 56.2% of subjects. Of these, 81% were considered to be of mild severity. 29 (18%) patients required device explantation due to balloon and/or port migration or erosion, and of these, 17 were reimplanted. CONCLUSIONS: The ACT system is an effective, simple, and minimally invasive treatment for recurrent female SUI. The balloons FDQEHDGMXVWHGSHUFXWDQHRXVO\WRHQKDQFHHI¿FDF\&RPSOLFDWLRQVDUH usually mild and easily managed. Source of Funding: Uromedica.

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1418 SAFETY OF SUB-MID URETHRAL TAPES: REPORT ON 3 AND 12 MONTHS FOLLOW-UP ON 1198 PATIENTS IN AN INTERNATIONAL REGISTRY Pierre Costa*. Nimes, France. INTRODUCTION AND OBJECTIVE: To evaluate the safety of the same type I polypropylene sub-mid urethral tape (MUT) implanted by two different approaches, transobturator out-in (TO) or retropubic (RP). METHODS: Surgeons prospectively registered pre, per and post-operative characteristics of patients in a registry particularly designed to capture adverse events. Physical examination, pain visual scale, and any reported side effect were registered at each follow-up visit. As this is an anonymous registry no IRB or ethical committee approval VXEPLVVLRQVZHUHUHTXLUHGKRZHYHUQRWL¿FDWLRQVZHUHPDGHLQ)UDQFH to National Medical Board and to the National Commission for Freedom of Information and Computers. RESULTS: By the end of September 2007, 46 surgeons from Australia, Finland, France, Italy, Spain, South Africa, and UK had enrolled 1198 patients, mean age 60 years (27-91). 69% of patients reported genuine SUI, 15% SUI with urgencies and 16% mixed incontinence. 90% had no previous surgery for SUI or prolapse. MUT implantation was mainly performed utilising the TO route (80.56%) and combined prolapse cure was made in 28.82% of patients. No per-operative complication was reported in 1144 patients (95,50%). Per-operative complications occurred in 54 (4.50%) patients. Local complications including vaginal GLVVHFWLRQGLI¿FXOWLHV1  DQGYDJLQDOVXOFXVSHUIRUDWLRQV1  9, 0.75%) were mainly reported with the TO route (N=28) and regional complications such as bladder perforations (N = 11, 0,92%) with the RP URXWH1  $WGLVFKDUJH¿OHVZHUHFRPSOHWHGSDLQZDVQRWHG as absent, normal and important in 559 (49.91%), 547 (48.84%) and 14 (1.25%) patients respectively. At 3 and 12 months follow up 998 and SDWLHQWVZHUHHYDOXDWHG7KHHI¿FDF\ZDVFRQ¿UPHGDWPRQWKV DQGPRQWKVUHVSHFWLYHO\ DQG GU\  DQG VLJQL¿FDQWO\LPSURYHG DQG  VOLJKWO\LPSURYHGVDPHRUZRUVH1RVLJQL¿FDQWUDWHRISDLQ was reported. Physical examination revealed tape extrusion in 3 (0.31%) patients at 3 months and in 3 (0.73%) patients at 12 months, 4 patients had been implanted utilising the TO route. &21&/86,2165HVXOWVRIWKLV¿UVWLQWHUQDWLRQDOSURVSHFWLYH analysis of outcomes and associated complications of the same M.U.T. LPSODQWHGE\GLIIHUHQWVXUJLFDOURXWHVFRQ¿UPHI¿FDF\DQGVDIHW\RIWKH polypropylene type I MUT at 12 months. Local complications are more common in the TO approach. Post-operative pain is not associated with the TO out in procedure. Source of Funding: Registry supported by an XQFRQGLWLRQDOHGXFDWLRQJUDQWIURP%RVWRQ6FLHQWL¿F

1419 URINARY RETENTION IS UNCOMMON AFTER COLPOCLEISIS WITH CONCOMITANT MIDURETHRAL SLING Shameem A Abbasy*, Lior Lowenstein, Thythy Pham, Elizabeth R Mueller, Kimberly Kenton, Mary Pat FitzGerald, Brubaker Linda. Maywood, IL. INTRODUCTION AND OBJECTIVE: The optimal method for treating stress urinary incontinence at the time of colpocleisis is unknown. Women undergoing colpocleisis with concomitant fascial sling have been found to have unacceptably high rates of postoperative urinary retention requiring surgical takedown. Our objective was to determine whether the use of midurethral slings in the setting of colpocleisis is associated with similarly high rates of postoperative urinary retention. METHODS: We reviewed data from consecutive women who had colpocleisis for treatment of symptomatic prolapse with a concomitant midurethral synthetic sling between January 2005 and January 2007. Prior to surgery and 3 months post surgery, patients completed the short form of the validated Pelvic Floor Distress Inventory (PFDI), prolapse TXDQWL¿FDWLRQ 3234  DQG VWDQGDUGL]HG F\VWRPHWURJUDP 6XUJHU\ included a midurethral sling (retropubic or trans-obturator approach ZLWK SRO\SURS\OHQH PHVK *\QHFDUHŠ  IROORZLQJ D PRGL¿HG /H )RUW FROSRFOHLVLV 8ULQDU\ UHWHQWLRQ ZDV GH¿QHG DV PHDVXUHG SRVW YRLG urine residual (PVR) greater than 100 mL at any time after surgery. For

486

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analysis, we used the prolapse (POPDI) and urinary (UDI) subscales of the PFDI. We used Wilcoxon ranked test and McNemar test for repeated parametric and categorical variables, respectively. RESULTS: Thirty-three women with a mean age of 79 years (65-90) were included in the analysis. The median follow-up was 9 months (3-23 months). Prior to surgery, the median POP-Q stage was 3 (range 2-4). Nearly all (91%) had some incontinence symptoms, and 80% reported symptoms of stress urinary incontinence (SUI). Preoperative urodynamic diagnoses included: urodynamic stress incontinence (USI)  1   ERWK 86, DQG GHWUXVRU RYHUDFWLYLW\ LQFRQWLQHQFH '2,   1   '2,  1   QR 86, RU '2,  1  $V H[SHFWHG in women with advanced prolapse, 30% (N=10) had urinary retention (PVR>100 ml) prior to surgery. Following surgery, 13 % reported SUI, and approximately one third (34%) reported urge incontinence. 6WDQGDUGL]HGSRVWRSHUDWLYHF\VWRPHWURJUDPGLDJQRVHVLQFOXGHG USI and 18% DOI. Urinary retention resolved in eight of 10 women with preoperative urinary retention. No patient had a persistently elevated PVR or symptoms of voiding dysfunction requiring surgical revision of sling beyond 6 weeks. CONCLUSIONS: Concomitant midurethral sling at the time of FROSRFOHLVLVUHVXOWVLQORZUDWHVRIVWUHVVLQFRQWLQHQFHZLWKRXWVLJQL¿FDQW postoperative urinary retention. Source of Funding: None

1420 ROLE OF URODYNAMICS ON CLINICAL DECISION-MAKING IN PATIENTS WITH URINARY INCONTINENCE AND VOIDING DYSFUNCTION Hardeep Phull*, Adonis K Hijaz, Howard S Goldman, Adrian V Hernandez, Tara Frenkl, Courtenay K Moore, Louis Moy, Raymond R Rackley, Sandip Vasavada, Firouz Daneshgari. Cleveland, OH, and Philadelphia, PA. INTRODUCTION AND OBJECTIVE: The role of urodynamic studies (UDS) in the management of urinary incontinence (UI) and voiding dysfunction (VD) remains controversial. We conducted a SURVSHFWLYHVWXG\WRLQYHVWLJDWHKRZ8'6LQÀXHQFHVFOLQLFDOGHFLVLRQ PDNLQJ IRU ZRPHQ ZLWK WKHVH GLVRUGHUV DQG K\SRWKHVL]HG WKDW 8'6 alters physicians’ diagnostic impressions. METHODS: Female patients with VD, UI, or pelvic organ prolapse (POP) were recruited into this IRB-approved study. Subjects with pelvic pain, previously treated stress urinary incontinence (SUI), or disabilities were excluded. After completing the Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7), participants were randomly assigned to physicians and some underwent UDS as part of normal workup. Physicians rendered their clinical GLDJQRVLVWUHDWPHQWSODQDQGOHYHORIFRQ¿GHQFHZLWKWKHLUGHFLVLRQ after: 1) initial physical exam 2) reviewing questionnaires 3) reviewing UDS results. Statistical analysis evaluated changes between these time points, using Wilcoxon Signed-Rank test and McNemar’s test for paired SURSRUWLRQVZLWKSLQGLFDWLQJVLJQL¿FDQWGLIIHUHQFHV RESULTS: Among the 141 patients recruited, median age and parity were 59 and 2.0, respectively. The most common initial diagnoses were mixed urinary incontinence (MUI) (23%), POP (15%), and VD (14%). Patients’ median UDI-6 and IIQ-7 scores were each 10.0. ([SRVXUHWRTXHVWLRQQDLUHVUHVXOWHGLQUH¿QHPHQWRIWKHGLDJQRVLVLQ patients (28%) and treatment plan in 37 patients (26%), which was not VLJQL¿FDQWO\GLIIHUHQW+RZHYHUWKHSK\VLFLDQV¶FRQ¿GHQFHOHYHOLQWKHLU GLDJQRVLVDQGWUHDWPHQWSODQVLJQL¿FDQWO\LPSURYHGIURP“DQG 7.9 ± 1.3 after initial exam to 8.5 ± 1.0 and 8.4 ± 1.0 after questionnaires, respectively (both p<0.001). UDS was completed in 76/141 (54%) of WKHSDWLHQWVDQGUHVXOWHGLQFKDQJHVWRWKH¿QDOGLDJQRVLVLQRI the subjects (41%) and treatment plan in 15 patients (20%). There was an overall increase in diagnosis of SUI and VD, but a decrease in diagnosis of MUI (p<0.05). There was also an overall decrease in treatment with sling surgery and anticholinergic medications (p<0.05). 7KHSK\VLFLDQV¶FRQ¿GHQFHOHYHOIXUWKHULPSURYHGWR“DQG ± 0.8 (p<0.001). CONCLUSIONS: Validated questionnaires improved the FRQ¿GHQFH RI WKH SK\VLFLDQ LQ WKH FOLQLFDO GLDJQRVLV DQG WUHDWPHQW SODQ$GGLWLRQDOH[SRVXUHWR8'6LPSURYHGFRQ¿GHQFHIXUWKHUDQGDOVR

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changed the diagnoses of SUI, MUI, and VD as well as the treatment plan. Source of Funding: Supported by Cleveland Clinic Clinician Investigator Award to Dr. Daneshgari.

1421 VALIDATION OF THE INCONTINENCE SYMPTOM SEVERITY INDEX: A SELF-ASSESSMENT INSTRUMENT FOR VOIDING SYMPTOM SEVERITY IN WOMEN Christian O Twiss*, Jennifer T Anger, Veronica Triaca, Mayank Patel, Ariana Smith, Ja-Hong Kim, Shlomo Raz, Larissa V Rodriguez. Los Angeles, CA. INTRODUCTION AND OBJECTIVE: Most voiding symptom self-assessment instruments assess symptom bother or effect on quality of life. The Incontinence Symptom Severity (ISS) Index is an 8 item instrument for self-assessment of severity of female urinary storage and voiding symptoms rather than symptom bother or effect on quality of life. We assessed the validity of the ISS for female voiding symptom self-assessment. METHODS: Internal consistency was assessed via itemtotal correlations and Cronbach’s alpha. Concurrent validity against the Urogenital Distress Inventory (UDI) was studied in 191 women with incontinence by correlating similar domains of the ISS and UDI-Short Form (UDI-6) plus two additional items from the UDI-Long Form for nocturia (“UDI7”) and urgency (“UDI8”). Concurrent validity against urinary items of the Pelvic Floor Distress Inventory (PFDI) was similarly studied in 74 women with prolapse. Criterion validity of ISS item 1 was studied by comparing mean post-void residuals (PVRs) amongst the 4 possible response levels. Criterion validity of ISS items 5,6,7, and 8 were similarly studied by comparing mean daily pad use amongst the four possible response levels for each. Response to change was assessed by comparing pre- and post-treatment ISS scores. Correlations were DQDO\]HGYLD6SHDUPDQ¶VUKRDQGFRQWLQXRXVGDWDYLDSDLUHGWWHVWRU one-way ANOVA. 5(68/766LJQL¿FDQWLWHPWRWDOFRUUHODWLRQVZHUHVHHQIRU each ISS item (table), and Cronbach’s alpha was 0.69. All ISS items VLJQL¿FDQWO\FRUUHODWHGZLWKVLPLODULWHPVRIWKH8',DQG3)',WDEOH  6LJQL¿FDQWSRVWWUHDWPHQWUHGXFWLRQVZHUHREVHUYHGIRUDOO,66LWHPV (table). Progressively higher PVRs were noted for the 4 response levels RI ,66 LWHP  )   ,WHP  VKRZHG VLJQL¿FDQWO\ LQFUHDVLQJ PHDQ pad use with each response level (F<0.0001). ISS items 5, 6, and  DOVR VKRZHG VLJQL¿FDQWO\ LQFUHDVLQJ WUHQGV LQ PHDQ GDLO\ SDG XVH (F<0.0001, F=0.022, F<0.0001, respectively) amongst the 4 response levels for each. CONCLUSIONS: This study validates the internal consistency, criterion validity, and response to change of the ISS. The ISS Index is suitable for assessing symptom severity and outcomes for treatment of female incontinence and voiding symptoms. †p<0.0001, **p<0.001, *p<0.05 ISS Symptom Item Domain 1 2 3 4 5 6 7 8

Incomplete Emptying Sensation of Urgency Nocturia Daytime Frequency Stress Incontinence Urge Incontinence Leakage with activity Degree of pad use

Correlation Correlation PostItem Total Corresponding Corresponding with UDI with Treatment Correlation UDI Item PFDI Item Item PFDI Item Reduction UDI5

0.70†

19

0.81

0.30†

UDI2 UDI8 UDI7

0.54† 0.53† 0.64†

16 22 21

0.58† 0.72† 0.69†

0.54

†

UDI1

0.50

†

15

0.60

0.61†

UDI3

0.78†

17

0.85†

-2.38†

0.72

†

UDI2 UDI8

0.68† 0.43†

16 22

0.67† 0.49†

-0.82†

0.61†

UDI3

0.55†

17

0.66†

-1.68†

0.60

--

--

--

--

-1.11**

0.39† 0.61†

†

Source of Funding: None

-0.43*

†

-0.88† -0.35† -0.65