59 Ultrasound study of urethral mobility after TVT

58

57 TRANSOBTURATOR APPROACH AND INFRA-COCCIGEAL SACROPEXY FOR CYSTOCELE, RECTOCELE, UTERINE AND VAGINAL VAULT PROLAPSES

PROSPECTIVE MULTICENTRE OBTURATOR SLING FOR 12 M O N T H F U N C T I O N A L DATA

Palma P., Riccetto C., Dambros M., Herrmann V., Fraga R., Thiel M., Netto Jr N.

De Ridder D. 1, Jacquetin B2, Debodinance E 3, Fischer A.4, Marques QueimadelosA.5, Courtieu C.6, Cervigni M.7, Rassler j.8, Rane A.9, Herschom S. 1°, Goetze W. H, Ouellet S. ~2, Schrader M. ~3, Mellier G. J4

University of Campinas, Dept. of Urology, Campinas, Brazil INTRODUCTION & OBJECTIVES: Anterior vaginal wall prolapse is a frequent condition that affects 11% of American women. A new transobturatory approach to treat anterior vaginal wall prolapse is presented. The device set consists of four helical needles and an intepro mesh (polypropylene) with two lateral self-anchoring arms to repair both central and lateral defects. This device also allows for uterine sparing surgery when used along with posterior compartiment meshes. This videotape aims is to show the new trends in reconstructive biosurgery. M A T E R I A L & METHODS: This is a patient with uterine prolapse and grade III cystocele. An inverted U subcervical incision is made. Hydro dissection is performed to facilitate dissection and hemostasia. Blunt and sharp dissection allows for the roll over of the vaginal wall to the bladder neck. The superior needles are inserted parallel to the ischio-pubic branch, and using only the wrist rotation, the needle is guided till the vaginal incision. The arm of the graft is connected to the tip of the needle and pulled the length till the armpit is at the lateral edge of the cystoeele. The same maneuver is repeated on the other sites. Inferior needles are passed 2 cm lateral and 3 cm inferiorly to the superior ones. The mesh should be underneath the cystocele in a tension-free manner and the redundant material is trimmed off. The incisions are closed in the usual manner. The procedure is completed with an inffa-eoceigeal sacropexy using the Apogee system. Apogee kit includes 2 needles and a specially constructed mesh that has two anchoring tails. It is used for the creation of neo-sacrouterine ligament and the posterior vaginal wall, from the sacrouterine ligament to the perineal body. After the posterior wall incision and dissection, the index finger is introduced in the isehio-rectal space just in front of the ischial spines. The mesh is connected to the needles tip and retracted back to skin incisions. The central mesh is fixed to the remanants of the sacrouterine ligaments. The upper vaginal wall is closed in the usual manner. The exceeding lengths of the self-anchoring tails are removed and the skin incisions are closed. RESULTS: Despite the short follow-up, the preliminar results are promising. There was no extrusion, infection or vaginal stennsis. CONCLUSIONS: These devices represent steps forward in the organ sparing management of uterine prolase and complex pelvic floor defects as well.

TRIAL OF STRESS

MONARC TRANSINCONTINENCE:

1UniversityHospitals K U Leuven, Urology, Leuven, Belgium, 2Matcmit6 Hotel Dieu, Gynecology, Clermont Ferrand, France, 3Maternit6 les Bazennes, Gynecology, St Pol sur Mer, France, 4Krankenhaus St. Jozef, Gynecology, Ruedesheim am Rhein, Germany, SHosp. Clin. Universitario, Urology, Santiago de Compostella, Spain, 6Clin. Beau Soleil, Gynecology, Montpellier, France, 7Univ. D. Studi di Pemgi, Gynecology, Rome, Italy, 8St. Elisabeth Krankenhans, Urology, Leipzig, Germany, 9TownsvilleHospital, Urology, Townsville,Australia, l°Sunnybronk & Women's Hospital, Gynecology, Toronto, Canada, ~ Krankenhuans Stransberg, Gynecology, Strausberg, Germany, 12Les Gynecologues Associ~s, Gynecology, Montreal, Canada, ~3Freie Univ. Berlin, Urology, Berlin, Germany, 14Hop.Ed. Herriot, Gynecology, Lyon, France INTRODUCTION & OBJECTIVES: To evaluate the efficacy and morbidity of Monarc transobturator sling as treatment for women with stress incontinence. This abstract is a planned interim report on the functional results at 1 year follow up. MATERIAL & METHODS: The study was designed as a multicentre prospective non-randomized trial, involving 15 European, Canadian, and Australian centres and was approved by local "IRB or Ethical committees. Only women with proven stress incontinence were included. Post implant evaluation was done at 4-6 weeks, 3, 6, 12 and 24 months. The evaluation consisted of registration of number of pads used per day, a lh pad test, cough test, uroflowmetry and measurement of residual volume and dipstick. Both physician and patients scored the post operative continence. In a subset of patients pre-operative and post-operative multichannel urodynamics were compared. Further evaluation was done using UDI-6, IIQ-7 questionnaires. Efficacy is expressed as the percentage of patients reaching continence, defined by padtest, coughtest, and patient/physician assessment. Appropriate statistical analysis was done using t-test and Mc Nemar's test. RESULTS: 148 patients with proven stress incontinence were enrolled from Jan 03 until Feb 04.122 have reached ly follow up and are included in this interim analysis. Patient assessment of continence revealed 83.5% cure rate: 62% completely dry and 21.5 % substantially continent (needing no protection). Some additional protection was needed in 12.4% and 4.1% remained substantially incontinent. Assessment by the physician correlated strongly with these numbers. The post-operative cough test was negative in 89.7%. Pad use on 24h was reduced from 3.5 ±2.2 to 0.6 ±1.3 (p<0.001). Urine loss during a 1 h pad test (n-ll0) was reduced from 112.4 ±83.3 to 9.7 ±29.8 (p<0.001). The UDI-6 showed significant improvement (62.3 ±15.9 to 16.2 ±21.3, p<0.001) as did the IIQ-7 (54.5 ±25.3 to 9.5 ±20, p<0.001). This improvement was stable over tile 12 month period. De novo urgency was seen in 10.6% while 27.6% of patients with pre-operative urge symptoms were relieved of their urgency. Uroflowmetry showed a mean voided volume of 333.8cc ±118.5 with a peak flow rate of 24.9 =10.7ml/sec and a post-void residual of 8.5 ±2hnl.

CONCLUSIONS: 1 year data show that Monarc transobturator sling successfully restores continence in women with SUI. Patient and physician assessed continence rate (completely dry and substantially continent) were 83.5% and 84.4%. UDI-6 and IIQ-7 were significantly improved and showed a stable curve over this 12 month period. Given the I0.6% of patients with de novo urge and the 27.6% of patients who were cured of their pre-operative urge, patients implanted with Monarc are significantly more likely to be cured of urge symptoms than to develop urge symptoms (p<0.01).

59 ULTRASOUND STUDY OF URETHRAL MOBILITY AFTER TVT

6O A NOVEL TRANSOBTURATOR SYSTEM FOR THE REPAIR ANTERIOR VAGINAL WALL PROLAPSE: A PILOT STUDY

OF

Khelaia A.. Pushkar D., Vasilieva M. Rane A., Naidu A., Barry C., Corstianns A. MGMSU, Urology, Moscow, Russia James Cook University, Obstetrics and Gynecology, Townsville, Queensland, Australia INTRODUCTION & OBJECTIVES: TVT (tension - free vaginal tape) is a new minimal jnvasive treatment for female stress urinary incontinence. The aim of our study was to evaluate changes of urethral mobility after TVT procedure and relationship between the mobility of urethra and quality of life (QoL). M A T E R I A L & METHODS: The prospective study included 52 patients, who underwent TVT between 1999 and 2002. Patients were divided into 3 groups. Group I involved 26 patients, with total subjective cure; group II - 12 patients suffered from voiding dysfunction, such as poor stream, stop-start voiding, need to strain and incomplete emptying (residual urine over 100 ml). Uroflowmetry showed obstructive urination in this group. Group III involved 14 patients with recurrence of stress incontinence. In each patient was performed introital ultrasound examination with a vaginal ultrasound probe 7.5 MHz. The mean volume of the bladder was 150 ml and was assessed by abdominal ultrasound examination. The following parameters were established: angle ct is the angle between the line, connecting the vertical axis of symphysis with the line of urethra and bladder neck; angle 13- posterior vesico-urethral angle between proximal urethra and bladder bottom. Measurement of ultrasound parameter was performed in rest and during Valsalva maneuver. These parameters in each patient had been compared with level of quality of life (QoL), assessing by original multidimensional questionnaire of QoL - MGMSU score (validated, test-retest coefficient - 0.93). Our original questionnaire consists of five domains (incontinence, voiding dysfunction, sexual function, social status, satisfaction), with score range from 0 tol 1 (higher levels mean lower QoL). All data were analyzed statistically using Students criteria. For all analyses p<0.01 was considered statistical significance. RESULTS: The mean value of angle a in group I in rest 20 - 28 °, during Valsalva maneuver - 35 - 38 °, angle {3 - 121 - 127 °in rest, and 130 - 137 °during Valsalva maneuver. Statistically no differences were observed in the same parameters in group III. In group II the mean value of angle c~in rest was 15 - 18 °, during Valsalva maneuver difference was only 5°or less (p<0.01)! Angle 13 -75 - 85°in rest and 105 - 110°during Valsalva maneuver. According to our original multidimensional questionnaire mean score in the group I was 0.9, in the group II - 5.4 and 5.6 in group IlL Same results between groups we found according SF - 36 (p<0.01). CONCLUSIONS: Uretlrral hypomobility is the reason for voiding dysfunctions. The questiormaireswith voiding problems were as dissatisfied with the results of surgery, as patients with recurrence of stress incontinence.

INTRODUCTION & OBJECTIVES: Recurrence of anterior wall prolapse is high following anterior colporrhaphy, ranging from 0%-29%. In an attempt to reduce recurrence, we would like to describe the outcomes of a novel transobturator total anterior wall prolapse repair system. M A T E R I A L & METHODS: Eleven patients with large cystoceles underwent the transobturator (TO) procedure (Perigee, American Medical Systems, Inc., Minnetonka, MN, U.S.A.) with follow-up at 6 weeks, 3, 6, 9 and 12 months. Urodynamics were performed at baseline (199 +/- 169 days) and post-op (72 +/- 18 days). Institutional Ethics Committee approval was obtained. A midline incision was made, and dissection followed superiorly to the vaginal vault and laterally to each inferior pubic ramus. Four helical needles were passed from outside to in, through the obturator foramen and levator ani muscles: two at tile level of the vaginal vault, two at the level of the bladder neck. A large-pore polypropylene mesh with four, self-fixating appendages covered in plastic sheaths restored the support to the eystocele. Concomitant repairs were performed following Perigee. Monarc was implanted via the same TO skin incision, but Perigee plastic appendage sheaths remained until the Monarc was fully positioned. RESULTS; Cystocele defects included lateral (7), central (2), both (1), and unknown (1). 5 (45%) had prior anterior repairs. Perigee operative time averaged 18.4 minutes (11-26 rain); total O.R. time averaged 45.3 minutes (31-80 rain). Nine had concomitant procedures and cystoscopy, including Monarc(4), SPARC(1), urethral dilation(l). No perioperative urethral or bladder perforations, bowel, vessel or nerve injuries were noted. One small bladder tear (< 0.5 cm) occurred during dissection and was repaired with 2-0 vicryl. At 6 weeks: UTI(1) and temporary pain down both legs for five days(l); at 3 months sore left hip(l); at 6 months constipation with bowel strain requiring digital support(l), poorer stream(l), and late menses coital pain(l). Clinically significant improvement (p _< 0.05) occurred with respect to max cystometric capacity volume (mI) difference (n 11) and Pdet (cmH20) difference of first desire bladder sensation (n=6). Pressure flow difference of final void volume (n=8) resulted in a p _< 0.072. There was no statistical difference, with respect to urodynamics, for patients who received a concomitant suburethral sling (n=5). POP-Q prolapse: pre-op stage III/IV (10); at 6-months, stage 0 (11). For POP-Q Aa and Ba, all follow-up visits showed statistical clinical improvement (p < 0.001) and no statistical difference between the 6-week, 3-month, or 6-month visit results. CONCLUSIONS: This pilot study has demonstrated that a TO repair system provides a safe and effective means of restoring anterior vaginal wall support.

European Urology Supplements 4 (2005) No. 3, pp. 17