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1 Predictive Title page Authors procedure value for of urinary urethra stress mobility incontinence before sub-urethra in women tape Xavier Khalid Alain Fabien Jean-Louis Pigné, Demaria, Zabak, Fritel, MD MD Institution Service Gynécologie Bénifla, MD MD Dr Université Correspondence Xavier Fritel Pierre-et-Marie-Curie, et Obstétrique, Paris, Hôpital France. Rothschild AP HP, Service 33, Telephone: Fax: boulevard Gynécologie , de Picpus, et Obstétrique, Paris cedex Hôpital 12, Rothschild, France. Running-head: Predictive Key-Words: urinary stress value incontinence; of urethra mobility surgical before mesh; urodynamics; sub-urethra tape female. procedure

2 Predictive Abstract Purpose: To value determine of urethra whether mobility preoperative before sub-urethra urethra mobility tape procedure is able to predict suburethra Materials tape procedure and methods: outcome This for women retrospective with urinary study included stress incontinence. 2 complete was anatomically assessed work-up superimposed on lateral with urethrocystograms preoperative and the angle standing taken formed urethrocystography. at by rest the and 2 at proximal strain. 78 Proximal women The urethra two who urethra axes images underwent defined support were a urethra 85% incontinence, Results: mobility. Surgical follow-up outcome was assessed 9 months by (1 37) negative and stress the objective and pad tests. success (66/78). 33 Median with rotation 1 previous of procedure the proximal and urethra 28 with was 67 without prior success surgery rate was mobility rate was 97% (29/30) when urethra mobility exceeded 2 procedures 60 versus (p 86% < ). (18/21) The rate unsuccessful was between 96% (26/27) 30 and without 60, and prior 70% surgery (19/27) for when incontinence was < 30 versus (p = 84% 0.023). (31/37) The when success for 0.026). Age at procedure surgery, had menopausal been performed, status, and mixed 64% incontinence, (9/14) with body 2 surgical mass index, failures parity, (p = 1 avoid overactive value. Conclusions: bladder and The low sub-urethra maximal sling urethral procedure closure takes pressure advantage had no of significant urethra mobility prognostic continence leakage. achieved. The more Risk the factors proximal for failure part of are the poor urethra mobility moves of under the proximal stress, the urethra better and the to previous surgery for incontinence.

3 Introduction Classical Predictive procedures value of urethra for urinary mobility stress before incontinence sub-urethra (retropubic tape procedure suspension or sling) 3 suspend placed suggested independent under the that bladder the the bladder mechanism neck neck to assure of but continence under continence. the middle for The the tape tension-free of the described urethra.i vaginal by Some Ulmsten tape preliminary (TVT) is no is longer Q-tip values of before correction and after of the TVT proximal (mean urethra before hypermobility. versus Klutke after).ii et al. Atherton found similar reports Stanton during following Valsalva used TVT, ultrasound the maneuver difference to was compare did reduced not bladder reach (mean significance neck 2 postoperatively mobility: (mean after 29 colposuspension versus versus ).iii preoperatively); We rotation and postulated hypothesis urethra be would that was rotate the that preoperative continence and descend after state under surgery of bladder stress would while neck be the mobility achieved middle could portion because predict of the the upper urethra outcome. part would of Our move held under place stress, by the sling. cannot In others assure words, continence. if the proximal To confirm part of this the hypothesis, urethra does we not the examined objectively the the objective preoperative outcomes mobility of women of the proximal who underwent urethra urethrocystography under stress. to determine

4 Predictive Materials Among the value and 275 patients Methods of urethra who mobility had a TVT before procedure sub-urethra for urinary tape procedure stress incontinence 4 between urethrocystography. evaluation postoperative January was incomplete 1998 The and X-rays December for 5 were others lost Finally, for 6 our patients, 78 institution, patients 1 died with 90 and underwent complete the postoperative preoperative Urethrocystography the work-up was could systematically be evaluated performed and constituted the first the year study (1998) population. of our experience and urethra TVT The mobility procedure. preoperative evaluated At that assessment by time, physical indications comprised examination. were a self-questionnaire, previous incontinence physical surgery examination, or low with pad 12, the urodynamic preoperative 24 test, and urodynamic 36 study. months evaluation study after the and with TVT urethrocystography. a self-questionnaire, procedure. The postoperative Postoperative pad test, physical assessment visits examination were scheduled was similar and 1, to 6, position drink coughing Physical with the examination trunk at 30 and the urodynamic thighs flexed work-up at 45. were The patients performed were given the 1/2 lithotomy defined 1 hour intrinsic or Valsalva before sphincter the maneuver. test. deficiency The A urinary maximal (ISD). stress urethra Overactive test closure was bladder positive pressure was when (MUCP) defined urine was < 20 involuntary lost cm liter upon H2O to detrusor minute carried Bladder-neck pad out contractions with test described the patient mobility 15 by cm standing Hahn.iv was H2O assessed before erect after 300 by lateral opacification ml during urethrocystography. the of filling the urethra phase. The and We examination the used bladder. the 20- A is

5 first strain X-ray during Predictive is a taken Valsalva value at rest of maneuver. urethra during mobility The a pelvic outlines before muscle of sub-urethra the contraction. urethra tape and A the procedure second bladder X-ray on both is taken X-rays at 5 are urethra, (figure then defined copied, as anatomically the upper half, superimposed is evaluated onto by tracing comparing paper. its The position mobility at rest of the and proximal proximal 1). A line axis. drawn The between angle the formed middle between of the the urethra two axes and the at rest bladder and neck strain defines at defined strain and urethra mobility. We classified urethra mobility into three categories, < 30, the 30 Fisher's 60, and > 60. data. StatView Objective Statistical exact test 4.5 success analyzes for software qualitative was was were defined used data, performed Mann-Whitney negative analysis. using stress bivariate or and Kruskal-Wallis pad non-parametric tests. test for tests, quantitative chi2 or

6 Predictive Results Median age value at surgery of urethra was mobility 56 years before (34 87). sub-urethra Among the tape 78 procedure patients, 51 (65%) had 6 and undergone Preoperative patients, 30 median least and 1 previous proximal unsuccessful urethra mobility procedure was 42 to ( 5 correct to +108). urinary It incontinence was < 30 for (table 21 I). for the the patients' characteristics 60 for 27, are and presented > 60 for in 30. table The II. relationships The number between of previous urethra procedures mobility procedure, incontinence was significantly associated with lower urethra mobility. Median rotation of patients, proximal Median and urethra 28 time with needed was 67 2 to procedures without complete any (p the prior < procedure , surgery Kruskal Wallis was for incontinence, 30 minutes test). (15 140). 33 with For 1 previous 17 repairs, regional injury. 3 another sacrospinofixations, surgical procedure 1 anterior was associated, repair. Anesthesia 4 vaginal was hysterectomies, local for 2, general 14 posterior bladder The perforation urethra 75. Surgical catheter or urethra complication was injury. removed Thirteen included the day (17%) 6 after bladder patients, surgery perforations who except had for (8%) severe patients and voiding 1 with urethra for 1 and difficulties, catheterization). major required Patients an additional were discharged period of a median catheterization of 2 days (suprapubic (0 16) postoperatively. or intermittent (66/78). complication Median objective occurred. follow-up was 9 months (1 37). The objective success rate was No intervention: (123 and Post-void 3822 days patients volume after with the was TVT vaginal > procedure), 100 mesh ml for erosion 18 1 patient (23%) underwent patients. with a bladder resection Six patients stone of the had required exposed lithotripsy further sling 85% (119 days later), 3 patients with persistent voiding dysfunction underwent a stretching of the

7 tape described using Predictive by a Hegar Wang value sound and of Lo.v to urethra push the mobility urethra before downwards sub-urethra (14, 15 tape and procedure 21 days later) as 7 success urethra According rate were previous to univariate surgery analysis, for incontinence factors significantly and preoperative associated mobility with the of objective when it (table exceeded was < III) The (p = versus objective 0.023, 86% chi² success (18/21) test). The rate when success was it 97% was rate between (29/30) reached when 3096% and the 60, (26/27) mobility and with 70% the of no the (19/27) proximal previous procedure, surgical surgery and 64% for failure (9/14) incontinence and with versus 2 surgical 84% failures < (31/37) 30, the (p with = success 0.026, 1 previous rate chi² was test). unsuccessful 68% For (17/25). patients with The (8/10) strong perform versus association The a multivariate success 85% between (58/68) rates analysis. did respectively urethra not differ mobility significantly (p = and 0.65, previous Fisher for MUCP test). surgical < 20 failure or 20 did cm not H2O, allow 80% us to

8 Predictive Discussion Standing urethrocystography value of urethra mobility has been before used sub-urethra for many years tape to procedure evaluate urethra and 8 bladder urethral methods carried out neck angle (Q-tip while mobilities, at test, rest the ultrasound and subject and at strain is is considered lying and has dynamic down, good the inter-observer which magnetic standard gives resonance examination.vi different reproductibility.vi imaging) values Measurement than are The those most others for often a the patient measured value standing with a erect.vii, method viii other It would than standing be informative urethrocystography to know whether would urethra also have mobility urethra for Our TVT data outcome. confirm our hypothesis that preoperative mobility of the upper part a predictive proximal sling can part predict of the the urethra objective moves outcome under stress, of the sub-urethra better continence tape procedure. will be The by placing more of the urethra the under mobility the middle to avoid of leakage urethra. instead We of advance correcting that the it. That TVT is the main difference takes advantage between the population, sub-urethra the more sling and previous the classical operations procedures the patient that had, block the bladder less her neck urethra mobility. moved In under our of strain. reliable had failed low This logistic mobility strong regression (< association 30 ). For impossible. other between patients, Only low urethra 2 we women do mobility not undergoing know and if their previous surgery previous surgery for procedure(s) the first make surgery because had already preoperative been performed. urethra mobility was low or if urethra mobility was low because time whose interventions Urethra mobility failed decreased were older with than increasing those with age successful and menopause outcomes, (table and II). 92% Patients of the

9 former our population were Predictive menopausal, did value not allow of but urethra us this to difference specify mobility the before was impact not sub-urethra significant of age and tape (table estrogen procedure III). deficiency The small in size of 9 factor surgical for Based outcome. TVT on outcome, our findings, because ISD objective (MUCP success < 20 cm rates H2O) with did or not without seem to ISD be a were prognostic (74% versus results, cured 85%, ix-x women and respectively). 12% with improved) low The urethral referent than pressure women Scandinavian (MUCP with normal team < 20 urethral cm had H2O) published pressure had lower their (85% long-term success cured similar rate and (80 11% Hanssen, test improved) there or was without but no the difference low urethral in did postoperative pressure not reach (MUCP significance. satisfaction In and the urinary study by symptoms Kulsengwomen 20 cm H2O), but postoperative between perforation and with stress low test urethral values were pressure higher were for older patients and with more low of them urethral had pressure.xi suffered bladder In that study, pad differences urethral Kulseng-Hanssen's mobility concerning during (or the findings unsuccessful TVT urethra procedure might mobility previous reflect than and the women surgery) previous role of with is low surgery often normal urethra associated were urethral mobility not specified. with pressure, (or low unsuccessful MUCP, Since but poor previous and systematically relationship(s) strain surgery) by assessed among Valsalva rather VLPP, in than leak our ISD. MUCP, point study. Sphincter pressure Further urethra (VLPP). competence investigations mobility Unfortunately and can sub-urethra are be needed estimated VLPP to tape specify at was procedure rest not the by MUCP outcome.

10 mobility. Predictive Female Burch's continence retropubic value of classically urethra procedure mobility relies corrects before on sphincter hypermobility. sub-urethra competence tape The procedure prognosis and bladder-neck therefore 10 depends abdominal the prognosis more on the is sphincter no pressure longer rises. competence, rises, determined With the the more by i.e., sub-urethra the sphincter the urethra ability tape competence. is of bent procedure, the by bladder the The tape, strain neck outcome meaning produces to remain depends that an closed the obstacle: rather when urethra of female the sub-urethra incontinence. mobility, which tape procedure allows its bending no way under puts in exertion. doubt the The classical different physiopathology mechanism of action of

11 Predictive Conclusion Based our value results, of urethra we advance mobility that before the sub-urethra sub-urethra sling tape procedure procedure takes advantage 11 of under value urethra stress, We mobility use the urethrocystogram better to avoid continence urine findings leakage. achieved. to The advise more incontinent the proximal women part of when the urethra the Q-tip moves previous emphasized is low surgical or when failure they is had not previous a formal surgical contraindication failure. A for poorly the sub-urethra mobile urethra tape procedure, after a test transurethral by injection, the 68% should success be rate discussed.xii in this context, but an alternative procedure, like as

12 Predictive Acknowledgments: We are grateful value to of Armelle urethra mobility Eveillard, before Sylvaine sub-urethra Baron and tape Nathalie procedure Fortez for their 12 help editing in entering our English data text. and handling files. We also thank Janet Jacobson for translating and

13 Predictive References value of urethra mobility before sub-urethra tape procedure 13 i correction Klutke Ulmsten procedure Urogynecol J.J., U., under Carlin J, Henriksson 7: local 81, B.I anesthesia and L., Klutke Johnson for C.G.: treatment P. and The Varhos tension-free of female G.: An urinary vaginal ambulatory incontinence. tape procedure: surgical mobility. Urology, of the stress 55: 512, incontinence 2000 with minimal alteration proximal urethral Int iii iv elevation 107: provocative Hahn Atherton 1366, I.: Objective M.J. after 2000 pad and tension-free test. Stanton quantification Neurourol S.L.: vaginal Urodyn, A of comparison tape stress and 10: urinary colposuspension. 475, of 1991 bladder incontinence: neck Br movement a J short Obstet reproducible, Gynaecol, and v cystourethrogram: cystocele Wang Showalter stress urinary A.C. repair P.R., and incontinence Lo Zimmern women. an T.S.: outcome Tension-free P.E., in Urology, women. measure Roehrborn 58: vaginal J after Reprod 33, C.G anti-incontinence tape, Med, and a Lemack minimally 43: 429, G.E.: 1998 procedures invasive Standing solution and to viii cystourethrography Tomogr, proximal Gufler Handa V.L., H., 24; urethral DeGregorio Jensen 382, mobility and J.K. G., dynamic and Allman Obstet Ostergard MRI Gynecol, K.H., in D.R.: Kundt bladder 86: The G. 273, neck effect and 1995 descent. Dohnicht of patient J Comput S.: position Comparison Assist on of ix incontinent Int Rezapour Urogynecol M., women Falconer J, 12 with (suppl C. intrinsic and 2): Ulmsten S12, sphincter 2001 U.: deficiency Tension-free (ISD), vaginal a long tape term (TVT) follow-up. in stress

14 x Nilsson Predictive C.G., value Kuuva of urethra N., Falconer mobility C., before Rezapour sub-urethra M. and tape Ulmsten procedure U.: Long-term results 14 xii Barranger pressure. Kulseng-Hanssen of stress the urinary tension-free Neurourol E., incontinence. Fritel S.: vaginal X., Urodyn, Success Kadoch tape Int 20: rate Urogynecol (TVT) O., 417, of Liou TVT 2001 procedure Y. operation J, and 12 Pigné (suppl for surgical A.: patients 2): Results S5, treatment 2001 with of low transurethral of female injection Urol, 165: of 1619, silicone 2000 micro-implants for female with intrinsic sphincter deficiency. J

15 Predictive Tables I value of urethra mobility before sub-urethra tape procedure 15 Previous procedure(s) Previous unsuccessful Type of continence procedure procedures None One Sling (Goebell Stoeckel, (Burch, Marshall Marchetti Krantz) Bologna) Number Two Anterior Retropubic Anterior microimplants) vaginal vaginal & 2 transurethral repair repair (Kelly & retropubic injection plication) (silicone 4 Three Total Retropubic Needle suspension x 3 & sling 178

16 Predictive Table Preoperative II value characteristics of urethra mobility and proximal before urethra sub-urethra mobility. tape Values procedure are medians [range] 16 Preoperative for qualitative continuous variables variables evaluated assessed with with the the chi² Kruskal Wallis test. Proximal test and urethra percentages mobility (fraction) for characteristic Age surgery, years All 56 (n[34 87] patients = 59 (n < [46 87] = 30 27) 55 (n [34 78] = 54 (n > [34 79] = value p Menopausal Body mass index, kg/m2 74% 25 [17 40] (58/78) 89% 24 [18 37] (24/27) 76% 25 [20 32] (16/21) 60% 25 [17 40] (18/30) Urge Parity Previous urinary incontinence incontinence surgery 65% 79% 2 [0 6] (51/78) (62/78) 93% 85% 2 [0 5] (25/27) (23/27) 62% 71% 2 [0 6] (13/21) (15/21) 43% 80% 2 [0 4] (13/30) (24/30) Overactive MUCP, * Cystometry cm bladder* H2O was missing for 3 patients % (4/75) [5 78] % (2/25) [5 78] % [12 62] (2/21) 37.5 [15-65] (0/29)

17 Preoperative Predictive Table III value risk of factors urethra and mobility objective before result. sub-urethra Values are tape median procedure [range] for 17 continuous qualitative Preoperative variables risk factors evaluated assessed with the Fisher's Mann Whitney Success exact test. test, and percentages (fraction) for Age Menopausal Body surgery, years 71% 55 (n[34 86] (47/66) =66) 92% 64 (n Failure [34 87] = (11/12) 12) p value Parity mass index, kg/m2 24 [17 40] 25 [20 37] Previous Urge urinary incontinence incontinence surgery 77% 61% 2 [0 6] (51/66) (40/66) 92% 2 [0 5] (11/12) * Overactive Proximal MUCP, Cystometry cm urethra bladder* H2O was rotation, missing degree for 3 patients % [0[12 78] (2/64) to 108] % [ 5[5 62] (2/11) to 66]

18 Predictive Legends Figure 1 value of urethra mobility before sub-urethra tape procedure 18 were (black proximal traced line). Measurement from A line lateral drawn of proximal urethrocystograms between urethra the middle mobility: at rest of (gray The urethra outlines line) and of the during the bladder bladder Valsalva neck and defines maneuver urethra mobility (102 urethra axis. this example). The angle formed between the two axes defines proximal urethra the

19 Predictive Figure 1 value of urethra mobility before sub-urethra tape procedure 19

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