Urethral hypermobility after anti-incontinence surgery a prognostic indicator?

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1 Int Urogynecol J (2006) 17: DOI /s ORIGINAL ARTICLE Volker Viereck. Hans-Ulrich Pauer. Oda Hesse. Werner Bader. Ralf Tunn. Rainer Lange. Reinhard Hilgers. Günter Emons Urethral hypermobility after anti-incontinence surgery a prognostic indicator? Received: 31 July 2005 / Accepted: 20 January 2006 / Published online: 15 March 2006 # International Urogynecology Journal 2006 Abstract The aim of this study was to define the concept of hypermobility of the bladder neck and determine its effects on the cure rate and postoperative complications in patients undergoing colposuspension. In a retrospective study, 310 patients who underwent primary colposuspension for urodynamically proven genuine stress urinary incontinence were assessed by introital ultrasound before surgery and during for up to 48 months postoperatively. A total of 152 women completed 48 months of. Mobility of the bladder neck during straining was described as linear dorsocaudal movement (LDM) with LDM >15 mm being defined as hypermobility. The overall objective cure rate was 90.0% at 6-month vs 76.8% at 48-month (Kaplan Meier estimators). Urge symptoms occurred in 12.6% (39/310) of the V. Viereck. H.-U. Pauer. O. Hesse. G. Emons Department of Gynecology and Obstetrics, Georg August University Goettingen, Goettingen, Germany W. Bader Department of Gynecology and Obstetrics, University Witten/Herdecke, Witten, Germany R. Tunn German Pelvic Floor Center, St. Hedwig Hospitals, Berlin, Germany R. Lange Office and German Red Cross Hospital, Alzey, Germany R. Hilgers Department of Medical Statistics, Georg August University Goettingen, Goettingen, Germany V. Viereck (*) Department of Obstetrics and Gynecology, Cantonal Hospital Frauenfeld, 8501 Frauenfeld, Switzerland volker.viereck@stgag.ch Tel.: Fax: women and de novo urge incontinence in 2.3% (7/310). Bladder neck hypermobility was significantly reduced after anti-incontinence surgery, from 67.1% (208/310) before surgery to 5.5% (17/310) immediately after surgery (P<0.0001). Postoperative hypermobility was associated with a higher recurrence rate. In the hypermobility group, 52.9 and 34.0% of the patients were continent for up to 6 and 48 months, respectively, as opposed to 92.2 and 79.2% in the group without hypermobility (P<0.0001). Women with postoperative hypermobility had a 3.2-fold higher risk of recurrence within 48 months. Bladder neck hypermobility after surgery was also associated with postoperative voiding difficulty (P=0.0278). Patients in whom hypermobility of the bladder neck diagnosed before surgery persists after colposuspension have a higher risk of recurrence and are more likely to develop postoperative complications than those without this hypermobility. Keywords Colposuspension. Bladder neck. Hypermobility. Introital ultrasound. Stress urinary incontinence Introduction As early as 1960, Enhorning postulated that stress urinary incontinence is due to the displacement of the bladder outlet from the zone of abdominopelvic pressure transmission [1, 2]. In Anglo-American countries, the Q-tip test continues to be widely used to diagnose inadequate anchorage of the urethra under increased intra-abdominal pressure [3 5]. Ultrasonography (introital, perineal, or endovaginal) is a noninvasive modality that is easy to perform and at the same time provides not only information on mobility but also morphologic data on the bladder neck and proximal urethra [6 16]. However, a generally accepted definition of abnormal bladder neck mobility, referred to as urethral hypermobility, does not exist [12 14]. Investigations of bladder neck mobility demonstrate wide variation in healthy nulliparous women. Some

2 587 investigators reported bladder neck mobility to range from 5.1 to 5.9 mm in healthy women [6, 8, 10], while others identified much higher values of 15 and 17.3 mm [9, 11]. These discrepancies are attributable to methodological differences between the studies, such as patient position, bladder filling, or measurement with the Valsalva maneuver, as well as to the use of different definitions of mobility and hypermobility of the bladder neck [13]. The aim of the Burch colposuspension is to reposition the bladder neck in the abdominopelvic pressure zone to improve pressure transmission to the bladder neck and proximal urethra [1]. The effects of bladder neck elevation on bladder neck mobility can be evaluated by ultrasound [6, 14 20]. The colposuspension procedure yields cure rates of 50 80% after 4 to 20 years [15, 20 24]. Despite several decades of experience with colposuspension, however, only individual studies have so far addressed the question as to how preoperative or persistent postoperative hypermobility of the bladder neck may affect the outcome of surgery [7, 17, 20, 25, 26]. In the study presented here, we provide a sonomorphologic definition for the concept of urethral hypermobility and investigate how bladder neck mobility is affected by colposuspension. Moreover, possible associations between pre- and postoperative bladder neck mobility and hypermobility and the outcome of surgery in terms of cure rates and complications are presented. This investigation was performed in the framework of a large retrospective study aimed at assessing the relationship between bladder neck position and surgical outcome including postoperative morbidity [15]. converting the Q-tip angle of 30 into LDM in millimeters. This yields an LDM of 0.52 mm per millimeter of urethral length, resulting in an LDM of 14.6 mm for a minimum urethral length of 28 mm (Fig. 1). In addition, bladder neck descent (BND) was defined as a one-dimensional, purely vertical distance according to Dietz [20, 30]. The outcome of the operation was objectively assessed by supine and standing coughing tests, clinical examination, and ultrasound (introitus and residual urine) 5 to 14 days after surgery (following removal of the catheter) and at after 6, 12, 24, 36, and 48 months. Voiding dysfunction was defined as symptoms of stranguria and a postmicturition residual volume >50 ml at discharge (median 40 ml, range 0 220). Urodynamic testing was repeated 6 months postoperatively or in case of recurrence [15]. Because all study patients underwent routine investigations and introital ultrasound was used for quality assurance purposes, the study was exempted from ethics committee approval by the Institutional Review Board of the University of Goettingen, Germany. All introital ultrasound examinations were done using a Siemens Sonoline Adara (Siemens AG, Erlangen, Germany) ultrasound machine. Introital ultrasound was performed with the vaginal probe (6 MHz) placed on the introitus just underneath the external urethral orifice without exerting pressure on the probe and in such a way that good views of the bladder, bladder neck, and urethra were obtained. The technique has been described in detail earlier [6, 14 16, 19]. All ultrasound measurements were Patients and methods A total of 310 women with genuine stress urinary incontinence (GSI) were operated on using primary open colposuspension [27] from September 1992 to December Modifications of the surgical technique used in this study primarily concern the exposure of the paraurethral tissue and anterior bladder wall, lateral tangential placement of nonabsorbable sutures (Ethibond no. 1 sutures), and the loose approximation of the vaginal fascia to Cooper s ligament. Before surgery, all patients underwent urodynamic testing and introital ultrasound in addition to comprehensive history and clinical examinations, as described earlier in full detail by Skala et al. [28]. Methods, definitions, and units conform to the standards recommended by the International Continence Society and the German Urogynecology Working Group, except where noted [14, 18, 29]. The presence and extent of bladder neck displacement during straining (Fig. 1) was determined by vector equation as the linear distance between the resting and straining position of the bladder neck [linear dorsocaudal movement (LDM) with straining]. Hypermobility was defined as sonographically determined movement >15 mm during straining. The cut-off value of 15 mm for the presence of hypermobility was obtained by Fig. 1 Schematic drawing of the bladder neck position at rest (solid line) and during straining (broken line) with representation of the parameters height H and distance D. Bladder neck descent (BND) refers to the one-dimensional, vertical difference between resting H and straining H (ΔH). The arrow symbolizes the two-dimensional, linear dorsocaudal movement (LDM) of the bladder neck that occurs during straining. Using the urethral rotation angle γ, bladder neck mobility during straining was converted from the so-called Q-tip angle (>30 ) into LDM (>15 mm) (B, bladder; S, symphysis pubis; L, horizontal line drawn through the inferior border of the symphysis pubis; γ, rotation angle; LDM, linear dorsocaudal movement during straining; l, length of urethra)

3 588 performed at rest and during the Valsalva maneuver with a bladder filling volume of about ml. The postoperative course was compared between patients with (n=208) and without (n=102) preoperatively diagnosed hypermobility of the bladder neck. The incidence of persistent hypermobility and the effect of postoperative hypermobility on the outcome of surgery were analyzed. Recurrent incontinence and voiding difficulties, as well as urgency and de novo urge incontinence, were recorded. The operations were performed by experienced urogynecologists. Ultrasonography was performed by four examiners in three hospitals [university hospitals in Marburg/Goettingen (n=92) and Witten (n=46) and German Red Cross Hospital in Alzey (n=171)]. All ultrasound scans were evaluated by the same reader. Intrarater variability was determined in earlier studies and was ±3 mm [15, 16]. Statistical analysis was performed using STATISTICA, version , English, and StatXact 5 at the Department of Medical Statistics of the University of Goettingen. Descriptive statistics were calculated for demographic and anamnestic patient data. Dichotomous data were assessed by means of McNemar s test. Treatment outcomes were classified as cure, improvement, or failure, using a combination of subjective and objective outcome measures [15, 16, 28]. Cure of incontinence was defined as a dry, symptom-free patient without objective urine loss during vigorous coughing (supine or standing) and other provocative activities, such as star jumping, at a standard bladder filling of 300 ml, and a demonstrable positive urethral closure pressure during stress provocation in the absence of detrusor instability. Additional criteria were no episodes of stress or urge incontinence in the 24-h voiding diary and no postvoid residual urine. Finally, the definition of cure comprised an assessment of subjective continence by means of a self-completed, detailed, urinary incontinence questionnaire [31] and the patient s history. Improvement was defined as a decrease by more than one grade of the severity of incontinence distinguished by urodynamics (urethral cough profile) and clinical stress tests, a postoperative decrease of at least 50% in the total number of incontinence episodes in the micturition protocol, and the patient considering herself improved and stating that she would undergo surgery again. Failure was defined as unchanged or worsened incontinence symptoms in urodynamics, a postoperative reduction of less than 50% in the total number of incontinence episodes, and the patient considering the operation a failure. In case of discrepancy between the objective data and the patient s subjective assessment, the latter was used as the final arbiter. The recurrence-free interval was defined as the period until incontinence occurred or recurred. Patients not becoming continent after surgery were assigned 0 for the time of recurrence. Objective cure rates at the different times were calculated using Kaplan Meier (KM) estimators for the time of recurrence and correlated with the presence of postoperative bladder neck hypermobility. Patients with and without postoperative hypermobility were compared using the Gehan Wilcoxon test for the KM estimators and exact permutation tests using the Pearson statistic for dichotomous data. Estimates of risks are complemented by exact 95% symmetric confidence intervals (CIs) denoted by 95%CI calculated using a macro under Statistical Analysis Software 9.1. Statistical significance was assumed at a P value<0.05. Results The 310 study patients with GSI had a median age at the time of surgery of 55 years (range years). Median height was 165 cm ( cm) and median weight was 70 kg ( kg), resulting in a body mass index (BMI) of 26.1 ( ). Median parity was 2 (0 8). The median Fig. 2 Recurrence-free interval (Kaplan Meier estimators) in patients with postoperative hypermobility (n=17, broken line) vs those without hypermobility (n=293, dotted line) compared to total study population (n=310, solid line) Proportion of cases Success rate after colposuspension by postoperative hypermobility no hypermobility postop, hypermobility postop, total (p< Gehan) Time [months]

4 589 length of was 36 months (6 48 months) with an average of 35.1 months. A total of 152 study patients (49%) have so far been followed up within a period of 48 months. The objective cure rate in the total study population (solid line in Fig. 2) in the early phase after colposuspension was 94.5% [293/310; 95%CI (91.4, 96.8)]. An improvement in symptoms of GSI was seen in 3.9% [12/310; 95%CI (2.0, 6.7)] of the cases. Surgery failed in 1.6% [5/310; 95%CI (0.5, 3.7)] of the cases. The cure rate at 6-month was 90.0% [95%CI (86.1, 93.1)], and at 48-month, 76.8% of the patients were cured. Comparison of the patient data according to the surgeons performing the operations and the centers participating in the study yielded no significant differences. Age and BMI could also be ruled out as possible confounders. Voiding difficulties were transient and observed in 3.5% [11/310; 95%CI (1.8, 6.3)] of cases at 6-month. Only two patients had voiding difficulties persisting after 12 months but these had disappeared after 2 years. The incidence of urgency was 3.5% [11/310; 95%CI (1.8, 6.3)] at 6-month, as opposed to 1.7% [5/294; 95%CI (0.6, 3.9)] at 12-month. Of the patients, 1.6% [5/310; 95%CI (0.5, 3.7)] were suffering from symptoms of de novo urge incontinence at 6 months and 1.0% [3/294; 95%CI (0.2, 3.0)] were suffering 1 year postoperatively. No further occurrences of urgency or de novo urge incontinence were observed after 24 months. Comparison of the patient data by the study center did not reveal any significant differences. No differences in preoperative height H (H rest and H straining ) were found when patients were graded into incontinence severity according to Ingelmann Sundberg (data not shown). The median values of BND and LDM during straining determined preoperatively and at yearly are presented in Table 1. Immediately after surgery, 17 patients had an LDM >15 mm, with only a subset of 9 of these 17 patients also showing a BND >15 mm. After colposuspension, ventrocranial displacement of the bladder neck was present in all women and persisted with straining. BND below the symphyseal line during straining was observed in 184 patients [59.4%; 95% CI (53.7, 64.9)] before surgery, resulting in a negative median height H preoperatively. At 12-month, 13 women [4.4%; 95%CI (2.4, 7.4)] had a negative height H, with a corresponding change in median height H at each visit. The modified Burch colposuspension procedure significantly reduced median BND and LDM of the bladder neck with straining, resulting in significantly fewer patients with bladder neck hypermobility during each interval. Anti-incontinence surgery resulted in a significant decrease in hypermobility (defined as LDM >15 mm) from 67.1% [208/310; 95%CI (61.6, 72.3)] before surgery to 4.8% [15/310; 95%CI (2.7, 7.9)] at 6-month (P<0.0001). The results at yearly s are presented in Table 1. Figure 2 presents KM curves depicting the medium-term efficacy of the colposuspension procedure based on the recurrence-free interval in patients with postoperative hypermobility (n=17) vs those without hypermobility (n=293). Patients with postoperative hypermobility (LDM>15 mm) showed a significantly higher rate of recurrence {up to 6-month : 47.1% [95%CI (23.0, 72.2)] vs 7.8% [95%CI (5.0, 11.5)]; Gehan-Wilcoxon test P<0.0001}. Up to the 48-month, the KM estimators were 66.0 vs 20.8%. The risk of recurrence within 48 months was 3.2 [95% CI (2.1, 4.8)] times higher in women with postoperative hypermobility, as compared with a 2.8-fold increased risk [95% CI (1.9, 4.1)] in women with an LDM >10 mm. Risk estimates based on bladder neck mobility defined by means of BND yielded 3.2 and 2.3 times higher risks [95% CI (1.8, 5.1) and (1.3, 3.5)] of recurrence for women with BND >15 mm and >10 mm, respectively. Table 2 presents the relationships between postoperative urethral hypermobility and symptoms of voiding dysfunction, urgency, and de novo urge incontinence within the observation period. Comparison of the patient data with regard to the presence or absence of preoperative hypermobility (BND and LDM) did not reveal any significant differences (data not shown). Postoperative hypermobility was associated with a higher rate of voiding dysfunction. In the hypermobility group, 52.9% [9/17; 95%CI (27.8, 77.0)] of the patients Table 1 Ultrasound parameters measured by introital ultrasound at rest and during straining before, immediately after surgery, and at 6- to 48-month Preoperative Immediately postoperative 6-month 12-month 24-month 36-month 48-month n BND (mm) 15 ( 10; 48) 4 ( 5; 26)*** 4 ( 6; 30)*** 4 ( 3; 26)*** 4 ( 7; 15)*** 4 ( 7; 20)*** 4 ( 15; 18)*** Sign test Hypermobility, 153 (49.4) 9 (2.9)*** 9 (2.9)*** 7 (2.4)*** 0 (0.0)*** 1 (0.5)*** 1 (0.7)*** McNemar BND n (%) LDM (mm) 18 (2; 49) 6 (1; 27)*** 6 (0; 33)*** 6 (0; 28)*** 6 (1; 19)*** 6 (1; 21)*** 6 (2; 22)*** Sign test Hypermobility, LDM n (%) 208 (67.1) 17 (5.5)*** 15(4.8)*** 18 (6.2)*** 7 (2.7)*** 2 (1.0)*** 3 (2.0)*** McNemar Data are median (range) in millimeters or n (%) BND bladder neck descent, LDM linear dorsocaudal movement *P<0.05; **P<0.01; ***P<0.001 Test

5 590 Table 2 Relationship between the presence or absence of postoperative urethral hypermobility (LDM) and complications after colposuspension Parameter complained of voiding dysfunction as opposed to 27.0% [79/293; 95%CI (22.0, 32.4)] in the group without hypermobility (Table 2). Comparison of the patient data in terms of voiding dysfunction yielded significant differences between women with and without postoperative hypermobility of the bladder neck (Pearson exact test P=0.0278). There was no significant difference between the two groups in terms of complications such as newly occurring urgency or de novo urge incontinence. Urge symptoms and de novo urge incontinence were diagnosed in the study in 23.5% [95%CI (6.8, 49.9)] and 5.9% [95%CI (0.1, 28.7)], respectively, of the patients with postoperative hypermobility, as compared with only 11.9% [95%CI (8.5, 16.2)] and 2.0% [95%CI (0.7, 4.4)], respectively, in the group without hypermobility (Table 2). Postoperative hypermobility may also increase the risk of urgency or de novo urge incontinence, but the difference was found not to be significant due to the rather small sample of women with postoperative hypermobility (Pearson exact test P= and , urgency and de novo urge incontinence, respectively; Table 2). Discussion Hypermobility n=17 No hypermobility n=293 Voiding 9 (52.9) 79 (27.0) difficulty Urgency 4 (23.5) 35 (11.9) De novo urge incontinence 1 (5.9) 6 (2.0) Data are number (%) of patients Pearson exact test Introital and perineal ultrasonography are noninvasive and easy-to-perform diagnostic tests that allow excellent evaluation of the bladder neck and its mobility [6, 9, 14 16, 18 20]. There appears to be an association between pronounced mobility of the bladder neck region and the presence of stress urinary incontinence [12, 14, 30, 32, 33]. Studies have shown that bladder neck mobility, or hypermobility, is a good predictor of stress urinary incontinence [30, 34]. In our study population we determined a median preoperative BND of 15 mm (range of 10 48) and a median LDM of 18 mm (range of 2 49). These results suggest a fairly wide range of motion of the bladder neck. The incidence of preoperative hypermobility (defined as LDM >15 mm) was as high as 67.1%. The diagnosis of preoperative hypermobility did not affect the outcome of surgery in our study. Colposuspension was found to significantly reduce both bladder neck mobility (BND and LDM) and hypermobility P at all postoperative examinations. Patients with postoperative urethral hypermobility had a markedly shorter recurrence-free interval (up to 6-month : 47.1 vs 7.8%, up to 48-month : 66.0 vs 20.8%). The risk of recurrence within the 48-month period was 3.2 times higher in women with postoperative hypermobility. Other studies reported in the literature likewise found a reduced bladder neck mobility following the Burch colposuspension [7, 26, 35]. Dietz et al., for instance, diagnosed hypermobility (here defined as vertical BND 15 mm) in 12% of patients, 6 years after surgery [20]. Only few investigators have so far studied the relationship between bladder neck mobility and cure rate [20]. Kil et al. found a lower mean BND of 5.2±4.4 mm in continent women vs 8.4±2.6 mm in incontinent women [17]. In the study by Dietz et al., BND was 9.0±5.0 mm in continent women 6 years postoperatively, and was thus significantly lower than in incontinent patients with a mean of 12.0±6.0 mm [20]. An important factor contributing to the discrepancies in BND found in different studies is the fact that measurements are not performed under standardized conditions (bladder filling, patient position, Valsalva maneuver, time of examination). Nevertheless, the results suggest that colposuspension should be performed with the aim of reducing urethral mobility by elevating the bladder neck [26, 36]. Restricting the mobility of the bladder neck region seems to be the only mechanism that results in an adequate improvement of abdominal pressure transmission to the proximal urethra [26]. Urethral hypermobility after the Burch colposuspension procedure appears to increase the risk of therapeutic failure. A review of the studies reported in the literature shows that most investigators measured vertical movement of the urethra during straining (BND) to assess bladder neck mobility [13, 17, 20, 30]. In contrast, the definition of bladder neck mobility and hypermobility (using LDM), as proposed here, additionally takes into account the dorsal movement component that occurs during straining. This parameter therefore comprises both the vertical and horizontal planes of movement, and thus reflects the true movement of the bladder neck during straining. Using the LDM parameter, we found nearly twice as many patients with postoperative bladder neck hypermobility (eight more than with the BND parameter). The colposuspension procedure has cure rates of 50 80% after 4 to 20 years [20 24]. Among the postoperative complications that have been described are voiding difficulties (3 32%) and urge symptoms or de novo urge incontinence (4 41%) [20 24]. The cure rates and complication rates in our study correspond to those reported in the literature. In our study population, disturbed voiding was present in 26.8% of patients immediately after the intervention and in 3.5% at the 6-month. According to Bombieri, voiding difficulty in the postoperative phase is of multifactorial origin including demographic factors (patient age), clinical effects (detrusor contractility, urethral rigid-

6 591 ity), and operative technique (height of elevation and urethral compression) [36, 37]. The height of elevation seems to be the most crucial determinant of the occurrence of postoperative complications. It is well established that excessive correction is typically associated with disturbed bladder voiding and residual urine, as well as a higher incidence of urge symptoms [15, 16, 36, 38, 39]. Because possible confounders like age, BMI, and the surgeon performing the operation were ruled out, our findings show that postoperative hypermobility is associated with a significantly higher incidence of voiding difficulties. Urge symptoms and de novo urge incontinence are likewise more common in patients with postoperative hypermobility. Unfortunately, only little data are available in the literature to confirm this association. Further prospective studies are therefore needed to definitely prove that patients with postoperative urethral hypermobility are at a higher risk of developing these kinds of complications. Conclusions and outlook The colposuspension procedure significantly reduces the mobility and hypermobility of the bladder neck, which appears to be crucial for the surgical success, as suggested by the observation that women with postoperative hypermobility had significantly higher recurrence rates with a 3.2-fold higher risk. Moreover, hypermobility was associated with a significantly higher incidence of postoperative voiding difficulty and a higher incidence of urge symptoms and de novo urge incontinence. Introital ultrasound is a suitable diagnostic modality to evaluate bladder neck mobility. The results of the study presented here show that the vector-based dorsocaudal movement (LDM) is a suitable parameter that adequately describes the true movement of the bladder neck. 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