- Email: [email protected]
Is Proximal Urethral Mobility Important for Transobturator Tape Procedure in Management of Female Patients with Stress Urinary Incontinence?
Adult Urology Is Proximal Urethral Mobility Important for Transobturator Tape Procedure in Management of Female Patients with Stress Urinary Incontinence? Jae-Seung Paick, Min Cheol Cho, Seung-June Oh, Soo Woong Kim, and Ja Hyeon Ku OBJECTIVES
METHODS
RESULTS
CONCLUSIONS
To assess the change in urethral mobility (UM) after the transobturator tape (TOT) procedure and to evaluate the effect of UM on the outcome of the TOT procedure in women with stress urinary incontinence. A total of 159 women 33 to 77 years old (mean 55.3) was included in this study. UM was quantified using the Q-tip angle. Patients were stratified into the urethral hypermobility (UH) group (Q-tip test angle 30° or greater, n ⫽ 96) and the non-UH group (Q-tip test angle less than 30°, n ⫽ 63). The mean follow-up time was 6.5 ⫾ 0.4 months. In the UH group, the Q-tip test values decreased significantly compared with the baseline data (41.2° ⫾ 1.1° versus 31.0° ⫾ 1.4°, P ⬍0.001). No difference was evident in the non-UH group (17.0° ⫾ 0.9° versus 17.0° ⫾ 1.1°, P ⫽ 965). The overall cure rate was not significantly different in either group (91.7% versus 84.1%, P ⫽ 0.142). After the TOT procedure, 66 had a Q-tip test result of 30° or greater. The overall cure rate was not significantly different in the postoperative UH and non-UH groups (92.4% versus 86.0%, P ⫽ 0.209). The results of our study have shown that UM decreases after the TOT procedure in the UH group but not in the non-UH group. The cure rate was not lower in the non-UH group compared with that in the UH group. Our findings suggest that the lack of UM should not be considered a factor indicating a high risk of failure after the TOT procedure. UROLOGY 70: 246 –251, 2007. © 2007 Elsevier Inc.
S
tress urinary incontinence (SUI) is a devastating condition that affects 15% to 35% of women in the general population.1 Of the anatomic abnormalities present in incontinent women, urethral hypermobility (UH) is the main factor. In 1996, a new surgical technique called the tension-free vaginal tape (TVT) procedure was proposed for SUI.2 Using the integral theory,3 the aim of this technique was to reinforce the pubourethral ligaments and the suburethral vaginal hammock, as well as the connections of the latter to the pubococcygeus muscles. Subsequently, the attractiveness to patients of such minimally invasive techniques has resulted in several modified versions of the TVT procedure, including the suprapubic arc and the transobturator tape (TOT) procedures.4,5 These procedures aim to restore urethral support by synthetic sling placement at the level of the mid-urethra. From the Department of Urology, Seoul National University College of Medicine, Seoul, South Korea; Department of Urology, Seoul Veterans Hospital, Seoul, South Korea Reprint requests: Ja Hyeon Ku, M.D., Department of Urology, Seoul National University Hospital, 28, Yongon Dong, Jongno Ku, Seoul 110-744 South Korea. E-mail: [email protected] Submitted: October 17, 2006; accepted (with revisions): March 12, 2007
246
© 2007 Elsevier Inc. All Rights Reserved
Theoretically, the prognosis of the mid-urethral sling is no longer determined by sphincteric competence but rather by urethral mobility (UM), which allows it to bend during exertion because the procedure is no longer placed under the bladder neck but under the middle of the urethra. Thus, one would expect that proximal UM is relatively more important than sphincteric impairment for the success of mid-urethral sling procedures. However, the relationship between proximal UM and the midurethral sling procedures was not systemically assessed in previous studies. The aim of the present study was to assess the change in proximal UM after the TOT procedure and to evaluate the effect of UM on the outcome of the TOT procedure in women with SUI.
MATERIAL AND METHODS From May 2004 to December 2005, female patients with urodynamically proven SUI were evaluated according to our protocol. This protocol included history and physical examination, urinalysis, urine culture, uroflowmetry, postvoid residual (PVR) urine measurement, a 1-hour pad test, Q-tip test, and multichannel video urodynamic studies (MMS UD-2000, Medical Measurement System, Ennschede, The Netherlands) with max0090-4295/07/$32.00 doi:10.1016/j.urology.2007.03.081
imal urethral closure pressure and Valsalva leak point pressure measurements. The internal review board of the Seoul National University Hospital approved this study. The study inclusion criteria included female sex, SUI, and age older than 18 years. The study exclusion criteria included the presence of any urinary tract infection, malignancy, pregnancy, and severe grade urogenital prolapse (grade III and IV). A total of 159 women, 33 to 77 years old (mean 55.3), with SUI was included in the study. Of the 159 women, 65 (40.9%) and 39 (24.5%) reported additional urgency and urge incontinence, respectively. Urgency was defined as the complaints of a sudden compelling desire to pass urine that was difficult to defer and urge incontinence was defined as the complaint of involuntary leakage accompanied, or immediately preceded, by urgency.6 Before the performance of objective testing, the patients were interviewed. On the basis of these interviews, the severity of urinary incontinence was classified according to the IngelmanSundberg scale,7 as follows: grade 1, urinary incontinence occurs when coughing or sneezing; grade 2, urinary incontinence occurs when running or picking up objects from the floor; and grade 3, urinary incontinence occurs when walking or climbing stairs. The degree of cystocele was assessed according to Juma et al.8 During the physical examination, each patient underwent an estimation of the urethral angle while at rest and while coughing, measured using the Q-tip test and a protractor. The Q-tip test was performed in a standardized manner and was performed with the patient in the supine position and an empty bladder. After cleansing the external urethral meatus, a sterile lubricated Q-tip was introduced in the urethra and withdrawn until resistance was met at the level of the urethrovesical junction. The angle of the Q-tip to the horizontal was measured in degrees and designated as the resting angle. With retraction of redundant labia to allow free movement of the swab, the angle of the Q-tip to the horizontal was again measured with the patient performing a maximal Valsalva maneuver (or cough if the Valsalva effort was inadequate). This angle was designated as the maximal straining angle. Both Q-tip angle measurements were taken using a standard goniometer placed against the patient’s perineum. The maximal urethral angle was recorded. UH was defined as a maximal straining angle of 30° or greater.9 The 1-hour pad test was performed as recommended by the International Continence Society. A fluid load of 500 mL was administered and followed 1 hour later by six separate exercises. Each pad was weighed before and after use to provide information about the severity of the incontinence. The tests were performed in the urologic laboratory by a specially trained nurse. Uroflowmetry was performed in the sitting position. Flows with voided volumes of at least 125 mL and without possible artifacts, including straining or using a Valsalva maneuver to urinate, which were determined on the basis of the first flow curve or the volume voided at the first few seconds, were included in our collected data. The PVR measurements were taken using a bladder scan (BVI-3000, Diagnostic Ultrasound, Redmond, Wash). Videourodynamics were performed using a 6F dual-lumen vesical catheter (Medtronic, Skovlunde, Denmark), a 9F rectal balloon catheter at medium filling (50 mL/ min), and radiographic contrast medium. The Valsalva leak point pressure was assessed with the patient standing at a bladder volume of 200 mL and defined as minimal intraabdominal pressure in the absence of involuntary detrusor contraction at which fluid was visualized emanating from the urethral meatus during the Valsalva maneuver. If no leakage was detected UROLOGY 70 (2), 2007
at 200-mL bladder filling, the test was repeated at greater volumes with stepwise 50-mL increments until the maximal functional bladder capacity was reached. A standard urethral pressure profilometry study was performed at an infusion rate of 4 mL/min and catheter withdrawal rate of 1 mm/s. The maximal urethral closure pressure was the difference between the maximal urethral pressure and bladder pressure and was recorded. All definitions corresponded to those of the International Continence Society.10 The TOT procedure was performed mostly under local anesthesia, but spinal or general anesthesia was chosen for 6 patients (3.8%). The procedure was performed by the same surgeon (J.S.P.) as reported by Delorme et al.,11 with some modifications. Cystoscopy was done to verify no bladder injury was present. After filling the bladder with 250 mL physiologic saline, the tape was adjusted without tension until no urinary leakage occurred when the patient coughed and without elevating the urethra to avoid difficult voiding postoperatively. The catheter was removed 3 hours after surgery unless bladder perforation had been observed during surgery. When the PVR urine volume was more than 100 mL or the patient did not void, she was instructed in clean intermittent self-catheterization and asked to catheterize at least four times daily until the PVR urine volume was less than 100 mL. Patients were discharged from the hospital on either the same evening as the procedure or on the following morning and were followed up at 1, 3, 6, and 12 months postoperatively and every 1 year thereafter. The mean follow-up time was 6.5 ⫾ 0.4 months. The follow-up evaluation included questionnaire assessment, physical examination with a stress test, uroflowmetry, and PVR urine measurement. A stress test was performed in the lithotomy and standing positions with the full bladder. Cure of incontinence after the procedure was defined as the absence of a subjective complaint of leakage and the absence of objective leakage on stress testing. Improvement was defined as no urine loss on the stress test plus a patient report of some leakage but overall satisfaction. In the present study, all cases except cure were considered failure. Descriptive statistics are reported as the mean ⫾ standard error or numbers with percentages in parentheses. For statistical analysis, patients were divided into those with UH (Q-tip test 30° or greater, n ⫽ 96) and those without UH (Q-tip test less than 30°, n ⫽ 63). The statistical analysis was performed using the Student t test for continuous data and chi-square test or Armitage test for categorical data. The paired t test was used to compare the values of the Q-tip test before and after treatment in each group. A 5% level of significance was used for all statistical testing, and all statistical tests were two sided. Statistical analyses were performed using a commercially available analysis program, Statistical Package for Social Sciences, version 10.0 (SPSS, Chicago, Ill).
RESULTS Table 1 shows the baseline characteristics of the two groups. The mean patient age for the UH and non-UH groups was 54.0 and 57.3 years, respectively (P ⫽ 0.013). The parity in the UH group was significantly lower than that in the non-UH group (P ⫽ 0.013). The rate of urgency in the UH group was significantly lower than that in the non-UH group (P ⫽ 0.017). The degree of cystocele was greater in the UH group than in the 247
Table 1. Patient characteristics Characteristic
Hypermobility
No Hypermobility
Patients (n) Age (yr) Height (cm) Weight (kg) Body mass index (kg/m2) Parity (n) Menopause Hysterectomy Comorbid disease Incontinence surgery Symptom duration (mo) Urgency Cystocele None Grade 1 Grade 2 Symptom severity Grade 1 Grade 2 Grade 3 Q-tip test (°) 1-hr Pad test (g) Maximal flow rate (mL/s) PVR urine volume (mL) Valsalva leak point pressure (cm H2O) Maximal urethral closure pressure (cm H2O) Maximal cystometric capacity (mL) Uninhibited detrusor contraction
96 54.0 ⫾ 0.8 156.5 ⫾ 0.6 60.6 ⫾ 0.8 24.7 ⫾ 0.3 2.3 ⫾ 0.1 60 (62.5) 20 (20.8) 42 (43.8) 6 (6.3) 84.8 ⫾ 7.7 32 (33.3)
63 57.3 ⫾ 1.1 155.0 ⫾ 0.7 60.1 ⫾ 1.0 25.0 ⫾ 0.3 2.6 ⫾ 0.3 44 (69.8) 20 (31.7) 29 (46.0) 7 (11.1) 95.0 ⫾ 12.6 33 (52.4)
14 (14.6) 56 (58.3) 26 (27.1)
P Value 0.013* 0.092* 0.710* 0.562* 0.013* 0.341† 0.121† 0.777† 0.274† 0.469* 0.017† 0.001‡
17 (27.0) 42 (66.7) 4 (6.3) 0.333‡
11 (11.5) 56 (58.3) 29 (30.2) 41.2 ⫾ 1.1 40.7 ⫾ 3.8 24.0 ⫾ 1.1 23.8 ⫾ 3.9 105.7 ⫾ 3.4 64.2 ⫾ 2.4 407.1 ⫾ 8.6 3 (3.1)
6 (9.5) 33 (52.4) 24 (38.1) 17.0 ⫾ 0.9 57.4 ⫾ 7.1 22.7 ⫾ 1.4 19.3 ⫾ 3.4 100.8 ⫾ 3.3 55.5 ⫾ 2.6 370.9 ⫾ 14.0 2 (3.2)
⬍0.001* 0.041* 0.456* 0.408* 0.295* 0.019* 0.021* 1.000†
PVR ⫽ postvoid residual. Data presented as mean ⫾ standard error or number of patients with the percentages in parentheses. * Student’s t test. † Chi-square test. ‡ Armitage test.
Table 2. Postoperative results Variable Patients (n) Urgency Q-tip test (°) 1-hr Pad test (g) Qmax (mL/s) PVR (mL) Cure rate Follow-up (mo)
Hypermobility
Preoperatively No Hypermobility
96 6 (6.3) 31.0 ⫾ 1.4 2.7 ⫾ 1.4 26.1 ⫾ 1.0 26.9 ⫾ 4.6 88 (91.7) 6.4 ⫾ 0.6
63 11 (17.5) 17.0 ⫾ 1.1 2.4 ⫾ 0.8 25.0 ⫾ 1.2 18.7 ⫾ 3.9 53 (84.1) 6.7 ⫾ 0.7
P Value
Hypermobility
Postoperatively No Hypermobility
0.025* ⬍0.001† 0.901† 0.475† 0.206† 0.142* 0.761†
66 5 (7.6) 38.6 ⫾ 1.1 0.9 ⫾ 0.4 27.2 ⫾ 1.2 20.8 ⫾ 5.0 61 (92.4) 6.5 ⫾ 0.7
93 12 (12.9) 16.1 ⫾ 0.7 3.7 ⫾ 1.5 24.6 ⫾ 1.0 25.8 ⫾ 4.1 80 (86.0) 6.5 ⫾ 0.6
P Value 0.284* ⬍0.001† 0.087† 0.097† 0.444† 0.209* 0.953†
Qmax ⫽ maximal flow rate; PVR ⫽ postvoid residual. Data presented as mean ⫾ standard error or number of patients, with percentages in parentheses. * Chi-square test. † Student’s t test.
non-UH group (P ⫽ 0.001). The amount of urine leakage during the 1-hour pad test was 40.7 g for the UH group and 57.4 g for the non-UH group (P ⬍0.001). The maximal urethral closure pressure in the UH group was significantly greater than that in the non-UH group (P ⫽ 0.019). The maximal cystometric capacity for the UH and non-UH groups was 407.1 and 370.9 mL, respectively (P ⫽ 0.021). No difference in the other characteristics was observed between the two groups. Of all the patients, the Q-tip test values decreased from a baseline of 31.6° ⫾ 1.2° to 25.5° ⫾ 1.1° (P 248
⬍0.001). In the UH group (n ⫽ 96), the Q-tip test values decreased significantly compared with the baseline data (41.2° ⫾ 1.1° versus 31.0° ⫾ 1.4°, P ⬍0.001). No difference was evident in the non-UH group (n ⫽ 63) with regard to the Q-tip test values (17.0° ⫾ 0.9° versus 17.0° ⫾ 1.1°, P ⫽ 0.965). Table 2 shows the overall results regarding voiding and continence status at follow-up. No serious complications occurred in either group. Only the preoperative urgency in the non-UH group was significantly greater than that of the UH group (P ⫽ 0.025) when the voiding and UROLOGY 70 (2), 2007
continence status were compared between the two groups. No significant difference was found between the two groups with regard to the other parameters. The overall cure rate was not significantly different between the UH and non-UH groups (91.7% versus 84.1%, P ⫽ 0.142). After the TOT procedure, 66 had a Q-tip test result of 30° or greater. No significant difference in the clinical outcome was found in the postoperative UH and non-UH groups. The overall cure rate also was not significantly different between the postoperative UH and non-UH groups (92.4% versus 86.0%, P ⫽ 0.209).
COMMENT Although UH has been measured by various methods, the Q-tip test is used widely for determining UH because it is simple, inexpensive, and has been proven equivalent to the more advanced imaging techniques.12 However, the Q-tip test has recognized shortcomings, including the inability to determine the exact Q-tip position, the information is limited to UH only, and it is difficult to standardize. Furthermore, a recent study has indicated that voiding cystourethrography and the Q-tip test measure UH differently.13 In classic procedures such as retropubic or transvaginal suspension, the bladder neck is suspended to ensure continence. Therefore, the prognosis depends on sphincteric competence (ie, the ability of the bladder neck to remain closed when abdominal pressure increases). However, theoretically, a successful mid-urethral sling procedure does not need to increase the resting urethral pressure but needs to support the urethra during stress and allow more effective pressure transmission. Continence after a midurethral sling procedure would be achieved because the proximal urethra would rotate and descend when under stress, and the mid urethra would be held in place by the tape. Because the mid-urethral sling procedure is no longer placed under the bladder neck but under the middle of the urethra, the prognosis is no longer determined by sphincteric competence, but rather by UM, which allows the urethra to bend during exertion. In the present study, we assessed the change in proximal UM after the TOT procedure. Although we found that the UM did not change significantly after the TOT procedure in women without UH, differences in the Q-tip test values were evident in women with UH. To our knowledge, this finding has not been previously described. Lo et al.14 demonstrated that the bladder neck position showed no significant difference before and after the TVT procedure. At 3 years of follow-up, Lo et al.15 proposed that the absence of UH postoperatively suggested that the vaginal tape was incorrectly placed at the proximal urethra. However, a recent study of the TVT procedure in vivo demonstrated that the sling can have a tendency to rest in the proximal one third of the urethra, rather than directly in the mid-urethra.16 In addition, with the TVT procedure, the Q-tip angle gradually approached baseline UROLOGY 70 (2), 2007
values during the course of 1 year, with the most significant difference from preoperative values noted at less than 4 weeks of follow-up.17 These findings suggest that the mid-urethral sling procedures will result in a greater reduction of the postoperative Q-tip angles within the first few weeks. This hypothesis is consistent with the results of other short-term reports. Klutke et al.18 demonstrated that UM was not maintained 3 weeks after a successful TVT procedure (42.75° versus 31.85°). Atherton and Stanton19 found that some decrease had occurred in bladder neck mobility with the TVT procedure at 4 weeks. Minaglia et al.20 reported that the UH, as measured by the Q-tip test, changed significantly 6 weeks after a successful TOT procedure in women with UH. Bakas et al.21 also noted an average 9° reduction in the Q-tip angle at 6 months after the TVT procedure. Therefore, at present, the significance of the Q-tip angle changes in women with UH is not known and longer follow-up is warranted, especially for this cohort. The effect of proximal UM on the cure rate for the mid-urethral sling procedure was not systemically assessed in previous studies. In the present study, no significant difference in the cure rate was found between the UH group and non-UH group in terms of the cure rate for SUI, although it was slightly lower in the non-UH group. Klutke et al.18 and Minaglia et al.20 demonstrated that cure of SUI using the mid-urethral sling procedure did not require the correction of proximal UM. The potential limitations should be mentioned. The mean follow-up time of this study was 6.5 months. Thus, although no significant difference was found between the two groups, the question remains of whether the results will be durable in both groups. Additional studies, including longer follow-up, are needed to verify our findings. In addition, no reference standard method is available to define UH, and the Q-tip test is difficult to standardize. However, our results should not be altered by intraobserver variation, because in this study the same examiner used the same method in the same population for the same period.
CONCLUSIONS The results of our study have shown that UM decreases after the TOT procedure in women with UH but not in women without UH. The cure rate was not lower in the patients without UH compared with the cure rate of those with UH. Our findings suggest that the lack of UM should not be considered a factor indicating a high risk of failure after the TOT procedure in patients with SUI. References 1. Klutke C, Siegel S, Carlin B, et al: Urinary retention after tensionfree vaginal tape procedure: incidence and treatment. Urology 58: 697–701, 2001. 2. Ulmsten U, Henriksson L, Johnson P, et al: An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 7: 81– 85, 1996.
249
3. Petros PE, and Ulmsten UI: An integral theory and its method for the diagnosis and management of female urinary incontinence. Scand J Urol Nephrol Suppl 153: 1–93, 1993. 4. Deval B, Levardon M, Samain E, et al: A French multicenter clinical trial of SPARC for stress urinary incontinence. Eur Urol 44: 254 –258, 2003. 5. de Leval J: Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out. Eur Urol 44: 724 –730, 2003. 6. Abrams P, Cardozo L, Fall M, et al: The standardisation of terminology of lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Neurourol Urodyn 21: 167–178, 2002. 7. Ingelman-Sundberg A, and Ulmsten U: Surgical treatment of female urinary stress incontinence. Contrib Gynecol Obstet 10: 51– 69, 1983. 8. Juma S, Little NA, and Raz S: Evaluation of stress urinary incontinence, in Buchsbaum HJ, and Schmidt JD (Eds): Gynecologic and Obstetric Urology. Philadelphia, WB Saunders, 1993, pp 251–263. 9. Gordon D, Gold RS, Pauzner D, et al: Combined genitourinary prolapse repair and prophylactic tension-free vaginal tape in women with severe prolapse and occult stress urinary incontinence: preliminary results. Urology 58: 547–550, 2001. 10. Abrams P, Blaivas JG, Stanton SL, et al., for the International Continence Society Committee on Standardisation of Terminology: The standardisation of terminology of lower urinary tract function. Scand J Urol Nephrol Suppl 114: 5–19, 1988. 11. Delorme E, Droupy S, de Tayrac R, et al: Transobturator tape (Uratape): a new minimally-invasive procedure to treat female urinary incontinence. Eur Urol 45: 203–207, 2004. 12. Bhatia NN, Ostergard DR, and McQuown D: Ultrasonography in urinary incontinence. Urology 29: 90 –94, 1987. 13. Walsh LP, Zimmern PE, Pope N, et al: Comparison of the Q-tip test and voiding cystourethrogram to assess urethral hypermobility among women enrolled in a randomized clinical trial of surgery for stress urinary incontinence. J Urol 176: 646 – 649, 2006. 14. Lo TS, Wang AC, Horng SG, et al: Ultrasonographic and urodynamic evaluation after tension free vagina tape procedure (TVT). Acta Obstet Gynecol Scand 80: 65–70, 2001. 15. Lo TS, Horng SG, Liang CC, et al: Ultrasound assessment of mid-urethra tape at three-year follow-up after tension-free vaginal tape procedure. Urology 63: 671– 675, 2004. 16. Kaum HJ, and Wolff F: TVT: on midurethral tape positioning and its influence on continence. Int Urogynecol J Pelvic Floor Dysfunct 13: 110 –115, 2002. 17. Lukacz ES, Luber KM, and Nager CW: The effects of the tensionfree vaginal tape on proximal urethral position: a prospective, longitudinal evaluation. Int Urogynecol J Pelvic Floor Dysfunct 14: 179 –184, 2003. 18. Klutke JJ, Carlin BI, and Klutke CG: The tension-free vaginal tape procedure: correction of stress incontinence with minimal alteration in proximal urethral mobility. Urology 55: 512–514, 2000. 19. Atherton MJ, and Stanton SL: A comparison of bladder neck movement and elevation after tension-free vaginal tape and colposuspension. Br J Obstet Gynecol 107: 1366 –1370, 2000. 20. Minaglia S, Ozel B, Hurtado E, et al: Effect of transobturator tape procedure on proximal urethral mobility. Urology 65: 55–59, 2005. 21. Bakas P, Liapis A, and Creatsas G: Q-tip test and tension-free vaginal tape in the management of female patients with genuine stress incontinence. Gynecol Obstet Invest 53: 170 –173, 2002.
Q-tip tests. Of these 159 women, 96 were considered to have UH preoperatively, of whom 60 had UH postoperatively, and 63 were considered to have non-UH preoperatively, and all remained so postoperatively. In this small series, no statistically significant difference was found in the cure rates between the two groups, with a rate of 91.7% in the UH group and 84.1% in the non-UH group. Cure was strictly defined as absence of a subjective complaint of leakage and the absence of objective leakage on stress testing. The average follow-up was only 6 months. UH is a common anatomic abnormality seen in women with SUI, and most of the early surgical treatment for SUI sought to correct the hypermobility by resuspending the bladder neck. In 1994, DeLancey proposed the “hammock hypothesis,” suggesting that, during stress maneuvers, the urethra is compressed against a hammock of support provided by the pubourethral ligaments. In many women with incontinence, that hammock is compromised. The tension-free tape procedures, whether performed by a retropubic or transobturator approach, seek to reinforce that hammock with a piece of mesh. In the early years of the TVT, several clinicians noted that, after the procedure, the urethra remained hypermobile. In 2000, Klutke et al.1 examined the effect of the TVT on UH measured by the Q-tip test. In their group of 20 women who underwent TVT placement, they found that the mean preoperative and postoperative Q-tip value was 42° and 31°, respectively. Furthermore, 12 of these patients remained hypermobile postoperatively, and of those 12, 11 were cured by the procedure. On the basis of this, they drew the following conclusion: although hypermobility certainly contributes to incontinence, the correction of UH is not necessary to restore continence. The results of the present study have reaffirmed the conclusions of Klutke et al.1 for the transobturator approach. The tension-free mid-urethral sling, performed either by a retropubic or transobturator approach, does not correct continence solely by correcting UH. We have a growing body of knowledge suggesting that the mid-urethral sling is curative for a broad spectrum of the incontinent population. We now need to focus on determining which preoperative factors will help us to choose candidates more judiciously. Two recent studies have looked at the preoperative predictors of success for the TOT mid-urethral sling. Deutsch et al.2 found age older than 55 years and incontinence grade greater than 2 on the Ingelman Sundberg scale were associated with failure. A recent study by O’Connor et al.3 evaluated the success of the TOT procedure according to the preoperative Valsalva leak point pressure and found that women with a Valsalva leak point pressure greater than 60 cm H2O had a greater cure rate postoperatively than did those with a Valsalva leak point pressure less than 60 cm H2O (77% versus 25%, respectively).3 Future efforts should be focused on determining the preoperative predictors of success through wellcontrolled, appropriately powered studies.
References
EDITORIAL COMMENT In this study, the authors sought to quantify the effect of the TOT mid-urethral sling placement on UH and to evaluate the relationship between preoperative UH and the cure rate. A total of 159 women with SUI treated with a TOT mid-urethral sling was assessed with both preoperative and postoperative 250
1. Klutke JJ, Carlin BI, and Klutke CG: The tension-free vaginal tape procedure: correction of stress incontinence with minimal alteration in proximal urethral mobility. Urology 55: 512–514, 2000. 2. Deutsch V, Boillot B, Michel A, et al: [Are there any factors predicting failure or complications rates of trans-obturator surgery for stress urinary incontinence?] Gynecol Obstet Fertil 34: 1118 – 1125, 2006.
UROLOGY 70 (2), 2007
METHODS
RESULTS
CONCLUSIONS
To assess the change in urethral mobility (UM) after the transobturator tape (TOT) procedure and to evaluate the effect of UM on the outcome of the TOT procedure in women with stress urinary incontinence. A total of 159 women 33 to 77 years old (mean 55.3) was included in this study. UM was quantified using the Q-tip angle. Patients were stratified into the urethral hypermobility (UH) group (Q-tip test angle 30° or greater, n ⫽ 96) and the non-UH group (Q-tip test angle less than 30°, n ⫽ 63). The mean follow-up time was 6.5 ⫾ 0.4 months. In the UH group, the Q-tip test values decreased significantly compared with the baseline data (41.2° ⫾ 1.1° versus 31.0° ⫾ 1.4°, P ⬍0.001). No difference was evident in the non-UH group (17.0° ⫾ 0.9° versus 17.0° ⫾ 1.1°, P ⫽ 965). The overall cure rate was not significantly different in either group (91.7% versus 84.1%, P ⫽ 0.142). After the TOT procedure, 66 had a Q-tip test result of 30° or greater. The overall cure rate was not significantly different in the postoperative UH and non-UH groups (92.4% versus 86.0%, P ⫽ 0.209). The results of our study have shown that UM decreases after the TOT procedure in the UH group but not in the non-UH group. The cure rate was not lower in the non-UH group compared with that in the UH group. Our findings suggest that the lack of UM should not be considered a factor indicating a high risk of failure after the TOT procedure. UROLOGY 70: 246 –251, 2007. © 2007 Elsevier Inc.
S
tress urinary incontinence (SUI) is a devastating condition that affects 15% to 35% of women in the general population.1 Of the anatomic abnormalities present in incontinent women, urethral hypermobility (UH) is the main factor. In 1996, a new surgical technique called the tension-free vaginal tape (TVT) procedure was proposed for SUI.2 Using the integral theory,3 the aim of this technique was to reinforce the pubourethral ligaments and the suburethral vaginal hammock, as well as the connections of the latter to the pubococcygeus muscles. Subsequently, the attractiveness to patients of such minimally invasive techniques has resulted in several modified versions of the TVT procedure, including the suprapubic arc and the transobturator tape (TOT) procedures.4,5 These procedures aim to restore urethral support by synthetic sling placement at the level of the mid-urethra. From the Department of Urology, Seoul National University College of Medicine, Seoul, South Korea; Department of Urology, Seoul Veterans Hospital, Seoul, South Korea Reprint requests: Ja Hyeon Ku, M.D., Department of Urology, Seoul National University Hospital, 28, Yongon Dong, Jongno Ku, Seoul 110-744 South Korea. E-mail: [email protected] Submitted: October 17, 2006; accepted (with revisions): March 12, 2007
246
© 2007 Elsevier Inc. All Rights Reserved
Theoretically, the prognosis of the mid-urethral sling is no longer determined by sphincteric competence but rather by urethral mobility (UM), which allows it to bend during exertion because the procedure is no longer placed under the bladder neck but under the middle of the urethra. Thus, one would expect that proximal UM is relatively more important than sphincteric impairment for the success of mid-urethral sling procedures. However, the relationship between proximal UM and the midurethral sling procedures was not systemically assessed in previous studies. The aim of the present study was to assess the change in proximal UM after the TOT procedure and to evaluate the effect of UM on the outcome of the TOT procedure in women with SUI.
MATERIAL AND METHODS From May 2004 to December 2005, female patients with urodynamically proven SUI were evaluated according to our protocol. This protocol included history and physical examination, urinalysis, urine culture, uroflowmetry, postvoid residual (PVR) urine measurement, a 1-hour pad test, Q-tip test, and multichannel video urodynamic studies (MMS UD-2000, Medical Measurement System, Ennschede, The Netherlands) with max0090-4295/07/$32.00 doi:10.1016/j.urology.2007.03.081
imal urethral closure pressure and Valsalva leak point pressure measurements. The internal review board of the Seoul National University Hospital approved this study. The study inclusion criteria included female sex, SUI, and age older than 18 years. The study exclusion criteria included the presence of any urinary tract infection, malignancy, pregnancy, and severe grade urogenital prolapse (grade III and IV). A total of 159 women, 33 to 77 years old (mean 55.3), with SUI was included in the study. Of the 159 women, 65 (40.9%) and 39 (24.5%) reported additional urgency and urge incontinence, respectively. Urgency was defined as the complaints of a sudden compelling desire to pass urine that was difficult to defer and urge incontinence was defined as the complaint of involuntary leakage accompanied, or immediately preceded, by urgency.6 Before the performance of objective testing, the patients were interviewed. On the basis of these interviews, the severity of urinary incontinence was classified according to the IngelmanSundberg scale,7 as follows: grade 1, urinary incontinence occurs when coughing or sneezing; grade 2, urinary incontinence occurs when running or picking up objects from the floor; and grade 3, urinary incontinence occurs when walking or climbing stairs. The degree of cystocele was assessed according to Juma et al.8 During the physical examination, each patient underwent an estimation of the urethral angle while at rest and while coughing, measured using the Q-tip test and a protractor. The Q-tip test was performed in a standardized manner and was performed with the patient in the supine position and an empty bladder. After cleansing the external urethral meatus, a sterile lubricated Q-tip was introduced in the urethra and withdrawn until resistance was met at the level of the urethrovesical junction. The angle of the Q-tip to the horizontal was measured in degrees and designated as the resting angle. With retraction of redundant labia to allow free movement of the swab, the angle of the Q-tip to the horizontal was again measured with the patient performing a maximal Valsalva maneuver (or cough if the Valsalva effort was inadequate). This angle was designated as the maximal straining angle. Both Q-tip angle measurements were taken using a standard goniometer placed against the patient’s perineum. The maximal urethral angle was recorded. UH was defined as a maximal straining angle of 30° or greater.9 The 1-hour pad test was performed as recommended by the International Continence Society. A fluid load of 500 mL was administered and followed 1 hour later by six separate exercises. Each pad was weighed before and after use to provide information about the severity of the incontinence. The tests were performed in the urologic laboratory by a specially trained nurse. Uroflowmetry was performed in the sitting position. Flows with voided volumes of at least 125 mL and without possible artifacts, including straining or using a Valsalva maneuver to urinate, which were determined on the basis of the first flow curve or the volume voided at the first few seconds, were included in our collected data. The PVR measurements were taken using a bladder scan (BVI-3000, Diagnostic Ultrasound, Redmond, Wash). Videourodynamics were performed using a 6F dual-lumen vesical catheter (Medtronic, Skovlunde, Denmark), a 9F rectal balloon catheter at medium filling (50 mL/ min), and radiographic contrast medium. The Valsalva leak point pressure was assessed with the patient standing at a bladder volume of 200 mL and defined as minimal intraabdominal pressure in the absence of involuntary detrusor contraction at which fluid was visualized emanating from the urethral meatus during the Valsalva maneuver. If no leakage was detected UROLOGY 70 (2), 2007
at 200-mL bladder filling, the test was repeated at greater volumes with stepwise 50-mL increments until the maximal functional bladder capacity was reached. A standard urethral pressure profilometry study was performed at an infusion rate of 4 mL/min and catheter withdrawal rate of 1 mm/s. The maximal urethral closure pressure was the difference between the maximal urethral pressure and bladder pressure and was recorded. All definitions corresponded to those of the International Continence Society.10 The TOT procedure was performed mostly under local anesthesia, but spinal or general anesthesia was chosen for 6 patients (3.8%). The procedure was performed by the same surgeon (J.S.P.) as reported by Delorme et al.,11 with some modifications. Cystoscopy was done to verify no bladder injury was present. After filling the bladder with 250 mL physiologic saline, the tape was adjusted without tension until no urinary leakage occurred when the patient coughed and without elevating the urethra to avoid difficult voiding postoperatively. The catheter was removed 3 hours after surgery unless bladder perforation had been observed during surgery. When the PVR urine volume was more than 100 mL or the patient did not void, she was instructed in clean intermittent self-catheterization and asked to catheterize at least four times daily until the PVR urine volume was less than 100 mL. Patients were discharged from the hospital on either the same evening as the procedure or on the following morning and were followed up at 1, 3, 6, and 12 months postoperatively and every 1 year thereafter. The mean follow-up time was 6.5 ⫾ 0.4 months. The follow-up evaluation included questionnaire assessment, physical examination with a stress test, uroflowmetry, and PVR urine measurement. A stress test was performed in the lithotomy and standing positions with the full bladder. Cure of incontinence after the procedure was defined as the absence of a subjective complaint of leakage and the absence of objective leakage on stress testing. Improvement was defined as no urine loss on the stress test plus a patient report of some leakage but overall satisfaction. In the present study, all cases except cure were considered failure. Descriptive statistics are reported as the mean ⫾ standard error or numbers with percentages in parentheses. For statistical analysis, patients were divided into those with UH (Q-tip test 30° or greater, n ⫽ 96) and those without UH (Q-tip test less than 30°, n ⫽ 63). The statistical analysis was performed using the Student t test for continuous data and chi-square test or Armitage test for categorical data. The paired t test was used to compare the values of the Q-tip test before and after treatment in each group. A 5% level of significance was used for all statistical testing, and all statistical tests were two sided. Statistical analyses were performed using a commercially available analysis program, Statistical Package for Social Sciences, version 10.0 (SPSS, Chicago, Ill).
RESULTS Table 1 shows the baseline characteristics of the two groups. The mean patient age for the UH and non-UH groups was 54.0 and 57.3 years, respectively (P ⫽ 0.013). The parity in the UH group was significantly lower than that in the non-UH group (P ⫽ 0.013). The rate of urgency in the UH group was significantly lower than that in the non-UH group (P ⫽ 0.017). The degree of cystocele was greater in the UH group than in the 247
Table 1. Patient characteristics Characteristic
Hypermobility
No Hypermobility
Patients (n) Age (yr) Height (cm) Weight (kg) Body mass index (kg/m2) Parity (n) Menopause Hysterectomy Comorbid disease Incontinence surgery Symptom duration (mo) Urgency Cystocele None Grade 1 Grade 2 Symptom severity Grade 1 Grade 2 Grade 3 Q-tip test (°) 1-hr Pad test (g) Maximal flow rate (mL/s) PVR urine volume (mL) Valsalva leak point pressure (cm H2O) Maximal urethral closure pressure (cm H2O) Maximal cystometric capacity (mL) Uninhibited detrusor contraction
96 54.0 ⫾ 0.8 156.5 ⫾ 0.6 60.6 ⫾ 0.8 24.7 ⫾ 0.3 2.3 ⫾ 0.1 60 (62.5) 20 (20.8) 42 (43.8) 6 (6.3) 84.8 ⫾ 7.7 32 (33.3)
63 57.3 ⫾ 1.1 155.0 ⫾ 0.7 60.1 ⫾ 1.0 25.0 ⫾ 0.3 2.6 ⫾ 0.3 44 (69.8) 20 (31.7) 29 (46.0) 7 (11.1) 95.0 ⫾ 12.6 33 (52.4)
14 (14.6) 56 (58.3) 26 (27.1)
P Value 0.013* 0.092* 0.710* 0.562* 0.013* 0.341† 0.121† 0.777† 0.274† 0.469* 0.017† 0.001‡
17 (27.0) 42 (66.7) 4 (6.3) 0.333‡
11 (11.5) 56 (58.3) 29 (30.2) 41.2 ⫾ 1.1 40.7 ⫾ 3.8 24.0 ⫾ 1.1 23.8 ⫾ 3.9 105.7 ⫾ 3.4 64.2 ⫾ 2.4 407.1 ⫾ 8.6 3 (3.1)
6 (9.5) 33 (52.4) 24 (38.1) 17.0 ⫾ 0.9 57.4 ⫾ 7.1 22.7 ⫾ 1.4 19.3 ⫾ 3.4 100.8 ⫾ 3.3 55.5 ⫾ 2.6 370.9 ⫾ 14.0 2 (3.2)
⬍0.001* 0.041* 0.456* 0.408* 0.295* 0.019* 0.021* 1.000†
PVR ⫽ postvoid residual. Data presented as mean ⫾ standard error or number of patients with the percentages in parentheses. * Student’s t test. † Chi-square test. ‡ Armitage test.
Table 2. Postoperative results Variable Patients (n) Urgency Q-tip test (°) 1-hr Pad test (g) Qmax (mL/s) PVR (mL) Cure rate Follow-up (mo)
Hypermobility
Preoperatively No Hypermobility
96 6 (6.3) 31.0 ⫾ 1.4 2.7 ⫾ 1.4 26.1 ⫾ 1.0 26.9 ⫾ 4.6 88 (91.7) 6.4 ⫾ 0.6
63 11 (17.5) 17.0 ⫾ 1.1 2.4 ⫾ 0.8 25.0 ⫾ 1.2 18.7 ⫾ 3.9 53 (84.1) 6.7 ⫾ 0.7
P Value
Hypermobility
Postoperatively No Hypermobility
0.025* ⬍0.001† 0.901† 0.475† 0.206† 0.142* 0.761†
66 5 (7.6) 38.6 ⫾ 1.1 0.9 ⫾ 0.4 27.2 ⫾ 1.2 20.8 ⫾ 5.0 61 (92.4) 6.5 ⫾ 0.7
93 12 (12.9) 16.1 ⫾ 0.7 3.7 ⫾ 1.5 24.6 ⫾ 1.0 25.8 ⫾ 4.1 80 (86.0) 6.5 ⫾ 0.6
P Value 0.284* ⬍0.001† 0.087† 0.097† 0.444† 0.209* 0.953†
Qmax ⫽ maximal flow rate; PVR ⫽ postvoid residual. Data presented as mean ⫾ standard error or number of patients, with percentages in parentheses. * Chi-square test. † Student’s t test.
non-UH group (P ⫽ 0.001). The amount of urine leakage during the 1-hour pad test was 40.7 g for the UH group and 57.4 g for the non-UH group (P ⬍0.001). The maximal urethral closure pressure in the UH group was significantly greater than that in the non-UH group (P ⫽ 0.019). The maximal cystometric capacity for the UH and non-UH groups was 407.1 and 370.9 mL, respectively (P ⫽ 0.021). No difference in the other characteristics was observed between the two groups. Of all the patients, the Q-tip test values decreased from a baseline of 31.6° ⫾ 1.2° to 25.5° ⫾ 1.1° (P 248
⬍0.001). In the UH group (n ⫽ 96), the Q-tip test values decreased significantly compared with the baseline data (41.2° ⫾ 1.1° versus 31.0° ⫾ 1.4°, P ⬍0.001). No difference was evident in the non-UH group (n ⫽ 63) with regard to the Q-tip test values (17.0° ⫾ 0.9° versus 17.0° ⫾ 1.1°, P ⫽ 0.965). Table 2 shows the overall results regarding voiding and continence status at follow-up. No serious complications occurred in either group. Only the preoperative urgency in the non-UH group was significantly greater than that of the UH group (P ⫽ 0.025) when the voiding and UROLOGY 70 (2), 2007
continence status were compared between the two groups. No significant difference was found between the two groups with regard to the other parameters. The overall cure rate was not significantly different between the UH and non-UH groups (91.7% versus 84.1%, P ⫽ 0.142). After the TOT procedure, 66 had a Q-tip test result of 30° or greater. No significant difference in the clinical outcome was found in the postoperative UH and non-UH groups. The overall cure rate also was not significantly different between the postoperative UH and non-UH groups (92.4% versus 86.0%, P ⫽ 0.209).
COMMENT Although UH has been measured by various methods, the Q-tip test is used widely for determining UH because it is simple, inexpensive, and has been proven equivalent to the more advanced imaging techniques.12 However, the Q-tip test has recognized shortcomings, including the inability to determine the exact Q-tip position, the information is limited to UH only, and it is difficult to standardize. Furthermore, a recent study has indicated that voiding cystourethrography and the Q-tip test measure UH differently.13 In classic procedures such as retropubic or transvaginal suspension, the bladder neck is suspended to ensure continence. Therefore, the prognosis depends on sphincteric competence (ie, the ability of the bladder neck to remain closed when abdominal pressure increases). However, theoretically, a successful mid-urethral sling procedure does not need to increase the resting urethral pressure but needs to support the urethra during stress and allow more effective pressure transmission. Continence after a midurethral sling procedure would be achieved because the proximal urethra would rotate and descend when under stress, and the mid urethra would be held in place by the tape. Because the mid-urethral sling procedure is no longer placed under the bladder neck but under the middle of the urethra, the prognosis is no longer determined by sphincteric competence, but rather by UM, which allows the urethra to bend during exertion. In the present study, we assessed the change in proximal UM after the TOT procedure. Although we found that the UM did not change significantly after the TOT procedure in women without UH, differences in the Q-tip test values were evident in women with UH. To our knowledge, this finding has not been previously described. Lo et al.14 demonstrated that the bladder neck position showed no significant difference before and after the TVT procedure. At 3 years of follow-up, Lo et al.15 proposed that the absence of UH postoperatively suggested that the vaginal tape was incorrectly placed at the proximal urethra. However, a recent study of the TVT procedure in vivo demonstrated that the sling can have a tendency to rest in the proximal one third of the urethra, rather than directly in the mid-urethra.16 In addition, with the TVT procedure, the Q-tip angle gradually approached baseline UROLOGY 70 (2), 2007
values during the course of 1 year, with the most significant difference from preoperative values noted at less than 4 weeks of follow-up.17 These findings suggest that the mid-urethral sling procedures will result in a greater reduction of the postoperative Q-tip angles within the first few weeks. This hypothesis is consistent with the results of other short-term reports. Klutke et al.18 demonstrated that UM was not maintained 3 weeks after a successful TVT procedure (42.75° versus 31.85°). Atherton and Stanton19 found that some decrease had occurred in bladder neck mobility with the TVT procedure at 4 weeks. Minaglia et al.20 reported that the UH, as measured by the Q-tip test, changed significantly 6 weeks after a successful TOT procedure in women with UH. Bakas et al.21 also noted an average 9° reduction in the Q-tip angle at 6 months after the TVT procedure. Therefore, at present, the significance of the Q-tip angle changes in women with UH is not known and longer follow-up is warranted, especially for this cohort. The effect of proximal UM on the cure rate for the mid-urethral sling procedure was not systemically assessed in previous studies. In the present study, no significant difference in the cure rate was found between the UH group and non-UH group in terms of the cure rate for SUI, although it was slightly lower in the non-UH group. Klutke et al.18 and Minaglia et al.20 demonstrated that cure of SUI using the mid-urethral sling procedure did not require the correction of proximal UM. The potential limitations should be mentioned. The mean follow-up time of this study was 6.5 months. Thus, although no significant difference was found between the two groups, the question remains of whether the results will be durable in both groups. Additional studies, including longer follow-up, are needed to verify our findings. In addition, no reference standard method is available to define UH, and the Q-tip test is difficult to standardize. However, our results should not be altered by intraobserver variation, because in this study the same examiner used the same method in the same population for the same period.
CONCLUSIONS The results of our study have shown that UM decreases after the TOT procedure in women with UH but not in women without UH. The cure rate was not lower in the patients without UH compared with the cure rate of those with UH. Our findings suggest that the lack of UM should not be considered a factor indicating a high risk of failure after the TOT procedure in patients with SUI. References 1. Klutke C, Siegel S, Carlin B, et al: Urinary retention after tensionfree vaginal tape procedure: incidence and treatment. Urology 58: 697–701, 2001. 2. Ulmsten U, Henriksson L, Johnson P, et al: An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 7: 81– 85, 1996.
249
3. Petros PE, and Ulmsten UI: An integral theory and its method for the diagnosis and management of female urinary incontinence. Scand J Urol Nephrol Suppl 153: 1–93, 1993. 4. Deval B, Levardon M, Samain E, et al: A French multicenter clinical trial of SPARC for stress urinary incontinence. Eur Urol 44: 254 –258, 2003. 5. de Leval J: Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out. Eur Urol 44: 724 –730, 2003. 6. Abrams P, Cardozo L, Fall M, et al: The standardisation of terminology of lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Neurourol Urodyn 21: 167–178, 2002. 7. Ingelman-Sundberg A, and Ulmsten U: Surgical treatment of female urinary stress incontinence. Contrib Gynecol Obstet 10: 51– 69, 1983. 8. Juma S, Little NA, and Raz S: Evaluation of stress urinary incontinence, in Buchsbaum HJ, and Schmidt JD (Eds): Gynecologic and Obstetric Urology. Philadelphia, WB Saunders, 1993, pp 251–263. 9. Gordon D, Gold RS, Pauzner D, et al: Combined genitourinary prolapse repair and prophylactic tension-free vaginal tape in women with severe prolapse and occult stress urinary incontinence: preliminary results. Urology 58: 547–550, 2001. 10. Abrams P, Blaivas JG, Stanton SL, et al., for the International Continence Society Committee on Standardisation of Terminology: The standardisation of terminology of lower urinary tract function. Scand J Urol Nephrol Suppl 114: 5–19, 1988. 11. Delorme E, Droupy S, de Tayrac R, et al: Transobturator tape (Uratape): a new minimally-invasive procedure to treat female urinary incontinence. Eur Urol 45: 203–207, 2004. 12. Bhatia NN, Ostergard DR, and McQuown D: Ultrasonography in urinary incontinence. Urology 29: 90 –94, 1987. 13. Walsh LP, Zimmern PE, Pope N, et al: Comparison of the Q-tip test and voiding cystourethrogram to assess urethral hypermobility among women enrolled in a randomized clinical trial of surgery for stress urinary incontinence. J Urol 176: 646 – 649, 2006. 14. Lo TS, Wang AC, Horng SG, et al: Ultrasonographic and urodynamic evaluation after tension free vagina tape procedure (TVT). Acta Obstet Gynecol Scand 80: 65–70, 2001. 15. Lo TS, Horng SG, Liang CC, et al: Ultrasound assessment of mid-urethra tape at three-year follow-up after tension-free vaginal tape procedure. Urology 63: 671– 675, 2004. 16. Kaum HJ, and Wolff F: TVT: on midurethral tape positioning and its influence on continence. Int Urogynecol J Pelvic Floor Dysfunct 13: 110 –115, 2002. 17. Lukacz ES, Luber KM, and Nager CW: The effects of the tensionfree vaginal tape on proximal urethral position: a prospective, longitudinal evaluation. Int Urogynecol J Pelvic Floor Dysfunct 14: 179 –184, 2003. 18. Klutke JJ, Carlin BI, and Klutke CG: The tension-free vaginal tape procedure: correction of stress incontinence with minimal alteration in proximal urethral mobility. Urology 55: 512–514, 2000. 19. Atherton MJ, and Stanton SL: A comparison of bladder neck movement and elevation after tension-free vaginal tape and colposuspension. Br J Obstet Gynecol 107: 1366 –1370, 2000. 20. Minaglia S, Ozel B, Hurtado E, et al: Effect of transobturator tape procedure on proximal urethral mobility. Urology 65: 55–59, 2005. 21. Bakas P, Liapis A, and Creatsas G: Q-tip test and tension-free vaginal tape in the management of female patients with genuine stress incontinence. Gynecol Obstet Invest 53: 170 –173, 2002.
Q-tip tests. Of these 159 women, 96 were considered to have UH preoperatively, of whom 60 had UH postoperatively, and 63 were considered to have non-UH preoperatively, and all remained so postoperatively. In this small series, no statistically significant difference was found in the cure rates between the two groups, with a rate of 91.7% in the UH group and 84.1% in the non-UH group. Cure was strictly defined as absence of a subjective complaint of leakage and the absence of objective leakage on stress testing. The average follow-up was only 6 months. UH is a common anatomic abnormality seen in women with SUI, and most of the early surgical treatment for SUI sought to correct the hypermobility by resuspending the bladder neck. In 1994, DeLancey proposed the “hammock hypothesis,” suggesting that, during stress maneuvers, the urethra is compressed against a hammock of support provided by the pubourethral ligaments. In many women with incontinence, that hammock is compromised. The tension-free tape procedures, whether performed by a retropubic or transobturator approach, seek to reinforce that hammock with a piece of mesh. In the early years of the TVT, several clinicians noted that, after the procedure, the urethra remained hypermobile. In 2000, Klutke et al.1 examined the effect of the TVT on UH measured by the Q-tip test. In their group of 20 women who underwent TVT placement, they found that the mean preoperative and postoperative Q-tip value was 42° and 31°, respectively. Furthermore, 12 of these patients remained hypermobile postoperatively, and of those 12, 11 were cured by the procedure. On the basis of this, they drew the following conclusion: although hypermobility certainly contributes to incontinence, the correction of UH is not necessary to restore continence. The results of the present study have reaffirmed the conclusions of Klutke et al.1 for the transobturator approach. The tension-free mid-urethral sling, performed either by a retropubic or transobturator approach, does not correct continence solely by correcting UH. We have a growing body of knowledge suggesting that the mid-urethral sling is curative for a broad spectrum of the incontinent population. We now need to focus on determining which preoperative factors will help us to choose candidates more judiciously. Two recent studies have looked at the preoperative predictors of success for the TOT mid-urethral sling. Deutsch et al.2 found age older than 55 years and incontinence grade greater than 2 on the Ingelman Sundberg scale were associated with failure. A recent study by O’Connor et al.3 evaluated the success of the TOT procedure according to the preoperative Valsalva leak point pressure and found that women with a Valsalva leak point pressure greater than 60 cm H2O had a greater cure rate postoperatively than did those with a Valsalva leak point pressure less than 60 cm H2O (77% versus 25%, respectively).3 Future efforts should be focused on determining the preoperative predictors of success through wellcontrolled, appropriately powered studies.
References
EDITORIAL COMMENT In this study, the authors sought to quantify the effect of the TOT mid-urethral sling placement on UH and to evaluate the relationship between preoperative UH and the cure rate. A total of 159 women with SUI treated with a TOT mid-urethral sling was assessed with both preoperative and postoperative 250
1. Klutke JJ, Carlin BI, and Klutke CG: The tension-free vaginal tape procedure: correction of stress incontinence with minimal alteration in proximal urethral mobility. Urology 55: 512–514, 2000. 2. Deutsch V, Boillot B, Michel A, et al: [Are there any factors predicting failure or complications rates of trans-obturator surgery for stress urinary incontinence?] Gynecol Obstet Fertil 34: 1118 – 1125, 2006.
UROLOGY 70 (2), 2007