Intussusception of bladder neck improves early continence after radical prostatectomy: Results of a prospective trial

Intussusception of bladder neck improves early continence after radical prostatectomy: Results of a prospective trial

ADULT UROLOGY INTUSSUSCEPTION OF BLADDER NECK IMPROVES EARLY CONTINENCE AFTER RADICAL PROSTATECTOMY: RESULTS OF A PROSPECTIVE TRIAL S. WILLE, Z. VARG...

94KB Sizes 6 Downloads 133 Views

ADULT UROLOGY

INTUSSUSCEPTION OF BLADDER NECK IMPROVES EARLY CONTINENCE AFTER RADICAL PROSTATECTOMY: RESULTS OF A PROSPECTIVE TRIAL S. WILLE, Z. VARGA, R.

VON

KNOBLOCH,

AND

R. HOFMANN

ABSTRACT Objectives. To evaluate the impact of intussusception of the bladder neck on post-radical prostatectomy incontinence. Methods. A total of 272 men with organ-confined prostate cancer who had undergone radical retropubic prostatectomy were studied. Of the 272 men, 139 underwent bladder neck intussusception and 133 did not. Patients completed validated questionnaires IIQ-7 and a symptom inventory. Continence was defined as the use of no or only one pad daily. Results. Of the 272 men, 100%, 98.5%, and 96% answered the questionnaire and urinary symptom inventory at baseline and 3 and 12 months postoperatively, respectively. According to the protective pad requirement, 100%, 60%, and 86% of patients without intussusception and 100%, 77%, and 83% of the patients with intussusception were continent at baseline and 3 and 12 months postoperatively, respectively. Univariate logistic regression analysis revealed a statistically significant impact of intussusception on postprostatectomy incontinence at 3 months (P ⫽ 0.009), although continence at 12 months did not differ significantly (P ⫽ 0.5). Conclusions. Intussusception of the bladder neck had a significant effect on regaining continence at 3 months, although continence at 12 months was not affected. UROLOGY 65: 524–527, 2005. © 2005 Elsevier Inc.

I

ncontinence after radical prostatectomy is one of the greatest worries for most patients. Many efforts have been made to improve urinary continence after radical retropubic prostatectomy.1,2 The incidence of urinary incontinence after radical retropubic prostatectomy (RRP) varies widely from 6% to 87%.3 This variation has been attributed to different definitions of continence, surgeon experience, and variations in surgical technique. Conflicting reports have been published regarding the effect of bladder neck preservation on postprostatectomy continence. For example, Selli et al.4 and Deliveliotis et al.5 found preservation of the bladder neck improved continence, but Licht et al.,6 Poon et al.,7 and Srougi et al.8 did not. Walsh From the Department of Urology and Pediatric Urology, Philipps-University Marburg, Marburg/Lahn, Germany Reprint requests: Sebastian Wille, M.D., Department of Urology and Pediatric Urology, Philipps-University Marburg, Baldingerstrasse, Marburg/Lahn 35043, Germany. E-mail: sebastian. [email protected] Submitted: June 27, 2004, accepted (with revisions): September 30, 2004 © 2005 ELSEVIER INC. 524

ALL RIGHTS RESERVED

and Marschke9 did not address bladder neck preservation; their technique instead used intussusception of the bladder neck with Lembert sutures to prevent the bladder neck from pulling open as the bladder fills. Their encouraging data of an earlier return of continence prompted us to evaluate this promising technique.9 MATERIAL AND METHODS A total of 272 patients with clinically localized prostate cancer who had undergone open RRP by three surgeons at our institution were studied. Of these patients, the first 133 consecutive patients (group 1) did not undergo bladder neck intussusception followed by 139 (group 2) who did. All patients were provided with the validated questionnaire Incontinence Impact Questionnaire short form (IIQ-7) and a standardized symptom inventory at baseline and 3 and 12 months postoperatively with written instructions to mail the completed questionnaires back to our department. In accordance with published data, continence was defined as the use of no or one pad daily. The ethics review board provided ethical approval for the study, and all patients gave written informed consent. All data were entered into a database and analyzed using the Statistical Package for Social Sciences, version 12.0, software. Univariate and multivariate logistic regression analyses were 0090-4295/05/$30.00 doi:10.1016/j.urology.2004.09.066

TABLE I. Baseline characteristics Bladder Neck Intussusception Characteristic

No

Mean age (yr) Mean TRUS prostate volume (cm3) Pathologic stage (n) T1 T2 T3 PSA preoperatively (ng/mL) Gleason score Nerve sparing (n)

P Value

Yes

66 ⫾ 6.69 37 ⫾ 23

66.4 ⫾ 6.38 35 ⫾ 18.3

3 (2) 86 (65) 44 (33) 7.79 ⫾ 10.7 6 43 (33)

2 (1.5) 87 (67) 41 (31.5) 7.2 ⫾ 9.29 6 52 (39)

0.48 0.23 0.811 0.888 0.865 0.847 0.43 0.498

KEY: PSA ⫽ prostate-specific antigen. Data in parentheses are percentages.

TABLE II. Continence status (use of no or one pad daily) Baseline Intussusception

3-mo Postoperatively

12-mo Postoperatively

Incontinent

Continent

Incontinent

Continent

Incontinent

Continent

0 0

133 (100) 139 (100)

53 (40) 29 (23)

79 (60) 98 (77)

18 (14) 21 (17)

110 (86) 103 (83)

No Yes

Data presented as number, with percentages in parentheses.

performed to determine the impact of intussusception of the bladder neck on post-prostatectomy incontinence. Quality of life was measured using the IIQ-7. The scores of the IIQ-7 were correlated with continence status. The practicability of the IIQ-7 for men after radical prostatectomy has been demonstrated by Moore and Jensen.10 The IIQ-7 consists of seven questions regarding household chores, physical recreation, entertainment activities, travel, social activities, emotional health, and frustration. Item responses are assigned values of 0 for “not at all,” 1 for “slightly,” 2 for “moderately,” and 3 for “greatly.” The score is summed (range 0 to 21), and a transformation is performed by calculating the mean score (summed score/7) and multiplying the mean score by 33.3. Thus, scores are on a common scale of 0 to 100. Higher IIQ-7 scores indicate a greater level of impact. Radical retropubic ascending prostatectomy was performed as described by Hofmann et al.11 The bladder neck was reconstituted with interrupted 3-0 absorbable sutures. The bladder mucosa was everted and sutured outward with a running 4-0 polyglactin suture on both sides. The bladder neck was narrowed to the width of the fifth finger for convenient passage of a 20F catheter. Intussusception of the bladder neck was performed according to the report by Walsh and Marschke.9 After reconstruction of the bladder neck, buttressing sutures were placed to intussuscept the bladder neck. A single 3-0 absorbable suture was placed into the edges of the posterior bladder wall about 2 cm from the reconstructed bladder neck. Care was taken to ensure the ureters were not grasped or kinked. The suture was tied loosely to avoid ischemia. A second suture was placed anteriorly, taking bites approximately 2 cm lateral to the bladder neck on either side. This suture was tied after placing the anastomotic sutures. The anastomotic sutures at the bladder neck were placed through the everted mucosa. After placing the 5-o’clock and 7-o’clock position sutures dorsally at the bladder neck, a 20F catheter was positioned in the bladder, inflated with 15 mL and held between two fingers by the assistant. Five additional anastomotic sutures were placed. When the anastomotic sutures were tied, the anterior suture was loosely tied, leading to intussusception of the UROLOGY 65 (3), 2005

bladder neck. The extra time required for intussusception of the bladder neck was no more than 10 minutes.

RESULTS Of the 139 patients in whom we planned to perform bladder neck intussusception, 9 were excluded from the study because intussusception was not performed. Thus, 130 patients with intussusception (group 2) and 133 without intussusception (group 1) were suitable for evaluation. The baseline characteristics of both patient groups were similar (Table I). According to the pad requirement, 100%, 60%, and 86% of the patients who underwent RRP without intussusception of the bladder neck (group 1) and 100%, 77%, and 83% who underwent RRP with intussusception were continent at baseline and 3 and 12 months postoperatively, respectively (Table II). In univariate analysis, intussusception of the bladder neck significantly influenced the continence status at 3 months postoperatively (P ⫽ 0.009) but not at 12 months postoperatively (Table III). In a multivariate logistic regression model, the various factors that might influence continence status after prostatectomy, including nerve sparing and patient age, were included. Multivariate logistic analyses revealed intussusception was an independent predictor for early continence at 3 months; however, the continence status at 12 months was not affected (Table IV). In this study, we noted dilation of the upper urinary tract in 6 patients in group 2 (4.6%). Three patients were treated with a ureteral stent for 6 weeks without additional complications. The remaining 3 patients un525

TABLE III. Impact of intussusception on urinary incontinence (logistic regression, univariate) P value Odds ratio 95% confidence interval

At 3 mo

At 12 mo

0.009* 0.451 0.249–0.817

0.458 1.332 0.626–2.835

* Statistically significant.

derwent psoas hitch neoureterocystostomy. The incidence of bladder neck contracture was 6% and 7% in groups 1 and 2, respectively. The continence rates correlated with the transformed scores of the IIQ-7. At 3 months, the transformed score in groups 1 and 2 was 33.55 and 13.98, respectively. Differences using the two-sided t test were statistically significant (P ⬍0.001). The transformed score of the incontinent and continent patients was 52.71 and 9.59, respectively (P ⬍0.001; Table V). At 12 months, the transformed score in groups 1 and 2 was 16.06 and 13.72, respectively. The differences were not statistically significant (P ⫽ 0.51). The transformed score of the incontinent and continent patients was 48.72 and 7.45, respectively. This difference was statistically significant (P ⬍0.001; Table V). COMMENT Intussusception of the bladder neck resulted in a significantly greater continence rate of 77% versus 60% at 3 months postoperatively, although the continence rates at 12 months were not significantly affected. These findings were complemented by the significantly reduced IIQ-7 scores of the patients in group 2 (intussusception), indicating a greater quality of life at 3 months than in group 1 (no intussusception). In the series published by Walsh and Marschke,9 82% of the 54 men were continent at 3 months postoperatively after intussusception of the bladder neck compared with 54% of 64 men who underwent RRP without intussusception. Continence in the latter group was defined as the use of no pads, although continence in the group with intussusception was defined as the use of no or one dry pad. This slight difference in the definition of continence may have led to decreased continence rates in the group without intussusception because many patients were continent but used one prophylactic pad. Nevertheless, in their series, the continence rates in both groups were significantly different (P ⫽ 0.0035). The precise mechanism behind the earlier return of continence with intussusception of the bladder neck remains unclear. Walsh and Marschke9 considered two factors that might have influence. First, through the use of buttressing sutures, the blad526

TABLE IV. Impact of intussusception, nerve sparing, and age on urinary incontinence (logistic regression, multivariate) Variable Intussusception P value Odds ratio 95% confidence interval Nerve sparing P value Odds ratio 95% confidence interval Age P value Odds ratio 95% confidence interval

At 3 mo

At 12 mo

0.011* 0.443 0.237–0.827

0.513 1.311 0.582–2.956

0.704 0.809 0.406–1.613

0.881 1.145 0.472–2.776

0.339 0.975 0.927–1.027

0.538 0.977 0.909–1.051

* Statistically significant.

der neck might be prevented from pulling apart as the bladder fills and second, the proximal urethral stump is prevented from opening, thereby increasing the functional urethral length.9 We also believe that the bladder neck is more securely fixed to the urethra using buttressing sutures, which might reduce straining of the sphincter when the bladder fills and may lead to better sphincter function. Although we did not perform profilometry analyses postoperatively, we strongly believe that the functional urethral length might be increased with the use of buttressing sutures, as described by Walsh and Marschke.9 The occurrence of bladder neck contracture was similar in both groups at 12 months postoperatively. However, we noted dilation of the upper urinary tract in 6 (4.6%) of the 130 patients in group 2. We believe the ureter might have been grasped or kinked during placement of the posterior buttressing suture. Care must be taken to ensure that the suture is not placed too deeply into the perivesical tissue. This complication occurred in the early period of the study, but was easily avoided in subsequent patients. Preservation of the bladder neck may be an alternative way of achieving earlier continence. Although published reports have not been consistent,6 – 8 recent reports have shown an earlier return of continence without a significant increased risk of margin positivity at the bladder neck.4,12 In this context, additional studies comparing bladder neck preservation and intussusception are needed. Several self-administered questionnaires have been developed to ascertain the effect on the quality of life of men with prostate cancer.13–18 The quality of life in this study was measured using the IIQ-7. Other investigators have used the IIQ-7 to assess the quality of life of men after RRP.19 –21 Moore and Jensen10 demonstrated the reliability and validity of the IIQ-7 when used with men with post-prostatectomy incontinence. These findings were highlighted in the present study, as the IIQ-7 scores of the UROLOGY 65 (3), 2005

TABLE V. Transformed scores of Incontinence Impact Questionnaire Intussusception No Yes Incontinent Continent

At 3 mo

P Value

At 12 mo

33.55 ⫾ 40.5 13.98 ⫾ 22.3 52.71 ⫾ 38.8 9.59 ⫾ 20.71

⬍0.001*

16.06 ⫾ 26.7 13.72 ⫾ 22.4 48.72 ⫾ 31.1 7.45 ⫾ 14.5

⬍0.001*

P Value 0.51 ⬍0.001*

Data presented as mean ⫾ SD. * Statistically significant.

incontinent and continent men differed significantly at 3 and 12 months postoperatively. In addition, the IIQ-7 scores between groups 1 and 2 were significantly different at 3 months when a significant difference in continence status was shown. In contrast, the IIQ-7 scores between groups 1 and 2 were not significantly different at 12 months when the continence status was similar. CONCLUSIONS The results of our study have shown that intussusception of the bladder neck leads to an earlier return of continence after surgery, although the continence status at 12 months was not significantly affected. These findings were also reflected in the quality-oflife scores of the IIQ-7. Care must be taken to avoid placing posterior sutures near the distal ureter. Additional randomized studies with longer follow-up are needed to compare bladder neck preservation with intussusception, with particular emphasis on the time to regaining continence and the incidence of bladder neck contracture. REFERENCES 1. Moore KN, Griffiths D, and Hughton A: Urinary incontinence after radical prostatectomy: a randomized controlled trial comparing pelvic muscle exercises with or without electrical stimulation. BJU Int 83: 57– 65, 1999. 2. Wille S, Sobottka A, Heidenreich A, et al: Pelvic floor exercises, electrical stimulation and biofeedback after radical prostatectomy: results of a prospective randomized trial. J Urol 170: 490 – 493, 2003. 3. Rudy DC, Woodside JR, and Crawford ED: Urodynamic evaluation of incontinence in patients undergoing modified Campbell radical retropubic prostatectomy: a prospective study. J Urol 132: 708 –712, 1984. 4. Selli C, De Antoni P, Moro U, et al: Role of bladder neck preservation in urinary continence following radical retropubic prostatectomy. Scand J Urol Nephrol 38: 32–37, 2004. 5. Deliveliotis C, Protogerou V, Alargof E, et al: Radical prostatectomy: bladder neck preservation and puboprostatic ligament sparing— effects on continence and positive margins. Urology 60: 855– 858, 2002. 6. Licht MR, Klein EA, Tuason L, et al: Impact of bladder neck preservation during radical prostatectomy on continence and cancer control. Urology 44: 883– 887, 1994. 7. Poon M, Ruckle H, Bamshad BR, et al: Radical retropubic prostatectomy: bladder neck preservation versus reconstruction. J Urol 163: 194 –198, 2000. UROLOGY 65 (3), 2005

8. Srougi M, Nesrallah LJ, Kauffmann JR, et al: Urinary continence and pathological outcome after bladder neck preservation during radical retropubic prostatectomy: a randomized prospective trial. J Urol 165: 815– 818, 2001. 9. Walsh PC, and Marschke PL: Intussusception of the reconstructed bladder neck leads to earlier continence after radical prostatectomy. Urology 59: 934 –938, 2002. 10. Moore KN, and Jensen L: Testing of the Incontinence Impact Questionnaire (IIQ-7) with men after radical prostatectomy. J Wound Ostomy Continence Nurs 27: 304 –312, 2000. 11. Hofmann R, Heidenreich A, and Moul JW: Radical ascending retropubic prostatectomy. Prostate Cancer 15: 141– 143, 2003. 12. Bianco FJ, Grignon DJ, Sakr WA, et al: Radical prostatectomy with bladder neck preservation: impact of a positive margin. Eur Urol 43: 461– 466, 2003. 13. Litwin MS, Hays RD, Fink A, et al: Quality-of-life outcomes in men treated for localized prostate cancer. JAMA 273: 129 –135, 1995. 14. Litwin MS, Hays RD, Fink A, et al: The UCLA Prostate Cancer Index: development, reliability, and validity of a healthrelated quality of life measure. Med Care 36: 1002–1012, 1998. 15. Wei JT, Dunn RL, Marcovich R, et al: Prospective assessment of patient reported urinary continence after radical prostatectomy. J Urol 164: 744 –748, 2000. 16. Borghede G, and Sullivan M: Measurement of quality of life in localized prostatic cancer patients treated with radiotherapy: development of a prostate cancer-specific module supplementing the EORTC QLQ-C30. Qual Life Res 5: 212– 222, 1996. 17. Stockler MR, Osoba D, Corey P, et al: Convergent discriminative, and predictive validity of the Prostate Cancer Specific Quality of Life Instrument (PROSQOLI) assessment and comparison with analogous scales from the EORTC QLQ-C30 and a trial-specific module. European Organisation for Research and Treatment of Cancer. Core Quality of Life Questionnaire. J Clin Epidemiol 52: 653– 666, 1999. 18. Stockler MR, Osoba D, Goodwin P, et al, for the European Organization for Research and Treatment of Cancer: Responsiveness to change in health-related quality of life in a randomized clinical trial: a comparison of the Prostate Cancer Specific Quality of Life Instrument (PROSQOLI) with analogous scales from the EORTC QLQ-C30 and a trial specific module. J Clin Epidemiol 51: 137–145, 1998. 19. Fleshner N, and Herschorn S: The artificial urinary sphincter for post-radical prostatectomy incontinence: impact on urinary symptoms and quality of life. J Urol 155: 1260 – 1264, 1996. 20. Haab F, Trockman BA, Zimmern PE, et al: Quality of life and continence assessment of the artificial urinary sphincter in men with minimum 3.5 years of followup. J Urol 158: 435– 439, 1997. 21. O’Connor RC, Gerber GS, Avila D, et al: Comparison of outcomes after single or double-cuff artificial urinary sphincter insertion. Urology 62: 723–726, 2003. 527