Does Surgical Repair of Pelvic Prolapse Improve Patients Quality of Life?

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1 European Urology European Urology 45 (2004) Does Surgical Repair of Pelvic Prolapse Improve Patients Quality of Life? Hiroshi Hirata a, Hideyasu Matsuyama a, Gen-ichiro Yamakawa b, Akinobu Suga b, Masato Tatsumura c, Hidenobu Ogata d, Masahiko Takemoto e, Ken Tomimatsu f, Katsusuke Naito a,* a Department of Urology, Yamaguchi University School of Medicine, Minami-Kogushi, Ube , Yamaguchi, Japan b Section of Urology, Yamaguchi Red Cross Hospital, 53-1 Yahatababa, Yamaguchi , Yamaguchi, Japan c Section of Gynecology, Yamaguchi Red Cross Hospital, 53-1 Yahatababa, Yamaguchi , Yamaguchi, Japan d Department of Gynecology, Yamaguchi University School of Medicine, Minami-Kogushi, Ube , Yamaguchi, Japan e Section of Urology, Nagato General Hospital, 85 Higashifukawa, Nagato , Yamaguchi, Japan f Section of Gynecology, Nagato General Hospital, 85 Higashifukawa, Nagato , Yamaguchi, Japan Accepted 9 September 2003 Published online 2 October 2003 Abstract Objectives: The aims of this study were to evaluate the efficacy of surgical repair in patients with pelvic prolapse, and to assess the postoperative quality of life (QOL). Methods: A total of 70 patients (mean age: 66.7 years) underwent transvaginal two-corner bladder neck suspension in combination with transvaginal hysterectomy (63 cases), and anterior with (49) or without (21) posterior colporrhaphy. The status of recurrence and complications were followed in all patients at a mean follow-up period of 32.0 months. Postoperative patients quality of life (QOL) consisting of four items (sensation of vaginal bulging, urinary incontinence, difficulty to urinate, and health-related QOL) was assessed in 52 cases whose were followed at least two years (mean: 41.6 months, range: ). Results: Sixty-eight patients (97%) were recurrence-free. Nine of the 39 (23%) patients with difficulty to urinate before surgery had persistent symptoms postoperatively. Multivariate analysis revealed that cystometric abnormalities, voiding symptoms at seventh days after surgery, and weak detrusor contraction were independent prognostic factors for persistent voiding symptoms. As for the QOL, all items had significant improvement at 13 months after surgery as compared to baseline condition. A longitudinal study showed improvement of these symptoms sustained at least up to four years. Conclusions: This study suggests that surgical repair can achieve results with long-term durability as well as improving the QOL. In addition, assessment of the detrusor function may be needed for patients who complain difficulty to urinate in avoiding persistent such symptoms. # 2003 Elsevier B.V. All rights reserved. Keywords: Pelvic prolapse; Cystocele; Bladder neck suspension; Colporrhaphy; Quality of life 1. Introduction Pelvic prolapse, including cystocele, interferes with the lifestyle of women. Although surgical repair of cystocele is one of the most frequent gynecological * Corresponding author. Tel. þ ; Fax: þ address: katsunai@yamaguchi-u.ac.jp (K. Naito). procedures, the wide variety of surgical techniques demonstrates how difficult it can be to manage due to the substantial portion of the recurrence as well as postoperative complications. Although Kelly plication and anterior colporrhaphy have been used most commonly, these methods have a 50% failure rate for cure of incontinence, probably due to the lack of restoration of the bladder neck and urethra to the anatomical /$ see front matter # 2003 Elsevier B.V. All rights reserved. doi: /j.eururo

2 214 H. Hirata et al. / European Urology 45 (2004) position [1]. Although Burch colposuspension combined with vaginal repair has been an accepted treatment modality for patients with moderate to severe (grade 3 to 4) cystocele, the need for laparotomy increases the morbidity as compared with the transvaginal approach [2,3]. A pubovaginal sling combined with anterior colporrhaphy could develop frequent de novo urge incontinence in patients with abnormalities on urodynamic evaluation [4]. Such results indicate that concomitant prophylactic anti-incontinence procedure should be planned according to the individual urodynamic findings [5]. The aims of this study were to evaluate the efficacy of surgical repair in patients with pelvic prolapse, in particular regarding postoperative quality of life (QOL), and to investigate whether urodynamic evaluation could predict postoperative complications including de novo urge incontinence and persistence of voiding symptoms. 2. Materials and methods 2.1. Subjects Patient demographics are listed in Table 1. The mean age was 66.7 years ranging from 41 to 81 years. The follow-up period was 32 months ranging from 1 to 68.5 months. Thirty-three patients (47%) had urinary incontinence including mixed, stress, and urge incontinence in 13, 18, and 2 patients, respectively. The cystocele was graded to mild (grade 2), moderate (grade 3), and severe (grade 4) in 23, 29, and 18, respectively (Table 1) Methods Regarding surgical technique, a bladder neck suspension (BNS) technique with anterior colporrhaphy was applied with slight modification [6]. Anterior colporrhaphy was performed with stringent trimming of the redundant vaginal wall along the line with 1 cm inside of the introitus, and was sutured in two layers. In patients having prolapse of the uterus, and rectocele, transvaginal hysterectomy and posterior colporrhapy with plication of the prerectal fascia were performed by gynecologists, respectively with standard fashion. The urethral catheter was removed on the third postoperative day, followed by measurement of postvoid residual urine (PVR) volume until it decreased to below 50 ml. If the PVR was more than 100 ml on the seventh postoperative day, bethanechol chloride (60 mg/day) was administered with or without alfa-blocker reagent. Postoperative storage symptom was clinically diagnosed as when postoperative patients complained urgency or frequency (more than 8 times a day) with or without urge incontinence. Concerning postoperative checkup, chain urethrocystography was performed to confirm the proper position of the bladder neck at one week, followed by regular checkup including physical examination, urinalysis, estimated post void residual urine by ultrasonography at three months, 6 months, and a year after operation. The postoperative QOL was assessed three times by mailing QOL questionnaires in 52 cases whose were followed at least two years. A mean follow-up period was 41.6 months ranging from 24.3 to 69.1 months. The questionnaires consisted of three diseasespecific items (sensation of vaginal bulging, urinary incontinence, Table 1 Patient background difficulty to urinate), and one health-related item (Appendix A). A visual analogue scale with score (1 to 5 points) was applied to each item Statistical assessment One way analysis of variance (ANOVA), w 2 -test, and unpaired t-test were applied for univariate analysis. Cox proportional hazard model was used for the multivariate analysis. 3. Results Cases (%) Cystocele Prolapse uteri a Rectocele Obstructive symptoms Incontinence Mixed b Stress Urge 2 3 Basic disease Diabetes mellitus Cerebro-vascular 2 3 Orthopedic 3 4 Urodynamic study Cystomery Pressure flow study Cystocele Grade 2 (mild) Grade 3 (moderate) Grade 4 (severe) Mode of operation c BNS þ VT þ A þ P BNS þ VT þ A BNS þ A and/or P 7 10 Mean age (years) 66.7 (41 81) Mean pariety 2.6 (1 6) Mean post-void residual urine (ml) 93.9 (0 384) Mean follow-up (months) 32.0 (1 68.5) Figures in parentheses: range. a Transabdominal hysterectomy had been performed in four patients due to non-malignant disease. b Mixed: stress þ urge. c BNS: bladder neck suspension, VT: transvaginal hysterectomy, A: anterior colporrhaphy, P: posterior colporrhaphy. Forty-eight patients (69%) underwent transvaginal bladder neck suspension, antero-posterior colporrhaphy, and transvaginal hysterectomy. 15 patients were treated by transvaginal bladder neck suspension, anterior colporrhaphy, and transvaginal hysterectomy, while seven patients had transvaginal bladder neck suspension and anterior and/or posterior colporrhaphy (Table 1). The mean operating time and estimated

3 H. Hirata et al. / European Urology 45 (2004) blood loss with standard deviation were min and 387 ml 315 ml, respectively. Operation time for cystocele repair was approximately 90 min including anterior colporrhaphy. The average hospital stay after surgery was 15 days ranging 8 to 37 days. After surgery, restoration of the bladder base was confirmed in all patients by urethrocystography. The mean posterior urethral vesical angle was 98:8 16:5. Thirty-nine patients complained voiding symptoms (hesitancy, or difficulty to urinate) before operation, of whom 30 (79%) achieved normal voiding, as defined by no obstructive symptoms and PVR below 50 ml. Out of 15 patients with preoperative urge incontinence, 4 (27%) had persistent symptoms postoperatively. In total, two patients (2.8%) were noted to have a recurrent cystocele at 10 and 21 months after surgery with a mean follow-up of 32.0 months. As for complications, blood loss that required blood transfusion, postoperative storage symptoms, and persistent voiding symptoms were observed in two, five and nine patient, respectively. Two cases who required blood transfusion were in the group of transvaginal hysterectomy with BNS. Additionally, vesical stone formation due to migration of suspension suture string was observed in one case 29 months after operation. None of the parameters assessed, including age, parity, cystocele grade, blood loss, operating time, and operative procedure, had any relation to the occurrence of postoperative storage symptoms. Out of nine patients with persistent voiding symptoms, diabetes mellitus and weak detrusor contractions were found in one and five, respectively. Bethanechol chloride (20 60 mg/day orally) and a 1 -blocker reagent were administered to all patients, and symptoms were gradually improved although medical therapy is still needed at present. Table 2 shows the result of statistical analyses of various factors that may influence on persistent voiding symptoms. Cystometric abnormalities was defined as either filling phase abnornalities such as uninhibited contraction on cystometry, or voiding phase abnormalities such as weak detrusor contraction or obstructive pattern on pressure-flow study. Weak detrusor contraction was determined either by Schäfer nomogram [7], or by less than 20 cmh 2 O of maximum detrusor pressure on cystometry. Univariate analysis demonstrated that PVR on the third post-operative day (POD 3), PVR on POD 7, bleeding volume, cystometric abnormalities, voiding symptoms on POD 7, and weak detrusor contraction were significant predictive factors for persistent voiding symptoms. Analysis using Cox hazard Table 2 Univariate and multivariate analysis for persistent obstructive symptoms Factor a Univariate analysis b Multivariate analysis b Persistent obstructive symptoms c p value Risk ratio 95% confidence interval Yes (9) No (61) p value PVR (POD3) PVR (POD7) Schäfer linear PURR Age Bleeding volume Abraham Griffith Nr Post-operative PUV Cystometric abnormalities Normal Abnormal 6 8 Obstructive symptoms (POD 7) No Yes 8 16 Detrusor contraction Non-weak Weak 4 6 Cystocele Grade II Grade III, IV 1 29 a PVR (POD3): Post-void residuals on the third post-operative day; Abraham Griffith Nr.: Detrusor pressure at maximum flow rate 2 maximum flow rate. b Univariate: Unpaired t-test or Fisher s test, multivariate: Cox proportional hazard model. c Persistent obstructive symptoms represent either difficulty to urinate or hesitancy or status which need medical treatment due to over 100 ml of postvoid residual urine.

4 216 H. Hirata et al. / European Urology 45 (2004) Fig. 1. Comparison of the quality of life regarding vaginal bulging (A), difficulty to urinate (B), urinary incontinence (C), and health-related QOL (D). Bar: standard deviation, figures in parentheses: number of patients who responded to questionnaires. The mean scores for four items are shown at baseline, after a mean follow-up period of 13 months (first questionnaire), 29 months (second questionnaire), and 49 months (third questionnaire). The mean scores for all items at the first questionnaire were significantly lower than those at baseline ((A), (B), (D): p < 0:01, (C): p < 0:05, ANOVA). There was no statistical difference of the mean score among first, second, and third questionnaires. model revealed that cystometric abnormalities, weak detrusor contraction, and the existence of voiding symptoms on POD 7 were independent predictors of persistent voiding symptoms. The patients quality of life (QOL) was assessed to 52 patients who were followed at least two years after operation. QOL questionnaires (Appendix A) were mailed at a mean follow-up of 13, 29, and 49 months after operation. The reply rate was 94%, 88%, and 67% respectively. The figure shows the changes of mean score of three disease-specific QOL items (sensation of vaginal bulging, difficulty to urinate, urinary incontinence) and health-related QOL at times of baseline, first, second, and the third questionnaires. There was a significant decrease of the score for all items at the time of the first questionnaire when compared to the baseline score. Improved QOL was sustained at the mean period of 49 months (Fig. 1). 4. Discussion Does surgical repair of pelvic prolapse improve patients QOL? Standing the viewpoint of longitudinal QOL analysis, the answer may be yes. Both postoperative disease-specific and health-related QOL improved significantly when compared with the baseline (preoperative) condition. With regard to validity of the QOL questionnaire, we have not done stringent validation analysis. However, quantitative analysis was done to the baseline questionnaire regarding distribution of the reply, and percentage of the reply in each item. The results were almost satisfied. Thus, we have used the same questionnaire to the first to third examinations without changing the content of questionnaire. Our longitudinal follow-up data showed that the improvement was sustained for four years or more. It has not been clearly defined when and how the QOL questionnaire should be done in patients who had cystocele operation. In this study, we have evaluated postoperative QOL at 1, 2, and 4 years. This interval may be appropriate for the short to intermediate-term QOL. More than 5 years surveillance using QOL questionnaire may be needed for the evaluation of long-term QOL. Surgical repair may have intermediate-term durability, although further follow-up and more cohorts will be needed to confirm the preliminary data.

5 H. Hirata et al. / European Urology 45 (2004) Raz et al. reported excellent results of surgical repair by four- to six-corner bladder and urethral suspension for moderate cystocele [6,8]. Whereas, Kohli et al. reported patients with anterior plication plus BNS procedure had higher frequency of recurrence than those with anterior plication only (33% vs. 7%), and suggested that destruction of pubocervical fascia may affect the poor outcome [9]. Our recurrence rate was lower than their report in spite of the routine BNS procedure in all patients. Possible explanations may be that the difference of surgical procedure (stringent plication of anterior with or without posterior vaginal wall as well as hysterectomy) and different lifestyle of Japanese middle-aged women in particular regarding sexual activity. Severe cystocele develops because of weakness of the levator sling and pubocervical fascia, resulting in the defects of the vesicopelvic fascia either in a central defect in the midline or a lateral one caused by lateral descent of the tedious arc at the attachment of the fascia [10,11]. Both types of defect are common in most of severe cystocele. Although the central defect can be repaired by anterior colporrhaphy, the lateral defect may not be repaired by our technique. Simultaneous vaginal hysterectomy and rectocele repair, when indicated, may provide adequate pelvic floor support in our series. We have undergone BNS to all patients. Although this may not be an essential procedure in all cystocele patients, 44 percent of the patients had stress incontinence before surgery. Urodynamic evidence of stress incontinence was reported to be much higher than apparent stress incontinence in patients with grade 3 or 4 cystocele [12]. Such patient at risk of potential stress incontinence might have had stress incontinence as a new symptom after cystocele repair. BNS procedure was reported to be effective for the treatment of stress incontinence. Restoration of the urethra and bladder neck to its anatomical position should be needed to prevent de novo stress incontinence which was reported to occur nearly 50% of the patients with Kelly s plication [1]. Proper evaluation of urethral function by urodynamic study, however, can reduce the proportion of the BNS procedure even in severe ctystocele [12]. Postoperative storage symptoms developed in five patients (7%). The incidence of postoperative storage symptoms was identical to that reported elsewhere [8]. Surgical procedure itself may cause urge incontinence in substantial portion of the patients, since no parameters could predict this complication preoperatively. Concerning nine patients who complained persistent voiding symptoms postoperatively, six (67%) had any abnormalities suggesting neurogenic disorders such as diabetes mellitus, or weak detrusor contraction. Voiding symptoms in severe cystocele may result either from anatomical dislocation of the bladder, or from weak detrusor contraction. Preoperative voiding symptoms may only be resolved if normal detrusor contraction would be guaranteed. It was generally recognized that the estimation of pressure-flow study might not be useful for analysis of voiding disorders in women [13]. Recent reports, however, have indicated that the estimation of the parameter area under the curve of detrusor pressure during voiding, or nomogram combining of maximum free uroflow rate and detrusor pressure at maximum flow rate could discriminate bladder outlet obstruction from unobstructed status for women [14,15]. In this study, weak detrusor contraction was tentatively determined either by Schäfer nomogram, or by less than 20 cmh 2 O of maximum detrusor pressure on cystometry. Although this criteria was in good agreement with clinical parameters, novel criteria may be needed for the evaluation of bladder outlet obstruction for women. Weak or poorly sustained detrusor contraction is often associated with a cystocele in patients who may have a history of an overstretched bladder and infrequent voiding [16]. Cox proportional hazard analysis demonstrated that the assessment of detrusor function by the Schäfer contractility nomogram, or cystometric abnormities both in filling phase and in voiding phase are prerequisite for the prediction of postoperative persistent voiding symptoms in cystocele patients with voiding disorders. In conclusion, preoperative urodynamic evaluation might be prerequisite to avoid persistent voiding symptoms as well as postoperative stress incontinence in patients with severe cystocele. Surgical repair by stringent anterior colporrhaphy and BNS may have intermediate-term durability, although further followup and more cohorts will be needed to confirm the preliminary data. Acknowledgements The authors thank Drs. Koichi Ishihara, Shigehisa Takao, Hiroki Yoshioka and Muneaki Shimada for their technical contributions to the surgery. Appendix A. Questionnaire 1^4 1. Do you bother about vaginal bulging? Never: 0, Once a week at straining: 1, Once every 2 3 days at straining: 2, Once a day at

6 218 H. Hirata et al. / European Urology 45 (2004) straining, Almost all time with long standing position: 4, Almost all time at rest: 5 2. Do you feel difficulty on urinate? Never: 0, Once a week at straining: 1, Once every 2 3 days at straining: 2, Once a day at straining, Almost all time with long standing position: 4, Almost all time at rest: 5 3. Do you leak urine? Never: 0, Once a week at straining: 1, Once every 2 3 days at straining: 2, Once a day at straining, Almost all time with long standing position: 4, Almost all time at rest: 5 4. How much does you urinary symptoms interfere with your life? Not at all: 0, A little: 1, Somewhat: 2, Not a little A lot: 3, A lot: 4, Very much: 5 References [1] Gordon D, Groutz A, Wolman I, Lessing J, David M. Development of postoperative urinary stress incontinence in clinically continent patients undergoing prophylactic Kelly plication during genitourinary prolapse repair. Neurourol Urodyn 1999;18: [2] Burch JC. Cooper s ligament urethrovesical suspension for stress incontinence: nine years experience- results, complications, technique. Am J Obstet Gynecol 1968;100: [3] Sekine H, Kojima S, Igarashi K, Toyoshima T, Hayashi T, Shimoji Y. Burch bladder neck suspension for cystocele repair: the necessity of combined vaginal procedures for severe cases. Int J Urol 1999;6:1 6. [4] Cross C, Cespedes R, McGuire E. Treatment results using pubovaginal slings in patients with large cystoceles and stress incontinence. J Urol 1997;158: [5] Chaikin D, Groutz A, Blaivas J. Predicting the need for antiincontinence surgery in continent women undergoing repair of severe urogenital prolapse. J Urol 2000;163: [6] Raz S, Little N, Juma S, Sussman E. Repair of severe anterior vaginal wall prolapse (grade IV cystourethrocele). J Urol 1991;146: [7] Schaefer W. Urethral resistance? Urodynamic concepts of physiological and pathological bladder outlet function during voiding. Neurourol Urodyn 1985;4: [8] Raz S, Klutke C, Golomb J. Four-corner bladder and urethral suspension for moderate cystocele. J Urol 1989;142: [9] Kohli N, Sze E, Roat T, Karram M. Incidence of recurrent cystocele after anterior colporrhaphy with and without concomitant transvaginal needle suspension. Am J Obstet Gynecol 1996;175: [10] Raz S., Stothers L., Chopra A., Vaginal reconstructive surgery for incontinence and prolapse. In: Walsh PC, Retik AB, Vaughan ED, Wein AJ, editors. Campbell s Urology. Philadelphia: W.B. Saunders Co; p [11] Richardson AC, Lyon JB, Williams NL. A new look at pelvic relaxation. Am J Obstet Gynecol 1976;126: [12] Gardy M, Kozminski M, DeLancey J, Elkins T, McGuire EJ. Stress incontinence and cystoceles. J Urol 1991;145: [13] Griffiths DJ. Pressure-flow studies of micturition. Urol Clin North Am 1996;23: [14] Cormier L, Ferchaud J, Galas J-M, Guillemin F, Mangin P. Diagnosis of female bladder outlet obstruction and relevance of the parameter area under the curve of detrusor pressure during voiding: preliminary results. J Urol 2002;167: [15] Blaivas JG, Groutz A. Bladder outlet obstruction nomogram for women with lower urinary tract symptomatology. Neurourol Urodynam 2000;19: [16] Abrams PH, Griffiths DJ. The assessment of prostatic obstruction from urodynamic measurements and from residual urine. Br J Urol 1979;51: