Lower urinary tract symptoms in female patients with pelvic organ prolapse: Efficacy of pelvic floor reconstruction

bs_bs_banner International Journal of Urology (14) 1, 301 307 doi:.1111/iju.181 Original Article: Clinical Investigation Lower urinary tract symptoms in female patients with pelvic organ prolapse: Efficacy of pelvic floor reconstruction Daisuke Obinata, Kenya Yamaguchi, Akiko Ito, Yasutaka Murata, Daisaku Ashikari, Tomohiro Igarashi, Katsuhiko Sato, Junichi Mochida, Yataro Yamanaka and Satoru Takahashi Department of Urology, Nihon University School of Medicine, Tokyo, Japan Abbreviations & Acronyms HRQL = health-related quality of life ICIQ-SF = International Consultation on Incontinence Questionnaires Short Form IPSS = International Prostate Symptom Score LUTS = lower urinary tract symptoms MFR = maximal flow rate OAB-Q = overactive bladder questionnaire POP = pelvic organ prolapse POP-Q = pelvic organ prolapse quantification PVR = postvoid residual QOL = quality of life SUI = stress urinary incontinence TOT = transobturator tape TVM = tension-free vaginal mesh Correspondence: Satoru Takahashi M.D., Ph.D., Department of Urology, Nihon University School of Medicine, 30-1 Ooyaguchikamicho, Itabashi, Tokyo 173-86, Japan. Email: takahashi.satoru@nihon-u.ac.jp Received 14 March 13; accepted 14 August 13. Online publication 30 September 13 Objective: To evaluate the impact of pelvic floor reconstruction on lower urinary tract symptoms in patients with pelvic organ prolapse. Methods: We carried out a prospective study at a single institution. A total of 3 female patients who underwent tension-free vaginal mesh surgery for pelvic organ prolapse between January 06 and February were enrolled and prospectively evaluated. A total of 171 cases with concurrent stress urinary incontinence (76% of all cases) underwent concomitant transobturator tape sling. For evaluation of lower urinary tract symptoms, parameters included International Prostate Symptom Score, its quality of life score, International Consultation on Incontinence Questionnaires Short Form, overactive bladder questionnaire, maximal flow rate and postvoid residual. These parameters were evaluated at baseline, and at 3, 6 and 1 months after the surgery. Results: The severity of International Prostate Symptom Score total scores significantly correlated with preoperative pelvic organ prolapse quantification stages, overactive bladder questionnaire total scores and International Consultation on Incontinence Questionnaires Short Form scores. A total of 37% of stage 4 showed International Prostate Symptom Score (severe cases). Postvoid residual significantly increased in stage 4 compared with stage. Tension-free vaginal mesh improved International Prostate Symptom Score, overactive bladder questionnaire and International Consultation on Incontinence Questionnaires Short Form significantly, and also achieved grade 0 pelvic organ prolapse quantification in 91% of all cases at 1 year after surgery. Postvoid residual values significantly improved and remained stable for 1 year. Worse overactive bladder questionnaire score was a significant predictive factor for poor postoperative International Prostate Symptom Score. Conclusion: The tension-free vaginal mesh plus transobturator tape procedure improves lower urinary tract symptoms in the majority of patients presenting pelvic organ prolapse. Key words: lower urinary tract symptoms, pelvic organ prolapse, quality of life, tensionfree vaginal mesh. Introduction POP is a common problem in the aging female. It has been reported that 11% of women in the USA have surgery for POP and/or a related condition by the age of years. 1 Recent studies have shown that POP impacts health-related QOL, as well as lower urinary tract function. 4 Although LUTS are common in women of all ages, the prevalence rises with age. Reports show that many of the female patients with LUTS have associated POP. Therefore, the treatment of POP might be effective for the improvement of female LUTS that cause a negative effect on QOL. The surgical procedure, known as TVM surgery, involved the implantation of a synthetic mesh (polypropylene mesh) in areas of vesicovaginal and rectovaginal dissection spaces. Although conventional treatment strategies for POP repair have a recurrence rate of 30%, 1,6,7 TVM surgery has gained popularity in POP repair since the higher rates of successful treatment. Consistent with previous reports, we have reported 9.3% of anatomical cure rates at 1 year with low incidences of surgical complications. 8,9 Although several studies have shown a relationship of POP with LUTS,,11 or the anatomical efficacies of TVM for POP, 1,13 just a few papers have prospectively evaluated both issues in the same cases, and the efficacies of concomitant TOT sling for SUI. 14 In the present study, we prospectively evaluated LUTS in patients with POP, and 1-year clinical efficacies of the TVM ± TOT procedure. 13 The Japanese Urological Association 301

D OBINATA ET AL. Table 1 Methods Patient characteristics and preoperative assessments n (SD) Age (years) 67. (7.9) Parity.1 (0.6) Number of previous or occult SUI 171 History of POP surgery 1 Previous hysterectomy 8 Preoperative POP-Q stage Stage 9 Stage 3 11 Stage 4 73 Procedure A-TVM 1 AP-TVM 6 Total TVM 8 Concomitant TOT 171 LUTS evaluations IPSS total score 13. (9.0) IPSS QOL score 4. (1.) OAB-q total score 67.4 (3.) ICIQ-SF 7. (.7) n = 3. These studies were carried out at a single institution after approval of the ethics committee and institutional review board of Nihon University School of Medicine (approval number: 0903). All participants gave their written informed consent to participate in the present study and undergo the TVM ± TOT procedure. Patients who underwent TVM surgery with various types of POP were considered eligible. Exclusion criteria included: previous history of treatment of POP, presence of an apparent neurogenic bladder or urogenital malignancy. Between January 06 and February, 3 female patients of 4 recruited cases agreed to participate in the study and were eligible. A total of 3 individuals were qualified as stage in the POP-Q system, 1 A total of 118 and 73 were stage 3 and 4, respectively (Table 1). All cases had cystocele, including eight cases with vaginal vault prolapse, 1 with uterine prolapse and 36 with rectocele. After obtaining written informed consents, anterior TVM repair was carried out in 1 cases with cystocele, anterior/posterior TVM in 4 cases with prolapse of the apical compartment, and total TVM in eight cases with vaginal vault prolapse. A total of 171 cases with concurrent SUI (76% of all cases) underwent concomitant TOT sling because of concurrent SUI (Table 1). SUI was confirmed by a pad test or stress test. The degree of POP was evaluated by the POP-Q system. To evaluate LUTS and the related QOL, we used IPSS, IPSS-QOL score, OAB-Q, 16 and ICIQ-SF. 17 As objective parameters, we evaluated MFR (ml/s) and PVR (ml). The efficacies and complications of each patient were systematically assessed before, and 3, 6 and 1 months after surgery. During the assessments, four of 3 dropped out of the study (one case underwent additional posterior TVM 3 months after the, and three cases had additional prolapse surgery after 6 months). Data were analyzed with Spearman s correlation, Mann Whitney U-test, Wilcoxon signed rank test, one-way ANOVA and Bonferroni s multiple comparison tests or Dunnett tests compared with the control group. P-values <0.0 were considered statistically significant. Logistic regression was used for uniand multivariate analysis. Variables with a P < 0.03 in univariate analysis were included in the multivariate analysis. Analyses were carried out using JMP version 9 (SAS Institute Japan, Tokyo, Japan). Results Although % of cases with POP-Q stage showed less than 8 points of IPSS (mild cases), 37% of stage 4 showed equal to or more than points (severe cases) (Fig. 1). Interestingly, just 8% or 6% cases with stage, 3 and 4 showed mild cases in IPSS-QOL (Fig. 1). All subscores of IPSS, especially incomplete emptying (stage 1.36 ± 1.46, stage 3 1.87 ± 1.74, stage 4.6 ±.03 points) and weak stream (stage 1.48 ± 1.3, stage 3.11 ± 1.84, stage 4.7 ± 1.99 points), tended to deteriorate in stage 4 (Table ). This tendency was also observed in OAB-Q total sores (stage 76.3 ± 1.0, stage 3 69.0 ± 1.0, stage 4.0 ± 6.0 points) and ICIQ-SF scores (stage.9 ±.8, stage 3 6.8 ±.4, stage 4 8.4 ± 6.1 points; Table ). Regarding urinary function, MFR showed no difference among these stages (stage 6.0 ± 11.0, stage 3 1.8 ± 8.1, stage 4 6. ± 6. ml/s); however, PVR significantly increased in stage 4 compared with stage (stage 7.9 ± 36.6, stage 3 4.4 ± 71.7, stage 4 6.9 ± 94.7 ml; Table ). Furthermore, the associations between type of prolapse, patient characteristics and LUTS were analyzed. There was a significant association between stage 4 cystocele (correlation coefficient 0.16, P = 0.08), uterine prolapse (correlation coefficient 0.19, P = 0.0077) and severe IPSS scores ( or more points). Regarding the efficacy of TVM surgery, anatomical cure rate (% grade 0 cases) was 91% at 1 year after surgery (Table 3). Although we found that seven cases remained in grade or 3 postoperatively, all of these cases were previously grade 4, and then they achieved a downgrade. After surgery, 76% and % of all cases were classified as mild in IPSS total scores, and also in IPSS-QOL (Fig. a). All subscores of IPSS, except nocturia, significantly improved 3 months after the surgery, which were maintained for 1 year (P < 0.0001; Fig. b). Like IPSS scores, all domains of OAB-Q and ICIQ-SF scores for all patients also significantly improved 3 months after surgery, which were maintained for 1 year (Fig. 3a,b). Various risk factors for postoperative severe IPSS scores were apparent in a univariate and multivariate logistic regression model. Among preoperative POP-Q, IPSS, OAB-Q, ICIQ-SF, MFR and PVR, worse OAB-Q score was the best predictor of postoperative severe IPSS (9% CI 0.0008 0.000, P = 0.009). Although there was no change in MFR before and after surgery, PVR was significantly improved, and maintained for 1 year (18.8 17.8 ml/s, P = 0.6; and 73.9 34.4 ml, P < 0.0001, respectively; Fig. 4a,b). There were no differences in voided volume among these time-points (pre ± 74.9, 3 months 17 ± 13.7, 6 months 1.6 ± 131.6, 1 months 19.6 ± 74.9 ml). To confirm the efficacy of LUTS by TOT, we 30 13 The Japanese Urological Association

LUTS in POP patients and TVM ± TOT IPSS Total score IPSS QOL score Fig. 1 Evaluation of IPSS total and IPSS-QOL scores according to POP-Q stage (mild: 0 7, moderate: 8 19, severe: or more points in IPSS total scores; mild: 0 or 1, moderate: 4, severe: or 6 points in IPSS QOL scores.), Mild;, moderate;, severe. (%) 16 44 41 37 3 34 8 Stage Stage 3 Stage 4 (%) 6 71 36 4 3 8 6 6 Stage Stage 3 Stage 4 Table Correlations between LUTS parameters and POP-Q stage POP-Q stage (SD) 3 4 Subjective parameters IPSS (points) Voiding symptom Incomplete emptying* 1.36 (1.46) 1.87 (1.74).6 (.03)* Intermittency 1. (1.) 1. (1.70) 1.88 (1.90) Weak stream* 1.48 (1.3).11 (1.84).7 (1.99)* Straining 1.4 (1.6) 1.41 (1.6) 1.9 (1.86) Storage symptom Frequency.08 (1.68).41 (1.6).6 (1.96) Urgency 1.3 (1.49) 1.93 (1.81).4 (.01) Nocturia 1.36 (1.03) 1.6 (1.09) 1.89 (1.36) Total scores*.3 (7.61) 11.8 (8.) 1.0 (.) OAB-Q (points) Symptom severity.4 (4.1) 3.9 (3.9) 41.6 (7.) Coping 71.3 (.3) 64. (7.3) 4.8 (3.) Concern 71.3 (19.3) 6.9 (3.6).3 (8.) Sleep 79.1 (17.7) 7.7 (.0) 66.4 (.) Social 88.3 (11.6) 79.0 (1.0) 7.6 (.9) Total* 76.3 (1.0) 69.0 (1.0).0 (6.0)* ICIQ-SF (points).9 (.8) 6.8 (.4) 8.4 (6.1) Objective parameters MFR (ml/s) 6.0 (11.0) 1.8 (8.1) 6. (6.) PVR (ml)* 7.9 (36.6) 4.4 (71.7) 6.9 (94.7)* Voided volume (ml) 6. (114.6) 6.1 (117.8). (148) *ANOVA with post-hoc (Dunnett analysis) test, P < 0.0 versus stage. Table 3 Surgical outcomes of TVM procedures during 1-year follow up POP-Q stage 0 1 3 4 Pre 0 0 34 1 64 1Years(n = 3) 16 0 0 91 % Cure Anatomical cure rate (%) is a percentage of stage 0 cases in total 3 cases. compared cases with TVM and concurrent TOT (TVM/TOT group; n = 171), and TVM without TOT cases ( group; n = ). Although preoperative ICIQ-SF of the TVM/ TOT group was significantly higher than the group, a significant improvement was observed in IPSS, OAB-q, ICIQ-SF and PVR, except MFR, in both groups after surgery (Fig. ). In addition, postoperative de novo or worsened OAB occurred in three out of 171 (1.8%) in the TVM/TOT group; however, they occurred in two of (3.8%) in the group. One patient was prescribed anticholinergic drugs for SUI and OAB symptoms after TVM/TOT surgery. As for postoperative SUI, although 1.8% of cases with TVM/ TOT group had persistent SUI, 9.6% of cases with group experienced de novo SUI. Discussion A significant association of LUTS with POP stage and efficacy of pelvic floor reconstructive procedure for LUTS were apparent in the present study. We showed deteriorated IPSS score in POP stage 4, and the maintenance of improved LUTS for 1 year after TVM ± TOT. Although there are some reports about the anatomical success rate of mesh surgical repair of POP, 1,13,18 few were addressed on its efficacy in LUTS. 14 Compared with previous reports about conventional POP repair on LUTS, our 13 The Japanese Urological Association 303

D OBINATA ET AL. (%) IPSS total score 3 7 33 3 66 Pre 3 7 73 76 6 1 Months after the 1 Pre 3 6 1 Incomplete emptying Pre 3 6 1 Intermittency Pre 3 6 1 Weak stream Pre 3 6 1 (months) Straining (%) IPSS QOL score 6 3 3 6 1 48 47 1 36 43 0 8 Pre 3 6 1 Months after the Pre 3 6 1 Frequency Pre 3 6 1 Urgency Pre 3 6 1 (months) Nocturia Fig. Changes in IPSS total and IPSS-QOL scores after the. A total of 67% of cases showed significant LUTS according to IPSS results, which reduced to 4% of cases postoperatively. Changes in IPSS domain after the. All domains of IPPS, except nocturia, were significantly improved. (P < 0.0001 vs preoperative score.), Mild;, moderate;, severe. 1 OAB-Q ICIQ-SF Points Points Pre 3 61 Pre 3 61 Pre 3 61 Pre 3 61 Pre 3 61 Pre 3 61(months) Symptom Coping Concern Sleep Social Total severity QOL Preoperatively 3 6 Months after the 1 Fig. 3 Changes in the OAB-Q and ICIQ-SF score 1 year after the. The domain of OAB-Q was significantly improved postoperatively. Only the symptom severity domain indicates that higher score values means greater symptom severity or bother, and lower scores indicate minimal symptom severity. (P < 0.0001 vs preoperative score) The preoperative ICIQ-SF score was high, and decreased after the. (P < 0.0001 vs preoperative score.) TVM ± TOT data seems to be favorable. Book et al. reported that approximately 3% of posterior colporrhaphy cases had postoperative transient urinary retention. 1 Costantini et al. reported that incontinence was successfully resolved in 8% cases, and instability persisted in 7% patients after four-corner colposuspension. Regarding two-corner bladder neck suspension, Hirata et al. reported that 3% patients with presurgical voiding difficulty had persistent symptoms, and 7% of cases had developed postoperative storage symptoms. 3 The IPSS, which was initially developed to assess LUTS in men with benign prostatic hyperplasia, has been recently reported to be relevant when used in women as well. 4 7 These 304 13 The Japanese Urological Association

LUTS in POP patients and TVM ± TOT PVR (ml) MFR (ml/s) 1 Fig. 4 (a,b) The improvement of urinary function. Although there was no change in MFR before and after surgery, PVR significantly improved postoperatively (P < 0.0001 vs preoperative score). Pre 3 6 1 (Months) Pre 3 6 1 (Months) (c) * IPSS (points) OAB-Q (points) ICIQ-SF (points) (d) (e) PVR (ml) MFR (ml/s) 1 Fig. Comparison in efficacies of the TVM/TOT group and group (TVM/TOT; n = 171, ; n = ). In both groups, a significant improvement was observed in IPSS, OAB-Q, (c) ICIQ-SF and (d) PVR, except MFR (e), after the (P < 0.0001 vs each preoperative scores). Preoperative ICIQ-SF of the TVM/TOT group was significantly higher than the group (*P < 0.0).,Pre;, post. reports show that IPSS is neither sex specific nor disease (benign prostate hyperplasia) specific. Many urologists and researchers have already used IPSS for analysis of female LUTS. IPSS classifies LUTS to mild, moderate and severe by total scores; in addition, each symptom is classified into storage or voiding/postvoid symptoms. The present study showed that many patients with POP experience both symptoms severely, especially in high-stage cystocele or significant uterine prolapse. Among the questions of the IPSS regarding voiding symptoms, deteriorated scores of two questions (incomplete emptying and weak stream) were significantly associated with advanced POP-Q stages. Although increased PVR was observed in severe POP cases, there was no difference in MFR among POP stages. Some reports showed that POP, especially anterior vaginal wall prolapse, might affect the lower urinary tract by causing urethral obstruction, or attenuation of abdominal pressure during voiding, which leads to voiding difficulty. 8 31 As all of the voiding symptoms and PVR were significantly improved, and no MFR change was observed after surgery, voiding difficulty might be relieved by a resupported pelvic floor. In addition, no difference was observed in postoperative MFR between the TVM/TOT group (n = 171) and group (n = ; Fig. d,e). Therefore, TOT was not likely to induce urethral stricture or bladder outlet obstruction. Storage symptoms were evaluated by IPSS, OAB-Q and ICIQ-SF. OAB-Q is a multidimensional instrument designed to assess the symptom of bother and HRQL impact of overactive bladder. The higher score of HRQL total score indicates the better HRQL. Interestingly, recent studies have shown that POP plays a key role in the symptomatic OAB caused by urethral obstruction and neurogenic factors. 4,3 34 We showed TVM ± TOT improves OAB symptoms, and it is supportive for results of these studies of POP patients. The ICIQ-SF questionnaire is used for evaluation of clinical manifestations in patients with 13 The Japanese Urological Association 30

D OBINATA ET AL. urinary incontinence. 3 The higher score means severe symptoms of urinary incontinence. In the present study, ICIQ-SF tends to be worse in high-stage POP. Before surgery, ICIQ-SF scores of the group were significantly lower than the TVM/TOT group, because all of the TVM/TOT cases already had SUI or occult SUI (Fig. c). Although de novo irritative symptoms and OAB might arise secondary to placement of a mesh, we found just five of 3 cases with de novo OAB after the surgery. Furthermore, the number of patients with postoperative de novo SUI and OAB is fewer in cases with concomitant TOT than in. A previous report showed that abdominal sacrocolpopexy with Burch colposuspension for POP patients significantly reduced postoperative symptoms of SUI without increasing other LUTS. 36 In that report, 3.8% of the concomitant Burch group and 44.1% of the sacrocolpopexy alone group had de novo SUI (P < 0.001) 3 months after surgery. That result was similar to the present data regarding concomitant surgery for SUI. Furthermore, these data show that some cases of POP have a potential risk of de novo SUI and OAB. To date, no established tests can identify cases with the risk preoperatively. In addition to subsequent improvements of storage symptoms by the TVM surgery, TOT might consolidate the effectiveness of TVM by supporting pre-existing, preclinical damaged urethral ligaments. Regarding postoperative LUTS, we studied preoperative predictive factors by univariate and multivariate models. Patient characteristics, such as age, POP-Q stage, preoperative IPSS, MFR and PVR, did not appear to influence the risk of severe IPSS after surgery. Interestingly, severe OAB-Q total score was by far the best preoperative predictor for postoperative severe IPSS scores. As the precise significance of this fact still remains unclear, preoperative OAB might at least relate to postoperative LUTS in POP patients. On October 08, US Food and Drug Administration issued a warning position statement with regards to mesh materials in SUI and POP surgery. This warning shows over 0 reported complications of vaginal and urinary erosion, as well as bowel and vascular injuries. Although complications might occur that are unique to specific mesh materials, these complications appear to be rare under the adequate indication and procedure. Our previous report shows that there are few cases with perisurgical complications. 9 Our observation in a single institution has shown a significant correlation between POP and LUTS, and favorable results of pelvic floor reconstructive procedure for the improvement of LUTS. The present data strongly support the efficacy of TVM ± TOT for LUTS. Further studies are necessary for longterm efficacy of TVM and TVM with concomitant TOT procedures. 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