Therapeutic efficacy and cognitive adverse events of overactive bladder medication in patients with central nervous system Disorders-A cohort study.

PURPOSE: This cohort study evaluates therapeutic efficacy and adverse events (AEs) of various overactive bladder (OAB) medications for patients with central nervous system (CNS) disorders. METHODS: Patients with OAB and CNS disorders were prospectively enrolled. They were randomly allocated to 3 different treatment subgroups: (1) mirabegron 50 mg once daily (2) solifenacin 5 mg per day, and (3) combined solifenacin 5 mg and mirabegron 50 mg once daily. Efficacy and safety questionnaires and objective parameters were compared among the subgroups, and subgroups between baseline and 3 and 6 months after treatment. AEs, including cognitive dysfunction, were assessed using the Mini-Mental State Examination (MMSE). RESULTS: 102 patients (mean age, 71.8 ± 8.7 years) were enrolled, including 35, 36, and 31 patients received mirabegron monotherapy, solifenacin monotherapy, and combination therapy, respectively. OAB symptoms scores all significantly improved 3 months after treatment in different subgroup. However, PVR increased and VE decreased significantly after treatment in patients receiving solifenacin monotherapy and combination therapy. Dry mouth and constipation were the most common AEs, especially in the solifenacin and combination subgroups. Mild incidence of AEs was noted in patients receiving mirabegron monotherapy. No significant change in MMSE was noted among the subgroups after treatment. CONCLUSION: OAB medication had good therapeutic efficacy in patients who had OAB with CNS disorders, especially in cerebrovascular accident and parkinsonism. No OAB medication or their combination affected cognitive function, whereas minimal AEs were noted with mirabegron. Mirabegron could be recommended as the first choice for managing OAB in these patients.

A Prospective, Multicenter, Double-Blind, Randomized Trial of Bladder Instillation of Liposome Formulation OnabotulinumtoxinA for Interstitial Cystitis/Bladder Pain Syndrome.

PURPOSE: Intravesical instillation of liposomal formulated botulinum toxin A (lipotoxin) has shown therapeutic effects as treatment of refractory overactive bladder without needle injections. We assessed lipotoxin to treat refractory interstitial cystitis/bladder pain syndrome. MATERIALS AND METHODS: This 2-center, double-blind, randomized, placebo controlled, physician initiated study enrolled patients with refractory interstitial cystitis/bladder pain syndrome. A total of 31 patients were assigned to intravesical instillation of lipotoxin (onabotulinumtoxinA 200 U with 80 mg sphingomyelin), 28 were assigned to onabotulinumtoxinA 200 U in normal saline and 31 were assigned to normal saline alone. The primary end point was the average change in O'Leary-Sant symptom scores, including ICSI (Interstitial Cystitis Symptom Index) and ICPI (Interstitial Cystitis Problem Index) between baseline and 4 weeks after treatment. Other end points included the average changes in a 3-day voiding diary, a visual analog scale for pain and a global response assessment of patient satisfaction. RESULTS: Improvements in the pain scale and O'Leary-Sant symptom scores occurred in all 3 groups by 4 weeks after treatment. Lipotoxin instillation was associated with a statistically significant decrease in O'Leary-Sant symptom scores (mean ± SD 7.38 ± 8.75), ICSI (4.00 ± 4.28), ICPI (3.35 ± 5.11) and the visual analog scale pain scale (1.64 ± 2.52), and an increase in the global response assessment (1.35 ± 1.28). However, there was no difference in improvement among the 3 groups. No significant adverse events were found in any group. CONCLUSIONS: Lipotoxin failed to demonstrate a positive proof of concept compared to onabotulinumtoxinA or placebo. However, a single intravesical instillation of lipotoxin was associated with decreased interstitial cystitis/bladder pain syndrome symptoms compared to baseline in patients with moderate to severe interstitial cystitis/bladder pain syndrome. The effect was likely due to a significant placebo effect.

Bladder instillation of liposome encapsulated onabotulinumtoxina improves overactive bladder symptoms: a prospective, multicenter, double-blind, randomized trial.

PURPOSE: Cystoscopic intradetrusor injection of botulinum toxin has helped patients with refractory overactive bladder but with the increased risks of urinary tract infection and urinary retention. We assessed whether catheter instillation of 200 U onabotulinumtoxinA formulated with liposomes is safe and effective for the treatment of overactive bladder. MATERIALS AND METHODS: This 2-center, double-blind, randomized, placebo controlled study enrolled patients with overactive bladder inadequately managed with antimuscarinics. Patients were assigned to intravesical instillation of lipo-botulinum toxin (31) or normal saline (31). The primary end point was the mean change in micturition events per 3 days at 4 weeks after treatment. Additional end points included mean changes in urgency events, frequency and urinary urge incontinence, as well as changes in overactive bladder symptom scores and urgency severity scores. RESULTS: At 4 weeks after treatment lipo-botulinum toxin instillation was associated with a statistically significant decrease in micturition events per 3 days (-4.64 for lipo-botulinum toxin vs -0.19 for placebo, p = 0.0252). Lipo-botulinum toxin instillation was also associated with a statistically significant decrease in urinary urgency events with respect to baseline but not placebo. However, lipo-botulinum toxin instillation was associated with a statistically significant decrease in urgency severity scores compared to placebo (p = 0.0181). These observed benefits of lipo-botulinum toxin instillation were not accompanied by an increased risk of urinary retention. The effects of lipo-botulinum toxin on urinary urge incontinence were inconclusive. CONCLUSIONS: A single intravesical instillation of lipo-botulinum toxin was associated with decreases in overactive bladder symptoms without side effects. Intravesical instillation of liposomal botulinum toxin may be a promising approach to treat refractory overactive bladder.

Treatment Patterns with Mirabegron and Antimuscarinics for Overactive Bladder: A Prospective, Registry Study in Taiwan and South Korea (FAITH).

INTRODUCTION: This study aimed to assess overactive bladder (OAB) treatment patterns and factors associated with effectiveness and persistence. METHODS: A prospective, longitudinal, observational registry study of adults starting OAB therapy with mirabegron or antimuscarinics was undertaken. Primary endpoints were time from treatment initiation to discontinuation/switching; proportion who discontinued/switched; and reasons for discontinuation/switching. Secondary endpoints included OAB Symptom Score (OABSS), OAB Questionnaire: Short Form, and OAB Bladder Assessment Tool scores; factors associated with effectiveness and persistence; and safety. RESULTS: In total, 556 patients initiating mirabegron and 250 initiating antimuscarinics were enrolled. There was no treatment switch, change, or discontinuation in 68.5% of the mirabegron initiator group and median time to treatment change was not reached. Mean initial treatment duration was 130.8 days. In multivariable models, baseline OABSS was the only variable significantly associated with change from baseline in OABSS, and patients with mild and moderate OAB had significantly better persistence with mirabegron than those with severe OAB. Urinary tract infection was the most common adverse event with mirabegron. There was no treatment switch, change, or discontinuation in 60.4% of the antimuscarinics initiator group and median time to treatment change was not reached. Solifenacin was the most frequent initial treatment (66.0%). Mean treatment duration was 122.2 days. In multivariable models, baseline OABSS was the only variable significantly associated with change from baseline in OABSS, while patients with OAB medication in the 12 months before enrollment had significantly better persistence with antimuscarinics than those with no previous OAB medication. Dry mouth was the most common adverse event with antimuscarinics. CONCLUSIONS: Mirabegron and solifenacin were commonly prescribed as first-line OAB medications. There was no treatment switch, change, or discontinuation in more than 60% of the mirabegron initiator and antimuscarinics initiator groups. Mean initial treatment duration was 130.8 days and 122.2 days for mirabegron and antimuscarinics, respectively. Graphical Abstract available for this article. TRIAL REGISTRATION: ClinicalTrials.gov NCT03572231.

How to choose appropriate medication for overactive bladder: Findings from the largest integrated clinical trial database analysis of mirabegron studies.

Medical treatment of overactive bladder (OAB) includes antimuscarinic agents, beta-3 adrenoceptor agonist (mirabegron), or combination with both drugs. Recently, a meta-analysis reported the integrated clinical trial data from 10 phase 2-4, double-blind, 12-week mirabegron monotherapy studies. The results confirmed that mirabegron is as effective as the previously used antimuscarinic agent to treat OAB. The treatment-emergent adverse events were similar across subgroups. This article comments on this largest integrated clinical trial data analysis, and reviews the recently published literature and tries to reveal how to choose the appropriate medication for OAB. For OAB patients, starting from antimuscarinic agent is feasible. However, if the patients have risk of cognitive dysfunction, a history of constipation, dry mouth, and urinary retention, starting with mirabegron 50 mg might be more safe and appropriate. In the elderly patients with low detrusor contractility, with central nervous system lesion, and men with benign prostatic hyperplasia, starting from 25 mg mirabegron is recommended. If the treatment result is not satisfactory to the 25 mg mirabegron, increase dose to 50 mg mirabegron is appropriate. In patients who have failed from the first OAB medication either with antimuscarinics or mirabegron 50 mg, the exchange of the OAB medication to each other should be tried first. If the treatment result is still not satisfactory, a combination of antimuscarinics and mirabegron is recommended.

Liposome-Encapsulated Botulinum Toxin A in Treatment of Functional Bladder Disorders.

Botulinum toxin A (BoNT-A) intravesical injections have been used to treat patients with refractory functional bladder disorders such as overactive bladder (OAB) and interstitial cystitis/bladder pain syndrome (IC/BPS), but the risk of adverse events and the need for repeated injections continue to prevent widespread application of this treatment. Liposomes are vesicles that comprise concentric phospholipid layers and an aqueous core; their flexible compositions enable them to adsorb and fuse with cell membranes and to deliver drugs or proteins into cells. Therefore, liposomes have been considered as promising vehicles for the less invasive delivery of BoNT-A. In previous placebo-controlled trials including patients with OAB refractory to medical treatment, it was shown that liposomal BoNT-A could significantly decrease the frequency and urgency of urination. In patients with IC/BPS, it was shown that liposomal BoNT-A could also improve bladder pain, but the therapeutic efficacy was not superior to that of the placebo. As the therapeutic mechanisms of BoNT-A include the decreased expression of nerve growth factors, P2X3 receptors, and vanilloid receptors on C-fibers, liposomal BoNT-A might play a more promising role in the treatment of bladder oversensitivity. This article features the contemporary literature regarding BoNT-A, liposomes, and liposomal BoNT-A treatment for functional bladder disorders and potential clinical applications in the future.

The efficacy of additive tolterodine extended release for 1-year in older men with storage symptoms and clinical benign proastatic hyperplasia.

AIM: To determine the efficacy of toterodine extended release (ER) treatment for 1 year in older men with benign prostatic hyperplasia (BPH) and storage symptoms treated with alpha-blockers and/or 5-alpha-reductase inhibitors (5ARI). METHODS: Men aged over 70 years with BPH/bladder outlet obstruction (BOO) and clinical storage symptoms were randomly treated with or without tolterodine ER in combination with alpha-blockers and/or 5ARI for 12 months. Among them, 50 patients (group 1) received additive tolterodine extended release (ER) 4 mg q.d., another 87 patients (group 2) did not. All patients had a baseline and 12th month post-treatment evaluation, which comprised of uroflowmetry, post-void residual (PVR) volume, International Prostate Symptom Score (IPSS), and quality of life index (QoL-I), transrectal ultrasound of the prostate and serum prostate specific antigen. RESULTS: One hundred thirty-seven of 153 enrolled patients with a mean age of 74.9 years completed the study. Treatment benefit demonstrated in both groups included deceased total, voiding and storage IPSS scores, increased peak urinary flow rate and deceased QoL-I. Inter-group difference was only observed on the storage domain of IPSS score (P = 0.012). The mean PVR after treatment did not significantly differ between two groups. Two patients of group 1 and three of group 2 developed acute urinary retention. Among group 1, six patients discontinued tolterodine ER for intolerable dry mouth; among group 2, three patients reported dizziness. CONCLUSIONS: This longer comparative study indicated that additive treatment with tolterodine ER in older men with BPH/BOO and significant storage symptoms is a beneficial and safe therapeutic option.

Novel Applications of Non-Invasive Intravesical Botulinum Toxin a Delivery in the Treatment of Functional Bladder Disorders.

Although intravesical botulinum toxin type A (BoNT-A) injection for functional bladder disorders is effective, the injection-related problems-such as bladder pain and urinary tract infection-make the procedure invasive and inconvenient. Several vehicles have recently been developed to deliver BoNT-A without injection, thereby making the treatment less or non-invasive. Laboratory evidence revealed that liposome can carry BoNT-A across the uroepithelium and act on sub-urothelial nerve endings. A randomized placebo controlled study revealed that intravesical administration of liposome-encapsulated BoNT-A and TC-3 hydrogel embedded BoNT-A can improve urinary frequency, urgency, and reduce incontinence in patients with overactive bladders. A single-arm prospective study also revealed that intravesical administration of TC-3 hydrogel embedded BoNT-A can relieve bladder pain in patients with interstitial cystitis/bladder pain syndrome (IC/BPS). We recently administered suprapubic energy shock wave (ESW) after BoNT-A intravesical administration in six patients with IC/BPS. Although pain reduction and symptom improvement were not significant, immunochemical staining showed cleaved synaptosome-associated protein 25 in the bladder after the procedure. This suggests that ESW can promote passage of BoNT-A across the uroepithelium. In conclusion, using vehicles to intra-vesically deliver BoNT-A for functional bladder disorders is promising. Further studies are necessary to confirm the efficacy and explore novel applications.

A double-blind, randomized, placebo-controlled, parallel study to evaluate the efficacy and safety of imidafenacin in patients with overactive bladder in Taiwan.

OBJECTIVE: This study evaluated the efficacy and safety of imidafenacin 0.1 mg twice daily vs placebo for Taiwanese patients with overactive bladder (OAB) after a 12-week oral administration. METHODS: This randomized, double-blind, placebo-controlled, two-arm, parallel-group, prospective study enrolled 118 patients across 11 study sites in Taiwan. Subjects were randomized to imidafenacin or placebo in a 2:1 ratio and entered the 12-week treatment period. At the subsequent visits, efficacy outcome measures and safety assessments were collected for analysis. The primary efficacy outcome was the change in the mean number of micturitions per day. Secondary endpoints included mean changes from baseline in urgency episodes and urge incontinence episodes per day and mean volume voided per micturition. Safety outcomes were also collected and compared between groups. RESULTS: A total of 78 and 40 patients were allocated to the imidafenacin and placebo groups, respectively. Among them, 100 patients (imidafenacin, 65 and placebo, 35) completed the trial. Compared with placebo, imidafenacin was significantly better at reducing the number of micturitions per day (-1.29 ± 2.23 vs -0.46 ± 3.49, P = .0171) and reducing the mean number of urge incontinence episodes (-0.15 ± 0.52 vs 0.04 ± 0.50, P = .0386) at week 12. Adverse events were reported in 35 subjects (44.9%) and 16 (40%) in the imidafenacin and placebo groups, including constipation (n = 3, 4), dry mouth (n = 11, 2), and urinary tract infection (n = 7, 4), respectively. One patient in the imidafenacin group had mild dysuria. CONCLUSION: Imidafenacin demonstrated efficacy and safety in the treatment of OAB in Taiwanese patients.

Efficacy and safety of mirabegron, a ß3 -adrenoceptor agonist, in patients with detrusor hyperactivity and impaired contractility.

OBJECTIVE: We examined the efficacy and safety of mirabegron in elderly patients with urodynamic detrusor hyperactivity with impaired contractility (DHIC). METHODS: Patients diagnosed with DHIC received daily dose of mirabegron (25mg). Subjective symptom scores, uroflowmetry data, and adverse events (AEs) were recorded for all patients at baseline and after 1, 3, and 6 months treatment. Comparisons were made for each patient individually and between patients with detrusor overactivity (DO). RESULTS: Of the 65 patients enrolled in the study, 25 had DHIC and 40 had DO (mean [± SD] age 79.3 ± 9.6 and 75.6 ± 10.7 years, respectively). At the 6-month follow-up, significant (P < .05) improvement was seen compared with baseline in both the DHIC and DO groups in terms of OAB symptom scores (4.72 ± 3.05 vs. 6.88 ± 4.06 and 4.50 ± 2.99 vs. 6.70 ± 3.60, respectively), urgency severity score (1.90 ± 2.00 vs. 3.35 ± 1.13 and 1.58 ± 1.93 vs. 3.00 ± 1.65, respectively), and global response assessment (1.80 ± 1.41 and 1.73 ± 1.34, respectively). In the DHIC group, post-void residual (PVR) volume decreased from 153 ± 52.7 mL at baseline to 85.8 ± 90.1 mL at 6th month (P < .05) and voiding efficiency improved from 40.0 ± 20.7% to 62.6 ± 28.3% (P < .05). Common AEs included dry mouth and dizziness, yet 16% of DHIC patients developed PVR >180 mL. CONCLUSION: Mirabegron was an effective treatment option in elderly patients with urodynamic DO and DHIC in the present study. The AEs reported were mild and infrequent.

Treatment Outcome of Overactive Bladder Patients Receiving Antimuscarinic Therapy for More than One Year.

OBJECTIVES: Details on the therapeutic effects of long-term antimuscarinic therapy have not been reported. Thus, the aim of this study is to evaluate the detailed long-term therapeutic effect of antimuscarinic therapy. METHODS: All consecutive patients who visited the urologic outpatient clinics of a medical center for treatment of overactive bladder syndrome and received antimuscarinic therapy of 12 months or more were retrospectively reviewed. All medical records, including the Overactive Bladder Symptom score (OABSS), the modified Indevus Urgency Severity Scale and the International Prostate Symptoms score (IPSS) questionnaires, and uroflowmetry parameters were reviewed at each visit. RESULTS: A total of 140 patients had received 12 months or more of antimuscarinic therapy. Sustained therapeutic effects were observed by persistent decreases of IPSS-storage score, IPSS-total score and OABSS score. Moreover, the maximum flow rate did not change over time. A temporary increase in postvoid residual volume and decrease in voiding efficiency were found, but these parameters improved over long-term visits. Side-effects were observed in 81 patients (57.9%) and included dry mouth (n = 58, 41.4%), constipation (n = 48, 34.3%) and blurred vision (n = 4, 2.9%); all side-effects were tolerable. Patients aged 75 years or more (n = 94) had a higher comorbidity rate (n = 46, 48.9%) before treatment but generally exhibited similar therapeutic effects as overall patients; elderly patients could also tolerate side-effects. CONCLUSION: Sustained therapeutic effects were observed in patients who received 12 months or more of antimuscarinic therapy, even in elderly patients. In addition, side-effects in patients receiving long-term therapy were also common but tolerable.

Presence of Cleaved Synaptosomal-Associated Protein-25 and Decrease of Purinergic Receptors P2X3 in the Bladder Urothelium Influence Efficacy of Botulinum Toxin Treatment for Overactive Bladder Syndrome.

OBJECTIVES: To evaluate whether botulinum toxin A (BoNT-A) injection and Lipotoxin (liposomes with 200 U of BoNT-A) instillation target different proteins, including P2X3, synaptic vesicle glycoprotein 2A, and SNAP-25, in the bladder mucosa, leading to different treatment outcomes. MATERIALS AND METHODS: This was a retrospective study performed in a tertiary teaching hospital. We evaluated the clinical results of 27 OAB patients treated with intravesical BoNT-A injection (n = 16) or Lipotoxin instillation (n = 11). Seven controls were treated with saline. Patients were injected with 100 U of BoNT-A or Lipotoxinin a single intravesical instillation. The patients enrolled in this study all had bladder biopsies performed at baseline and one month after BoNT-A therapy. Treatment outcome was measured by the decreases in urgency and frequency episodes at 1 month. The functional protein expressions in the urothelium were measured at baseline and after 1 month. The Wilcoxon signed-rank test and ordinal logistic regression were used to compare the treatment outcomes. RESULTS: Both BoNT-A injection and Lipotoxin instillation treatments effectively decreased the frequency of urgency episodes in OAB patients. Lipotoxin instillation did not increase post-void residual volume. BoNT-A injection effectively cleaved SNAP-25 (p < 0.01). Liposome encapsulated BoNT-A decreased urothelial P2X3 expression in the five responders (p = 0.04), while SNAP-25 was not significantly cleaved. CONCLUSIONS: The results of this study provide a possible mechanism for the therapeutic effects of BoNT-A for the treatment of OAB via different treatment forms. BoNT-A and Lipotoxin treatments effectively decreased the frequency of urgency episodes in patients with OAB.

Pilot study of liposome-encapsulated onabotulinumtoxina for patients with overactive bladder: a single-center study.

BACKGROUND: Intradetrusor onabotulinumtoxinA (BoNT-A) injection benefits overactive bladder (OAB) patients, but increased postvoid residual (PVR) urine volume and urinary tract infection (UTI) remain risks. Intravesical instillation of liposomal BoNT-A instead of injection could prevent such adverse events. OBJECTIVE: To evaluate instillation of liquid liposomal BoNT-A (Lipotoxin) for the treatment of OAB and to determine its mechanism of action. DESIGN, SETTING, AND PARTICIPANTS: A double-blind randomized parallel controlled pilot trial in 24 OAB patients at a single tertiary center. INTERVENTION: Patients were randomly assigned to intravesical instillation of Lipotoxin containing 80 mg liposomes and 200 U BoNT-A or normal saline (N/S). Patients were retreated with Lipotoxin 1 mo later if they failed the first treatment. OUTCOME MEASUREMENT AND STATISTICAL ANALYSIS: Voiding diaries, OAB symptom scores, urodynamic studies, and adverse events were monitored. The primary end point was change of total urinary frequency per 3 d at 1 mo after treatment. Immunohistochemistry and Western blotting for synaptic vesicle glycoprotein 2A (SV2A) and synaptosomal-associated protein, 25 kDa (SNAP25) were performed at baseline and 3 mo after treatment. The Wilcoxon rank sum test and Wilcoxon signed rank test were used for statistical analysis. RESULTS AND LIMITATIONS: At 1 mo after treatment, the change of urinary frequency per 3 d significantly improved in the Lipotoxin group (n=12; median: -6.50; interquartile range [IQR]: -18.3 to -0.25; p=0.008) but not in the N/S group. (n=12.0; IQR: -7.75 to 8.0; p=0.792). Urgency episodes also showed a significant decrease in the Lipotoxin group (-12.0; IQR: -20.3 to -2.75; p=0.012) but not in the N/S group (-1.0; IQR: -11.0 to 2.5; p=0.196). SV2A and SNAP25 were expressed in urothelial cells and suburothelial tissues. However, the protein expression did not significantly differ between responders and nonresponders at 3 mo after treatment. CONCLUSIONS: Intravesical Lipotoxin instillation effectively reduced frequency episodes 1 mo after treatment in OAB patients without any increase in PVR or risk of UTI. PATIENT SUMMARY: We demonstrated that intravesical Lipotoxin instillation reduced frequency episodes at 1 mo in overactive bladder patients. This procedure is safe, without an increase in postvoid residual or the risk of urinary tract infection.

Effect of detrusor function on the therapeutic outcome of a suburethral sling procedure using a polypropylene sling for stress urinary incontinence in women.

OBJECTIVE: To assess the effect of detrusor function on the therapeutic outcome of a suburethral sling procedure in women with stress urinary incontinence (SUI). MATERIAL AND METHODS: A total of 192 women with SUI who had undergone a suburethral sling procedure were enrolled. According to the baseline urodynamic results, patients' bladder functions were classified as follows: (i) normal detrusor function; (ii) detrusor overactivity; and (iii) detrusor underactivity or acontractile detrusor. Surgical results, urodynamic parameters and patient satisfaction were compared among these three groups. RESULTS: Overall, 106 patients had normal detrusor function, 36 had detrusor overactivity and 50 had detrusor underactivity or an acontractile detrusor. A continent outcome was achieved in 135 women (70.3%), urge incontinence in 23 (12%), minimal SUI in 32 (16.7%) and moderate SUI in two (1%). Persistent urge incontinence was noted in 13 women (36%) with detrusor overactivity, and recurrent SUI occurred in 18 women (36%) with detrusor underactivity or an acontractile detrusor. No significant change in urodynamic parameters between baseline and after treatment was found in any of the patient groups. The satisfaction rate was 98.1% in patients with normal detrusor function, 82% in patients with detrusor underactivity or an acontractile detrusor and 75% in patients with detrusor overactivity (p<0.05). CONCLUSION: Compared to women with normal detrusor function, those with preoperative detrusor overactivity and those with detrusor underactivity or an acontractile detrusor experienced an unfavorable therapeutic outcome of the suburethral sling procedure in terms of urge incontinence and recurrent SUI after surgery.

Long-term surgical results of pubovaginal sling procedure using polypropylene mesh in the treatment of stress urinary incontinence.

INTRODUCTION: Surgery for stress urinary incontinence (SUI) in women might cure incontinence symptom but develop new problems. This study assessed the long-term outcome of pubovaginal sling procedure using polypropylene mesh in patients with SUI. MATERIALS AND METHODS: A total of 108 patients with various types of SUI received pubovaginal sling procedure using polypropylene mesh. A surgical technique that did not create bladder outlet obstruction after operation was used in all the patients. Video urodynamic study was performed at baseline, 2 weeks and 3 months after operation. The long-term surgical results and patients' satisfaction were assessed. RESULTS: The age of patients ranged from 33 to 94 years (mean 62.6 +/- 12.0 years). The follow-up period ranged from 24 to 72 months (median 46 months). Among the 108 patients, a successful result was noted in 92 (85.2%), including a continence rate of 65.7% and mild SUI in 19.4% of patients. Treatment failure was noted in 16 patients (14.8%), including 13 (12%) with urge incontinence and 3 (2.8%) with severe SUI that was cured by a second sling. There were 104 patients (96.3%) who could void volitionally with little residual urine, whereas 4 (3.7%) needed transvaginal urethrolysis. Urodynamic study revealed no significant changes in the mean values of parameters at 3 months after operation. However, 22 (20%) patients had an increase in voiding pressure by 50% at 3 months postoperatively. The reported satisfactory rate was 89.8%. CONCLUSIONS: Pubovaginal sling procedure using polypropylene mesh had a high success rate in all types of SUI. The continence rate was suboptimal, indicating that the absence of bladder outlet obstruction might result in inadequate urethral compression after pubovaginal sling procedure.