Solifenacin Research Articles

Efficacy and safety of tamsulosin hydrochloride 0.2 mg and combination of tamsulosin hydrochloride 0.2 mg plus solifenacin succinate 5 mg after transurethral resection of the prostate: a prospective, randomized controlled trial.

ObjectiveThe objective of this study was to evaluate the safety and efficacy of tamsulosin hydrochloride 0.2 mg (TAM) and its combination with solifenacin succinate 5 mg (SOL) after transurethral resection of the prostate (TURP).Patients and methodsThe patients were randomized into three groups: TURP (group 1), TURP plus TAM (group 2), and TURP plus TAM + SOL (group 3). Patients in group 2 and group 3 received medication for 4 weeks. The primary efficacy end points were the mean change in total International Prostate Symptom Score (IPSS) and IPSS subscores. The secondary end points included quality-of-life score, Overactive Bladder Symptom Score, and short-form voiding and storage score of International Continence Society.ResultsIn total, 37 men (31.8%) in group 1, 37 men (31.8%) in group 2, and 42 men (36.2%) in group 3 completed the study. In total IPSS, no significant improvement was seen from baseline to the end of treatment in groups 2 and 3 compared with group 1. However, in group 2, the decrement in the IPSS storage score was smaller than group 1 (P=0.02), and in group 3, the decrement in the IPSS voiding score was smaller than group 1 (P=0.05). In groups 2 and 3 compared with group 1, improvements in the quality of life score, total score of Overactive Bladder Symptom Score, and short-form voiding score and storage score of International Continence Society were not statistically significant.ConclusionTreatment with TAM and combination of TAM and SOL did not have significant additional benefits for lower urinary tract symptoms during the early recovery period after TURP.

Long-term prospective study of the persistence of solifenacin succinate in previously untreated Japanese female patients with overactive bladder.

To prospectively evaluate the persistence of solifenacin treatment in previously untreated Japanese female patients with overactive bladder. A total of 73 previously untreated Japanese female patients diagnosed with overactive bladder were given 5 mg of solifenacin once daily and prospectively followed for 3 years with periodic evaluations. The drug persistence rate was estimated using the Kaplan-Meier method. If solifenacin had to be terminated or a patient did not come to the hospital to receive a prescription, the reason was determined. After solifenacin treatment, the overactive bladder symptom score and average voided volume were significantly improved and maintained for 3 years. The 6-month, 1-year, 2-year and 3-year persistence rates were 50.7%, 41.1%, 32.9% and 23.3%, respectively. The major reasons for solifenacin therapy discontinuation were symptom resolution (27.4%) and adverse events (20.5%). Patients with nocturia three times or more at baseline had lower persistence than those with nocturia more than three times. Patients without detrusor overactivity at baseline had lower drug persistence than those with detrusor overactivity. Approximately one-quarter of previously untreated Japanese overactive bladder female patients continue solifenacin treatment for 3 years. Many patients discontinue solifenacin for various reasons, including symptom resolution and adverse events.

DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING HPTLC METHOD FOR DETERMINATION OF SOLIFENACIN SUCCINATE AS BULK DRUG AND IN TABLET DOSAGE FORM

A new simple, stability- indicating high performance thin layer chromatographic (HPTLC) method has been developed and validated for estimation of Solifenacin succinate in bulk and in tablet dosage form. The optimized mobile phase was Methanol: Water: Glacial acetic acid (9:1:0.1v/v/v) with UV detection at 216 nm. The retention factor for Solifenacin succinate was found to be 0.49 ± 0.03. The drug was subjected to stress conditions of hydrolysis under different pH conditions, oxidation, photolysis and thermal degradation as per ICH guidelines. Results were found to be linear in the concentration range of 2000-10000ng band-1.

Efficacy of solifenacin in the treatment of bladder spasm after surgical operation of chlidren hypospadias

Objective To evaluate the efficacy and safety of solifenacin in the treatment of bladder spasm after surgical operation of chlidren hypospadias. Methods From January 2014 to May 2015, 60 cases of children more than 4 years old after surgical operation of hypospadias who had symptom of bladder spasm on the day of surgery were assigned into the study group(n=30) and control group(n=30), based on simple randomization.On the first day , the frequency of spasm, the duration of spasm and the incidence of urine extravasation were recorded regarded as the first day condition of bladder spasm. Patients in the study group were treated with solifenacin (5 mg once daily) for a nine days period from 1th day postoperation.Patients in the control group were not treated with solifenacin.The frequency of spasm , the duration of spasm and the incidence of urine extravasation of the two groups were recorded and compared on the 3th and 9th day.Adverse events with solifenacin of two groups were recorded .The function of liver and kidney in the study group were recorded and compared. Results There were statistically significant differences(P<0.01) in favor of the study group over the control group in the aspect of the frequency of spasm, the duration of spasm and the incidence of urine extravasation on the 3th and 9th day.In the study group, the data compared among 1th, 3th and 9th was statistically significantly different, opposite to the control group.There was no statistically significant difference between the liver and kidney function of preoperation and the 9th day in the study group .The frequency of adverse events between two groups had no statistically significant difference. Conclusions Solifenacin is effective and safe in the treatment of bladder spasm after surgical operation of chlidren hypospadias Key words: Solifenacin; Children; Bladder spasm; Overactive bladder

Efficacy of hot–water hip bath combined with pelvic floor training in the treatment of overactive bladder

Objectives To investigate the efficacy of hot–water hip bath combined with pelvic floor training (PFT) in the treatment of overactive bladder(OAB). Methods 197 cases with OAB were allocated to four groups according to registration order and gender: group A(simple medicine, solifenacin ), group B(hot–water hip bath combined with solifenacin), group C(pelvic floor muscle training combined with solifenacin) and group D(hot–water hip bath combined with pelvic floor muscle training and solifenacin). After 8 weeks of treatment, estimate the effects of four groups according to voiding diary (the first three days and the last three days) and the OAB symptoms score card were estimated. Results The efficacy of the group B, group C and group D were more effective than group A. There was no significant difference in group B and group C. The efficacy of group D was better than group A, group B and group C obviously. Conclusions Hot–water hip bath with solifenacin is a potential therapy for OAB patients. A combination of hot–water hip bath and PFT with solifenacin can relieve the symptoms of OAB obviously. The clinical efficacy of the combination is better than the simple hip bath or PFT, worth clinical promotion. Key words: Urinary Bladder Diseases; Pelvic Floor

Comparison of Therapeutic Efficacy and Urodynamic Findings of Solifenacin Succinate versus Mirabegron in Women with Overactive Bladder Syndrome: Results of a Randomized Controlled Study

Introduction: We assessed clinical and urodynamic effects of solifenacin versus mirabegron in women with overactive bladder (OAB) syndrome. Material and Methods: Eighty women with OAB were randomized into 2 groups. In group A, the patients received solifenacin 5 mg once a day for 12 weeks; in group B, the patients received mirabegron 50 mg once a day for 12 weeks. Symptoms were assessed with OAB Symptom Score (OABSS). Patients underwent urodynamic investigation with pressure flow study. OABSS and urodynamic study were performed before and after treatment. Results: Both solifenacin and mirabegron were effective in improving OAB symptoms. Mirabegron showed greater tolerability with fewer patients discontinuing therapy because of side effects. Both solifenacin and mirabegron were effective in improving the storage function in the pressure flow study, but solifenacin showed a significant reduction of the detrusor pressure in the voiding phase with an increase in the postvoid residual urine volume. Conclusions: Mirabegron has shown to be a drug with the better balance between efficacy and tolerability in women with OAB.

Electrical stimulation with non-implanted electrodes for overactive bladder in adults.

Several options exist for managing overactive bladder (OAB), including electrical stimulation (ES) with non-implanted devices, conservative treatment and drugs. Electrical stimulation with non-implanted devices aims to inhibit contractions of the detrusor muscle, potentially reducing urinary frequency and urgency. To determine the effectiveness of: ES with non-implanted electrodes compared with placebo or any other active treatment for OAB; ES added to another intervention compared with the other intervention alone; different methods of ES compared with each other. We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 10 December 2014). We searched the reference lists of relevant articles and contacted specialists in the field. We imposed no language restrictions. We included randomised or quasi-randomised controlled trials of ES with non-implanted devices compared with any other treatment for OAB in adults. Eligible trials included adults with OAB with or without urgency urinary incontinence (UUI). Trials whose participants had stress urinary incontinence (SUI) were excluded. Two review authors independently screened search results, extracted data from eligible trials and assessed risk of bias, using the Cochrane Collaboration's 'Risk of bias' tool. We identified 51 eligible trials (3443 randomised participants). Thirty-three trials did not report the primary outcomes of subjective change in OAB symptoms. The majority of trials were deemed to be at low or unclear risk of selection and attrition bias and unclear risk of performance and detection bias. Lack of clarity with regard to risk of bias was largely due to poor reporting.Twenty-three trials (1654 participants) compared ES with no active treatment, placebo or sham treatment. Moderate-quality evidence indicated that OAB symptoms were more likely to improve in people receiving ES than with no active treatment, placebo or sham treatment (relative risk (RR) for no improvement 0.54, 95% confidence interval (CI) 0.47 to 0.63). Moderate-quality evidence indicated that similar numbers of people receiving ES and no active treatment, placebo or sham treatment experienced adverse effects.Eight trials (542 participants) compared ES with conservative treatment. Very low-quality evidence suggested no evidence of a difference between ES and PFMT or PFMT plus biofeedback in OAB symptoms (RR for no improvement 0.79, 95% CI 0.51 to 1.21 and 0.97, 95% CI 0.60 to 1.57 respectively). There was no evidence of a difference between ES and conservative treatment with regard to adverse effects.Sixteen trials (894 participants) compared ES with drug treatment (probanthine, tolterodine, oxybutynin, propantheline bromide, solifenacin succinate, terodiline, trospium chloride, terodiline). Moderate-quality evidence indicated that OAB symptoms were more likely to improve with ES than drug treatment (RR for no improvement 0.66, 95% CI 0.48 to 0.90). Low-quality evidence suggested a greater risk of adverse effects with oxybutynin (RR 1.26, 95% CI 1.07 to 1.49) and with tolterodine (RR 1.51, 95% CI 1.21 to 1.89) than with ES. There was insufficient evidence of a difference between ES and trospium hydrochloride (RR 0.73, 95% CI 0.43 to 1.25).Eight trials (252 participants) compared ES combined with another treatment versus the other treatment alone, two trials (48 participants) compared ES plus conservative treatment with no active treatment, placebo or sham treatment and six trials (361 participants) compared different types of ES. None of these comparisons had sufficient evidence to indicate any differences between the treatment groups in terms of OAB or adverse effects.Moderate-quality evidence suggested that ES improved OAB-related quality of life more than no active treatment, placebo or sham treatment. There was insufficient evidence of any difference between ES and any other treatment with regard to quality of life.There was insufficient evidence to determine if the benefits of ES persisted after the active treatment period stopped. Electrical stimulation appeared to be more effective than both no treatment and drug treatment for OAB. There was insufficient evidence to determine if ES was more effective than conservative treatment or which type of ES was more effective. This review underlines the need to conduct well-designed trials in this field measuring subjective outcomes and adverse effects.

An animal model of detrusor overactivity induced by depression

IntroductionDepression is frequently found in patients suffering from overactive bladder. The aim of the study was to verify whether the 13-cis-retinoic acid, a synthetic retinoid used in the treatment of acne, which was proven to induce depressive changes in both humans and animals, can cause detrusor overactivity symptoms in conscious rats. MethodsIn order to assess the 13-cis-retinoic acid impact on the behavioural parameters, after 6weeks of intraperitoneal administration of retinoid in a dose of 1mg/kg/day, a forced swim test and cystometry were performed, and the locomotor activity of animals was assessed. The control group received a mixture of DMSO and physiological saline at a 1:1 ratio. Results13-cis-retinoic acid caused cystometric parameter changes analogous to those observed in people with a urodynamic diagnosis of detrusor overactivity. The retinoid caused also an extension of the immobility time in the forced swim test which is consistent with increased depression-related behaviour, with no impact on the locomotor activity of rats. The intravenous administration of solifenacin succinate in a single dose of 0.03mg/kg turned out to reverse changes in the cystometric parameters modified by 13-cis-retinoic acid treatment. The histopathological analysis of bladders did not show any lesions in the upper layer of the umbrella cells, urothelium or muscles. The retinoid concentration level achieved in the animals tested turned out to be identical to that occurring in humans. Discussion13-cis-retinoic acid can induce detrusor overactivity symptoms that are reversed by solifenacin succinate.

Efficacy and safety of solifenacin succinate tablets versus solifenacin succinate tablets with local estrogen for the treatment of overactive bladder in postmenopausal women—a multicenter, randomized, open-label, controlled comparison study

The aim of the study was to compare the effectiveness and safety of solifenacin succinate tablets alone or combined with local estrogen for overactive bladder treatment in postmenopausal women. This multicenter, randomized, open, parallel-controlled clinical trial enrolled 104 women between January 2012 and August 2013. Participants meeting the inclusion criteria were randomized 1:1 to 12 weeks of treatment with group A (solifenacin 5 mg qd + promestriene vaginal capsules intravaginally) or group B (solifenacin 5 mg qd). Before and after 12 weeks of treatment, symptoms (urinary urgency, frequency, and urge incontinence) were analyzed. Our primary outcome was the change from baseline to the end of treatment in the mean number of voids in 24 hours. Quality of life (QoL) was assessed using International Prostate Symptom Score and Overactive Bladder Symptom Score questionnaires and safety according to the incidence of adverse events. The t test or the Mann-Whitney U test was used to compare continuous variables, and the χ(2) test or Fisher's exact test was used to compare categorical variables. The median decreases in the mean number of voids in 24 hours in groups A and B were 5.2. and 4.3, respectively, which were not significantly different. The median decreases in urgency episodes in groups A and B were 2.0 and 2.5, respectively. In addition, the QoL scores significantly changed in both groups (both P < 0.05). The most common adverse event was dry mouth (19.2% in both groups). Solifenacin with or without local estrogen was effective and safe for overactive bladder treatment in postmenopausal women. The addition of local estrogen improved subjective feelings and QoL.

Ovariectomy May Induce Detrusor Overactivity in Rats: The Therapeutic Role of Rho Kinase Inhibition

To verify the impact of ovariectomy (OVX) on the micturition cycle in conscious rats; to examine the influence of rho kinase (ROCK) inhibition on the bladder detrusor in OVX rats; to assess the effect of the joint administration of the ROCK inhibitor (GSK 269962) and solifenacin succinate (SOL) to these animals. The impact of OVX or a single dose of GSK 269962 and/or SOL on the cystometric parameters was assessed 28 days after the procedure. OVX caused an increase in detrusor overactivity index, amplitude, and frequency of nonvoiding contractions, along with a decrease in voided volume, volume threshold, intercontraction interval, bladder compliance, and volume threshold to elicit nonvoiding contractions. GSK 269962 administered in a dose of 10 mg/kg (but not 5 mg/kg) or SOL in a dose of 0.03 mg/kg (but not 0.015 mg/kg) triggered an increase in voided volume, volume threshold, intercontraction interval, bladder compliance, and volume threshold to elicit nonvoiding contractions, along with a decrease in detrusor overactivity index, amplitude, and frequency of nonvoiding contractions. A combined administration of GSK 269962 (5 mg/kg) and SOL (0.15 mg/kg), in doses ineffective in monotherapy, triggered a reversal in the OVX-induced cystometric changes. It appears that ROCK inhibitors can become an alternative worth considering in overactive bladder syndrome treatment, especially in the light of the findings pointing to the decreased efficiency of antimuscarinic drugs in the overactive bladder syndrome treatment of postmenopausal women.

LIQUID CHROMATOGRAPHIC DETERMINATION OF SOLIFENACIN SUCCINATE, FLAVOXATE HYDROCHLORIDE AND TOLTERODINE TARTRATE IN BULK DRUGS AND THEIR PHARMACEUTICAL DOSAGE FORMS

A simple, precise, specific and accurate reversed phase HPLC (RP-HPLC) method has been developed for the determination of solifenacin succinate (SOLS), flavoxate HCl (FLXHC) and toltoridine tartarate (TOLT) in bulk and pharmaceutical dosage forms. The proposed RP-HPLC method was carried out using Xterra RP-18 column (5 μm practical size, 25 cm x 4.6 mm i.d.). The flow rate, the injection volume and the detection wavelength were 1.0 mL/min, 20 mL and 200 nm, respectively. The mobile phase consisted of 0.05 M pentane sulfonic acid sodium salt (SOLS: pH 3.0±0.05, FLXHC and TOLT: pH 5.5±0.05) and acetonitrile (50:50 v/v). The retention times for SOLS, FLXHC and TOLT drugs were found to be 4.1±0.1 min, 4.3±0.0 min and 5.8±0.1 min, respectively. The calibration was linear over the concentration range of 0.1-100 μg/mL. The mean recoveries for SOLS, FLXHC and TOLT drugs were about 99.80%, 100.43% and 100.00%, respectively. The method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness.

LC–MS/TOF, LC–MSn and H/D Exchange Studies on Solifenacin Succinate Targeted to Characterize its Forced Degradation Products

Solifenacin was subjected to hydrolysis (acidic, basic and neutral), photolysis, oxidation and dry heat stress conditions, as prescribed by International Conference on Harmonisation guideline Q1A (R2). The drug was found to be unstable under oxidative and photolytic stress, but was stable to hydrolysis and thermal degradation. In total, three degradation products were formed, which were resolved from the drug and each other on a C-18 column employing a gradient elution method. A complete mass fragmentation pattern of the drug was established with the help of mass spectrometry/time of flight and multi-stage tandem mass spectrometric data. The structures of degradation products were elucidated through comparison of their mass fragmentation patterns with the drug. A most plausible mechanistic explanation for drug degradation is proposed.

Stability Indicating HPLC Method for Quantification of Solifenacin Succinate &amp;amp; Tamsulosin Hydrochloride along with Its Impurities in Tablet Dosage Form

A novel stability-indicating RP-HPLC method was developed and validated for simultaneous determination of Solifenacin Succinate & Tamsulosin Hydrochloride and its impurities in tablet dosage form. The method was developed using L1 column with gradient using the mobile phase consist of solvent-A (pH = 6.6, phosphate buffer + 0.5% Triethylamine) and solvent-B (90% Acetonitrile). The eluted compounds were monitored at 225 nm. Solifenacin Succinate & Tamsulosin Hydrochloride was subjected to oxidative, acid, base, hydrolytic, thermal and photolytic stress conditions. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantitation, accuracy, precision and robustness. The limit of quantification results was ranged from 0.135 - 0.221 μg/mL for Solifenacin Succinate impurities and 0.043 - 0.090 μg/mL for Tamsulosin Hydrochloride impurities. This method is suitable for the estimation of impurities and assay of Solifenacin Succinate & Tamsulosin Hydrochloride in tablets dosage form.

Solifenacin is effective and well tolerated in patients with neurogenic detrusor overactivity: Results from the double-blind, randomized, active- and placebo-controlled SONIC urodynamic study.

To investigate the effect on urodynamics of 4 weeks treatment with solifenacin succinate in patients with neurogenic detrusor overactivity (NDO) due to multiple sclerosis (MS) or spinal cord injury (SCI). SONIC was a prospective, multicenter, double-blind, phase 3b/4 study investigating the efficacy and safety of solifenacin 10 mg in patients with NDO due to MS or SCI. Patients (n = 189) were randomized to placebo or active treatment (solifenacin 5 mg, 10 mg or oxybutynin hydrochloride 15 mg) for 4 weeks, after a 2-week, single-blind, placebo run-in period. The primary endpoint was change in maximum cystometric capacity (MCC) from baseline to end of treatment. The primary analysis compared solifenacin 10 mg versus placebo; all other comparisons were considered secondary. Secondary endpoints included changes in urodynamic parameters, patient-reported outcomes, and safety assessments. In the primary analysis, solifenacin 10 mg significantly improved mean change from baseline MCC versus placebo (P < 0.001) and was associated with improvements in bladder volume at first contraction and at first leak as well as detrusor pressure at first leak. Similar results were obtained for oxybutynin versus placebo. Patient perception of bladder condition significantly improved with solifenacin 10 mg versus placebo (P = 0.041). There was a clear improvement in quality of life (QoL) in the solifenacin arms versus placebo. The overall incidence of adverse events was low. In patients with NDO due to MS and SCI, 4 weeks of treatment with solifenacin 10 mg improved urodynamic variables and QoL versus placebo and was well tolerated. Neurourol. Urodynam. 36:414-421, 2017. © 2015 Wiley Periodicals, Inc.

Efficacy and Safety of Solifenacin Succinate Tablets Versus Solifenacin Succinate Tablets With Local Oestrogen for Overactive Bladder in Post-Menopausal Women – A Multi-Centre, Randomised, Open, Controlled Comparison Study

Efficacy and Safety of Solifenacin Succinate Tablets Versus Solifenacin Succinate Tablets With Local Oestrogen for Overactive Bladder in Post-Menopausal Women – A Multi-Centre, Randomised, Open, Controlled Comparison Study

New clinical trials for nonmotor manifestations of Parkinson's disease.

Nonmotor manifestations in Parkinson's disease (PD) encompass a range of clinical features, including neuropsychiatric problems, autonomic dysfunction, sleep disorders, fatigue, and pain. Despite their importance for patients' quality of life, the evidence base for their treatment is relatively sparse. Nevertheless, the last few years have seen a number of new trials starting that specifically address nonmotor features as an outcome measure in clinical trials. Large randomized, controlled trials in the last 3 years reported improvement of psychosis with the new selective serotonin 5-HT2A inverse agonist pimavanserin and of postural hypotension with the oral norepinephrine precursor droxidopa. Smaller new randomized, controlled trials support the effectiveness of Deep Brain Stimulation and opiates for pain, of rivastigmine for apathy and piribedil for apathy post-DBS, group cognitive behavioral therapy for depression and/or anxiety, continuous positive airway pressure for sleep apnea in PD and doxepin for insomnia, and of solifenacin succinate and transcutaneous tibial nerve stimulation for urinary symptoms. A number of new smaller or open trials as well as post-hoc analyses of randomized, controlled trials have suggested usefulness of other treatments, and new randomized, controlled trials are currently ongoing.

Ocular surface changes following oral anticholinergic use for overactive bladder

Objective: To investigate the effect of oral solifenacin succinate on Schirmer I test results, tear break-up time (TBUT) and Ocular Surface Disease Index (OSDI) scores in overactive bladder (OAB) patients and to compare these results with those of healthy control subjects.Materials and methods: The female OAB patients who were prescribed oral solifenacin succinate 5 mg/day (Group I, N = 80) and age-matched healthy female subjects (Group II, N = 40) were recruited for the study and underwent ophthalmological examination prior to oral treatment and after 4 weeks. They completed the OSDI questionnaire and underwent ocular surface tests including Schirmer I test and TBUT.Results: The statistical analysis of the Schirmer I test and TBUT revealed no significant difference between the baseline and 4th week values in both groups (Group I, p = 0.506 and p = 0.070 consecutively) (Group II, p = 0.810 and p = 0.823 consecutively). OSDI scores were found to be significantly increased in group I (21.8 ± 4.2 vs 23.1 ± 4.6, p = 0.020) and remained unchanged in group II (20.5 ± 7.0 vs 20.7 ± 7.0, p = 0.805).Conclusions: Short-term solifenacin succinate treatment has no effect on the Schirmer I test results and TBUT, but ocular surface symptoms appeared to be exacerbated in respect with increased OSDI scores. However, the clinical significance needs to be further evaluated with larger studies.

A nurse-led long-term pelvic floor muscle training program in the management of female patients with overactive bladder – A study protocol for a randomized controlled trial

BackgroundPrevious research has suggested that pelvic floor muscle training (PFMT) offers a therapeutic benefit in patients with overactive bladder. MethodsWe conducted a single-blind, randomized trial of pelvic floor muscle training (PFMT) as compared with usual care. The intervention group (n = 54) received a 6-month a nurse-led long-term pelvic floor muscle training program (three sessions a day, 15–20 times per session) and the control group (n = 53) received usual care. All patients received 3-month solifenacin succinate tablets (5 mg – once daily). The treatment outcomes were measured by the Modified Oxford Scale (MOS), Overactive Bladder Symptom Score (OABSS) and the King's Health Questionnaire (KHQ) at baseline, 3 months and 6 months respectively. ResultsOf the 91 randomly assigned patients, 46 patients in the PFMT group and 45 patients in the control group completed the trial. The trial revealed statistically significant differences between groups in pelvic muscle strength at 3 months following the intervention (p < 0.05), but no significant difference was found between two groups in OABSS scores (p > 0.05). In regards to quality of life, the experimental group showed significant improvements compared to the control group on 6 of 10 domains (p < 0.05). At 6 months, there were significant improvements in OABSS scores and quality of life in the experimental group compared to the control group (p < 0.05). No adverse events were observed. ConclusionA nurse-led long-term (6 months) pelvic floor muscle training program may alleviate OAB symptoms effectively and improve the quality of life more than a short term (3 months) pelvic floor muscle training program combined with solifenacin succinate tablets.

Solifenacin or Mirabegron Could Improve Persistent Overactive Bladder Symptoms After Dutasteride Treatment in Patients With Benign Prostatic Hyperplasia

To evaluate the clinical response and adverse events (AEs) of solifenacin (SOL) or mirabegron (MIR) in benign prostatic hyperplasia patients with persistent overactive bladder (OAB) symptoms after dutasteride (DUT) treatment. Fifty cases with residual OAB symptom score (OABSS) ≥ 5 and OABSS Q3 ≥ 2 after at least 6 months treatment of DUT were included in this study. Patients were administered 5 mg/d of SOL (N = 25) or 50 mg/d of MIR (N = 25), and International Prostate Symptom Score (IPSS) and OABSS were prospectively collected at 4 and 12 weeks. The safety was evaluated by changes in postvoided residual urine volume and the incidence of AEs. After DUT administration, the mean prostate volume, IPSS, and OABSS were 39.0 mL, 17.6, and 8.1, respectively. SOL 5 mg significantly reduced the IPSS, OABSS, and OABSS Q3 at 4 and at 12 weeks (-3.1, -2.7, -1.3; P <.05); however, 4 patients could not continue the SOL treatment owing to AEs. All patients could continue the 12 weeks of MIR treatment, and MIR 50 mg reduced IPSS and OABSS at 4 weeks and reduced IPSS, OABSS, and the OABSS Q3 (-3.0, -2.5, -0.9; P <.05) at 12 weeks. Postvoided residual urine volume increased by ≥ 100 mL after treatment in 2 cases in the SOL group but not in any patient in the MIR group. Additional SOL or MIR might result in amelioration of the persistent OAB symptom after DUT treatment in patients with an enlarged prostate.

Randomized, controlled pilot trial of solifenacin succinate for overactive bladder in Parkinson's disease.

To evaluate the efficacy of solifenacin succinate in Parkinson's disease (PD) patients suffering from overactive bladder (OAB). Urinary dysfunction is a commonly encountered non-motor feature in PD that significantly impacts patient quality of life. This was a double-blind, randomized, placebo-controlled, 3-site study with an open label extension phase to determine the efficacy of solifenacin succinate in idiopathic PD patients with OAB. Patients were randomized to receive solifenacin succinate 5-10mg daily or placebo for 12 weeks followed by an 8-week open label extension. The primary outcome measure was the change in the mean number of micturitions per 24h period. Secondary outcome measures included the change in the mean number of urinary incontinence episodes and the mean number of nocturia episodes. Twenty-three patients were randomized in the study. There was no significant improvement in the primary outcome measure in the double-blind phase, but there was an improvement in the number of micturitions per 24h period in the solifenacin succinate group compared to placebo at a mean dose of 6mg/day (p=0.01). In the open label phase, the mean number of urinary incontinence episodes per 24h period decreased (p=0.03), as did the number of nocturia episodes per 24h period (p=0.01). Adverse events included constipation and xerostomia, which resolved after treatment was discontinued. In this pilot trial, solifenacin succinate treatment led to an improvement in urinary incontinence, despite persistence in other OAB symptoms.