Comparison of stent related symptoms in patients taking mirabegron, solifenacin, or tamsulosin: A double blinded randomized clinical trial.

BACKGROUND: The present study aims to assess the efficacy of mirabegron, a novel beta-3 agonist for ameliorating stent related symptoms (SRSs) as compared to tamsulosin and solifenacin. METHODS: Total of 150 patients undergoing ureteral stent placement following ureteroscopic lithotripsy, percutaneous nephrolithotomy, or laparoscopic/robotic pyeloplasty were randomized in 1:1:1 fashion to receive mirabegron 50 mg (group A), solifenacin 5 mg (group B), and tamsulosin 0.4 mg (group C) OD respectively. Patients were followed at POD10 (I visit), 4 weeks (II visit) after surgery, and 2 weeks post-stent removal. Validated vernacular version of ureteric stent symptoms questionnaire (USSQ) was administered to the patients at each visit. RESULTS: Out of 150 patients randomized, 123 patients (A; n = 41, B; n = 40, and C; n = 42) completed the study. The groups were comparable in terms of urinary index score of USSQ at I and II visits (p = 0.119 and 0.076, respectively). A lower proportion of patients in group B experiencing bodily pain at II visit (p = 0.039), however, pain scores were comparable. Significantly lower general health index scores were observed in group A at I visit and over 4 weeks (p = 0.007). No significant differences were observed in other domains of USSQ. Age, sex, and surgical procedure undertaken did not significantly impact the scores in various USSQ domains. CONCLUSION: Mirabegron demonstrates comparable benefit in alleviating SRSs with better general health indices and may be an effective alternative for SRSs, especially when tamsulosin or solifenacin are contra-indicated or poorly tolerated.

Chemical profiles of the active fraction from Prinsepia utilis Royle leaves and its anti-benign prostatic hyperplasia evaluation in animal models.

BACKGROUND: The Prinsepia utilis Royle leaves (P. utilis) is a folk herb used for benign prostatic hyperplasia (BPH) control by ethnic minorities for centuries in China with rich in resources. Our previous studies have confirmed the anti-BPH effect of its water extract (QCJ) and the active fraction (Fr. B) separated from the QCJ by animal test. The Fr. B from P. utilis should be a potential candidate for BPH control. METHODS: In this study, the chemical ingredients of Fr. B were identified by UPLC-QTOF-MS, and quantified by HPLC. Murine animal models were divided into 8 groups, Sham rats, BPH rats, BPH rats administered with finasteride (1 mg/kg), BPH rats administered with Pule'an (460 mg/kg), BPH rats administered with low, high dosage of QCJ (860 mg/kg, 2580 mg/kg respectively), BPH rats administered with low, high dosage of Fr. B (160 mg/kg, 480 mg/kg respectively). The expression of vascular endothelial growth factor (VEGF) in the prostate tissue of rats was tested, and serum levels of dihydrotestosterone (DHT), testosterone (T), estradiol (E2), interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α) and total superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), catalase (CAT), malondialdehyde (MDA) in prostate homogenate were measured. One-way ANOVA followed by LSD was used for statistical analysis. RESULTS: The BPH rats treated by Fr. B exhibited significant reductions of VEGF and MDA levels, as well as significant increases of SOD, GSH-Px and CAT in the prostate tissue after 28 day administration (P < 0.05). Moreover, Fr. B significantly reduced DHT, DHT/E2 ratio, TNF-α, while increased T levels in serum of BPH rats (P < 0.05). UPLC-QTOF-MS analysis revealed 10 flavonoids as the key constituents of this fraction, which accounted for 54.96% of all substance of Fr. B. The relative contents of compound 1, 2 are 11.1%, 13% in Fr. B respectively. CONCLUSIONS: These results indicated that the Fr. B obtained from P. utilis alleviated the symptoms of BPH rats through multiple mechanisms including reduction of DHT/E2 ratio, inhibition of growth factor, anti-inflammation and anti-oxidation, in which flavonoids might be the key constituents. It supported the hypothesis that the Fr. B should be further explored as a candidate for BPH patients.

Pumpkin seed oil (Cucurbita pepo) versus tamsulosin for benign prostatic hyperplasia symptom relief: a single-blind randomized clinical trial.

BACKGROUND: Benign prostatic hyperplasia (BPH) is very common in aging men. We aimed to compare the effects of tamsulosin and pumpkin (Cucurbita pepo) seed oil on BPH symptoms. METHODS: This single-blind randomized clinical trial included patients with BPH aged ≥ 50 years referred to the Urology Clinic of Shahid Beheshti Hospital, Hamadan, Iran, from August 23, 2019 to February 19, 2020. Patients were randomized into two groups. One group received 0.4 mg tamsulosin every night at bedtime and the other received 360 mg pumpkin seed oil twice a day. Patients' age, weight, height, and body mass index (BMI) were recorded. The International Prostate Symptom Score (IPSS) was filled out by the patients at baseline and then 1 month and 3 months after the initiation of treatment. The BPH-associated quality of life (QoL), serum prostate-specific antigen, prostate and postvoid residual volume, and maximum urine flow were also assessed at baseline and 3 months later. Drug side effects were also noted. RESULTS: Of the 73 patients included in this study with a mean age of 63.59 ± 7.04 years, 34 were in the tamsulosin group and 39 in the pupkin seed oil group. Patients were comparable with respect to age, weight, height, BMI, and baseline principal variables in both groups. Also, there was no significant difference between groups in terms of principal variables at any time point. However, there was a significant decrease in IPSS and a significant improvement in QoL in both groups. Although the decrease in IPSS from baseline to 1 month and 3 months was significantly higher in the tamsulosin group compared to the pumpkin group (P = 0.048 and P = 0.020, respectively), the decrease in IPSS from 1 to 3 months was similar (P = 0.728). None of the patients in the pumpkin group experienced drug side effects, while dizziness (5.9%), headache (2.9%), retrograde ejaculation (2.9%), and erythema with pruritus occurred in the tamsulosin group. CONCLUSIONS: Pumpkin (Cucurbita pepo) seed oil relieved BPH symptoms with no side effects, but was not as effective as tamsulosin. Further studies are required to confirm the role of pumpkin seed oil as an option for the treatment of BPH symptoms. Trial registration Iranian Registry of Clinical Trials, IRCT20120215009014N340. Registered 19.02.2020. Retrospectively registered, https://en.irct.ir/trial/45335 .

Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA GUIDELINE PART I-Initial Work-up and Medical Management.

PURPOSE: Benign prostatic hyperplasia (BPH) is a histologic diagnosis describing proliferation of smooth muscle and epithelial cells within the prostatic transition zone. The prevalence and severity of lower urinary tract symptoms (LUTS) in aging men are progressive and impact the health and welfare of society. This revised Guideline provides a useful reference on effective evidence-based management of male LUTS/BPH. See the accompanying algorithm for a summary of the procedures detailed in the Guideline (figures 1 and 2[Figure: see text][Figure: see text]). MATERIALS AND METHODS: The Minnesota Evidence Review Team searched Ovid MEDLINE, Embase, Cochrane Library, and AHRQ databases to identify eligible English language studies published between January 2008 and April 2019, then updated through December 2020. Search terms included Medical Subject Headings (MeSH) and keywords for pharmacological therapies, drug classes, and terms related to LUTS or BPH. When sufficient evidence existed, the body of evidence was assigned a strength rating of A (high), B (moderate), or C (low) for support of Strong, Moderate, or Conditional Recommendations. In the absence of sufficient evidence, information is provided as Clinical Principles and Expert Opinions (table 1[Table: see text]). RESULTS: Nineteen guideline statements pertinent to evaluation, work-up, and medical management were developed. Appropriate levels of evidence and supporting text were created to direct both primary care and urologic providers towards streamlined and suitable practices. CONCLUSIONS: The work up and medical management of BPH requires attention to individual patient characteristics, while also respecting common principles. Clinicians should adhere to recommendations and familiarize themselves with standards of BPH management.

Linh Phu Khang Tue Tinh inhibited prostate proliferation in rats induced benign prostatic hyperplasia by testosterone propionate.

ETHNOPHARMACOLOGICAL RELEVANCE: Benign prostatic hyperplasia (BPH) is the hyperproliferation of the stromal and the epithelial cells within the prostatic transition zone. In recent years, phytotherapy have been studied with the concern for increasing quality of life, improving lower urinary tract symptoms (LUTS) as well as reducing prostate volume and the frequency of adverse events was similar to that of placebo. Linh Phu Khang Tue Tinh (LPKTT) capsules are formulated from 4 herbs widely used in traditional Vietnamese medicine - Panax notoginseng (Burkill) F.H.Chen - Tam that (radix), Crinum asiaticum L. - Náng hoa trang or giant crinum lily, Polygonum cuspidatum Willd. ex Spreng. (= Reynoutria japonica Houtt) - Cot cu khí or Japanese knotweed (radix), Oldenlandia herbacea (L.) Roxb. (formerly known as Hedyotis diffusa Spreng.) - Bach hoa xà thie^t thao or slender oldenlandia (herb). The preparation has been used in traditional Vietnamese medicine to treat nocturia, weak urine stream, urinary tract infection. According to modern studies, these herbs have anti-inflammation, antitumor, and antioxidant activities. AIMS OF THE STUDY: Evaluating the effects of LPKTT capsules on the development of BPH using a rat model of BPH induced by testosterone propionate (TP). MATERIALS AND METHODS: 60 male Wistar rats, 10-12 weeks of age, weight 200-250 g were separated into six groups: (G1) a normal control group that was taken orally phosphate-buffered saline (p.o.; PBS.) with corn oil (subcutaneous injection- Sc); (G2) a BPH model group that received PBS (p.o) with TP (Sc); (G3) a positive control group that received dutasteride (25 µg/kg BW/24 h, p.o.) with TP (Sc); (G4) a positive control group that received alfuzosin HCl (1.8 mg/kg BW/24 h, p.o.) with TP (s.c.) and (G5 and G6) LPKTT groups that received LPKTT at 289.8 or 869.4 mg/kg(p.o.) respectively, with TP (s.c.). BPH model was induced by Sc of TP, 3 mg/kg for 4 weeks. After that, rats were received NaCl/Dutasteride/Alfuzosin/LPKTT for the next 28 days. On the 56th day, assessed the results were through the indicators: micturition frequency, voided volume, total voided volume, the prostate and body weights, the ratio of prostate weight to body weight, prostate histology. RESULTS: LPKTT reduced micturition frequency and increased the voided volume when compared to the control group (p < 0.01). The results were equivalent to those of the alfuzosin ones (G4). LPKTT lowered prostate weight and the ratio of prostate weight to body weight when compared to the control group (p < 0.01). These reductions were the same in the dutasteride ones. Histomorphology in G5 and G6 also showed that LPKTT inhibited TP induced prostatic hyperplasia. The results were similar to that in the dutasteride group. Microscopic images of prostate in G5 and G6 were almost similar to that of G1. CONCLUSION: LPKTT capsules work to inhibit prostate proliferation in rats induced BPH by TP.

Alternative Treatment for Erectile Dysfunction: a Growing Arsenal in Men's Health.

PURPOSE OF REVIEW: To highlight and review encouraging preliminary studies behind several alternative products and interventions for erectile dysfunction (ED). RECENT FINDINGS: Alternative treatments for ED are becoming more prevalent with increased consumer interest. "Natural" products are sold online, and numerous clinics offer various off-label and investigational interventions. These alternative treatments have demonstrated varying degrees of efficacy in randomized trials and meta-analyses, but none of these interventions has robust enough evidence to be considered first-line therapy. These treatments may find a role in combination with guideline treatments or may be used in novel penile rehabilitation research protocols. With growing interest in alternative treatment for men's health, an awareness of the literature is imperative for patient counsel. Alternative treatments, like L-arginine, have a growing body of evidence for efficacy in combination with PDE5i, and low-intensity shock wave therapy and stem cell therapy continue to demonstrate encouraging outcomes in ED trials.

Medication Discontinuation Following Transurethral Prostatectomy: an Unrecognized Effectiveness Measure?

PURPOSE OF REVIEW: Freedom from medication is a common goal for patients undergoing surgical treatment of benign prostatic hyperplasia (BPH)/lower urinary tract symptoms (LUTS). Knowing medication discontinuation rates following various forms of transurethral prostatectomy may aid patient counseling and assessing the comparative effectiveness of different approaches. This review examined discontinuation rates of BPH/LUTS medications following transurethral prostatectomy. RECENT FINDINGS: Rates of BPH/LUTS medication use after transurethral resection of the prostate varied from 15% to 55%, and discontinuation rates were 54-95% across medications and follow-up periods. For laser prostatectomy, approximately 18% of patients continued medications postoperatively and discontinuation rates ranged from 53% to 75%. Minimal data on holmium laser enucleation existed. For reference, medication discontinuation rates after transurethral needle ablation or microwave therapy were only 15-28%. No recommendations or best practices inform the use of medical therapy following BPH surgery. Rates of BPH/LUTS medication use following transurethral prostatectomy are considerable.

Tamsulosin plus a new complementary and alternative medicine in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: Results from a retrospective comparative study.

BACKGROUND: We aimed to compare the efficacy of tamsulosin 0.4 mg once a day alone and the combination therapy involving tamsulosin 0.4 mg once a day plus the complementary and alternative medicine consisting of vitamins (C and D), herbal products (Cucurbita maxima, Capsicum annum, Polygonum capsicatum) and amino acid L-Glutamine bid in patients with lower urinary tract symptoms related to benign prostatic hyperplasia (LUTS/BPH). METHODS: We performed a retrospective matched paired comparison. The clinical records of LUTS/BPH patients who underwent medical therapy with tamsulosin 0.4 mg/day plus the complementary and alternative medicine consisting of vitamins (C and D), herbal products (Cucurbita maxima, Capsicum annum, Polygonum capsicatum) and amino acid L-Glutamine bid between January 2019 to September 2019 were reviewed (Group 1). These patients were compared in a 1:1 fashion with LUTS/BPH patients who underwent therapy with tamsulosin 0.4 mg/day alone (Group 2). Total, storage, voiding and Quality of Life (QoL) international prostate symptom (IPSS) score, as well as overactive bladder (OAB)-v8 score and treatment- related adverse events recorded at 40 days follow-up in both groups were compared. RESULTS: At 40 days follow-up mean total, storage, voiding and QoL IPSS sub-scores as well as OAB-v8 score significantly improved in both groups. Intergroup comparison showed statistically significant lower mean total IPSS score (11.6 vs 12.4, p = 0.04) mean storage IPSS sub-score (6.5 vs 7.5, p = 0.01), and mean OAB v8 score (16.7 vs 18.8, p = 0.03) in patients in the Group 1. CONCLUSIONS: The combination of tamsulosin 0.4 mg/die plus the complementary and alternative medicine consisting of vitamins (C and D), herbal products (Cucurbita maxima, Capsicum annum, Polygonum capsicatum) and amino acid LGlutamine bid provides statistically significant advantages in terms of storage LUTS improvements in patients with LUTS/BPH compared to tamsulosin 0.4 mg/day alone. These findings are preliminary and further prospective studies on a greater number of patients are needed to confirm it.

Management of urinary incontinence.

Urinary incontinence is a common problem affecting 25-45% women. Effective management can have a huge impact on a patient's quality of life and many treatments are available. Management should be dictated by the degree of bother the symptoms are having, and vary depending on the type on incontinence. Conservative measures should always be initiated, including optimisation of body mass index and smoking cessation. Overactive bladder and urge urinary incontinence can be improved with bladder retraining and avoidance of bladder stimulants. Medical treatment then includes anticholinergic medications or Mirabegron. More invasive options include Botulinum Toxin A (Botox®) injections, sacral nerve stimulation or urological surgery. Stress urinary incontinence should be managed initially with pelvic floor exercises, and input from a specialist nurse or physiotherapist is beneficial. The surgical options for managing stress incontinence have changed considerably over the years, but include bladder neck injections, mid-urethral slings, colposuspension or autologous fascial slings. Mixed urinary incontinence is more challenging to manage, but all conservative measures should be started. Further treatment is directed towards the predominant symptom, but overactivity should be controlled before surgical measures for stress urinary incontinence are performed.

A double blind, placebo-controlled randomized comparative study on the efficacy of phytosterol-enriched and conventional saw palmetto oil in mitigating benign prostate hyperplasia and androgen deficiency.

BACKGROUND: The present clinical trial was conducted to evaluate the efficacy and tolerability of a standardized saw palmetto oil containing 3% ß-sitosterol in the treatment of benign prostate hyperplasia (BPH) and androgen deficiency. METHODS: Subjects aged 40-65 years with symptomatic BPH were randomized to 12-week double-blind treatment with 500 mg doses of ß-sitosterol enriched saw palmetto oil, conventional saw palmetto oil and placebo orally in the form of capsules (n = 33 in each group). BPH severity was determined using the International Prostate Symptom Score (IPSS), uroflowmetry, serum measurement of prostate specific antigen (PSA), testosterone and 5α-reductase. During the trial, the androgen deficiency was evaluated using Aging Male Symptoms (AMS) scale, the Androgen Deficiency in the Aging Male (ADAM) questionnaire, serum levels of free testosterone. RESULTS: Subjects treated with ß-sitosterol enriched saw palmetto oil showed significant decrease in IPSS, AMS and ADAM scores along with reduced postvoiding residual volume (p < 0.001), PSA (p < 0.01) and 5α-reductase from baseline to end of 12-week treatment as compared to placebo. There was also a significant increment in the maximum and average urine flow rate (p < 0.001), and serum free testosterone level of subjects treated with enriched saw palmetto oil as compared to placebo. CONCLUSION: This study demonstrates the efficacy of ß-sitosterol enriched saw palmetto oil superior to conventional oil thus extending the scope of effective BPH and androgen deficiency treatment with improved quality of life through the intake of functional ingredients. TRIAL REGISTRATION: CTRI/2018/12/016724 dated 19/12/2018 prospectively registered. URL: http://ctri.nic.in/Clinicaltrials/advsearch.php.

Management of benign prostatic hyperplasia in the 21st century: temporal trends in Australian population-based data.

OBJECTIVE: To examine national trends in the medical and surgical treatment of benign prostatic hyperplasia (BPH) using Australian Medicare Benefits Schedule (MBS) and Pharmaceutical Benefits Scheme (PBS) population data from 2000 to 2018. PATIENTS AND METHODS: Annual data was extracted from the MBS, PBS and Australian Institute of Health and Welfare databases for the years 2000-2018. Population-adjusted rates of BPH procedures and medical therapies were calculated and compared in relation to age. Cost analysis was performed to estimate financial burden due to BPH. RESULTS: Overall national hospital admissions due to BPH declined between 2000 and 2018, despite an increased proportion of admissions due to private procedures (42% vs 77%). Longitudinal trends in the medical management of BPH showed an increased prescription rate of dutasteride/tamsulosin combined therapy (111 vs 7649 per 100 000 men) and dutasteride monotherapy (149 vs 336 per 100 000 men) since their introduction to the PBS in 2011. Trends in BPH surgery showed an overall progressive increase in rate of total procedures between 2000 and 2018 (92 vs 133 per 100 000 men). Transurethral resection of the prostate (TURP) remained the most commonly performed surgical procedure, despite reduced utilisation since 2009 (118 vs 89 per 100 000 men), offset by a higher uptake of photoselective vaporisation of prostate, holmium:YAG laser enucleation of prostate, and later likely due to minimally invasive surgical therapies including prostatic urethral lift and ablative technologies (including Rezum™). Financial burden due to BPH surgery has remained steady since 2009, whilst the burden due to medical therapy has risen sharply. CONCLUSION: Despite reduced national BPH-related hospitalisations, overall treatment for BPH has increased due to medical therapy and surgical alternatives to TURP. Further exploration into motivators for particular therapies and effect of medical therapy on BPH progression in clinical practice outside of clinical trials is warranted.

Mirabegron in female patients with overactive bladder syndrome: What's new? A systematic review and meta-analysis.

Reviews assessing mirabegron's safety and efficacy, synthesize data from both genders, without providing specific details for female patients with OAB. The aim of this study is to qualitatively and quantitatively synthesize data evaluating mirabegron's use on female patients with OAB. PubMed/Scopus/Cochrane library/Web of Knowledge were searched for full texted, published in English-language and in peer-reviewed journals, up to November 2019, using the keyword "mirabegron".Jadad score modified by adding allocation concealment, MINORS and RoB were used for the Methodological quality and risk of bias assessment. Twenty-one studies were included in this review;7 RCTs, 3 non-RCTs and 11 observational studies. Controlled trials were of unclear (75%), high (12.5%) or serious risk (12.5%) of bias. Twelve weeks of mirabegron use resulted in significant decrease of urgency, frequency, nocturia and UUI by 1.3-2.2,2.04-2.33,0.42-0.5 and 0.9-1.04 episodes/24 h, respectively. Quality of life and sexual health was improved significantly. Sexual dysfunction decreased from 98% (84/85) at baseline, to 60% (51/85) after 12-weeks of mirabegron (p-value < 0.001). Mirabegron had the same efficacy as anticholinergics in improving all OAB symptoms but with fewer adverse events. Hypertension and antimuscarinics' effects (i.e dry mouth, constipation) had an incidence of 2% (28/1221) and 1.9% (23/1221) when mirabegron was administered, respectively. Mirabegron is a safe and effective alternative therapy for females with OAB. However, there is a paucity of high-quality RCTs, with large sample sizes, long-term follow-up focusing on mirabegron's comparison to other therapies, quality of life and sexual health of female patients with OAB.

The clinical effect of traditional chinese medicine on middle-aged women with Interstitial Cystitis: Protocol for a randomized controlled trial.

INTRODUCTION: Interstitial cystitis (IC), as a common disease in urology, is prolonged and repeated. IC has caused great harm to the patient's physical and psychological. Traditional Chinese medicine (TCM) is characterized by overall concepts and dialectical treatment. It provides clinicians with safer and more reliable alternatives in terms of clinical prescriptions and prepared medicines, and also improves the quality of life of patients with IC. Therefore, in this study, we will use the research method of randomized controlled trials to explore the effects of TCM combined with western medicine on renal function and urine metabolism on middle-aged women with IC. METHODS/DESIGN: Use randomized controlled trials. According to the proposed diagnostic, inclusion, and exclusion criteria. Sixty patients with interstitial bladder inflammation that met the criteria were randomized into a treatment group and a control group of 30 cases each. The intervention group was treated with integrated traditional Chinese and western medicine. The control group was given conventional Western medicine treatment. The course of treatment is 8 weeks. Interstitial bladder inflammation symptoms score (ICS worker), problem score (worker CPI), pelvic pain and urinary urgency symptoms, and urodynamics were used as the evaluation criteria. DISCUSSION: This trial may provide evidence regarding the clinical effectiveness, safety, and cost-effectiveness of TCM for patients with IC. TRIAL REGISTRATION: ClinicalTrials.gov, ChiCTR2000029971, Registered on 17 February 2020.

Comparison of Serenoa repens With Tamsulosin in the Treatment of Benign Prostatic Hyperplasia: A Systematic Review and Meta-Analysis.

Studies reported that Serenoa repens was effective in relieving lower urinary tract symptoms (LUTS). This article carried out a systematic review and meta-analysis to compare Serenoa repens with tamsulosin in the treatment of benign prostatic hyperplasia (BPH) after at least 6-month treatment cycle. Four studies involving 1,080 patients (543 in the Serenoa repens group and 537 in the tamsulosin group) were included in the meta-analysis. The results were as follows: compared with tamsulosin, Serenoa repens had a same effect in treating BPH in terms of International Prostate Symptom Score (IPSS) (mean difference [MD] 0.63, 95% confidence interval [CI] [-0.33, 1.59], p = 0.20), quality of life (QoL) (MD 1.51, 95% CI [-1.51, 4.52], p = 0.33), maximum flow rate (Qmax) (MD 0.27, 95% CI [-0.15, 0.68], p = 0.21), postvoid residual volume (PVR) (MD -4.23, 95% CI [-22.97, 14.44], p = 0.65), prostate-specific antigen (PSA) (MD 0.46, 95% CI [-0.06, 0.97], p = 0.08) with the exception of prostate volume (PV) (MD -0.29, 95% CI [-0.41, -0.17], p < 0.00001). For side effects, Serenoa repens was well tolerated compared with tamsulosin especially in ejaculation disorders (odds ratio [OR] = 12.56, 95% CI [3.83, 41.18], p < 0.0001) and decreased libido (OR = 5.40; 95% CI [1.17, 24.87]; p = 0.03). This study indicated that Serenoa repens had the same effect in treating BPH compared with tamsulosin in terms of IPSS, QoL, and PVR after at least 6-month treatment cycle, however, the latter had a greater improvement in PV compared with the former. And Serenoa repens did not increase the risk of adverse events especially with respect to ejaculation disorders and libido decrease.

Medications used to treat bladder disorders may alter effects of neuromodulation.

AIMS: Neuromodulation (nerve stimulation) can produce analgesia. One form, bilateral pudendal nerve stimulation (bPNS), suppresses responses to urinary bladder distension (UBD) in hypersensitive rats. Drugs can modify this effect (eg, benzodiazepines, but not opioids, suppress bPNS effects). Prior to a clinical trial of bPNS effects on bladder pain, we felt it was prudent to survey the effects of medications commonly used in patients with bladder disorders. METHODS: Bladder hypersensitivity was produced by neonatal bladder inflammation in rat pups coupled with a second inflammatory insult as an adult. Antimuscarinic (oxybutynin), ß3 -adrenoceptor agonist (mirabegron, CL316243), α1 -adrenoceptor antagonist (tamsulosin), antidepressant (amitriptyline), muscle relaxing (baclofen), and sedative (propofol) agents were administered and effects of bPNS on responses to UBD assessed. bPNS consisted of bilateral biphasic electrical stimulation of the mixed motor/sensory component of the pudendal nerves. Visceromotor responses (VMRs; abdominal muscle contractile responses) were used as nociceptive endpoints. RESULTS: Many of these drugs directly inhibited the VMRs to UBD, but only mirabegron, at the doses employed, significantly reduced inhibitory effects of bPNS. In the presence of the other drugs, bPNS continued to produce statistically significant inhibition of VMRs to UBD. CONCLUSIONS: This study suggests that concurrent therapy with drugs used to treat bladder disorders could affect assessment of the effects of bPNS on bladder hypersensitivity. This study gives guidance to clinical trials using bPNS for the treatment of painful bladder syndromes and suggests potential clinical use of some of these medications in the treatment of these same disorders.

Evaluation of Femaxeen® for control of urinary incontinence in women: A randomized, double-blind, placebo-controlled study.

BACKGROUND AND AIMS: Urinary incontinence (UI) is common in women, with up to 50 % experiencing involuntary loss of urine at some point. Femaxeen®, a formulation containing purified and specific cytoplasmic extracts of pollen, pumpkin seed extract and vitamin E (referred to hereafter as Femaxeen), is indicated for control of UI in women. This study investigated the efficacy and safety of Femaxeen for the prevention and treatment of UI symptoms in women. METHODS: In this randomized, double-blind, placebo-controlled trial, 81 women with moderate, severe, or very severe urge (43.4 %), stress (31.6 %) or mixed (25.0 %) UI were allocated to receive Femaxeen or placebo once daily for 90 days. Treatment efficacy was assessed using three validated questionnaires. FINDINGS: Thirty-eight patients per group were analyzed. Femaxeen produced statistically significant improvements from baseline to Day 90 (p < 0.001 for all comparisons) in scores on the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), Measurement of Urinary Handicap (MHU) questionnaire, and Sandvik Incontinence Severity Index. Reduction from baseline in ICIQ-SF and MHU scores at Day 60 and Day 90 was significantly greater with Femaxeen than placebo (p < 0.05 for all comparisons). Femaxeen significantly reduced ICIQ-SF and MHU scores from baseline to Day 60 and Day 90 in all UI types (p < 0.05 for all comparisons except ICIQ-SF scores for stress UI). Femaxeen and placebo were well tolerated. Associated adverse events were few and mild in intensity. CONCLUSIONS: Femaxeen is effective for treating UI, and has a safety profile comparable to that of placebo.

In vivo effects of Rauvolfia vomitoria (Apocynaceae) ethanolic extract on sexual performance and reproductive activity in male rats.

Plants and plant-derived products have a long history in the treatment of sexual disorders. Rauvolfia vomitoria is one of such plant used traditionally for the enhancement of male sexual and reproductive activity. This study was carried out to elucidate the potential activity of R. vomitoria ethanolic extract on sexual behaviour and male reproductive function. Twenty-five male rats were assigned to five groups and orally treated with distilled water (control), sildenafil citrate (standard) and R. vomitoria ethanolic extract (50, 100 and 200 mg/kg BW) for 22 days. Sexual behaviour parameters such as mount latency (ML), intromission latency (IL), ejaculation latency (EL), mount frequency (MF), intromission frequency (IF), ejaculation frequency (IF) and post-ejaculatory interval (PEI) were recorded at day 0, 1, 8, 15 and 22. The reproductive function including reproductive organ weights, testicular histology and sperm parameters was also assessed. Results showed enhancement in sexual behaviour through significant reduction (p < .01) in ML, IL and PEI and significant increase (p < .01) in EL, MF IF and EF. The extract also caused an increase in sperm count, motility and transit. Present findings demonstrate the ability of R. vomitoria ethanolic extract to improve male sexual behaviour and reproductive activity in rats.

Electroacupuncture for women with urgency-predominant mixed urinary incontinence: secondary analysis of a randomized noninferiority trial.

OBJECTIVE: To compare the effects and safety of electroacupuncture (EA) and the integration of pelvic floor muscle training (PFMT) and solifenacin in women with urgency-predominant mixed urinary incontinence (MUI). METHODS: The study was a secondary analysis of a randomized noninferiority trial which recruited 500 women with MUI and randomized 178 with urgency-predominant MUI to either receive 12-week EA treatment and 24-week follow-up or 36-week PFMT-solifenacin treatment. Clinical response was defined as at least 50% reduction in average 24-h urgency incontinence episode frequency (IEF), measured by 72-h voiding diary through weeks 1-12. RESULTS: Of the patients randomized, 173 completed the study. The clinical response was 45.78% in EA group, similar with 50.0% in PFMT-solifenacin group, with a difference of - 3.54 (95% CI - 19.08 to 12.0; P = 0.66). In both groups, the proportion of patients with at least 50% reduction of IEF and stress IEF were improved, while the score of ICIQ-SF, episodes of urination, nocturia and urgency, 1-h amount of urinary leakage (AUL), proportion of patients using pads and the number consumed were all decreased after 12-week treatment. The effects could sustain till 36 weeks. Adverse events occurred less in EA group. CONCLUSIONS: EA might reduce IEF, AUL and improve the life quality of female patients with urgency-predominant MUI. The effect may sustain till 36 weeks.

Morphological Assessment of Prostatotropic Activity of (3,5-Dimethyl-4-Hydroxy)Benzyl Thiododecane on a Model of Benign Prostatic Hyperplasia in Rats.

Prostatotropic activity of (3,5-dimethyl-4-hydroxy)benzyl thiododecane (T-DD) was evaluated on a model of benign prostatic hyperplasia induced in Wistar rats by chronic (2 months) intraperitoneal administration of sulpiride (40 mg/kg). Morphometric analysis of the dorsolateral lobe of the prostate showed that after the 2-month course of intragastric T-DD (100 mg/kg) administered in parallel with sulpiride, the volume density of glandular epithelium decreased by 1.7 times, while the volume density of prostate stroma increased by 2 times. After administration of the reference drug Permixon at a dose of 50 mg/kg, the volume densities of epithelium decreased by 1.3 times and stromal volume density increased by 1.5 times. The observed effects are presumably related to suppression of 5α-reductase activity and modulation of estrogen receptors in the prostate.

Combination therapy in overactive bladder-untapped research opportunities: A systematic review of the literature.

AIMS: Overactive bladder (OAB) affects over 17% of the population and significantly effect the health-related quality of life. The treatments for OAB include first line (lifestyle modification, pelvic floor muscle training), second line (anticholinergic or beta-3 agonist medications), and third line therapies (intradetrusor botulinum toxin injection, sacral neurostimulation [SNM], or percutaneous tibial nerve stimulation [PTNS]). For those with urinary incontinence secondary to OAB, complete continence is the goal of therapy, though cure rates are only 5% to 40%. The use of combination therapies can be employed in refractory OAB, however, the efficacy of pooled modalities is relatively unknown. Our objective was to determine the volume of data supporting combination therapy in treating OAB. METHODS: We systematically reviewed PubMed, EMBASE, the Cochrane Library, and Google Scholar for articles published before October 2018. Each was independently reviewed by two reviewers and examined in detail if they met inclusion criteria. RESULTS: A total of 32 studies met inclusion criteria and were reviewed. Most large prospective studies evaluated combinations of medications with behavioral therapy or medications together. Combination therapy studies of third-line treatments were rare and centered on medication with PTNS. No studies examined intradetrusor botulinum toxin injections in combination with another therapy and only one retrospective study briefly examined SNM therapy in combination with medication. CONCLUSION: Combination therapy, with certain first, second, and third-line OAB therapies, appears to be efficacious. There is a further need for carefully designed combination therapy studies, particularly those including third line modalities.