Comparison of cernitin pollen extract vs tadalafil therapy for refractory chronic prostatitis/chronic pelvic pain syndrome: A randomized, prospective study

Matsukawa, Yoshihisa; Naito, Yasuhito; Funahashi, Yasuhito; Ishida, Susumu; Fujita, Takashi; Tochigi, Kosuke; Kato, Masashi; Gotoh, Momokazu

doi:10.1002/nau.24454

Cited by 8 publications

(16 citation statements)

References 22 publications

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“…Clinically, there are few studies discussing its role in CP/CPPS. Unfortunately, most of these studies either lacked control arm or run in BPH associated CP/CPPS or in combination with other medications [19][20][21].…”

Section: Discussionmentioning

confidence: 99%

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Tadalafil monotherapy in management of chronic prostatitis/chronic pelvic pain syndrome: a randomized double-blind placebo controlled clinical trial

et al. 2022

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Purpose In this placebo-controlled trial, we aimed to evaluate the clinical results of using PDE-5 inhibitor, tadalafil 5 mg OD, for management of CP/CPPS. Patients and methods 140 patients ≤ 45 years old with moderate/severe CP/CPPS associated with ED (IIEF-5 < 22) were randomly divided and received either tadalafil 5 mg OD (tadalafil-group) or placebo (control-group) for 6 weeks. Post-treatment CPSI scores were compared to baseline and to placebo. Clinically significant responders (≥ 25% reduction from baseline score) were calculated. Tadalafil-induced changes in IIE-5 were evaluated in correlation to that of CPSI scores. Results By the 6th week, 59 and 56 patients were available in both groups respectively. Compared to baseline, tadalafil-group patients showed significant improvement in total, pain, urinary and Qol domains of CPSI (19.1 ± 5.26, 10.42 ± 3.55, 4.2 ± 1.72 and 4.47 ± 1.64 vs. 24.21 ± 5.05, 12.14 ± 3.57, 6.08 ± 1.53 and 6.22 ± 1.76), p < 0.5. When compared to placebo, all 6th week CPSI domains scores, except for pain, were significantly better in tadalafil-group (p < 0.05). Post-treatment pain score didn't significantly differ between both groups (10.42 ± 3.55, vs. 11.71 ± 3.9, p > 0.05). Clinically significant responders were 30 patients (50.8%) in tadalafil-group vs. 3 patients (5.4%) in control. Tadalafil-induced changes in IIEF-5 score had weak but significant correlation to Qol domain (r = − 0.28, p < 0.05). Conclusion Tadalafil 5 mg OD can significantly improve all CPSI domains as compared to baseline. Post-treatment CPSI scores, except for pain, were better than placebo. About 50.8% of patients can develop ≥ 25% reduction in their total CPSI scores after treatment. Apart from Qol domain, these changes are not significantly correlated to tadalafil-induced IIEF-5 scores changes.

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Section: Discussionmentioning

confidence: 99%

“…Clinically; few limited studies had investigated the outcome of PDE5-inhibitors in management of CP/CPPS, unfortunately, these studies mostly lacked control arm [19][20][21][22]. In this placebo-controlled clinical trial we aimed to evaluate the results of tadalafil treatment alone in management of non BPH-related CP/CPP patients.…”

Section: Introductionmentioning

confidence: 99%

Tadalafil monotherapy in management of chronic prostatitis/chronic pelvic pain syndrome: a randomized double-blind placebo controlled clinical trial

et al. 2022

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“…As a consequence of an aging society, the number of men complaining of LUTS induced by BPE is increasing. In clinical practice, some patients complain not only of LUTS but also of chronic pelvic pain or discomfort, such as prostatitis‐like symptoms 1,2 . Prostatitis syndromes are classified into the infectious type (acute and chronic), chronic pelvic pain type, or asymptomatic type 1 .…”

Section: Introductionmentioning

confidence: 99%

“…In clinical practice, some patients complain not only of LUTS but also of chronic pelvic pain or discomfort, such as prostatitis-like symptoms. 1,2 Prostatitis syndromes are classified into the infectious type (acute and chronic), chronic pelvic pain type, or asymptomatic type. 1 Among these, CP/CPPS, which is classified as category III prostatitis by the United States National Institutes of Health, has the highest frequency (>90% of men with prostatitis) and is often refractory to treatment.…”

Section: Introductionmentioning

confidence: 99%

Clinical features and urodynamic findings in elderly men with chronic prostatitis

et al. 2022

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Objectives To investigate the complication rate of chronic prostatitis/chronic pelvic pain syndrome in men with lower urinary tract symptoms, and to clarify their clinical features and urodynamic findings. Methods We retrospectively reviewed the clinical data of treatment‐naïve men with lower urinary tract symptoms. Patients were divided into two groups (chronic prostatitis/chronic pelvic pain syndrome + lower urinary tract symptoms and lower urinary tract symptoms only) according to the presence or absence of chronic prostatitis/chronic pelvic pain syndrome, and the patient characteristics as well as the parameters of lower urinary tract symptoms and lower urinary tract function assessed by urodynamics were compared. The diagnostic criteria for chronic prostatitis/chronic pelvic pain syndrome included a complaint of pelvic pain for ≥3 months, National Institutes of Health Chronic Prostatitis Symptom Index pain subscore ≥4, and negative culture of a urine specimen collected after prostate massage. Results Out of 386 men, 123 (31.9%) had chronic prostatitis/chronic pelvic pain syndrome. Parameters of lower urinary tract symptoms and National Institutes of Health Chronic Prostatitis Symptom Index scores were significantly higher in the chronic prostatitis/chronic pelvic pain syndrome + lower urinary tract symptoms group. Although there were no significant intergroup differences in voiding parameters such as maximum flow rate and bladder outlet obstruction index, storage functions such as the incidence of detrusor overactivity and bladder compliance were significantly reduced in the chronic prostatitis/chronic pelvic pain syndrome + lower urinary tract symptoms group. The multivariable regression analysis revealed that a low serum total testosterone level (<3.5 ng/mL), complications of hyperlipidemia, and presence of overactive bladder and detrusor overactivity were significantly associated with the development of chronic prostatitis/chronic pelvic pain syndrome. Conclusions Chronic prostatitis causes a significant decrease in storage function, such as an increase in detrusor overactivity. Additionally, low serum testosterone levels and hyperlipidemia were found to be significantly associated with the development of chronic prostatitis/chronic pelvic pain syndrome in men with lower urinary tract symptoms.

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“…More recently in a randomized clinical trial, Matsukawa et al [ 17 ] evaluated the effect of a 3-month treatment with pollen extract (n. 42 men) or tadalafil (n. 45 men) in men with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) and lower urinary tract symptoms (LUTS). In this study, the authors documented that both pollen extract and tadalafil significantly improved chronic pelvic pain, even if the pollen extract was more effective than tadalafil in the improvement of pelvic pain and discomfort.…”

Section: Introductionmentioning

confidence: 99%

Effectiveness and Safety of a New Nutrient Fixed Combination Containing Pollen Extract Plus Teupolioside, in the Management of LUTS in Patients with Benign Prostatic Hypertrophy: A Pilot Study

Gallelli¹,

Scuteri²,

Burdino³

et al. 2022

Life

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Benign prostatic hyperplasia (BPH) is a common cause of male lower urinary tract symptoms (LUTS) that can reduce quality of life. Even if several drugs can be used in its treatment, the development of adverse drug reactions (ADRs) represents the most common cause of low adherence. In the present study, we evaluate both the efficacy and the safety of a new nutrient fixed combination of Pollen Extract plus Teupolioside, named Xipag®, in patients with LUTS. We conduct a pilot single center open label clinical study between 1 March 2020 and 30 June 2020 in patients with BPH referred to general practitioner’s ambulatories. Male patients > 45 years, sexually active, with clinical symptoms of LUTS and with a diagnosis of HPB were enrolled and received one tablet/day of Xipag® (T0), for three months (T1: end of treatment). The IPSS and IIEF-5 questionnaires were carried out at T0 and T1 and represent the first end point, whereas the primary safety end point was considered the absence of ADR or of drug–drug interactions related to Xipag® administration. During the study period, 25 subjects aged 43 to 76 years (mean 62.7 ± 9) were enrolled and completed the study. The clinical evaluation in T1 documented that Xipag® induced a statistically significant improvement (p < 0.01) in symptoms, as documented by the IPSS questionnaire (range 22.7–88.9; mean 55.2 ± 23.6), without the development of ADRs. In conclusion, this is the first real-world study that showed the efficacy and the safety of Xipag® in the BPH patients with LUTS.

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Comparison of cernitin pollen extract vs tadalafil therapy for refractory chronic prostatitis/chronic pelvic pain syndrome: A randomized, prospective study

Cited by 8 publications

References 22 publications

Tadalafil monotherapy in management of chronic prostatitis/chronic pelvic pain syndrome: a randomized double-blind placebo controlled clinical trial

Tadalafil monotherapy in management of chronic prostatitis/chronic pelvic pain syndrome: a randomized double-blind placebo controlled clinical trial

Clinical features and urodynamic findings in elderly men with chronic prostatitis

Effectiveness and Safety of a New Nutrient Fixed Combination Containing Pollen Extract Plus Teupolioside, in the Management of LUTS in Patients with Benign Prostatic Hypertrophy: A Pilot Study

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