Highlights
- •Femaxeen® is a natural product for control of urinary incontinence (UI) in women.
- •This study compared Femaxeen with placebo in women with urge, stress, or mixed urinary incontinence.
- •Femaxeen provided effective control of all three types of urinary incontinence.
- •The safety profile of Femaxeen was similar to that of placebo.
- •Femaxeen is a useful addition to the armamentarium for treating urinary incontinence in women.
Abstract
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.
Keywords
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to MaturitasAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- EAU guidelines on assessment and nonsurgical management of urinary incontinence.Eur. Urol. 2018; 73: 596-609
- Urinary tract disorders in perimenopausal and postmenopausal women.in: Lobo R.A. Treatment of the Postmenopausal Woman: Basic and Clinical Aspects. 2nd ed. Lippincott, Williams & Wilkins, Philadelphia, PA1999: 213-227
- Clinical epidemiological insights into urinary incontinence.Int. Urogynecol. J. 2017; 28: 687-696
- Urinary incontinence in women: variation in prevalence estimates and risk factors.Obstet. Gynecol. 2008; 111: 324-331
- Prevalence and risk factors of urinary incontinence in young and middle-aged women.BJU Int. 2002; 89: 61-66
- Risk factors for urinary incontinence among middle-aged women.Am. J. Obstet. Gynecol. 2006; 194: 339-345
- Age-specific prevalence of, and factors associated with, different types of urinary incontinence in community-dwelling Australian women assessed with a validated questionnaire.Maturitas. 2009; 62: 134-139
- Lower urinary tract symptoms in women-a common but neglected problem.J. Am. Acad. Nurse Pract. 2008; 20: 311-318
- How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study.BJU Int. 2001; 87: 760-766
- EAU Guidelines on Urinary Incontinence in Adults.EAU Guidelines Office, Arnhem, The Netherlands2018 (Available online at: https://uroweb.org/wp-content/uploads/EAU-Guidelines-on-Urinary-Incontinence-2018-large-text.pdf (Accessed June 2019))
- Management of urinary incontinence.P&T. 2012; 37: 345-361H
- Urinary incontinence in women: a review.JAMA. 2017; 318: 1592-1604
- Cernilton for benign prostatic hyperplasia.Cochrane Database Syst. Rev. 2002; CD001042
- A critical review of Cernitin™ for symptomatic relief of lower urinary tract symptoms (LUTS) in men.Res. Comm. Pharmacol. Toxicol. 2003; 8: 2-10
- Effects of pollen extract preparation Prostat/Poltit on lower urinary tract symptoms in patients with chronic nonbacterial prostatitis/chronic pelvic pain syndrome: a randomized, double-blind, placebo-controlled study.Urology. 2006; 67: 60-63
- A severity index for epidemiological surveys of female urinary incontinence: comparison with 48-hour pad-weighing tests.Neurourol. Urodyn. 2000; 19: 137-145
- ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence.Neurourol. Urodyn. 2004; 23: 322-330
- Evaluation scale of the pelvic handicap: measurement of the urinary handicap (MHU).in: Pelissier J. Costa P. Lopez S. Mares P. Rééducation vésico-sphinctérienne et ano-rectale. Masson, Paris2007: 498-504
- Treatment of chronic prostatitis and prostatodynia with pollen extract.Br. J. Urol. 1989; 64: 496-499
Internal report. Sérélys Pharma, Monaco.
- Acetylcholine and the overactive bladder.Eur. Urol. 2007; 51: 881-883
- The neural control of micturition.Nat. Rev. Neurosci. 2008; 9: 453-466
- Duloxetine: a serotonin-noradrenaline re-uptake inhibitor for the treatment of stress urinary incontinence.Expert Opin. Invest. Drugs. 2003; 12: 1559-1566
- Duloxetine in the treatment of stress urinary incontinence.Ther. Clin. Risk Manag. 2005; 1: 259-264
- Inhibition of testosterone-induced hyperplasia of the prostate of Sprague-Dawley rats by pumpkin seed oil.J. Med. Food. 2006; 9: 284-286
- Pumpkin seed oil and phytosterol-F can block testosterone/prazosin-induced prostate growth in rats.Urol. Int. 2006; 77: 269-274
- Anabolic effects of androgens on muscles of female pelvic floor and lower urinary tract.Curr. Opin. Obstet. Gynecol. 2004; 16: 405-409
- Pumpkin seed oil extracted from Cucurbita maxima improves urinary disorder in human overactive bladder.J. Tradit. Complement. Med. 2014; 4: 72-74
- Clinical study of effectiveness and safety of CELcomplex® containing Cucurbita Pepo Seed extract and Flax and Casuarina on stress urinary incontinence in women.J. Tradit. Complement. Med. 2019; 9: 138-142
- A randomized, double-blind, placebo-controlled clinical trial: evaluating safety and efficacy of a composition of purified and specific cytoplasm extracts of pollen (PSCEP), pumpkin seed extract and vitamin E (Femaxeen®) in women with stress urinary incontinence.in: Presented at: 12th European Congress on Menopause and Andropause, 15–17 May 2019, Berlin, Germany2019
- Can incontinence be cured? A systematic review of cure rates.BMC Med. 2017; 15: 63
Article info
Publication history
Published online: December 11, 2019
Accepted:
December 10,
2019
Received in revised form:
November 25,
2019
Received:
July 12,
2019
Identification
Copyright
© 2019 Elsevier B.V. All rights reserved.
