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

2020-03
Maturitas 133
- Santiago Palacios
- Marieta Ramirez
- Mariella Lilue
- Barbara Vega

PubMed: 32005419
DOI: 10.1016/j.maturitas.2019.12.008

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 81
Population: 81 women with moderate, severe, or very severe urge (43.4%), stress (31.6%) or mixed (25.0%) UI
Methods: Randomized, double-blind, placebo-controlled trial, once daily for 90 days
Blinding: Double-blind
Duration: 90 days
Funding: Unclear

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.

Research Insights

Pumpkin→Reduced Incontinence Severity Index
Femaxeen produced statistically significant improvements from baseline to Day 90 (p < 0.001 for all comparisons) in scores on the Sandvik Incontinence Severity Index
Effect
Beneficial
Effect size
Small
Dose
once daily
Pumpkin→Reduced Urinary Handicap Score
Femaxeen produced statistically significant improvements from baseline to Day 90 (p < 0.001 for all comparisons) in scores on the Measurement of Urinary Handicap (MHU) questionnaire
Effect
Beneficial
Effect size
Small
Dose
once daily
Pumpkin→Reduced Urinary Incontinence Symptom Score
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)
Effect
Neutral
Effect size
Small
Dose
once daily
Vitamin E→Reduced Incontinence Severity Index
Femaxeen produced statistically significant improvements from baseline to Day 90 (p < 0.001 for all comparisons) in scores on the Sandvik Incontinence Severity Index
Effect
Beneficial
Effect size
Small
Dose
once daily
Vitamin E→Reduced Urinary Handicap Score
Femaxeen produced statistically significant improvements from baseline to Day 90 (p < 0.001 for all comparisons) in scores on the Measurement of Urinary Handicap (MHU) questionnaire
Effect
Beneficial
Effect size
Small
Dose
once daily
Vitamin E→Reduced Urinary Incontinence Symptom Score
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)
Effect
Neutral
Effect size
Small
Dose
once daily

Adverse Events Reported

Pumpkin→Overall tolerability
Associated adverse events were few and mild in intensity.
Finding
Reported
Grade
mild
Vitamin E→Overall tolerability
Associated adverse events were few and mild in intensity.
Finding
Reported
Grade
mild