Effect of Nigella Sativa Oil on Urinary Incontinence and Quality of Life in Menopausal Women: A Triple-Blind Randomized Controlled Trial

Abstract

Abstract Introduction: Increased urinary incontinence is one of the most common changes during menopause. To treat such disorders, various methods including medication, surgery, or a combination of them are used. However, patients in many cases complain about the return of symptoms after their treatment. Furthermore, incontinence and menopause are associated with reduced quality of life and lower sexual function. Therefore, the present study is aimed to investigate the effect of Nigella Sativa seed oil on urinary incontinence and quality of life in menopause women (primary outcomes) and sexual function ,quality of life in urinary incontinence women and side effects (secondary outcomes). Methods: The present triple-blind randomized controlled trial was conducted on 60 menopausal women in Tabriz in 2021. The participants were allocated to two intervention and control groups using the block randomization method. The participants applied 2-3 drops of the Nigella Sativa oil or the placebo on their stomachs below the novel without massaging twice a day for 8 weeks. Besides, the questionnaires including QUID (Questionnaire for Urinary Incontinence Diagnosis), ICIQ-UISF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form), MENQOL (Menopause-specific Quality of Life), FSFI (Female Sexual Function Index), and I-QoL (Incontinence Quality of Life) were completed before and after the intervention. Also, the Mann-Whitney U test, independent t-test, and ANCOVA test were used to compare the outcomes between groups. Findings: In terms of personal-social characteristics and base scores of the studied variables, no statistically significant difference was observed between the study groups before the intervention (p>0.05). However, after the intervention, the average score of mixed urinary incontinence in the intervention group was significantly lower than that in the control group (p=0.04). Also, the average score of the incontinence-QoL in the intervention group was significantly higher than the control group (mean difference: 11.11; 95% Confidence Interval: 2.05 to 20.17; p=0.017). However, concerning the variables of stress incontinence (p=0.081), urge incontinence (p=0.062), sexual function (p=0.573), and menopause-specific QoL of women (p=0.634), no significant difference was observed between the study groups. Conclusion: The obtained results indicated the positive effect of the Nigella Sativa oil on mixed incontinence and incontinence-QoL; nevertheless, to make an absolute conclusion in this regard requires further studies.