Efficacy of mace (Arils of Myristica fragrans Houtt) plus pelvic floor muscle training on symptoms in mixed urinary incontinence: a randomized placebo-controlled trial

BACKGROUND: It is not only to evaluate the efficacy and safety of mace (Arils of Myristica fragrans Houtt) but also to compare pelvic floor muscle training vs. pelvic floor muscle training (PFMT) for improving symptoms and health-related quality of life (HRQoL) of woman with mixed urinary incontinence (MUI). METHODS: A prospective, single-blind randomized controlled study was conducted. Patients (n = 60) were randomly allocated (1:1) to receive either mace powder or placebo (1.5 g) orally twice daily along with pelvic floor muscle training in both groups for three consecutive months. The primary outcomes included symptom evaluation with Patient Global Impression Index of Improvement (PGI-I) and the Patient Global Impression Index of Severity (PGI-S) for MUI. For safety, clinical examination and biochemical parameters were assessed. Secondary outcomes included Short form of Urogenital Distress Inventory Questionnaire-6 (UDI-6) and quality of life assessment with questionnaire tools such as Short form of Incontinence Impact Questionnaire-7 (IIQ-7), Short form of the Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) and ICIQ-SF. The data were statistically interpreted with 5% level of significance. RESULTS: After treatment (at third month), the patient reported cure for PGI-I and PGI-S was 46.66% and 90% for the mace group, whereas 0% and 16.66% for the control group, respectively (P < 0.001), statistically significant. No side effects were reported in the mace group. The mean difference noted in terms of scores, at the third month from baseline for UDI-6 (51.09 vs. 24.78), IIQ-7 (45.48 vs. 23.49), PISQ (11.33 vs. 5.40), and ICIQ-SF (8.10 vs. 2.43) scores were higher in the mace than that in the control group (P < 0.001). CONCLUSION: Mace is effective and safe for the subjective improvement of mixed urinary incontinence symptoms and for the improvement of women's HRQoL than the placebo. Clinical Trial Registry No.: CTRI/2017/04/008342