Use of Fermented Red Clover Isoflavones in the Treatment of Overactive Bladder in Postmenopausal Women: A Randomized, Double-Blinded, Placebo-Controlled Trial

Author:

Villadsen Annemarie B.12ORCID,Holm-Jacobsen Julie N.1,Prabhala Bala K.3ORCID,Bundgaard-Nielsen Caspar12ORCID,Huntjens Pam1ORCID,Kornum Jette B.4,Glavind Karin5,Leutscher Peter D. C.12,Christensen Lars P.3ORCID,Jeppesen Per B.6ORCID,Sørensen Suzette127ORCID,Arenholt Louise T. S.128

Affiliation:

1. Centre for Clinical Research, North Denmark Regional Hospital, 9800 Hjoerring, Denmark

2. Department of Clinical Medicine, Aalborg University, 9000 Aalborg, Denmark

3. Department of Physics, Chemistry and Pharmacy, University of Southern Denmark, 5230 Odense M, Denmark

4. Department of Clinical Microbiology, Aalborg University, 9000 Aalborg, Denmark

5. Department of Obstetrics and Gynecology, Aalborg University Hospital, 9000 Aalborg, Denmark

6. Department of Clinical Medicine, Aarhus University, Aarhus University Hospital, 8200 Aarhus N, Denmark

7. Steno Diabetes Center North Denmark, 9000 Aalborg, Denmark

8. Department of Obstetrics and Gynecology, North Denmark Regional Hospital, 9800 Hjoerring, Denmark

Abstract

Postmenopausal women are at risk of developing an overactive bladder (OAB). Conventional vaginal estrogen has shown promise for symptom relief. Isoflavones have proven effective as an alternative to estrogen treatment against menopause-related symptoms. However, its effect on OAB symptoms has not been studied. This study investigates if fermented red clover isoflavones reduce OAB symptoms in postmenopausal women. In this randomized, double-blinded, placebo-controlled trial, women were administered red clover extract (RCE) or a placebo twice daily for three months. Women filled out the International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB) and Urinary Incontinence Short Form (ICIQ-UI-SF), together with a fluid intake and voiding diary. A total of 33 women (16 in the RCE group and 17 in the placebo group) were included in the analysis. Baseline demographics and OAB characteristics were comparable across groups. Intake of RCE did not lead to significant relief in most urinary bladder symptom measures, although a significant reduction in the bother of urinary urgency (p = 0.033) and a tendency towards a decreased ICIQ-OAB score were observed (p = 0.056). In contrast, the placebo exhibited a significant decrease in the ICIQ-OAB score (p = 0.021) and in some diary outcomes. We found that an intake of isoflavones did not relieve OAB symptoms in postmenopausal women.

Funder

Ulla og Mogens Folmer Andersen’s Legat

Marie Pedersen og Jensine Heiberg’s Legat

Niels Jensens Forskningslegat

Region Nordjyllands Sundhedsvidenskabelige Forskningsfond

Torben og Alice Frimodt’s Legat

Aase og Ejnar Danielsen’s Legat

Lilly og Herbert Hansen’s Legat

Publisher

MDPI AG

Subject

Food Science,Nutrition and Dietetics

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