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A medical device containing purified bovine colostrum ( M onurelle B iogel) in the treatment of vulvovaginal atrophy in postmenopausal women: R etrospective analysis of urinary symptoms, sexual function, and quality of life
Author(s) -
Schiavi M. C.,
Di Tucci C.,
Colagiovanni V.,
Faiano P.,
Giannini A.,
D’Oria O.,
Prata G.,
Perniola G.,
Monti M.,
Zullo M. A.,
Muzii L.,
Benedetti Panici P.
Publication year - 2019
Publication title -
luts: lower urinary tract symptoms
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.451
H-Index - 15
eISSN - 1757-5672
pISSN - 1757-5664
DOI - 10.1111/luts.12204
Subject(s) - medicine , nocturia , overactive bladder , urology , urination , urinary incontinence , quality of life (healthcare) , colostrum , gynecology , distress , genitourinary system , urinary system , pathology , nursing , clinical psychology , alternative medicine , antibody , immunology
Objective This study assessed the effectiveness and safety of a medical device containing purified bovine colostrum ( M onurelle B iogel; Zambon, Bresso, Italy) in improving vulvovaginal atrophy ( VVA ), sexual function, urinary symptoms, and quality of life (QoL) in postmenopausal women. Methods In all, 172 postmenopausal women with VVA were included in the study . All women were treated with vaginal M onurelle B iogel daily for 12 weeks. Patients underwent clinical examinations, completed a 3‐day voiding diary, and had VVA graded using the V aginal H ealth I ndex ( VHI ) at baseline and 12 weeks. Patients also completed the Female Sexual Function Index (FSFI), overactive bladder questionnaire ( OAB ‐ Q) , and the Urogenital Distress Inventory (UDI‐6), among others. Results After 12 weeks, there were significant increases in mean (± SD) VHI (12.53 ± 3.67 vs. 19.31 ± 3.49; P < .0001), the number of patients engaging in regular sexual activity 102 (59.3%) vs. 144 (83.7%), and in the total FSFI score (21.64 ± 2.99 vs. 28.16 ± 1.93; P < .0001) compared with baseline. In addition, there were significant reductions in the mean number of 24‐hour voids (9.57 ± 2.12 vs. 7.13 ± 1.22; P < .0001), urgent micturition episodes per 24 hours (1.75 ± 0.76 vs. 1.14 ± 0.87; P = .001), nocturia episodes (1.58 ± 0.85 vs. 0.97 ± 1.18; P = .0002), and urinary incontinence episodes per 24 hours (0.74 ± 0.59 vs. 0.28 ± 0.52; P = .003). Finally, after 12 weeks treatment, there were significant differences in UDI ‐6 (7.85 ± 0.81 vs. 5.56 ± 1.40), OAB ‐ Q symptom (53.60 ± 12.57 vs. 22.08 ± 9.63), and OAB ‐ Q health‐related QoL (21.75 ± 8.51 vs. 69.34 ± 14.59) scores compared with baseline ( P < .0001 for all). The Patient Impression of Global Improvement scale revealed global improvement in 143 women (83.14%). Conclusions M onurelle B iogel is an effective treatment for VVA in postmenopausal women, improving sexual life, urinary symptoms, and QoL.