A medical device containing purified bovine colostrum (Monurelle Biogel) in the treatment of vulvovaginal atrophy in postmenopausal women: Retrospective analysis of urinary symptoms, sexual function, and quality of life

被引：19
作者：
Schiavi, M. C. [1 ]
Di Tucci, C. [1 ]
Colagiovanni, V. [1 ]
Faiano, P. [1 ]
Giannini, A. [1 ]
D'Oria, O. [1 ]
Prata, G. [1 ]
Perniola, G. [1 ]
Monti, M. [1 ]
Zullo, M. A. [2 ]
Muzii, L. [1 ]
Panici, P. Benedetti [1 ]
机构：
[1] Univ Rome Sapienza, Umberto Hosp 1, Dept Gynecol & Obstet Sci & Urol Sci, Viale Policlin 155, I-00161 Rome, Italy
[2] Univ Rome, Dept Surg Week Surg, Campus Biomed, Rome, Italy
来源：
LUTS-LOWER URINARY TRACT SYMPTOMS | 2019年 / 11卷 / 02期
关键词：
bovine colostrum; genitourinary syndrome; quality of life; sexual function; vulvovaginal atrophy; GENITOURINARY SYNDROME; MENOPAUSE; HEALTH; GEL; DRYNESS; IMPACT;
D O I：
10.1111/luts.12204
中图分类号：
R5 [内科学]; R69 [泌尿科学（泌尿生殖系疾病）];
学科分类号：
1002 ; 100201 ;
摘要：
Objective This study assessed the effectiveness and safety of a medical device containing purified bovine colostrum (Monurelle Biogel; 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 Monurelle Biogel daily for 12 weeks. Patients underwent clinical examinations, completed a 3-day voiding diary, and had VVA graded using the Vaginal Health Index (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 Monurelle Biogel is an effective treatment for VVA in postmenopausal women, improving sexual life, urinary symptoms, and QoL.
引用
收藏
页码：O11 / O15
页数：5
相关论文
共 23 条
  • [11] Vulvo-vaginal atrophy: A new treatment modality using thermo-ablative fractional CO2 laser
    Perino, Antonino
    Calligaro, Alberto
    Forlani, Francesco
    Tiberio, Corrado
    Cucinella, Gaspare
    Svelato, Alessandro
    Saitta, Salvatore
    Calagna, Gloria
    [J]. MATURITAS, 2015, 80 (03) : 296 - 301
  • [12] Genitourinary syndrome of menopause: New terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and The North American Menopause Society
    Portman, D. J.
    Gass, M. L. S.
    [J]. MATURITAS, 2014, 79 (03) : 349 - 354
  • [13] Robinson Dudley, 2013, Menopause Int, V19, P155, DOI 10.1177/1754045313511398
  • [14] Effective treatment of vaginal atrophy with isoflavone vaginal gel
    Rolim Rosa Lima, Sonia M.
    Yamada, Silvia Saito
    Reis, Benedito Fabiano
    Postigo, Sostenes
    Galvao da Silva, Maria Antonieta L.
    Aoki, Tsutomu
    [J]. MATURITAS, 2013, 74 (03) : 252 - 258
  • [15] Retrospective analysis in 46 women with vulvovaginal atrophy treated with ospemifene for 12 weeks: improvement in overactive bladder symptoms
    Schiavi, Michele Carlo
    Zullo, Marzio Angelo
    Faiano, Pierangelo
    D'Oria, Ottavia
    Prata, Giovanni
    Colagiovanni, Vanessa
    Giannini, Andrea
    Di Tucci, Chiara
    Perniola, Giorgia
    Di Donato, Violante
    Monti, Marco
    Muzii, Ludovico
    Panici, Pierluigi Benedetti
    [J]. GYNECOLOGICAL ENDOCRINOLOGY, 2017, 33 (12) : 942 - 945
  • [16] Severe pelvic organ prolapse treated by vaginal native tissue repair: long-term analysis of outcomes in 146 patients
    Schiavi, Michele Carlo
    Perniola, Giorgia
    Di Donato, Violante
    Visentin, Virginia Sibilla
    Vena, Flaminia
    Di Pinto, Anna
    Zullo, Marzio Angelo
    Monti, Marco
    Panici, Pierluigi Benedetti
    [J]. ARCHIVES OF GYNECOLOGY AND OBSTETRICS, 2017, 295 (04) : 917 - 922
  • [17] HEALTH-RELATED QUALITY-OF-LIFE MEASURES FOR WOMEN WITH URINARY-INCONTINENCE - THE INCONTINENCE IMPACT QUESTIONNAIRE AND THE UROGENITAL DISTRESS INVENTORY
    SHUMAKER, SA
    WYMAN, JF
    UEBERSAX, JS
    MCCLISH, D
    FANTL, JA
    [J]. QUALITY OF LIFE RESEARCH, 1994, 3 (05) : 291 - 306
  • [18] The Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale (FSDS): Psychometric properties within a Dutch population
    ter Kuile, Moniek M.
    Brauer, Marieke
    Laan, Ellen
    [J]. JOURNAL OF SEX & MARITAL THERAPY, 2006, 32 (04) : 289 - 304
  • [19] Non-hormonal treatment of vulvo-vaginal atrophy-related symptoms in post-menopausal women
    Tersigni, C.
    Di Simone, N.
    Tempestilli, E.
    Cianfrini, F.
    Russo, R.
    Moruzzi, M. C.
    Amar, I. D.
    Fiorelli, A.
    Scambia, G.
    Villa, P.
    [J]. JOURNAL OF OBSTETRICS AND GYNAECOLOGY, 2015, 35 (08) : 835 - 838
  • [20] Tucci S, 2013, CLIN EXP OBSTET GYN, V40, P219
123