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：20
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 [J].
Perino, Antonino ;
Calligaro, Alberto ;
Forlani, Francesco ;
Tiberio, Corrado ;
Cucinella, Gaspare ;
Svelato, Alessandro ;
Saitta, Salvatore ;
Calagna, Gloria .
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 [J].
Portman, D. J. ;
Gass, M. L. S. .
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 [J].
Rolim Rosa Lima, Sonia M. ;
Yamada, Silvia Saito ;
Reis, Benedito Fabiano ;
Postigo, Sostenes ;
Galvao da Silva, Maria Antonieta L. ;
Aoki, Tsutomu .
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 [J].
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 .
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 [J].
Schiavi, Michele Carlo ;
Perniola, Giorgia ;
Di Donato, Violante ;
Visentin, Virginia Sibilla ;
Vena, Flaminia ;
Di Pinto, Anna ;
Zullo, Marzio Angelo ;
Monti, Marco ;
Panici, Pierluigi Benedetti .
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 [J].
SHUMAKER, SA ;
WYMAN, JF ;
UEBERSAX, JS ;
MCCLISH, D ;
FANTL, JA .
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 [J].
ter Kuile, Moniek M. ;
Brauer, Marieke ;
Laan, Ellen .
JOURNAL OF SEX & MARITAL THERAPY, 2006, 32 (04) :289-304
[19]   Non-hormonal treatment of vulvo-vaginal atrophy-related symptoms in post-menopausal women [J].
Tersigni, C. ;
Di Simone, N. ;
Tempestilli, E. ;
Cianfrini, F. ;
Russo, R. ;
Moruzzi, M. C. ;
Amar, I. D. ;
Fiorelli, A. ;
Scambia, G. ;
Villa, P. .
JOURNAL OF OBSTETRICS AND GYNAECOLOGY, 2015, 35 (08) :835-838
[20]  
Tucci S, 2013, CLIN EXP OBSTET GYN, V40, P219
123