Local Estrogen Adherence: A Prospective Pilot Study

Abstract

Objectives:

Local estrogen therapy (LET) has many benefits, but little is known regarding adherence and reasons for discontinuation. We aimed to evaluate fill/continuation rates of LET and assess factors associated with not filling/discontinuation.

Materials and Methods:

Prospective observational study of adult women newly prescribed LET. Participants completed Pelvic Floor Distress Inventory 20 (PFDI-20) and the Day-to-Day Impact of Vaginal Aging (DIVA) at baseline, 3-, 6-, and 12-months from initial prescription. Participants who discontinued LET were queried regarding reason for discontinuation.

Results:

A total of 155 participants were included. Mean age was 65 (+/−10) and 57% had private insurance. The most common indications for prescription with LET were atrophic vaginitis 61 (39%) and recurrent urinary tract infection 34 (22%). At baseline, 94% filled initial prescription. Continuation rates were 78%, 90%, and 79% at 3-, 6-, and 12-months, respectively, but 93 (60%) were lost to follow-up over the study period. Common reasons for not starting LET included cost (33%) and concern for side effects (22%). Common reasons for discontinuing were mess of using therapy (19%) and concern for side effects (16%). PFDI-20 and DIVA domain scores except self-concept decreased across all timepoints for all participants with no difference between women who continued versus discontinued LET. Univariate analysis did not find any factors associated with LET discontinuation.

Conclusions:

LET use is associated with improved pelvic floor and vaginal symptoms up to 12 months following initiation. Prospective evaluation was challenging due to high loss to follow-up. A total of 26% discontinued LET over 1 year. Barriers to initiation and discontinuation such as cost, mess, and concern for side effects are potentially modifiable factors that physicians can address to improve adherence.

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References

Moehrer

, Hextall

, Jackson

. Oestrogens for urinary incontinence in women. Cochrane Database Syst Rev, 2003(2):Cd001405. (In eng); doi: 10.1002/14651858.Cd001405

The 2017 hormone therapy position statement of The North American Menopause Society. Menopause, 2017; 24(7):728–753 (In eng); doi: 10.1097/gme.0000000000000921

Dueñas-Garcia

, Sullivan

, Hall

, et al. Pharmacological agents to decrease new episodes of recurrent lower urinary tract infections in postmenopausal women. A Systematic Review. Urogynecology, 2016; 22(2):63–69; doi: 10.1097/spv.0000000000000244

Rahn

, Carberry

, Sanses

, et al.; Society of Gynecologic Surgeons Systematic Review Group. Vaginal estrogen for genitourinary syndrome of menopause: A systematic review. Obstet Gynecol, 2014; 124(6):1147–1156; doi: 10.1097/aog.0000000000000526

Dessie

, Armstrong

, Modest

, et al. Effect of vaginal estrogen on pessary use. Int Urogynecol J, 2016; 27(9):1423–1429 (In eng); doi: 10.1007/s00192-016-3000-1

Niigaki

, Silva

RSP

, Bortolini

MAT

, et al. Predictors for long-term adherence to vaginal pessary in pelvic organ prolapse: A prospective study. Int Urogynecol J, 2022; 33(11):3237–3246 (In eng); doi: 10.1007/s00192-022-05133-5

Shulman

, Portman

, Lee

, et al. A retrospective managed care claims data analysis of medication adherence to vaginal estrogen therapy: Implications for clinical practice. J Womens Health (Larchmt), 2008; 17(4):569–578 (In eng); doi: 10.1089/jwh.2007.0407

Weissmann-Brenner

, Bayevsky

, Yoles

. Compliance to vaginal treatment-tablets versus cream: A retrospective 9 years study. Menopause, 2017; 24(1):73–76 (In eng); doi: 10.1097/gme.0000000000000729

Harris

, Taylor

, Thielke

, et al. Research electronic data capture (REDCap)—A metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform, 2009; 42(2):377–381; doi: 10.1016/j.jbi.2008.08.010

10.

Geller

, Barbee

, Wu

, et al. Validation of telephone administration of 2 condition-specific quality-of-life questionnaires. Am J Obstet Gynecol, 2007; 197(6):632.e1–632.e4; doi: 10.1016/j.ajog.2007.08.019

11.

Barber

, Walters

, Bump

. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol, 2005; 193(1):103–113 (In eng); doi: 10.1016/j.ajog.2004.12.025

12.

Huang

, Gregorich

, Kuppermann

, et al. Day-to-Day Impact of Vaginal Aging questionnaire: A multidimensional measure of the impact of vaginal symptoms on functioning and well-being in postmenopausal women. Menopause, 2015; 22(2):144–154 (In eng); doi: 10.1097/gme.0000000000000281

13.

Portman

, Shulman

, Yeaw

, et al. One-year treatment persistence with local estrogen therapy in postmenopausal women diagnosed as having vaginal atrophy. Menopause, 2015; 22(11):1197–1203. (In eng); doi: 10.1097/gme.0000000000000465

14.

Minkin

, Maamari

, Reiter

. Improved compliance and patient satisfaction with estradiol vaginal tablets in postmenopausal women previously treated with another local estrogen therapy. Int J Womens Health, 2013; 5:133–139 (In eng); doi: 10.2147/ijwh.S41897

15.

Minkin

, Maamari

, Reiter

. Postmenopausal vaginal atrophy: Evaluation of treatment with local estrogen therapy. Int J Womens Health, 2014; 6:281–288 (In eng); doi: 10.2147/ijwh.S57900

16.

Lethaby

, Ayeleke

, Roberts

. Local oestrogen for vaginal atrophy in postmenopausal women. Cochrane Database Syst Rev, 2016; 2016(8):Cd001500 (In eng); doi: 10.1002/14651858.CD001500.pub3

17.

Reiter

. Barriers to effective treatment of vaginal atrophy with local estrogen therapy. Int J Gen Med, 2013; 6:153–158 (In eng); doi: 10.2147/ijgm.S43192

18.

Jiang

, Zhu

, Xu

, et al. Efficacy and safety of solifenacin succinate tablets versus solifenacin succinate tablets with local estrogen for the treatment of overactive bladder in postmenopausal women—a multicenter, randomized, open-label, controlled comparison study. Menopause, 2016; 23(4):451–457.