Patient Adherence to Premarin Versus Vagifem Therapy After Female Pelvic Reconstructive Surgery

Genitourinary syndrome is the consequence of the lack of estrogen exposure to the
genitourinary tract during menopause. The result of this hypoestrogenic state is the
thinning, shrinking, increased vaginal friction, and increase in lower urinary tract
symptoms. It is estimated that up to 60% of postmenopausal women experience these symptoms
and the widely accepted treatment for genitourinary syndrome is the application of local
estrogen.

Estrogen has been widely prescribed as a beneficial adjunct in the treatment of menopausal
genitourinary syndrome and is used to decrease the incidence of urgency, frequency, nocturia,
stress urinary incontinence, urge urinary incontinence, and recurrent urinary tract
infections. Despite the well described use of local estrogen therapy for genitourinary
syndrome, not all forms of vaginal estrogen are created equally and patient adherence to
prescriptions has not been uniform among different formulations. Shulman and colleagues noted
that when used for genitourinary syndrome, patients who were prescribed local estrogen
tablets demonstrated significantly longer compliance to therapy than those prescribed
estrogen cream (149 days vs. 92 days). Similarly, in a cohort of 30,000 patients, Portman
demonstrated that patients prescribed vaginal estrogen tablets were also more likely to be
adherent to therapy than those given the cream formulation. Some of the reasons for early
discontinuation of local vaginal cream was due to messiness with application, leakage,
concerns about underdosing or overdosing, and that the cream was generally unpleasant.

Given the extensive use of local estrogen for genitourinary syndrome, despite limited data,
surgeons have been prescribing local estrogen to prevent the development of postoperative
complications like lower urinary tract symptoms after female pelvic reconstructive surgery.
In a postoperative 12 week follow up, Karp and colleagues noted that the administration of a
vaginal estrogen tablets in postmenopausal women is associated with improved vaginal
maturation indices and objective atrophy assessment after vaginal reconstructive surgery.
Vaccaro also noted that preoperative administration of vaginal estrogen administered 2- 12
weeks before reconstructive surgery improves the vaginal maturation index by more than 15.5%
and may improve the tissue as a substrate for suture placement. There have been two studies
evaluating the effect of vaginal estrogen after midureteral sling placement: Zullo studied
retropubic midureteral slings and noted that patients who did not receive vaginal estrogen
tablets exhibited a higher incidence of urinary urgency than patients who did (4% vs. 29%).
Liapias evaluated local estrogen application for 6 months after transobturator tape slings
and noted statistically significant decreases in urinary frequently and urgency.

Given this data, there appears to be a role for postoperative local estrogen therapy after
pelvic reconstructive surgery but it not clear if patients are adherent to therapy and the
form of therapy: cream or tablet. To the best of the investigators knowledge, there is no
data that describes patient adherence to local estrogen therapy after female pelvic surgery.
Therefore, the purpose of this study is to evaluate patient adherence to cream versus tablet
based local estrogen therapy by randomizing treatment modalities to determine differences in
adherence to either form.

Inclusion Criteria:

- Patients who underwent female pelvic reconstructive surgery at University Hospitals
Case Medical Center and were given postoperative local estrogen therapy.

- Patients who consented to the study.

- Postmenopausal

Exclusion Criteria:

- Patients who were not given a prescription for postoperative lower estrogen therapy
despite undergoing surgery.

- Patients with contraindications to vaginal estrogen.

- Any obliterative procedures. Patients who are unable to participate in informed
consent. Patients younger than 18. Non English speaking patients