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

PURPOSE: To evaluate patient adherence to cream versus tablet based local estrogen therapy by randomizing treatment modalities to determine differences in adherence to either form.

HYPOTHESIS: There is no difference in adherence to cream versus tablet based local estrogen therapy when prescribed as a 6 week course of postoperative therapy after female pelvic reconstructive surgery.

Study Overview

• Status: Withdrawn
• Conditions: Menopause; Surgery; Pelvic Floor Disorders; Estrogen
• Intervention / Treatment: Drug: Premarin; Drug: Vagifem

Detailed Description

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.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Case Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vaginal estrogen cream	Drug: Premarin; Vaginal estrogen cream
Experimental: Vaginal estrogen tablet	Drug: Vagifem; Vaginal estrogen tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in days to discontinuation of vagifem tablet or premarin cream.	Days upon which patients stopped using vagifem tablets or premarin cream	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic floor disease inventory-20	The investigators will use the pelvic floor disease inventory-20 survey and compare its results preoperatively, 2 weeks and 6 weeks after surgery.	preoperatively, 2 weeks, 6 weeks.
Postoperative complications		6 weeks

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): April 1, 2017
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: July 28, 2016
• First Submitted That Met QC Criteria: August 8, 2016
• First Posted (Estimate): August 9, 2016

Study Record Updates

• Last Update Posted (Actual): May 2, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Pelvic Floor Disorders; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Estrogens, Conjugated (USP)
• Other Study ID Numbers: 08-15-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No