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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02860897
Recruitment Status : Withdrawn (Unable to provide study medications due to cost.)
First Posted : August 9, 2016
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Andrey Petrikovets, University Hospitals Cleveland Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Estrogen Menopause Pelvic Floor Disorders Surgery Drug: Premarin Drug: Vagifem Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patient Adherence to Premarin Versus Vagifem Therapy After Female Pelvic Reconstructive Surgery
Study Start Date : July 2016
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : July 2017


Arm Intervention/treatment
Experimental: Vaginal estrogen cream Drug: Premarin
Vaginal estrogen cream

Experimental: Vaginal estrogen tablet Drug: Vagifem
Vaginal estrogen tablet




Primary Outcome Measures :
  1. Time in days to discontinuation of vagifem tablet or premarin cream. [ Time Frame: 6 weeks ]
    Days upon which patients stopped using vagifem tablets or premarin cream


Secondary Outcome Measures :
  1. Pelvic floor disease inventory-20 [ Time Frame: preoperatively, 2 weeks, 6 weeks. ]
    The investigators will use the pelvic floor disease inventory-20 survey and compare its results preoperatively, 2 weeks and 6 weeks after surgery.

  2. Postoperative complications [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860897


Locations
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United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
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Responsible Party: Andrey Petrikovets, Fellow in Female Pelvic Medicine and Reconstructive Surgery, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT02860897    
Other Study ID Numbers: 08-15-39
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pelvic Floor Disorders
Pregnancy Complications
Estrogens, Conjugated (USP)
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs