Impact of Vaginal Estrogen in the Treatment of Symptomatic Mild Pelvic Organ Prolapse With Pelvic Floor Physical Therapy

Status: Terminated
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is a randomized controlled trial in which women with symptomatic mild pelvic organ prolapse undergoing Pelvic Floor Physical Therapy (PFPT) receive vaginal estrogen versus placebo to see if a combined approach to treatment leads to improvement in clinical outcomes. The investigators predict that PFPT in combination with vaginal estrogen will lead to decreased pelvic floor symptoms and improved anatomical support corroborated by biomarker data.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• Women in good health aged 40-80

• Has symptoms of pelvic organ prolapse; answers yes to at least 1 of the following questions:

⁃ Do you feel or see a vaginal bulge? Do you feel pressure in the vagina?

• Meets POP-Q criteria on exam for stage I, II, or III prolapse

• Interested in PFPT for management of POP

• Normal mammogram within 1 year of enrollment

Locations
United States
Pennsylvania
Magee-Womens Hospital, University of Pittsburgh
Pittsburgh
Time Frame
Start Date: 2012-05
Completion Date: 2023-03-02
Participants
Target number of participants: 21
Treatments
Experimental: Vaginal estrogen
Patients in the experimental group will receive vaginal estrogen cream
Placebo_comparator: Placebo cream
Patients in the comparison group will receive placebo vaginal cream
Sponsors
Collaborators: American Urogynecologic Society, Pfizer, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Leads: Pamela Moalli

This content was sourced from clinicaltrials.gov