Vaginal Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Mild Prolapse

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01648751
• Other study ID #: PRO09090064
• Secondary ID: R01HD061811
• Status: Recruiting
• Phase: N/A
• Start date: May 2012
• Est. completion date: December 2023

Study information

• Verified date: February 2023
• Source: University of Pittsburgh
• Contact: Laura C Skoczylas, MD, MS
• Phone: 323-857-2238
• Email: lauraskoczylas[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The pathogenesis of pelvic organ prolapse (POP) is unknown. Few studies have correlated patient symptoms and amount of prolapse with biomarkers. POP has traditionally been managed with a pessary or surgery. Recent studies suggest a reduction in POP symptoms following Pelvic Floor Physical Therapy (PFPT). Vaginally delivered hormones are also commonly used to treat prolapse symptoms, with little evidence supporting a clinical benefit. The investigators hypothesize that the optimal approach to improving prolapse symptoms in the patient with mild prolapse requires re-alignment and strengthening of levator muscles via PFPT, and optimization of tissue integrity via local estrogen therapy. The investigators propose to test this hypothesis in a randomized controlled trial in which women with symptomatic mild prolapse opting for PFPT, receive treatment with PFPT in combination with vaginal estrogen versus placebo. The investigators predict that the combined approach will lead to decreased symptoms and improved anatomical support corroborated by biomarker data.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 53
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Prior surgery for prolapse or incontinence

• Other prior interventions for prolapse (e.g. pessary, PFPT)

• Previous bilateral salpingo-oophorectomy (women with 1 ovary will be eligible)

• Known liver dysfunction

• Connective tissue diseases known to affect collagen or elastin remodeling (including:

Lupus, Rheumatoid Arthritis, Scleroderma, Sjogrens syndrome, Marfan syndrome, and Ehlers-Danlos syndrome)

• Unevaluated abnormal vaginal bleeding or abnormal pap smear in the previous year

• BMI > 35 kg/m2

• Estrogen therapy (including birth control) in the previous year

• Current or prior breast or pelvic malignancy (ovarian, tubal, uterine, cervical or vaginal)

• Contraindication to hormone use (i.e. thromboembolic disorder, use of anti-coagulants, coronary artery disease, history of stroke)

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Drug:
• Vaginal estrogen
1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter
• Placebo
1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter

Locations

Country	Name	City	State
United States	Magee-Womens Hospital, University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
Pamela Moalli	American Urogynecologic Society, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global impression of improvement in prolapse symptoms, using the PGI-I	To determine the impact of vaginally delivered estrogen on global impression of improvement in women with symptomatic mild pelvic organ prolapse who are undergoing pelvic floor physical therapy	6 months
Secondary	Pelvic floor symptoms, using the PFDI-20		6 months
Secondary	Quality of life, using the PFIQ-7		6 months
Secondary	Sexual function, using the PISQ-12		6 months
Secondary	Pelvic organ prolapse stage, using the POP-Q exam		6 months
Secondary	Collagenase activity	Vaginal swabs collected from the posterior fornix will be used for biochemical analysis	6 months