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

• ClinicalTrials.gov Identifier: NCT01648751
• Recruitment Status: Recruiting
• First Posted: July 24, 2012
• Last Update Posted: March 10, 2020
• Sponsor: Pamela Moalli
• Collaborators: American Urogynecologic Society; National Institutes of Health (NIH); Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Pfizer
• Information provided by (Responsible Party): Pamela Moalli, University of Pittsburgh

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Pelvic Organ Prolapse	Drug: Vaginal estrogen; Drug: Placebo	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 53 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Impact of Vaginal Estrogen in the Treatment of Symptomatic Mild Pelvic Organ Prolapse With Pelvic Floor Physical Therapy
• Study Start Date: May 2012
• Estimated Primary Completion Date: December 2020
• Estimated Study Completion Date: December 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Vaginal estrogen; Patients in the experimental group will receive vaginal estrogen cream	Drug: Vaginal estrogen; 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter; Other Name: Premarin vaginal cream
Placebo Comparator: Placebo cream; Patients in the comparison group will receive placebo vaginal cream	Drug: Placebo; 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter; Other Name: Placebo cream

Outcome Measures

Primary Outcome Measures :

1. Global impression of improvement in prolapse symptoms, using the PGI-I [ Time Frame: 6 months ]
   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

Secondary Outcome Measures :

1. Pelvic floor symptoms, using the PFDI-20 [ Time Frame: 6 months ]
2. Quality of life, using the PFIQ-7 [ Time Frame: 6 months ]
3. Sexual function, using the PISQ-12 [ Time Frame: 6 months ]
4. Pelvic organ prolapse stage, using the POP-Q exam [ Time Frame: 6 months ]
5. Collagenase activity [ Time Frame: 6 months ]
   Vaginal swabs collected from the posterior fornix will be used for biochemical analysis

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Contacts

Contact: Laura C Skoczylas, MD, MS; 323-857-2238; lauraskoczylas@gmail.com

Contact: Pamela Moalli, MD, PhD; moalpa@mail.magee.edu

Locations

United States, Pennsylvania

Magee-Womens Hospital, University of Pittsburgh; Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contact: Lori Geraci, BS 412-641-2634

Sub-Investigator: Laura C Skoczylas, MD, MS

Principal Investigator: Pamela Moalli, MD, PhD

Sponsors and Collaborators

Pamela Moalli

American Urogynecologic Society

National Institutes of Health (NIH)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Pfizer

Investigators

• Study Director: Laura C Skoczylas, MD, MS; University of Pittsburgh
• Principal Investigator: Pamela Moalli, MD, PhD; University of Pittsburgh

More Information

• Responsible Party: Pamela Moalli, Associate Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT01648751
• Other Study ID Numbers: PRO09090064; R01HD061811 ( U.S. NIH Grant/Contract )
• First Posted: July 24, 2012
• Last Update Posted: March 10, 2020
• Last Verified: March 2020

Keywords provided by Pamela Moalli, University of Pittsburgh:

Pelvic organ prolapse; Pelvic floor physical therapy; Vaginal estrogen; Placebo

Additional relevant MeSH terms:

Prolapse; Pelvic Organ Prolapse; Pathological Conditions, Anatomical; Estrogens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs