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

NCT01648751 | Terminated Results DMC

• 2 other identifiers: STUDY19030408R01HD061811
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Patient Global Impression of Improvement

  The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy (transition scale). It is a simple, direct, easy to use scale that is intuitively understandable to clinicians. Potential Responses: 1. Very Much Better 2. Much Better 3. A Little Better 4. No Change 5, A Little Worse 6\. Much Worse 7. Very Much Worse Lower scores indicate more imiprovment / better outcome.

  6 months after starting vaginal cream

Secondary Outcomes (5)

• Pelvic Floor Symptoms

  6 months

• General Quality of Life

  6 months

• Pelvic Organ Prolapse Stage

  6 months

• Collagenase Activity

  6 months

• Sexual Function

  6 months

Study Arms (2)

Vaginal estrogen

EXPERIMENTAL

Patients in the experimental group will receive vaginal estrogen cream

Drug: Vaginal estrogen

Placebo cream

PLACEBO COMPARATOR

Patients in the comparison group will receive placebo vaginal cream

Drug: Placebo

Interventions

Vaginal estrogen DRUG

1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter

Also known as: Premarin vaginal cream

Vaginal estrogen

Placebo DRUG

1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter

Also known as: Placebo cream

Placebo cream

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pamela Moalli: lead
• American Urogynecologic Society: collaborator
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Pfizer: collaborator

Study Sites (1)

Magee-Womens Hospital, University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Pamela Moalli MD PHD
• Organization: University of PIttsburgh

moalpa@upmc.edu

412-641-6052

Study Officials

• Laura C Skoczylas, MD, MS

  University of Pittsburgh

  STUDY DIRECTOR

• Pamela Moalli, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 19, 2012
• First Posted: July 24, 2012
• Study Start: May 1, 2012
• Primary Completion: March 2, 2023
• Study Completion: March 2, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Locations

US (1)