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

Primary Purpose

Pelvic Organ Prolapse

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Vaginal estrogen

Placebo

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring Pelvic organ prolapse, Pelvic floor physical therapy, Vaginal estrogen, Placebo

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

Magee-Womens Hospital, University of PittsburghRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vaginal estrogen

Placebo cream

Arm Description

Patients in the experimental group will receive vaginal estrogen cream

Patients in the comparison group will receive placebo vaginal cream

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pelvic floor symptoms, using the PFDI-20

Quality of life, using the PFIQ-7

Sexual function, using the PISQ-12

Pelvic organ prolapse stage, using the POP-Q exam

Collagenase activity

Vaginal swabs collected from the posterior fornix will be used for biochemical analysis

Full Information

NCT ID

NCT01648751

First Posted

July 19, 2012

Last Updated

February 7, 2023

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

1. Study Identification

Unique Protocol Identification Number

NCT01648751

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 2012 (undefined)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the 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

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pelvic Organ Prolapse

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Vaginal estrogen

Arm Type

Experimental

Arm Description

Patients in the experimental group will receive vaginal estrogen cream

Arm Title

Placebo cream

Arm Type

Placebo Comparator

Arm Description

Patients in the comparison group will receive placebo vaginal cream

Intervention Type

Drug

Intervention Name(s)

Vaginal estrogen

Other Intervention Name(s)

Premarin vaginal cream

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Placebo cream

Intervention Description

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

Primary Outcome Measure Information:

Title

Global impression of improvement in prolapse symptoms, using the PGI-I

Description

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Pelvic floor symptoms, using the PFDI-20

Time Frame

6 months

Title

Quality of life, using the PFIQ-7

Time Frame

6 months

Title

Sexual function, using the PISQ-12

Time Frame

6 months

Title

Pelvic organ prolapse stage, using the POP-Q exam

Time Frame

6 months

Title

Collagenase activity

Description

Vaginal swabs collected from the posterior fornix will be used for biochemical analysis

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Laura C Skoczylas, MD, MS

Phone

323-857-2238

lauraskoczylas@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Pamela Moalli, MD, PhD

moalpa@mail.magee.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laura C Skoczylas, MD, MS

Organizational Affiliation

University of Pittsburgh

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Pamela Moalli, MD, PhD

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

Magee-Womens Hospital, University of Pittsburgh

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lori Geraci, BS

Phone

412-641-2634

First Name & Middle Initial & Last Name & Degree

Laura C Skoczylas, MD, MS

First Name & Middle Initial & Last Name & Degree

Pamela Moalli, MD, PhD

12. IPD Sharing Statement

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

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