Clinical trial

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

Name

PRO09090064

Description

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.

Trial arms

Trial start

2012-05-01

Estimated PCD

2023-12-01

Trial end

2023-12-01

Status

Recruiting

Treatment

Vaginal estrogen

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

Arms:

Vaginal estrogen

Other names:

Premarin vaginal cream

Placebo

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

Arms:

Placebo cream

Other names:

Placebo cream

Size

Primary endpoint

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

6 months

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)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 53, 'type': 'ESTIMATED'}}

Updated at

2023-02-08

1 organization

1 product

1 drug

1 indication

Organization

Pamela Moalli

Product

Vaginal estrogen

Indication

Pelvic organ prolapse

Drug

Varlilumab