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

Not Applicable

Recruiting

• Conditions: Pelvic Organ Prolapse
• Interventions: Drug: Vaginal estrogen; Drug: Placebo

• Registration Number: NCT01648751
• Lead Sponsor: Pamela Moalli

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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-07-19
• Study First Submitted QC: 2012-07-23
• Study First Posted: 2012-07-24
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 53

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaginal estrogen	Vaginal estrogen	Patients in the experimental group will receive vaginal estrogen cream
Placebo cream	Placebo	Patients in the comparison group will receive placebo vaginal cream

Primary Outcome Measures

Name	Time	Method
Patient Global Impression of Improvement	6 months after starting vaginal cream	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.

Secondary Outcome Measures

Name	Time	Method
Pelvic Floor Symptoms	6 months	Pelvic Floor Symptoms, using the PFDI-20. The Pelvic Floor Distress Inventory is a condition specific quality of life instrument that assesses distress from pelvic organ prolapse, colorectal-anal, and urinary symptoms.; Higher scores indicate greater disease burden. Range: 0 to 300
General Quality of Life	6 months	Quality of Life, using the PFIQ-7 The Pelvic Floor Impact Questionnaire assesses how bladder, bowel, and vaginal symptoms affect activity, relationships, ad feelings.; Higher numbers indicate greater disease burden. Score range: 0 to 300
Pelvic Organ Prolapse Stage	6 months	Pelvic Organ Prolapse Stage, using the POP-Q exam. The Pelvic Organ Prolapse Quantification System use 9 measurements in the vagina to assess prolapse stage.; Higher stage indicates greater prolapse. Range: 0 to 4
Collagenase Activity	6 months	Collagenase Activity, via vaginal swabs collected from the posterior fornix will be used for biochemical analysis.
Sexual Function	6 months	Sexual Function, using the PISQ-12 The Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire evaluates sexual function in patients with incontinence and/or vaginal prolapse.; Higher scores indicate greater disease burden. Scale: 0 to 48

Trial Locations

Locations (1)

Magee-Womens Hospital, University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States