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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
21
1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter
1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter
Magee-Womens Hospital, University of Pittsburgh
Pittsburgh, Pennsylvania, United States
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.
Time frame: 6 months after starting vaginal cream
Pelvic Floor Symptoms
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
Time frame: 6 months
General Quality of Life
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
Time frame: 6 months
Pelvic Organ Prolapse Stage
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
Time frame: 6 months
Collagenase Activity
Collagenase Activity, via vaginal swabs collected from the posterior fornix will be used for biochemical analysis.
Time frame: 6 months
Sexual Function
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Time frame: 6 months