Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen
Purpose
This study randomizes postmenopausal women with symptomatic pelvic organ prolapse planning native tissue transvaginal surgical repair to 6-8 weeks of preoperative and 1-year continued postoperative vaginal estrogen cream compared to placebo cream. This clinical trial and basic science investigation are designed to understand the mechanisms by which local estrogen treatment affects connective tissues of the pelvic floor and determine whether its use before and after prolapse repair will (i) improve success rates of the surgical intervention and minimize prolapse recurrence and (ii) impact favorably upon symptoms of other pelvic floor disorders.
Conditions
- Pelvic Organ Prolapse
- Urogenital Prolapse
- Vaginal Vault Prolapse
- Cystocele
- Uterine Prolapse
- Vaginal Prolapse
- Pelvic Floor Disorders
Eligibility
- Eligible Ages
- Over 48 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Postmenopausal: no menses for >1 year - Minimum age: 48 years - Symptomatic apical and/or anterior vaginal wall prolapse, stage 2 or greater - No estrogen replacement within the last month (may come off current treatment, i.e. wash out, to join the study) - Medically fit for elective surgery - Physically able to apply/insert the study drug - Available for clinic follow-up for minimum 1yr
Exclusion Criteria
- Concurrent use of steroid creams for other indications (e.g. lichen sclerosis) - BMI >35 kg/m2 - Recent history (within last month) of vaginal infection or vaginitis - Contraindications to estrogen therapy (e.g. spontaneous DVT, stroke, breast or endometrial/ hormone-responsive cancer, genital bleeding of unknown cause) - History of connective tissue disease - Any oral or transdermal estrogen, SERM, or other medication impacting vaginal milieu - History of vaginal irradiation - Allergy to Premarin or its constituents - Prior apical repair or use of mesh for prolapse repair - Current tobacco use
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Estrogen Cream |
Conjugated Estrogens cream |
|
|
Placebo Comparator Placebo Cream |
Placebo cream |
|
More Details
- Status
- Completed
- Sponsor
- University of Texas Southwestern Medical Center
Study Contact
Detailed Description
This is a double-blind randomized trial of intravaginal estrogen (conjugated estrogens, 0.625mg/1g cream) vs. placebo in postmenopausal women (up to n=222 enrolled and randomized in order for 188 to undergo surgery) with symptomatic prolapse beyond the hymen planning transvaginal native tissue repairs. Medication will be started >5 weeks before surgery and continued for 1 year postoperatively, i.e. until scar remodeling is complete. The investigators aim to determine if pre- and postoperative intravaginal estrogen therapy (i) results in anatomic and patient-reported subjective improvement in pelvic organ support, and (ii) impacts other pelvic floor disorders (overactive bladder and incontinence, sexual function and pain, postoperative cystitis), satisfaction, quality of life, and vaginal wound healing. Finally, (iii) the investigators will determine the potential mechanisms by which local estrogen treatment alters pelvic organ support by examining full-thickness vaginal wall biopsies taken at the time of surgery for histologic, connective tissue, and smooth muscle synthesis and degradative changes. The investigators expect this will highlight other novel targets for future therapies in prolapse repair and prevention.