Phase 4
Completed N=199
Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen
pelvic organ prolapse · Urogenital Prolapse · Vaginal Vault Prolapse · Cystocele
Source: ClinicalTrials.gov NCT02431897 ↗
Enrolled (actual)
199
Serious AEs
10.5%
Results posted
Dec 2022
Primary outcomePrimary: Surgical "Failure" Defined by (i) Anatomic Assessment of Prolapse, (ii) Presence of Bulge Symptoms, and/or (Iii) Retreatment of Prolapse — 18; 8 Participants
◆ Published Evidence
Established
23citations · ~8 / year
Perioperative Vaginal Estrogen as Adjunct to Native Tissue Vaginal Apical Prolapse Repair: A Randomized Clinical Trial.
Summary
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.
Linked Publications (5)
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Perioperative Vaginal Estrogen as Adjunct to Native Tissue Vaginal Apical Prolapse Repair: A Randomized Clinical Trial.
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Oestrogen therapy for treating pelvic organ prolapse in postmenopausal women.
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Effects of preoperative intravaginal estrogen on pelvic floor disorder symptoms in postmenopausal women with pelvic organ prolapse.
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Three-year outcomes of a randomized clinical trial of perioperative vaginal estrogen as adjunct to native tissue vaginal apical prolapse repair.
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Characteristics Associated With Surgical Failure After Native Tissue Apical Prolapse Repair.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Surgical "Failure" Defined by (i) Anatomic Assessment of Prolapse, (ii) Presence of Bulge Symptoms, and/or (Iii) Retreatment of Prolapse |
18; 8 | — |
| SECONDARY Condition Specific (i.e. Pelvic Organ Prolapse) Symptom Bother as Measured by Pelvic Floor Distress Inventory-20 (PFDI-20) Questionnaire |
23.1; 23.1 | — |
| SECONDARY Condition Specific (i.e. Pelvic Organ Prolapse) Quality of Life as Measured by Pelvic Floor Impact Questionnaire-7 (PFIQ-7) |
8.9; 9.5 | — |
| SECONDARY Generic Quality of Life as Measured by SF-12 Questionnaire |
52.1; 53.2 | — |
| SECONDARY Urinary Symptoms as Measured by Urinary Subscale Questions of the Pelvic Floor Distress Inventory-20 (PFDI-20) Questionnaire, i.e. the Urinary Distress Inventory, UDI-6 |
9.8; 9.2 | — |
| SECONDARY Urinary Symptoms as Measured by Urinary Subscale Questions of the Pelvic Floor Impact Questionnaire (PFIQ-7), i.e. the Urinary Impact Questionnaire |
1.2; 2.6 | — |
| SECONDARY Sexual Function as Measured by the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) |
3.55; 3.70 | — |
| SECONDARY Number of Participants With Adverse Events |
73; 68 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02431897) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.