Topical Vaginal Estrogen for Postpartum Obstetric Anal Sphincter Injury Recovery

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Obstetric; Injury Pelvic Floor, Sexual Dysfunction, Anal Incontinence, Urinary Incontinence

In brief

Obstetric anal sphincter injuries (OASIS) cause significant morbidity and are well known risk factors for sexual dysfunction, urinary and anal incontinence. Postpartum and breastfeeding are relative hypoestrogenic states with risk factors for dyspareunia and vaginal atrophy. Estrogen deficiency results in changes in the vaginal epithelium and poor tissue quality which results in poor wound healing. For postmenopausal women with vaginal atrophy undergoing surgery for pelvic organ prolapse, early administration of topical vaginal E2 therapy resulted in improved markers of tissue quality. Currently, there are limited studies to reference for proposed treatment modalities to improve sexual function and incontinence in this population. In this proposed randomized, placebo-controlled trial, women who sustain OASIS will be recruited and randomized to begin intravaginal estrogen therapy or placebo at their 2-week follow-up visit after hospital discharge. Participants will complete validated questionnaires relating to sexual function and pelvic floor disorders (urinary and anal incontinence) symptom distress and impact. The primary outcome of this study will be sexual dysfunction symptom severity measured by the female sexual function index (FSFI) at 6 months postpartum. Secondary outcomes will be urinary and anal incontinence distress and impact measured by St. Mark's score and the fecal incontinence quality of life (FIQOL) questionnaire for anal incontinence and urogenital distress inventory (UDI-6) for urinary incontinence. The objective of this study is to determine if intra-vaginal estrogen therapy improves sexual function and incontinence symptom distress and impact for postpartum women after OASIS.

Key facts

Study ID

NCT05317364

Run by

University of Alabama at Birmingham

People needed

38

Starts

2022-07-14

Expected to finish

2026-02-13

Last updated by the study team

2026-02-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• women who sustained 3rd or 4th degree lacerations
• aged 18 years or older
• must be able to self apply vaginal cream

You may not qualify if…

• Contraindications to intra-vaginal estrogen therapy (spontaneous DVT, stroke, hormone responsive breast cancer)
• tobacco use
• allergy to estradiol vaginal cream 0.01% or its constitutions
• perineal wound breakdown or infection at 2-week Postpartum visit.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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