Topical Vaginal Estrogen for Postpartum Obstetric Anal Sphincter Injury Recovery

NCT ID: NCT05317364

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-14
• Study Completion Date: 2026-07-01

Brief Summary

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.

Detailed Description

Obstetric anal sphincter injuries (OASIS) are known to cause significant morbidity and are known risk factors for sexual dysfunction, urinary and anal incontinence. Recent studies have reported that women with OASIS experience more problems with sexual dysfunction compared to their age and parity matched counterparts who do not have these tears. Despite this, little attention is paid to its prevalence or treatment in this population. These women are also at a 4-fold higher risk of anal incontinence. Additionally, significantly more women with OASIS report urinary incontinence 10 weeks after delivery and have significantly worse quality of life scores. 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.

Due to the significant morbidity associated with OASIS, it is critical to further explore treatment options to ultimately improve wound healing and outcomes in women who sustain OASIS tears in their postpartum recovery. Training in identification of OASIS and close follow up in specialized OASIS clinics have improved outcomes for these women. However, there are limited studies to reference for proposed treatment modalities to improve sexual function and incontinence in this population. Intra-vaginal estrogen therapy has proven to be safe and feasible in this population as demonstrated by no difference in the serum estrogen concentration in those women treated with intra-vaginal estrogen therapy for treatment of granulation tissue. Although evidence is limited, anecdotally, vaginal estrogen cream has been used to treat postpartum women with OASIS to treat vaginal atrophy and improve wound healing. This proposed research is critical to ultimately improving the postpartum recovery for women who sustain OASIS. This information will add to the growing literature aiming to optimize quality of life and improve care for these women.

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, (upon establishing care at postpartum perineal clinic), after hospital discharge. Participants will complete validated questionnaires relating to sexual function and pelvic floor disorders (urinary and anal incontinence) symptom distress and impact at the 2-week postpartum visit (baseline). Participants will follow up at designated intervals (12-weeks and 6 months) and complete questionnaires with plan for total of 6-months intravaginal estrogen or placebo therapy. The primary outcome 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 and the fecal incontinence quality of life (FIQOL) scores 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. We hypothesize that topical vaginal estrogen cream therapy postpartum will improve sexual function scores thereby improving functional status and related quality of life.

Conditions

Obstetric; Injury Pelvic Floor; Sexual Dysfunction; Anal Incontinence; Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Topical vaginal estrogen group

Estradiol vaginal cream 0.01% 1g will be administered vaginally, initiated at 2 weeks postpartum and continued until 6 months postpartum. Beginning at 2 weeks postpartum, 1g estradiol vaginal cream 0.01% will be administered by participants nightly for 2 weeks then twice weekly to complete 6 months therapy

Group Type: ACTIVE_COMPARATOR

Estradiol 0.01% Vag Cream

Intervention Type: DRUG

1g estradiol vaginal cream 0.01% or placebo will be administered nightly for 2 weeks then twice weekly to complete 6 months therapy

Placebo group

Placebo cream, 1g will be administered vaginally, initiated at 2 weeks postpartum and continued until 6 months postpartum. Beginning at 2 weeks postpartum, 1g of placebo cream will be administered by participants nightly for 2 weeks then twice weekly to complete 6 months therapy.

Group Type: PLACEBO_COMPARATOR

Placebo vaginal cream

Intervention Type: DRUG

Placebo cream

Interventions

Estradiol 0.01% Vag Cream

1g estradiol vaginal cream 0.01% or placebo will be administered nightly for 2 weeks then twice weekly to complete 6 months therapy

Intervention Type: DRUG

Placebo vaginal cream

Placebo cream

Intervention Type: DRUG

Other Intervention Names

Estrace cream; Versabase vaginal cream

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Hannah Chapman

Clinical instructor, fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hannah L Chapman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Hannah L Chapman, MD

Role: CONTACT

hlchapman@uabmc.edu

3072626398

Facility Contacts

Hannah L Chapman, MD

Role: primary

References

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Other Identifiers

300008970

Identifier Type: -

Identifier Source: org_study_id