Topical Vaginal Estrogen for Postpartum Obstetric Anal Sphincter Injury Recovery

NCT05317364 | Terminated Phase 4 FDA Drug

• 1 other identifier: 300008970
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Obstetric anal sphincter injury; sexual dysfunction; anal incontinence; urinary incontinence

Outcome Measures

Primary Outcomes (1)

• sexual dysfunction symptom severity

  measured by the female sexual function index (FSFI). Minimum score 1, maximum score 36. Higher scores indicate a higher level of sexual function.

  6 months postpartum

Secondary Outcomes (2)

• Urinary incontinence

  6 months postpartum

• Anal incontinence

  6 months postpartum

Study Arms (2)

Topical vaginal estrogen group

ACTIVE COMPARATOR

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

Drug: Estradiol 0.01% Vag Cream

Placebo group

PLACEBO COMPARATOR

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.

Drug: Placebo vaginal cream

Interventions

Estradiol 0.01% Vag Cream DRUG

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

Also known as: Estrace cream

Topical vaginal estrogen group

Placebo vaginal cream DRUG

Placebo cream

Also known as: Versabase vaginal cream

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

Related Publications (10)

• Sayed Ahmed WA, Kishk EA, Farhan RI, Khamees RE. Female sexual function following different degrees of perineal tears. Int Urogynecol J. 2017 Jun;28(6):917-921. doi: 10.1007/s00192-016-3210-6. Epub 2016 Dec 6.

  PMID: 27924373 BACKGROUND

• Andrews V, Thakar R, Sultan AH, Jones PW. Evaluation of postpartum perineal pain and dyspareunia--a prospective study. Eur J Obstet Gynecol Reprod Biol. 2008 Apr;137(2):152-6. doi: 10.1016/j.ejogrb.2007.06.005. Epub 2007 Aug 2.

  PMID: 17681663 BACKGROUND

• Soerensen MM, Buntzen S, Bek KM, Laurberg S. Complete obstetric anal sphincter tear and risk of long-term fecal incontinence: a cohort study. Dis Colon Rectum. 2013 Aug;56(8):992-1001. doi: 10.1097/DCR.0b013e318299c209.

  PMID: 23838869 BACKGROUND

• Stedenfeldt M, Pirhonen J, Blix E, Wilsgaard T, Vonen B, Oian P. Anal incontinence, urinary incontinence and sexual problems in primiparous women - a comparison between women with episiotomy only and women with episiotomy and obstetric anal sphincter injury. BMC Womens Health. 2014 Dec 16;14:157. doi: 10.1186/s12905-014-0157-y.

  PMID: 25511413 BACKGROUND

• Scheer I, Andrews V, Thakar R, Sultan AH. Urinary incontinence after obstetric anal sphincter injuries (OASIS)--is there a relationship? Int Urogynecol J Pelvic Floor Dysfunct. 2008 Feb;19(2):179-83. doi: 10.1007/s00192-007-0431-8. Epub 2007 Aug 2.

  PMID: 17671753 BACKGROUND

• Woodward AP, Matthews CA. Outcomes of revision perineoplasty for persistent postpartum dyspareunia. Female Pelvic Med Reconstr Surg. 2010 Mar;16(2):135-9. doi: 10.1097/SPV.0b013e3181cc8702.

  PMID: 22453161 BACKGROUND

• Karp DR, Jean-Michel M, Johnston Y, Suciu G, Aguilar VC, Davila GW. A randomized clinical trial of the impact of local estrogen on postoperative tissue quality after vaginal reconstructive surgery. Female Pelvic Med Reconstr Surg. 2012 Jul-Aug;18(4):211-5. doi: 10.1097/SPV.0b013e31825e6401.

  PMID: 22777369 BACKGROUND

• Ripperda CM, Maldonado PA, Acevedo JF, Keller PW, Akgul Y, Shelton JM, Word RA. Vaginal estrogen: a dual-edged sword in postoperative healing of the vaginal wall. Menopause. 2017 Jul;24(7):838-849. doi: 10.1097/GME.0000000000000840.

  PMID: 28169915 BACKGROUND

• Bochenska K, Kujawa S, Zhao H, Kenton K, Bulun SE, Lewicky-Gaupp C. Molecular Effects of Topical Estrogen on Vaginal Granulation Tissue in Postpartum Women. Female Pelvic Med Reconstr Surg. 2021 Aug 1;27(8):521-526. doi: 10.1097/SPV.0000000000001076.

  PMID: 34261104 BACKGROUND

• Brown O, Heliker BD, Geynisman-Tan J, Tavathia M, Mueller MG, Collins S, Kenton K, Lewicky-Gaupp C. Vaginal Electrical Stimulation for Postpartum Neuromuscular Recovery: A Randomized Clinical Trial. Female Pelvic Med Reconstr Surg. 2021 Nov 1;27(11):659-666. doi: 10.1097/SPV.0000000000001037.

  PMID: 34608032 BACKGROUND

MeSH Terms

Conditions

Sexual Dysfunction, Physiological; Encopresis; Urinary Incontinence

Interventions

Estradiol; Vaginal Creams, Foams, and Jellies

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dosage Forms; Pharmaceutical Preparations; Feminine Hygiene Products; Equipment and Supplies

Study Officials

• Hannah L Chapman, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical instructor, fellow

Model Details: Participants are assigned to receive either topical vaginal estrogen or placebo cream and will continue this therapy for duration of study.

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 7, 2022
• Study Start: July 14, 2022
• Primary Completion: February 13, 2026
• Study Completion: February 13, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)