Topical Vaginal Estrogen for Postpartum Obstetric Anal Sphincter Injury Recovery

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.

Timeline

Start

2022-07-14

Primary completion

2026-02-13

Completion

2026-02-13

Publications

• Background 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Drugs

Indications