Topical Vaginal Estrogen for Postpartum Obstetric Anal Sphincter Injury Recovery

Urinary Incontinence Clinical Trial

Official title:

Topical Vaginal Estrogen for Postpartum Obstetric Anal Sphincter Injury Recovery: a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05317364
• Other study ID #: 300008970
• Status: Recruiting
• Phase: Phase 4
• Start date: July 14, 2022
• Est. completion date: July 1, 2026

Study information

• Verified date: January 2024
• Source: University of Alabama at Birmingham
• Contact: Hannah L Chapman, MD
• Phone: 3072626398
• Email: hlchapman[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anal Incontinence
• Enuresis
• Fecal Incontinence
• Obstetric; Injury Pelvic Floor
• Sexual Dysfunction
• Urinary Incontinence
• Wounds and Injuries

Intervention

Drug:
• 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
• Placebo vaginal cream
Placebo cream

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Urinary incontinence	measured by urogenital distress inventory (UDI-6). Minimum score is 0, maximum score 75. Higher scores indicate a higher level of distress and impact on quality of life caused by urinary incontinence.	6 months postpartum
Secondary	Anal incontinence	measured by St. Mark's and the fecal incontinence quality of life (FIQOL) scores. For St. Marks, minimum score 0, maximum 24. A higher score indicates a higher degree of incontinence and impact on lifestyle. For FIQOL, minimum score is 4, maximum score is 20. A lower score indicates a lower functional status and related quality of life.	6 months postpartum