Effect of Local Estriol Treatment Before Vaginal Repair Surgery

NCT06391372 | Active Not Recruiting Phase 3

• 1 other identifier: 2023000504-2
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate the effects of local estriol treatment applied before vaginal repair surgery on steroid receptors, inflammatory cell response, vascular, connective and nervous tissues in the vagina, and its effects on early postoperative period pelvic floor functions, satisfaction with the surgery and vaginal health.

Conditions

Pelvic Organ Prolapse; Pelvic Floor Disorders; Menopause; Vaginal Atrophy

Keywords

local estriol; colporrhaphy

Outcome Measures

Primary Outcomes (5)

• Morphological examinations of vaginal tissues obtained after surgery from the study and control groups

  1x0.5 cm tissue samples, made by Ankara University Faculty of Medicine, Department of Medical Pathology, will be taken from the vaginal tissues obtained after surgery from the study and control groups. After paraffin blocking, Epithelial thickness will be evaluated during routine histopathological evaluation with H.E staining. Epithelial thickness will be evaluated in micrometers

  4 weeks after starting local estriol treatment

• Immunohistochemical examinations of vaginal tissues obtained after surgery from the study and control groups

  Sections obtained from the blocks will be sectioned with 6 samples per glass, and steroid receptors (ER, PR, AR), CD3/CD20/CD68/CD4/CD8, CD34 and S100 will be stained with the Ventana automatic staining device and as secondary antibodies. (A total of 60 immunohistochemical tests will be performed in 6 glasses of 10 antibodies to be studied). With these dyes, the presence and density of CD3/CD20/CD68/CD4/CD8 and inflammatory cells in the epithelial and subepithelial tissue and the type distribution of immune cells will be determined. Vascular endothelial density will be evaluated with CD34 and nerve fiber density will be evaluated with S100.

  4 weeks after starting local estriol treatment

• Morphological examinations of vaginal tissues obtained after surgery from the study and control groups

  The alignment and maturation of vaginal epithelial squamous cells will be evaluated during routine histopathological evaluation. Alignment and maturation of squamous cells will be evaluated as a percentage.

  4 weeks after starting local estriol treatment

• Morphological examinations of vaginal tissues obtained after surgery from the study and control groups

  Connective tissue changes in the vaginal subepithelial area will be evaluated during routine histopathological evaluation. Connective tissue change in the subepithelial area will be evaluated as a percentage.

  4 weeks after starting local estriol treatment

• Morphological examinations of vaginal tissues obtained after surgery from the study and control groups

  Distribution of vaginal vascular structures will be evaluated during routine histopathological evaluation. Distribution of vascular structures will be evaluated as a percentage.

  4 weeks after starting local estriol treatment

Secondary Outcomes (6)

• Turkish version of Pelvic Floor Distress Inventory-20 (PFDI-20) was used to evaluate pelvic floor functions in the study and control groups.

  The determined questionnaires will be administered to the patients 4 weeks before the surgical procedure, before the surgery and 4 weeks after the surgery.

• Patient Global Improvement Impression Scale (PGI-I) was used to understand the change in the patient's complaints after vaginal repair surgery in the treatment and control groups.

  4 weeks after surgery

• Questioning the feeling of pain/discomfort in the vagina after surgery using VAS

  4 weeks after surgery

• To evaluate the effect of preoperative local estirol treatment on vaginal health in the preoperative period between the study and control groups using the vaginal health index (VHI).

  4 weeks before and before surgery

• Turkish version of Pelvic Floor Impact Questionnaire (PFIQ-7) was used to evaluate pelvic floor functions in the study and control groups.

  Determined questionnaires will be administered to patients 4 weeks before the surgical procedure, before surgery, and 4 weeks after the surgery.

Study Arms (2)

local estriol

EXPERIMENTAL

Patients will receive 1 g of intravaginal estriol via an applicator twice a week before going to bed for 4 weeks preoperatively.

Drug: estriol cream

control

NO INTERVENTION

Patients who met the same criteria as the study group and were not treated with local estriol

Interventions

estriol cream DRUG

1 g intravaginal estriol via applicator twice a week before going to bed for 4 weeks

local estriol

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women with a diagnosis of pelvic organ prolapse and an indication for vaginal repair surgery including colporrhaphy anterior and/or posterior surgery

You may not qualify if:

• Psychiatric and neurological disease that causes disability in mental and motor functions
• receiving systemic/local hormone replacement therapy in the last three months
• applying vulvar/local steroids for any reason within the last three months
• receiving treatment for pelvic and/or lower genital tract infection in the last three months
• history of malignancy
• previous vaginal repair surgery with/without mesh

Sponsors & Collaborators

• Hatice Tukenmez Kurnaz: lead

Study Sites (1)

Ankara University Faculty of Medicine

Ankara, Turkey (Türkiye)

Location

Related Publications (18)

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  PMID: 24463674 BACKGROUND

• Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6. doi: 10.1016/S0029-7844(97)00058-6.

  PMID: 9083302 BACKGROUND

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  PMID: 12527458 BACKGROUND

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  PMID: 25047897 BACKGROUND

• Kim NN, Min K, Pessina MA, Munarriz R, Goldstein I, Traish AM. Effects of ovariectomy and steroid hormones on vaginal smooth muscle contractility. Int J Impot Res. 2004 Feb;16(1):43-50. doi: 10.1038/sj.ijir.3901138.

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• Kim SW, Kim NN, Jeong SJ, Munarriz R, Goldstein I, Traish AM. Modulation of rat vaginal blood flow and estrogen receptor by estradiol. J Urol. 2004 Oct;172(4 Pt 1):1538-43. doi: 10.1097/01.ju.0000137744.12814.2e.

  PMID: 15371887 BACKGROUND

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  PMID: 20500443 BACKGROUND

• Rahn DD, Ward RM, Sanses TV, Carberry C, Mamik MM, Meriwether KV, Olivera CK, Abed H, Balk EM, Murphy M; Society of Gynecologic Surgeons Systematic Review Group. Vaginal estrogen use in postmenopausal women with pelvic floor disorders: systematic review and practice guidelines. Int Urogynecol J. 2015 Jan;26(1):3-13. doi: 10.1007/s00192-014-2554-z. Epub 2014 Nov 13.

  PMID: 25392183 BACKGROUND

• Weber MA, Kleijn MH, Langendam M, Limpens J, Heineman MJ, Roovers JP. Local Oestrogen for Pelvic Floor Disorders: A Systematic Review. PLoS One. 2015 Sep 18;10(9):e0136265. doi: 10.1371/journal.pone.0136265. eCollection 2015.

  PMID: 26383760 BACKGROUND

• Raju R, Linder BJ. Evaluation and Management of Pelvic Organ Prolapse. Mayo Clin Proc. 2021 Dec;96(12):3122-3129. doi: 10.1016/j.mayocp.2021.09.005.

  PMID: 34863399 BACKGROUND

• Barber MD, Brubaker L, Nygaard I, Wheeler TL 2nd, Schaffer J, Chen Z, Spino C; Pelvic Floor Disorders Network. Defining success after surgery for pelvic organ prolapse. Obstet Gynecol. 2009 Sep;114(3):600-609. doi: 10.1097/AOG.0b013e3181b2b1ae.

  PMID: 19701041 BACKGROUND

• Diwadkar GB, Barber MD, Feiner B, Maher C, Jelovsek JE. Complication and reoperation rates after apical vaginal prolapse surgical repair: a systematic review. Obstet Gynecol. 2009 Feb;113(2 Pt 1):367-73. doi: 10.1097/AOG.0b013e318195888d.

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• Ismail SI, Bain C, Hagen S. Oestrogens for treatment or prevention of pelvic organ prolapse in postmenopausal women. Cochrane Database Syst Rev. 2010 Sep 8;(9):CD007063. doi: 10.1002/14651858.CD007063.pub2.

  PMID: 20824855 BACKGROUND

• Kaplan PB, Sut N, Sut HK. Validation, cultural adaptation and responsiveness of two pelvic-floor-specific quality-of-life questionnaires, PFDI-20 and PFIQ-7, in a Turkish population. Eur J Obstet Gynecol Reprod Biol. 2012 Jun;162(2):229-33. doi: 10.1016/j.ejogrb.2012.03.004. Epub 2012 Apr 4.

  PMID: 22480412 BACKGROUND

• Hossack T, Woo H. Validation of a patient reported outcome questionnaire for assessing success of endoscopic prostatectomy. Prostate Int. 2014 Dec;2(4):182-7. doi: 10.12954/PI.14066. Epub 2014 Dec 30.

  PMID: 25599074 BACKGROUND

• Samuels JB, Garcia MA. Treatment to External Labia and Vaginal Canal With CO2 Laser for Symptoms of Vulvovaginal Atrophy in Postmenopausal Women. Aesthet Surg J. 2019 Jan 1;39(1):83-93. doi: 10.1093/asj/sjy087.

  PMID: 29726916 BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse; Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Officials

• Fulya Dokmeci

  Ankara University Faculty of Medicine, Department of Gynecology and Obstetrics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: pathologist who will examine the tissue samples in the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident,M.D.

Model Details: Patients who will be administered 1 g of intravaginal estriol via an applicator twice a week before going to bed for 4 preoperative weeks will constitute the study group. Patients who meet the same criteria as the study group and are not treated with local estriol will constitute the control group.

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 30, 2024
• Study Start: April 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)