Pelvic Organ ProlapsePhase 3NCT06391372
Effect of Local Estriol Treatment Before Vaginal Repair Surgery
A Phase 3 study testing estriol cream in people with Pelvic Organ Prolapse and Pelvic Floor Disorders, run by Hatice Tukenmez Kurnaz at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Pelvic Floor Disorders, Menopause
- What is being tested?
- estriol cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to Mar 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- -Postmenopausal women with a diagnosis of pelvic organ prolapse and an indication for vaginal repair surgery including colporrhaphy anterior and/or posterior surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Local Estriol Treatment Before Vaginal Repair Surgery on Vaginal Tissues and Early Postoperative Pelvic Floor Functions
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.
Read the detailed description
Pelvic organ prolapse (POP) is the herniation of pelvic organs into or beyond the vaginal walls and is a common health problem that affects daily activities and sexual function. Its negative impact on women's quality of life has been the subject of clinical research all over the world due to the economic burden it brings to the healthcare system.
The use of different classification systems for diagnosis and the fact that many women with mild prolapse are asymptomatic make it difficult to determine the exact prevalence of pelvic organ prolapse. Among women aged 50-79, the prevalence is 41% and the lifetime risk of prolapse surgery is 11%. This risk is expected to increase in the future.
Advancing age and postmenopausal status are known risk factors for pelvic organ prolapse. Since estradiol receptors alpha and beta (ESR1/2) are found in the squamous epithelium of the bladder, urethra, vagina, and pelvic floor muscles, it is evident that the pelvic organs and their surrounding muscle and connective tissue are sensitive to estrogen and that menopause is an important risk factor for the development of pelvic organ prolapse. The decline in estrogen during the postmenopausal period contributes not only to symptoms of pelvic organ prolapse but also to other pelvic floor disorders, including vulvovaginal atrophy, stress urinary incontinence (SUI), urge urinary incontinence (UUI), sexual dysfunction, and dyspareunia.
Studies show that estrogen levels have a significant impact on the function of the genital and lower urinary tract. Estrogen regulates the function of the vascular smooth muscles in the vaginal wall, affecting vaginal wall perfusion and smooth muscle tone. It also regulates bladder smooth muscle contractility, cellular and extracellular composition, and nerve density.
Local estrogen therapy (LET) works by increasing vaginal tissue blood flow, epithelial thickening, increased epithelial secretion and decrease in vaginal pH. From a physiological and psychosocial perspective, women using estrogen therapy describe positive effects such as normalization of sexual function, increased quality of life, improvement in relationships with their spouses, feeling 'less old', higher self-esteem and having a better social life.
In recent years, local estrogen therapy has become the focus of treatment of pelvic floor disorders. Various conservative and surgical methods have been described in the treatment of pelvic organ prolapse. Conservative treatment methods include topical estrogen. Among the surgical approaches, many vaginal and abdominal methods with or without graft material have been described. Surgical methods are mostly preferred in treatment.
The primary goal of POP surgery is to reduce symptoms and improve health-related quality of life. However, despite the continuous evolution in current surgical techniques, recurrence of symptoms is common. It is important to find ways to improve pelvic organ prolapse surgery outcomes. It is unclear whether preoperative LET is beneficial. Ismail and colleagues concluded in a Cochrane systematic review that further studies with long-term follow-up are needed to evaluate the effects of estrogen preparations before prolapse surgery.
The aim of this study is to evaluate the effects of preoperative local estriol application on the vaginal tissues and the effects of preoperative local estriol application on early postoperative period pelvic floor functions, satisfaction with the surgery and vaginal health in postmenopausal women planned for vaginal repair surgery.
As a result, steroid receptors (ER, PR, AR), immune cell types and distribution, CD34 and vascular endothelial density, collagen fiber density, S100 in the anterior and/or posterior vaginal wall in patients with and without local estriol treatment before colporrhaphy anterior and/or posterior. The difference in nerve fiber density and epithelial maturation index levels will be investigated. In addition, the Pelvic Floor Distress Inventory (PFDI-20), which is valid in Turkish, Pelvic Floor Impact Questionnaire (PFIQ-7), Patient General Impression of Improvement (PGI-I) and VAS scoring and early postoperative pelvic floor functions were evaluated in the study and control groups before and after surgery. and patient satisfaction regarding the surgery will be compared. There will also be comparisons between the pre-surgical study and control group through the vaginal health index (VHI), which is a quantitative assessment of vaginal health. Follow-ups are planned to be carried out with the patients' routine check-up visits to the hospital.
- Being tested
- estriol cream
- Keywords
- local estriol, colporrhaphy
- Medical subject headings
- Pelvic Organ Prolapse, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estriol creamDrug
1 g intravaginal estriol via applicator twice a week before going to bed for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: estriol cream |
| control | No intervention | Patients who met the same criteria as the study group and were not treated with local estriol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 PFDI-20 Scale includes 20 items with 3 subscales:POPDI-6,UDI-6, and CRADI-8. The total score of the scale is between 0-300. The best score that can be obtained from the entire survey is 0, the worst score is 300. The higher the score obtained as a result of this survey, the greater the degree of complaint of pelvic floor dysfunction.
Measured: 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.
The Patient Global Impression of Improvement Scale (PGI-I) is a tool designed to measure patient interpretation of symptom changes following intervention. We will use it in this study to understand the change in the patient's complaints after vaginal repair surgery in the treatment and control groups. In this way, we will avoid relying on disease-specific questions and the inherent researcher bias that may be present in these questions. PGI-I score was recorded on a 7-point scale where 1 = very much better/improved, 2 = much better/improved, 3 = a little better/improved, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse.
Measured: 4 weeks after surgery
Questioning the feeling of pain/discomfort in the vagina after surgery using VAS
Questioning the feeling of pain/discomfort in the vagina after surgery using VAS; We aim to compare the effect of local estriol treatment applied in the preoperative period on these complaints.
Measured: 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).
Vaginal health index (VHI), a quantitative assessment of vaginal health, is used to evaluate vaginal elasticity, fluid volume, vaginal pH level, epithelial integrity, and changes in moisture. The VHI scale is interpreted as ranging from 5 points (severe) to 25 points (normal) on all five parameters. The vaginal health index will be determined in line with the vaginal examination performed by me 4 weeks before and just before the operation. In this way, the effect of preoperative local estirol treatment on vaginal health in the preoperative period will be compared between the study and control groups.
Measured: 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.
The Pelvic Floor Impact Questionnaire (PFIQ-7) is a functional status measure that assesses the degree of impact of a person's bowel, bladder, and/or pelvic symptoms on different activities of daily living, social relationships, or emotions. It also has three scales: POPIQ-7; UIO-7; and CRAIQ-7. In the form, patients' complaints were none (0); less (1); middle (2); many (3); It is rated as.
Total score ranges from 0 to 21. Lower score means less quality of life impact expresses.
Measured: Determined questionnaires will be administered to patients 4 weeks before the surgical procedure, before surgery, and 4 weeks after the surgery.
VAS scoring for postmenopausal genitourinary syndrome complaints in the study and control groups
Through VAS evaluation, the severity of genital burning, genital dryness, genital itching and dysuria symptoms of the patients in the study and control groups will be scored between 0-10. Visual Analog Scale (VAS) is used to convert some values that cannot be measured numerically into numerical values.No complaints are scored as 0 points and complaints of the worst severity imaginable are rated as 10 points.
Measured: Determined questionnaires will be administered to patients 4 weeks before the surgical procedure, before surgery, and 4 weeks after the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 Apr 2024
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hatice Tukenmez Kurnaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hatice Tukenmez Kurnaz, Ankara University
- Investigators
- Fulya Dokmeci, Study director, Ankara University Faculty of Medicine, Department of Gynecology and Obstetrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391372
- Sponsor's protocol ID
- 2023000504-2
- Status last verified
- Feb 2025
- First submitted
- 5 Apr 2024
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maher C, Feiner B, Baessler K, Schmid C. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2013 Apr 30;(4):CD004014. doi: 10.1002/14651858.CD004014.pub5.
PubMed 23633316Wu JM, Matthews CA, Conover MM, Pate V, Jonsson Funk M. Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol. 2014 Jun;123(6):1201-1206. doi: 10.1097/AOG.0000000000000286.
PubMed 24807341Wu JM, Vaughan CP, Goode PS, Redden DT, Burgio KL, Richter HE, Markland AD. Prevalence and trends of symptomatic pelvic floor disorders in U.S. women. Obstet Gynecol. 2014 Jan;123(1):141-148. doi: 10.1097/AOG.0000000000000057.
PubMed 24463674Olsen 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.
PubMed 9083302Lang JH, Zhu L, Sun ZJ, Chen J. Estrogen levels and estrogen receptors in patients with stress urinary incontinence and pelvic organ prolapse. Int J Gynaecol Obstet. 2003 Jan;80(1):35-9. doi: 10.1016/s0020-7292(02)00232-1.
PubMed 12527458Weber MA, Limpens J, Roovers JP. Assessment of vaginal atrophy: a review. Int Urogynecol J. 2015 Jan;26(1):15-28. doi: 10.1007/s00192-014-2464-0. Epub 2014 Jul 22.
PubMed 25047897Kim 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.
PubMed 14963470Kim 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.
PubMed 15371887Ibe C, Simon JA. Vulvovaginal atrophy: current and future therapies (CME). J Sex Med. 2010 Mar;7(3):1042-50; quiz 1051. doi: 10.1111/j.1743-6109.2009.01692.x.
PubMed 20500443Rahn 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.
PubMed 25392183Weber 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.
PubMed 26383760Raju 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.
PubMed 34863399Barber 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.
PubMed 19701041Diwadkar 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.
PubMed 19155908Ismail 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.
PubMed 20824855
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Local Estriol Treatment Before Vaginal Repair Surgery on Vaginal Tissues and Early Postoperative Pelvic Floor Functions
- ClinicalTrials.gov ID
- NCT06391372
- Acronym / sponsor ID
- 2023000504-2
- Keywords
- local estriol, colporrhaphy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Hatice Tukenmez KurnazUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pelvic organ prolapse (POP) is the herniation of pelvic organs into or beyond the vaginal walls and is a common health problem that affects daily activities and sexual function. Its negative impact on women's quality of life has been the subject of clinical research all over the world due to the economic burden it brings to the healthcare system.
The use of different classification systems for diagnosis and the fact that many women with mild prolapse are asymptomatic make it difficult to determine the exact prevalence of pelvic organ prolapse. Among women aged 50-79, the prevalence is 41% and the lifetime risk of prolapse surgery is 11%. This risk is expected to increase in the future.
Advancing age and postmenopausal status are known risk factors for pelvic organ prolapse. Since estradiol receptors alpha and beta (ESR1/2) are found in the squamous epithelium of the bladder, urethra, vagina, and pelvic floor muscles, it is evident that the pelvic organs and their surrounding muscle and connective tissue are sensitive to estrogen and that menopause is an important risk factor for the development of pelvic organ prolapse. The decline in estrogen during the postmenopausal period contributes not only to symptoms of pelvic organ prolapse but also to other pelvic floor disorders, including vulvovaginal atrophy, stress urinary incontinence (SUI), urge urinary incontinence (UUI), sexual dysfunction, and dyspareunia.
Studies show that estrogen levels have a significant impact on the function of the genital and lower urinary tract. Estrogen regulates the function of the vascular smooth muscles in the vaginal wall, affecting vaginal wall perfusion and smooth muscle tone. It also regulates bladder smooth muscle contractility, cellular and extracellular composition, and nerve density.
Local estrogen therapy (LET) works by increasing vaginal tissue blood flow, epithelial thickening, increased epithelial secretion and decrease in vaginal pH. From a physiological and psychosocial perspective, women using estrogen therapy describe positive effects such as normalization of sexual function, increased quality of life, improvement in relationships with their spouses, feeling 'less old', higher self-esteem and having a better social life.
In recent years, local estrogen therapy has become the focus of treatment of pelvic floor disorders. Various conservative and surgical methods have been described in the treatment of pelvic organ prolapse. Conservative treatment methods include topical estrogen. Among the surgical approaches, many vaginal and abdominal methods with or without graft material have been described. Surgical methods are mostly preferred in treatment.
The primary goal of POP surgery is to reduce symptoms and improve health-related quality of life. However, despite the continuous evolution in current surgical techniques, recurrence of symptoms is common. It is important to find ways to improve pelvic organ prolapse surgery outcomes. It is unclear whether preoperative LET is beneficial. Ismail and colleagues concluded in a Cochrane systematic review that further studies with long-term follow-up are needed to evaluate the effects of estrogen preparations before prolapse surgery.
The aim of this study is to evaluate the effects of preoperative local estriol application on the vaginal tissues and the effects of preoperative local estriol application on early postoperative period pelvic floor functions, satisfaction with the surgery and vaginal health in postmenopausal women planned for vaginal repair surgery.
As a result, steroid receptors (ER, PR, AR), immune cell types and distribution, CD34 and vascular endothelial density, collagen fiber density, S100 in the anterior and/or posterior vaginal wall in patients with and without local estriol treatment before colporrhaphy anterior and/or posterior. The difference in nerve fiber density and epithelial maturation index levels will be investigated. In addition, the Pelvic Floor Distress Inventory (PFDI-20), which is valid in Turkish, Pelvic Floor Impact Questionnaire (PFIQ-7), Patient General Impression of Improvement (PGI-I) and VAS scoring and early postoperative pelvic floor functions were evaluated in the study and control groups before and after surgery. and patient satisfaction regarding the surgery will be compared. There will also be comparisons between the pre-surgical study and control group through the vaginal health index (VHI), which is a quantitative assessment of vaginal health. Follow-ups are planned to be carried out with the patients' routine check-up visits to the hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| local estriol | Experimental | Drug: estriol creamPatients will receive 1 g of intravaginal estriol via an applicator twice a week before going to bed for 4 weeks preoperatively. |
| control | No intervention | –Patients who met the same criteria as the study group and were not treated with local estriol |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -Postmenopausal women with a diagnosis of pelvic organ prolapse and an indication for vaginal repair surgery including colporrhaphy anterior and/or posterior surgery
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| estriol cream1 g intravaginal estriol via applicator twice a week before going to bed for 4 weeks | Drug | local estriol |
Primary outcome
Morphological examinations of vaginal tissues obtained after surgery from the study and control groups
Time frame: 4 weeks after starting local estriol treatment
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
Immunohistochemical examinations of vaginal tissues obtained after surgery from the study and control groups
Time frame: 4 weeks after starting local estriol treatment
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.
Morphological examinations of vaginal tissues obtained after surgery from the study and control groups
Time frame: 4 weeks after starting local estriol treatment
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.
Morphological examinations of vaginal tissues obtained after surgery from the study and control groups
Time frame: 4 weeks after starting local estriol treatment
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.
Morphological examinations of vaginal tissues obtained after surgery from the study and control groups
Time frame: 4 weeks after starting local estriol treatment
Distribution of vaginal vascular structures will be evaluated during routine histopathological evaluation. Distribution of vascular structures will be evaluated as a percentage.
6 secondary outcomes
Turkish version of Pelvic Floor Distress Inventory-20 (PFDI-20) was used to evaluate pelvic floor functions in the study and control groups.
Time frame: 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.
Time frame: 4 weeks after surgery
Questioning the feeling of pain/discomfort in the vagina after surgery using VAS
Time frame: 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).
Time frame: 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.
Time frame: Determined questionnaires will be administered to patients 4 weeks before the surgical procedure, before surgery, and 4 weeks after the surgery.
VAS scoring for postmenopausal genitourinary syndrome complaints in the study and control groups
Time frame: Determined questionnaires will be administered to patients 4 weeks before the surgical procedure, before surgery, and 4 weeks after the surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Background: PubMed 23633316Maher C, Feiner B, Baessler K, Schmid C. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2013 Apr 30;(4):CD004014. doi: 10.1002/14651858.CD004014.pub5.
- Background: PubMed 24807341Wu JM, Matthews CA, Conover MM, Pate V, Jonsson Funk M. Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol. 2014 Jun;123(6):1201-1206. doi: 10.1097/AOG.0000000000000286.
- Background: PubMed 24463674Wu JM, Vaughan CP, Goode PS, Redden DT, Burgio KL, Richter HE, Markland AD. Prevalence and trends of symptomatic pelvic floor disorders in U.S. women. Obstet Gynecol. 2014 Jan;123(1):141-148. doi: 10.1097/AOG.0000000000000057.
- Background: PubMed 9083302Olsen 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.
- Background: PubMed 12527458Lang JH, Zhu L, Sun ZJ, Chen J. Estrogen levels and estrogen receptors in patients with stress urinary incontinence and pelvic organ prolapse. Int J Gynaecol Obstet. 2003 Jan;80(1):35-9. doi: 10.1016/s0020-7292(02)00232-1.
- Background: PubMed 25047897Weber MA, Limpens J, Roovers JP. Assessment of vaginal atrophy: a review. Int Urogynecol J. 2015 Jan;26(1):15-28. doi: 10.1007/s00192-014-2464-0. Epub 2014 Jul 22.
- Background: PubMed 14963470Kim 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.
- Background: PubMed 15371887Kim 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.
- Background: PubMed 20500443Ibe C, Simon JA. Vulvovaginal atrophy: current and future therapies (CME). J Sex Med. 2010 Mar;7(3):1042-50; quiz 1051. doi: 10.1111/j.1743-6109.2009.01692.x.
- Background: PubMed 25392183Rahn 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.
- Background: PubMed 26383760Weber 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.
- Background: PubMed 34863399Raju 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fulya Dokmeci study director
Ankara University Faculty of Medicine, Department of Gynecology and Obstetrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing estriol cream in people with Pelvic Organ Prolapse and Pelvic Floor Disorders, run by Hatice Tukenmez Kurnaz at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphological examinations of vaginal tissues obtained after surgery from the study and control groups (time frame: 4 weeks after starting local estriol treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06391372, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.