Evaluation of Neuromuscular Morphometry of the Vaginal Wall

Completed

• Conditions: Pelvic Organ Prolapse

• Registration Number: NCT06363838
• Lead Sponsor: Gaziosmanpasa Research and Education Hospital

Brief Summary

In this prospective study, women aged between 40 and 75 years who had not undergone any vaginal surgery and had not undergone any abdominal prolapse surgery were included. Thirty-one women diagnosed with rectocele on examination were included in the study group. Thirty-one patients who underwent vaginal intervention and hysterectomy for reasons other than rectocele (colposcopy, conization, etc.) without anterior or posterior wall prolapse were included in the control group.

Detailed Description

In this prospective study,who had not undergone any vaginal surgery and had not undergone any abdominal prolapse surgery were included. Thirty-one women diagnosed with rectocele on examination were included in the study group. Thirty-one patients who underwent vaginal intervention and hysterectomy for reasons other than rectocele (colposcopy, conization, etc.) without anterior or posterior wall prolapse were included in the control group. Biopsy material was obtained from the epithelium of the posterior wall of the vagina, including the fascia that fits the Ap point. Immunohistochemical staining with Protein Gene Product 9.5 and smooth muscle α-actin was performed in the pathology laboratory. The epithelial thickness measurement and smooth muscle density parameters obtained with these immunohistochemical stainings were compared between the two groups. The collected data were analyzed using SPSS 23 package program

Study Timeline

• Study Start: 2019-12-01
• Primary Completion: 2020-06-25
• Study Completion: 2020-06-30
• Status Verified: 2024-03
• Study First Submitted: 2024-04-09
• Study First Submitted QC: 2024-04-09
• Last Update Submitted: 2024-04-09
• Study First Posted: 2024-04-12
• Last Update Posted: 2024-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 62

Inclusion Criteria

• Patients aged 40-75 years
• Patients operated for prolapse
• Patients who did not have prolapse and who would undergo vaginal intervention for other gynecologic reasons were designed to constitute the control group.
• who had not undergone any vaginal surgery, had not undergone any abdominal uterine suspension surgery, had posterior wall prolapse, and for whom surgery was planned.

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Exclusion Criteria

• Patients whose age was not suitable
• who had previously undergone vaginal surgery, who had undergone abdominal surgery and a uterine suspension surgery, who were not suitable for the specified examination conditions
• who had undergone rectocele surgery, urinary incontinence, or bladder surgery

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
epithelial thickness	one year	Biopsy material was obtained from the epithelium of the posterior wall of the vagina, including the fascia that fits the Ap point. Immunohistochemical staining with Protein Gene Product 9.5 and smooth muscle α-actin was performed in the pathology laboratory
smooth muscle density	one year	Biopsy material was obtained from the epithelium of the posterior wall of the vagina, including the fascia that fits the Ap point. Immunohistochemical staining with Protein Gene Product 9.5 and smooth muscle α-actin was performed in the pathology laboratory

Trial Locations

Locations (1)

Hakan Timur; 🇹🇷 Ordu, Turkey