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OpenTrials
Completed

NCT Number: NCT06363838

Evaluation of Neuromuscular Morphometry of the Vaginal Wall

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.

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Key information

Age range

40 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Hakan Timur

Ordu, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

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

Treatment and study plan

Primary outcomes

  1. epithelial thickness

    Time frame: 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

  2. smooth muscle density

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Gaziosmanpasa Research and Education Hospital

Other Gov

Collaborators

  • Ordu University

Registry information

Official study title

Evaluation of Neuromuscular Morphometry of the Vaginal Wall Using Protein Gene Product 9.5 (Pgp 9.5) and Smooth Muscle α-Actin (Sma) in Patients With Posterior Vaginal Wall Prolapse

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 12, 2024
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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