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OpenTrials
Completed

NCT Number: NCT06410469

A Novel Suturing Technique of Cystocele Treatment

The rug weaving-like plication technique may offer a viable alternative for cystocele repair without mesh, utilizing natural tissue.

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Key information

Conditions

Cystocele Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

40 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

About this study

The aim of this study is to compare patients who underwent cystocele repair using the rug weaving plication technique, a natural tissue repair method implemented since 2022 for anterior prolapse, with those treated using conventional techniques.

The investigators retrospectively reviewed 33 patients who underwent anterior vaginal wall repair with the rug weaving-like plication technique and 32 patients who underwent surgery using conventional colporrhaphy. The investigators recorded demographic data and operative details of the patients. At the 6-month postoperative follow-up,the investigators assessed patients' complaints, Pelvic Organ Prolapse Quantification (POP-Q), Modified Oxford Scoring (MOS), and pelvic floor muscle strength. The investigators measured bladder wall thickness between the bladder and anterior vaginal wall using Transvaginal Ultrasonography (USG) and compared demographic data, operative details, and postoperative outcomes between the two groups.

Who can participate

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

Inclusion criteria

Patients operated on using the rug weaving plication technique

Exclusion criteria

Patients operated on using the conventional anterior colporrhaphy

Treatment and study plan

rug weaving-like plication technique

Procedure

anterior vaginal wall repair with the rug weaving-like plication technique in cystosel

Primary outcomes

  1. Pelvic Organ Prolapse Quantification (POP-Q)

    Time frame: Maximum 6 months

    Postoperative anterior wall POP-Q

    Measurements were conducted with a scaled abeslang while the patient was in the lithotomy position. Evaluation of the anterior compartment involved measuring points Aa and Ba, the apical compartment involved points C and D, and the posterior compartment involved points Ap and Bp. Staging was determined based on the lowest point of prolapse. Stage 0 indicated normal pelvic floor support, Stage 2 indicated a distance between -1 and 1 from the hymen, and Stage 4 indicated total uterine prolapse (prosidentia). Stages 1,2 and 3 indicated intermediary levels of prolapse severity, counting for grades between Stage 0 and 4.

Secondary outcomes

  1. Bladder thickness

    Time frame: Maximum 6 months

    Postoperative bladder thickness:Bladder wall thickness between the bladder and anterior vaginal wall was measured using transvaginal ultrasonography and recorded in millimeters

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

A Novel Suturing Technique for Natural Tissue Repair in Cystocele Treatment

Acronym: cystosel

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 13, 2024
Registry last updated
May 28, 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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