A Novel Suturing Technique of Cystocele Treatment

Completed

• Conditions: Cystocele
• Interventions: Procedure: rug weaving-like plication technique

• Registration Number: NCT06410469
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2023-06-01
• Primary Completion: 2023-08-01
• Study Completion: 2023-09-15
• Status Verified: 2024-05
• Study First Submitted: 2024-05-03
• Study First Submitted QC: 2024-05-07
• Study First Posted: 2024-05-13
• Last Update Submitted: 2024-05-24
• Last Update Posted: 2024-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 65

Inclusion Criteria

Patients operated on using the rug weaving plication technique

Exclusion Criteria

Patients operated on using the conventional anterior colporrhaphy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
33 patients operated with rug wave	rug weaving-like plication technique	Group1

Primary Outcome Measures

Name	Time	Method
Pelvic Organ Prolapse Quantification (POP-Q)	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 Outcome Measures

Name	Time	Method
Bladder thickness	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

Trial Locations

Locations (1)

Ankara City Hospital; 🇹🇷 Ankara, Turkey