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NCT06410469 Clinical Trial

A Novel Suturing Technique of Cystocele Treatment

Cystocele Clinical Trial

— cystosel  

Official title:
A Novel Suturing Technique for Natural Tissue Repair in Cystocele Treatment

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06410469
Other study ID # AnkaraCHBilkent-MH-RBF-04
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date September 15, 2023

Study information
Verified date May 2024
Source Ankara City Hospital Bilkent
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 65
Est. completion date September 15, 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers
Gender Female
Age group 40 Years to 90 Years
Eligibility Inclusion Criteria: Patients operated on using the rug weaving plication technique Exclusion Criteria:Patients operated on using the conventional anterior colporrhaphy

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Turkey Ankara City Hospital Ankara

Sponsors (1)
Lead Sponsor Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pelvic Organ Prolapse Quantification (POP-Q) 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.		 Maximum 6 months
Secondary Bladder thickness Postoperative bladder thickness:Bladder wall thickness between the bladder and anterior vaginal wall was measured using transvaginal ultrasonography and recorded in millimeters Maximum 6 months
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