A Novel Suturing Technique of Cystocele Treatment (cystosel)

May 24, 2024 updated by: Rahime Bedir Fındık, Ankara City Hospital Bilkent

A Novel Suturing Technique for Natural Tissue Repair in Cystocele Treatment

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06800
        • Ankara City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Women operated on for anterior wall prolapse in POP-Q

Description

Inclusion Criteria: Patients operated on using the rug weaving plication technique

Exclusion Criteria:Patients operated on using the conventional anterior colporrhaphy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
33 patients operated with rug wave
Group1
Procedure: rug weaving-like plication technique
anterior vaginal wall repair with the rug weaving-like plication technique in cystosel
32 patients who underwent surgery using conventional colporrhaphy.
Group 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Maximum 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Maximum 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Investigators

  • Principal Investigator: Rahime Bedir Findik, Ankara City Hospital Bilkent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

August 1, 2023

Study Completion (Actual)

September 15, 2023

Study Registration Dates

First Submitted

May 3, 2024

First Submitted That Met QC Criteria

May 7, 2024

First Posted (Actual)

May 13, 2024

Study Record Updates

Last Update Posted (Actual)

May 28, 2024

Last Update Submitted That Met QC Criteria

May 24, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AnkaraCHBilkent-MH-RBF-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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