NCT06410469

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 13, 2024

Completed
Last Updated

May 28, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

May 3, 2024

Last Update Submit

May 24, 2024

Conditions

Keywords

anterior colporraphynaturel tissuesuture technique

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Bladder thickness

    Maximum 6 months

Study Arms (2)

33 patients operated with rug wave

Group1

Procedure: rug weaving-like plication technique

32 patients who underwent surgery using conventional colporrhaphy.

Group 2

Interventions

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

33 patients operated with rug wave

Eligibility Criteria

Age40 Years - 90 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsResults of cystocele surgery in women
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women operated on for anterior wall prolapse in POP-Q

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (1)

  • Findik RB, Doganay M, Aksakal OS, Coskun ZY, Karakaya J. A novel suturing technique for natural tissue repair in cystocele treatment. BMC Womens Health. 2024 Aug 29;24(1):474. doi: 10.1186/s12905-024-03317-3.

MeSH Terms

Conditions

Cystocele

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPelvic Organ ProlapseProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Rahime Bedir Findik

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Dr

Study Record Dates

First Submitted

May 3, 2024

First Posted

May 13, 2024

Study Start

June 1, 2023

Primary Completion

August 1, 2023

Study Completion

September 15, 2023

Last Updated

May 28, 2024

Record last verified: 2024-05

Locations