NCT07336108

Brief Summary

In this study was to compare the 2-year results of the Rug Wave plication technique, which it present as a natural tissue repair technique in cystocele, with the conventional technique in terms of both recurrence and patient quality of life satisfaction scales.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2025

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2025

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 16, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
Last Updated

January 13, 2026

Status Verified

December 1, 2025

Enrollment Period

14 days

First QC Date

December 16, 2025

Last Update Submit

January 2, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pelvic Organ Prolapse Quantification (POP-Q) Postoperative anterior wall POP-Q

    The POP-Q staging system, introduced in 1996 and widely accepted as the standard quantitative classification system for pelvic organ prolapse, was utilized in this study. 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. Figure -1 schematically shows the POP-Q staging system .

    2 years

Study Arms (2)

Group 1:there were data of 29 patients who were operated for cystocele with the Rug Wave techniq

Rug Waiving plication techniqe

Procedure: rug weaving-like plication technique

Group 2: 31 patients who underwent surgery using conventional colporrhaphy.

anterior vaginal wall repair with theconventional technique in cystosel

Procedure: group 2:conventional technique cystocele treatment

Interventions

Rug Waeving plication technique :This technique is a technique that has not been used before.

Group 1:there were data of 29 patients who were operated for cystocele with the Rug Wave techniq

Patients operated on using the conventional anterior colporrhaphy

Group 2: 31 patients who underwent surgery using conventional colporrhaphy.

Eligibility Criteria

Age40 Years - 90 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women operated on for anterior wall prolapse in POP-Q

You may qualify if:

  • Patients operated on using the rug weaving plication technique
  • Patients operated on using the conventional anterior colporrhaphy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Ankara, 06200, 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.

    PMID: 39210362BACKGROUND

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 Design

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

Study Record Dates

First Submitted

December 16, 2025

First Posted

January 13, 2026

Study Start

December 1, 2025

Primary Completion

December 15, 2025

Study Completion

December 15, 2025

Last Updated

January 13, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

due to patient privacy

Locations