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RUG-WEAVING PLICATION IN CYSTOCELE TREATMENT

RUG-WEAVING PLICATION TECHNIQUE RESULTS IN CYSTOCELE TREATMENT:TWO YEAR FOLLOW-UP

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07336108
Enrollment
60
Registered
2026-01-13
Start date
2025-12-01
Completion date
2025-12-15
Last updated
2026-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystocele

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.

Detailed description

The study was planned as a retrospective case-control observational study. It included 60 patients who underwent surgery solely for cystocele or cystocel with other organ prolapse conditions; of them, 29 received the rug-weaving plication technique, a natural tissue repair method implemented for anterior wall defects since 2022, and 31 underwent conventional anterior colporrhaphy.Data were collected in 2 groups. In Group 1, there were data of 29 patients who were operated for cystocele with the Rug Wave technique and Group 2, there were data of 31 patients who were operated with the classical colporrhaphy technique. Data from these patients were recorded at 6 months and 2 years postoperatively. At the 6 months and 2 years postoperative follow-up, it assessed patients' complaints, degree of prolapse (using the simplified Pelvic Organ Prolapse Quantification system), pelvic floor muscle strength (using the Modified Oxford Score) and the anterior vaginal wall thickness in transvaginal ultrasound. In addition, the data of the questionnaire applied to the patients in the 2nd year were also recorded(Pelvic Floor Distress Inventory, Sandvik Severity Index, Overactive bladder, Surgical satisfaction questionnaire, Patient global impression of improvement questionnaire, Pelvic Organ Prolapsed / Urinary Incontinence Sexual Questionnaire, Incontinence Impact Questionnaire).The results of the two groups were compared.Data were entered and analyzed in SPSS program. Mann-Whitney -U test, Independent simple test, Chi-Square test were used in group comparisons. Chi-Square test was used to compare categorical variables; Mann-Whitney U test was used to compare continuous variables that were not normally distributed; Independent Simple test was used to evaluate the significance of the differences between the means of continuous variables between two groups.

Interventions

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

PROCEDUREgroup 2:conventional technique cystocele treatment

Patients operated on using the conventional anterior colporrhaphy

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Patients who did not undergo cystocele surgery were excluded from the study.

Design outcomes

Primary

MeasureTime frameDescription
Pelvic Organ Prolapse Quantification (POP-Q) Postoperative anterior wall POP-Q2 yearsThe 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 .

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026