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CompletedNCT07336108Updated Jan 13, 2026

RUG-WEAVING PLICATION IN CYSTOCELE TREATMENT

An observational study in Cystocele, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-01-13.

Sponsored by Ankara City Hospital Bilkent · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
60
Ages
40 Years to 90 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Cystocele

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03

In context

Cystocele

62 studies on the registry are indexed under Cystocele; 4 are open to participants now.

This study's enrollment of 60 is below the median of 300 across 19 observational studies indexed under Cystocele.

Browse Cystocele studies →

Lead sponsor

Ankara City Hospital Bilkent is the lead sponsor of 424 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 90 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women operated on for anterior wall prolapse in POP-Q

Eligibility criteria

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.

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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Procedurerug weaving-like plication technique

    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

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What researchers measure

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 .

    Time frame: 2 years

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Study locations

1 site
  • Ankara Bilkent City Hospital
    Ankara, Ankara 06200, Turkey (Türkiye)
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References and documents

Publications

  • 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. PubMed 39210362 ↗

Individual participant data

Plan to share: No — due to patient privacy

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07336108
Lead sponsor
Ankara City Hospital Bilkent
Responsible party
Rahime Bedir Fındık (DR, Ankara City Hospital Bilkent) — Principal investigator
First posted
Jan 13, 2026
Start date
Dec 1, 2025
Primary completion
Dec 15, 2025
Completion
Dec 15, 2025
Last update
Jan 13, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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