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RUG-WEAVING PLICATION IN CYSTOCELE TREATMENT

A

Ankara City Hospital

Status

Completed

Conditions

Cystocele

Treatments

Procedure: group 2:conventional technique cystocele treatment
Procedure: rug weaving-like plication technique

Study type

Observational

Funder types

Other

Identifiers

NCT07336108
There is no sponsor.

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

Female

Ages

40 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

60 participants in 2 patient groups

Group 1:there were data of 29 patients who were operated for cystocele with the Rug Wave techniq
Description:
Rug Waiving plication techniqe
Treatment:
Procedure: rug weaving-like plication technique
Group 2: 31 patients who underwent surgery using conventional colporrhaphy.
Description:
anterior vaginal wall repair with theconventional technique in cystosel
Treatment:
Procedure: group 2:conventional technique cystocele treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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