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临床试验/NCT07336108
NCT07336108已完成不适用

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

Ankara City Hospital Bilkent2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Pelvic Organ Prolapse Quantification (POP-Q) Postoperative anterior wall POP-Q

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
40 Years 至 90 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

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

Rug Waiving plication techniqe

干预措施: rug weaving-like plication technique (Procedure)

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

anterior vaginal wall repair with theconventional technique in cystosel

干预措施: group 2:conventional technique cystocele treatment (Procedure)

结局指标

主要结局

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

时间窗: 2 years

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 .

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rahime Bedir Fındık

DR

Ankara City Hospital Bilkent

研究点 (2)

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