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临床试验/NCT05452811
NCT05452811已完成不适用

Open Retropubic Versus Laparoscopic Colposuspension (Burch Operation) Techniques for Female Stress or Mixed Urinary Incontinence; A Ten-year Experience in a Tertiary Center

Kanuni Sultan Suleyman Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
Surgical success

研究概览

简要总结

To evaluate postoperative course, efficacy, and complication rates of Open Burch Colposuspension and Laparoscopic Burch Colposuspension techniques in stress or mixed urinary incontinence at a single training and research hospital over the last 10 years in Istanbul, Turkey.

详细描述

A retrospective cohort study was conducted in all Burch Colposuspension cases performed between January 2001 and May 2022 at Kanuni Sultan Süleyman Training and Research Center. All patients' data were reviewed from the electronic medical records and analyzed who underwent Burch colposuspension surgery either with an open or laparoscopic approach. The primary outcome was surgical success, whereas secondary outcomes were perioperative and postoperative data including surgical type (open or laparoscopic), operating time, duration of hospital stay, estimated blood loss, complications during surgery, and additional interventional procedure types.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • patients having SUI or mixed urinary incontinence whom conservative therapy (Kegel's pelvic floor exercises, bladder training, electrical stimulation, or medication) failed
  • SUI had been proven by urodynamic assessments.
  • patients who had urethral hypermobility supported by a Q-type test with a cotton swab angle greater than 300
  • patients having a residual urinary volume of less than 100 mL were included.

排除标准

  • history of anti-incontinence surgery
  • pelvic inflammatory diseases
  • urinary retention
  • SUI with intrinsic sphincter deficiency
  • neurogenic bladder
  • suspected malignancy
  • urge incontinence
  • chronic cystitis
  • urinary tract infection
  • prescription of anticoagulant or antipsychotic treatment
  • coagulation disorders
  • physically and medically unsuitable for colposuspension surgery
  • pregnancy and loss to follow-up.

结局指标

主要结局

Surgical success

时间窗: 12 months after intervention

Provided by the patient's feeling of the "Absence of a bulge in the vagina"

次要结局

  • estimated blood loss(intraoperative)
  • complications(up to 6 weeks)

研究者

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

Ozan Karadeniz

Principal investigator

Kanuni Sultan Suleyman Training and Research Hospital

研究点 (1)

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