跳至主要内容
临床试验/NCT03515109
NCT03515109Unknown不适用

Prospective Randomized Trial of Altis Minisling With the TVTO Transobturator Tape Procedure for the Management of Genuine Stress Urinaty Incontinence in Women

Aretaieio Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年11月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
2
主要终点
the objective urinary continence rate at 12 months

研究概览

简要总结

Prospective randomized comparison of minisling (altis) with the TVTO procedure for the management of women with genuine stress urinary incontinence.

详细描述

Prospective randomized study double blinded. Two group of patients consisting group A of 40 patients being operated with altis minisling and group B with 40 patients operated with TVTO procedure. All patients will be operated with epidural anesthesia.

The patients participating in the study will meet the following requirements. a. Having genuine stress urinary incontinence proven by urodynamics, b. be willing to be operated and participate in the study. Exclusion criteria wil be the following: a.History of previous irradiation in the lower genital tract, b. BMI more than 30kg/m2, c.previous anti-incontinence surgery, previous vaginal surgery, e. having MUCP< 20 cm H2O or Valsava leak point pressure less than than 60 cm H2O.

Patients will be allocated in each operation by an automatic system using a computer software.

Primary outcome measure will be the objective cure rate at 6 months as it is assessed with cough stress test during urodynamics. Secondary outcome measures will be the subjective cure rate, improvement and failure rate, the incidence of complications such as obstruction, voiding difficulties, hemorrhage etc. Patients will be asked to complete preoperatively and postoperatively the ICIQ-FLUTS, patient satisfaction questionnaire and the female sexual function index.postoperatively the patients will complete the PGI-I questionnaire.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

they will not be aware of the procedure they are going to perform or have.

入排标准

年龄范围
25 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Inclusin Criteria:
  • Having genuine stress urinary incontinence proven by urodynamics
  • be willing to be operated and participate in the study.

排除标准

  • History of previous irradiation in the lower genital tract
  • BMI more than 30kg/m2
  • previous anti-incontinence surgery, previous vaginal surgery
  • having MUCP< 30 cm H2O or Valsava leak point pressure less than than 60 cm H2O
  • Mixed urinary incontinence.

研究组 & 干预措施

group B

Placebo Comparator

TVT transobturator tape placement

干预措施: TVTO (Procedure)

group A

Active Comparator

Altis tape surgical placement

干预措施: Altis tape (Procedure)

结局指标

主要结局

the objective urinary continence rate at 12 months

时间窗: 1 year

Primary outcome measure will be the objective urinary continence rate at 12 months as it is assessed with cough stress test during urodynamics.

次要结局

  • Subjective urinary continence rate at 12 months follow up(1year)
  • Preoperative and postoperative assessment of sexual function(1 year)

研究者

发起方
Aretaieio Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

PANAGIOTIS BAKAS MD

Associate Professor Obstetrics and Gynecology

Aretaieio Hospital

研究点 (2)

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