The Effect of Concurrent Cystocele Repair on Transobturator Tape in Patients With Stress Urinary Incontinence - A Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Degree of Pelvic organ Prolapse (POP-Q)
研究概览
简要总结
The goal of this interventional study is to compare the effect of Concurrent cystocele repair and trans obturator tape (TOT) and TOT alone in a sample of Iraqi Female participants with diagnosed stress urinary incontinence and cystocele. The main questions to answer are:
1-What are the effects of the tested Interventions on the outcomes measured by The Pelvic Organ Prolapse Quantification (POP-Q) System?
- What are the effects of the tested Interventions on the degree of pelvic organ prolapse?
- What are the effects of the tested Interventions on the frequency, severity, and effect of Stress urinary incontinence on the quality of life of the patients?
- What are the effects of the tested Interventions on the impact of lower urinary tract symptoms on the quality of the patient's life?
Female Patients diagnosed with SUI indicated for intervention were divided into 2 groups
Group I: (n=49) offered TOT alone
Group II: (n=49) offered concurrent TOT and Cystocele Repair
Patients were then followed up and evaluated using The Pelvic Organ Prolapse Quantification (POP-Q) System, The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), and the King Health Questionnaire (KHQ). The efficacy of both procedures and their impact on SUI and quality of life was measured.
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
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients.
- •Pure stress and/or stress-predominant mixed urinary incontinence (MUI) associated with cystocele.
- •Had not undergone a previous SUI surgery.
- •BMI less than 35 kg/m2
排除标准
- •Patients out of the age limit.
- •Patients refused to participate in the study.
- •Severe comorbid disease (heart failure HYHA class II and above, etc.).
- •Patients with a previous surgical history of transvaginal mesh.
- •Patients suffering detrusor overactivity.
- •Patients diagnosed with the female genital system or urinary bladder Malignancies.
- •Patients diagnosed with the presence of neurological disorders that caused voiding dysfunction.
结局指标
主要结局
Degree of Pelvic organ Prolapse (POP-Q)
时间窗: At baseline, and at 9 months
Assessed using the pelvic organ prolapse quantification system, in which it classified into: 1. Stage 0: No prolapse is observed 2. Stage 1: The most proximal portion of prolapse is greater than 1 cm above the level of the hymen 3. Stage 2: The most proximal portion of prolapse is found between 1 cm higher than hymen and 1cm beneath hymen 4. Stage 3: The most distal part of the prolapse extends more than 1cm beneath the hymen but no further than 2 cm 5. Stage 4: vaginal eversion has taken place or eversion to with 2cm of TVL
Frequency, severity, and effect of urine incontinence on quality of life.
时间窗: At baseline, and at 9 months
Assessed using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF). The score runs from "0 to 21", with higher values indicating more severe illness
次要结局
- Impact of lower urinary tract symptoms including urinary incontinence on health-related quality of life.(At baseline, and after 9 months)
研究者
Hayder Adnan Fawzi
Assistant Prof.
Al-Mustafa University College