Reduce Voiding Dysfunction After Laparoscopic Burch Colposuspension by Using Lateral Tension for the Anterior Vaginal Wall Before Cooper's Ligament Suspension in Stress Incontinence Women. (A Randomized Controlled Clinical Trial).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Urinary retention after surgery, second evaluation
研究概览
简要总结
The progress in surgical procedures for treating female stress urinary incontinence has led to the development of tension-free techniques such as the trans-obturator tape (TOT). Nonetheless, concerns regarding complications associated with the use of artificial mesh have sparked renewed interest in traditional retropubic suspension techniques (Burch). This study introduces a modified technique that creates lateral tension for the anterior vaginal wall before the conventional suspending to the Cooper ligament, limiting the tension on the urethra and reducing the risk of postoperative urinary voiding dysfunction with the same success rates. This technique offers the advantages of a tension-free procedure while still providing the benefits of retropubic suspension. Moreover, this modified technique eliminates the need for artificial mesh, reducing the risk of associated complications. This promising alternative offers effective support for the urethra and reduces postoperative emptying disorders. However, further research and studies are necessary to validate the long-term efficacy and safety of this modified technique.
详细描述
This is a randomized controlled clinical trial that aims to collect a sample within two years from the date of approval of the Scientific Research Council at Damascus University. The study will focus on a group of patients who will undergo a Burch colposuspension procedure, which is a surgical treatment for stress urinary incontinence. The patients will be randomly divided into two groups.
The first group will undergo a traditional Burch colposuspension, which involves lifting the vagina towards the Cooper ligament. The second group will receive a modified Burch colposuspension, which involves applying lateral tension for the anterior vaginal wall before the routine suspension on the Cooper ligament. The patients will then be followed for at least 3 months.
Data will be collected from the patients included in the study before the surgical operation, and then the patients will be followed up for at least three months after the surgery. The data will be compared between the two groups in terms of voiding dysfunction after surgery, which will be assessed according to International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms ICIQ_FLUTS and by assessing uroflowmetry, urinary retention, and post-void residual (PVR) urine.
Additionally, the recovery from stress incontinence will be compared by using The Patient's Global Impression of Improvement (PGI-I) and the stress test.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The female patients with urinary incontinence are visiting the urology clinic due to a history of stress urinary incontinence, with failure of conservative treatment or non-compliance with treatment.
排除标准
- •Patients refusing study participation.
- •Contraindication to general anesthesia.
- •Contraindication to laparoscopic surgery.
- •Coexisting other type of urinary incontinence with urodynamic disturbance.
- •Preoperative post-void residual urine.
- •Previous pelvic irradiation.
- •Concurrent anatomical deformity associated with genital prolapse, cystocele, or intrinsic sphincteric deficiency ( ISD ).
研究组 & 干预措施
Traditional laparoscopic Burch procedure
Patients who were randomized to receive classic laparoscopic Burch colposuspension.
干预措施: Traditional Burch colposuspension (Procedure)
Modified laparoscopic Burch procedure:
Patients who were randomized to receive modified laparoscopic Burch colposuspension by applying lateral tension for the anterior vaginal wall before performing traditional anterior vaginal wall suspension toward Cooper's ligament.
干预措施: Modified Burch colposuspension (Procedure)
结局指标
主要结局
Urinary retention after surgery, second evaluation
时间窗: One month after surgery
Urinary retention will be assessed by clinical examination and ultrasound. It refers to the inability to void despite having a full bladder.
Urinary retention after surgery, third evaluation
时间窗: Three months after surgery
Urinary retention will be assessed by clinical examination and ultrasound. It refers to the inability to void despite having a full bladder.
Urinary peak flow rate after surgery, first evaluation
时间窗: One week after surgery
Urinary peak flow rate will be determined by uroflowmetry, and divided into normal urinary flow rate for any value above or equal to 12 ml/sec, and abnormal urinary flow rate for any value under 12 ml/sec.
Urinary peak flow rate after surgery, second evaluation
时间窗: One month after surgery
Urinary peak flow rate will be determined by uroflowmetry, and divided into normal urinary flow rate for any value above or equal to 12 ml/sec, and abnormal urinary flow rate for any value under 12 ml/sec.
Subjective voiding dysfunction after surgery, third evaluation
时间窗: Three months after surgery
Voiding dysfunction will be assessed by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). It is composed of 12 questions, each question with a score from 0 to 4. Thus, the range of overall scores is from 0 to 16, 12, and 20 for filling, obstructive voiding, and incontinence scales, respectively. The total score range is from 0 to 48 for all types of voiding dysfunction after surgery
Subjective voiding dysfunction after surgery, first evaluation
时间窗: One week after surgery
Voiding dysfunction will be assessed by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). It is composed of 12 questions, each question with a score from 0 to 4. Thus, the range of overall scores is from 0 to 16, 12, and 20 for filling, obstructive voiding, and incontinence scales, respectively. The total score range is from 0 to 48 for all types of voiding dysfunction after surgery
Residual urine after surgery, first evaluation
时间窗: One week after surgery
Residual urine will be assessed by ultrasound after voiding. All residual urine below 50 ml is considered insignificant and normal, while any residual urine above 50 ml is considered clinically significant and abnormal.
Subjective voiding dysfunction after surgery, second evaluation
时间窗: One month after surgery
Voiding dysfunction will be assessed by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). It is composed of 12 questions, each question with a score from 0 to 4. Thus, the range of overall scores is from 0 to 16, 12, and 20 for filling, obstructive voiding, and incontinence scales, respectively. The total score range is from 0 to 48 for all types of voiding dysfunction after surgery
Residual urine after surgery, second evaluation
时间窗: One month after surgery
Residual urine will be assessed by ultrasound after voiding. All residual urine below 50 ml is considered insignificant and normal, while any residual urine above 50 ml is considered clinically significant and abnormal.
Urinary peak flow rate after surgery, third evaluation
时间窗: Three months after surgery
Urinary peak flow rate will be determined by uroflowmetry, and divided into normal urinary flow rate for any value above or equal to 12 ml/sec, and abnormal urinary flow rate for any value under 12 ml/sec.
Residual urine after surgery, third evaluation
时间窗: Three months after surgery
Residual urine will be assessed by ultrasound after voiding. All residual urine below 50 ml is considered insignificant and normal, while any residual urine above 50 ml is considered clinically significant and abnormal.
Urinary retention after surgery, first evaluation
时间窗: One week after surgery
Urinary retention will be assessed by clinical examination and ultrasound. It refers to the inability to void despite having a full bladder.
次要结局
- Subjective recovery from urinary incontinence, first evaluation(one week after surgery)
- Objective recovery from urinary incontinence, second evaluation(One month after surgery)
- Subjective recovery from urinary incontinence, third evaluation(three months after surgery)
- Objective recovery from urinary incontinence, third evaluation(three months after surgery)
- Objective recovery from urinary incontinence, first evaluation(one week after surgery)
- Subjective recovery from urinary incontinence, second evaluation(One month after surgery)