Advanced Genital Prolapse Surgery With and Without Mid Urethral Sling to Prevent Stress Urinary Incontinence. A Multicenter, Randomized, Double-blind, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 374
- 试验地点
- 2
- 主要终点
- Incidence of de novo stress urinary incontinence
研究概览
简要总结
Pelvic organ prolapse (POP) is a public health problem worldwide, affecting about 30 %. It implies physical, psychological and social losses. A frequent complication after surgeries for POP is developing de novo stress urinary incontinence (SUI). SUI and POP have similar pathophysiology and therefore it is common to coexist in the same patient. De novo SUI has a prevalence 11-44 % after surgical correction of genital prolapse. Occult urinary incontinence (OUI) is considered the major risk factor for postoperative SUI. Studies on this topic show conflicting results. In a recent meta-analysis on this subject, Maher et al concluded that the value of performing any anti- incontinence procedure in continent women undergoing prolapse surgery remains unknown.
The aims of this study are to evaluate whether the association of a transvaginal tape (TVT®) in continent patients undergoing surgery for prolapse decreases the risk of de novo SUI and if it implies an improvement in their quality of life. The secondary endpoints are to assess the complications associated with this procedure, as irritative symptoms and voiding dysfunction postoperatively and assessing the ability of stress testing with reduced POP and urodynamics in predicting the risk of de novo SUI. This study will be a prospective, multicentric, randomized experimental study.
Patients with anterior or apical prolapse stages 3 and 4 (POP - Q) will be invited to participate in the study. The study will assess these patients for staging of prolapse, the presence of occult urinary incontinence and quality of life. Selected patients will be randomized to perform correction of genital prolapse and prophylactic anti-incontinence procedure or correction of genital prolapse only. Patients will be assessed 3, 6 and 12 months after surgery. Postoperative evaluation will be similar to preoperative. The exclusion criteria are: complaint or diagnosis of stress urinary incontinence before reduction of the prolapse, previous surgery for incontinence or pelvic organ prolapse, hypocontractility detrusor in urodynamics and inability to understand and give informed consent.
详细描述
The sample size calculation was based on a study with similar design. It was estimated that 312 patients would be sufficient to demonstrate a 15% difference between groups in a sample with 80% power and a significance level of 95 %. Considering a 20% margin of loss throughout the study we came to the final sample of 374 patients.
Preoperative evaluation: Genital prolapse will be staged according to the system of quantification of pelvic organ prolapse (ICS Pelvic Organ Quantification Prolapse - POP - Q ). All patients will be initially analyzed for quantitative urinalysis and urine culture prior to testing to IUO. In case of urinary infection, the patient will be subjected to antibiotics and reassessed after a negative urine culture. To perform the effort test, during the physical examination, the patient's bladder will be emptied with a urinary catheter and soon after instilled with 300ml of saline solution. By this time the stress test (Valsalva maneuver and cough) will be held before and after prolapse reduction. The test will be performed with the patient in supine and prone positions. The prolapse reduction will be performed using gauzes on a DeLee forceps. The urodynamics consists of three stages: initial uroflowmetry, cystometry and voiding study. The stress test will be performed during cystometry in the cystometric capacity of 300ml, with and without prolapse reduction. The reduction will be carried out on the same fashion as stress test. Schafer nomogram will be used for the diagnosis of detrusor hypocontractility and the Blaivas - Groutz nomogram for the diagnosis of obstruction. The presence of urinary incontinence after prolapse reduction in the clinical stress test or urodynamics configure the diagnosis of occult stress urinary incontinence.
The patients will be submitted for assessment of quality of life through the following questionnaires : Quality of Life Questionnaire Prolapse and Incontinence Quality of Life Questionnaire ( I-QOL ).
The surgical repair will be conducted on this way: Surgical correction of genital prolapse will be taken vaginally. The prolapse of the anterior vaginal wall will be treated with site-specific correction of pubocervical fascia . The correction of apical prolapse will be performed with the use of High McCall culdoplasty technique. In uterine prolapse, associated vaginal hysterectomy will be performed.
The posterior vaginal wall prolapse will be treated with site-specific correction of rectovaginal fascia.If present, the perineal tear will be corrected.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •genital prolapse POP-Q stages 3 or 4
- •surgical treatment planning.
排除标准
- •signals or symphtoms of stress urinary incontinence before prolapse reduction
- •previous surgery for stress urinary incontinence
- •previous surgery for genital prolapse
- •inability to understand and give informed consent
结局指标
主要结局
Incidence of de novo stress urinary incontinence
时间窗: 3, 6 and 12 months postoperatively
Number of participants presenting with de novo stress urinary incontinence as assessed by simple clinical examination (3 and 12 months) or with an standadized effort test (6m) and by the Incontinence Quality of Life Questionnaire (not answering NO to the question number 2).
次要结局
- Complications related to the surgical procedure (s)(7 days postoperatively)
- Positive predictive value of urodynamics and Standadized Effort Test to detect patients who will became incontinence after surgery.(3, 6 and 12 months postoperatively)
- Eficaccy of surgery to treat and relief prolapse symptoms(12 months)
- Negative predictive value of urodynamics and Standadized Effort Test to detect patients who will remain continents after surgery.(3, 6 and 12 months)
- need for surgery or any treatment for urinary incontinence postoperatively(12 months)
- Incidence of overactive bladder and urinary obstruction symptoms(3, 6 and 12 months postoperatively)
- Impact of urinary incontinence on patient´s quality of life(3, 6 and 12 months)
- Impact of prolapse on patient´s quality of life(12 months)
研究者
Jorge Milhem Haddad
Head Chef of Urogynecology Section - University of Sao Paulo General Hospital
University of Sao Paulo General Hospital