Advanced Genital Prolapse Surgery With and Without Mid Urethral Sling to Prevent Stress Urinary Incontinence

Summary

Participation Requirements

Description

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 th...

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. Patients randomized to anti-incontinence surgery will undergo TVT as standard technique. Patients randomized to pelvic organ prolapse surgery alone will undergo two small incisions of 0.5 cm in the suprapubic region in a similar way to that used for the insertion of the sling (sham incisions). These incisions intended to keep the raters blind to the achievement or otherwise of the sling during the postoperative evaluation. Randomization will be held by a computer-generated random numbers software. The result of randomization will be revealed in the operating room after the patient is anesthetized, ie, the patient will be blinded for carrying or not a sling. The surgeon will be blinded to the results of preoperative IUO evaluation and results of quality of life questionnaires. Patients and researchers who will carry out the postoperative evaluations will be blinded to treatment. Statistical Evaluation Continuous variables will be presented as mean and standard deviation and compared using the two-tailed Student t test for two samples. Categorical variables will be presented as frequencies and percentages and compared between groups by the Fisher exact test, p < 0.05 will be considered statistically significant. These evaluations will be performed using a SPSS software.

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