A multicenter, prospective, randomized clinical trial comparing tension-free vaginal tape surgery and no treatment for the management of stress urinary incontinence in elderly women. [Infection prevention in elective large intestine surgery. Results of a prospective randomized comparative study]. Randomized controlled trial between perineal and anal repairs of rectocele in obstructed defecation. Vaginal versus abdominal reconstructive surgery for the treatment of pelvic support defects: a prospective randomized study with long-term outcome evaluation. Transanal or vaginal approach to rectocele repair: a prospective, randomized pilot study. A randomized comparison of tension-free vaginal tape and endopelvic fascia plication in women with genital prolapse and occult stress urinary incontinence. Return to continence after radical retropubic prostatectomy: a randomized trial of verbal and written instructions versus therapist-directed pelvic floor muscle therapy. Comparison of controlled-intermittent anal dilatation and lateral internal sphincterotomy in the treatment of chronic anal fissures: a prospective, randomized study. Randomized, prospective, double-blind comparison of abdominal and vaginal hysterectomy in women without uterovaginal prolapse.
The aim of our study was to test the hypothesis that elderly women undergoing tension-free vaginal tape surgery (TVT) will have a better quality of life (QOL) and satisfaction compared to non-treated women despite age- and technique-related potential morbidity.
                This multicenter, prospective, randomized, controlled trial enrolled a total of 69 women aged over 70 years who initially consented to be randomized to either undergo immediate TVT surgery or to wait for 6 months before submitting to the same surgery (control group). The main outcomes measured at every visit (pre-randomization, 8-12 weeks and 6 months) consisted of the Incontinence-Quality of Life (I-QOL) Questionnaire, the Patient Satisfaction Questionnaire and the Urinary Problems Self-assessment Questionnaire, among others.
                The analysis included 31 patients in the immediate surgery group and 27 subjects in the control group. Peri-operative complications in the immediate surgery group were bladder perforation (22.6%), urinary retention (12.9%), urinary tract infection (3.2%) and de novo urgency (3.2%). At 6 months, the mean I-QOL scores for the TVT and control groups were respectively 96.5 +/- 15.5 and 61.6 +/- 19.8 (P < 0.0001); mean Patient Satisfaction scores were respectively 8.0 +/- 2.7 and 2.0 +/- 2.4 (P < 0.0001); and mean Urinary Problems scores were respectively 4.5 +/- 4.3 and 11.6 +/- 3.5 (P < 0.0001).
                At 6 months post-randomization, the group of elderly women who underwent immediate TVT surgery showed a significant improvement in QOL, patient satisfaction and less urinary problems compared to the group of women waiting for the same surgery.
                (c) 2007 Wiley-Liss, Inc. In a prospective randomized trial clinical results of orthograde bowel lavage alone (group I) versus combined bowel lavage and parenteral antibiotic prophylaxis with 4 gm Cefoxitin (group II) in two separate dosages (perioperative short-term-prophylaxis) are compared with regard to the reduction of septic complications after colorectal surgery. Septic wound complications were 11/27 = 41% in group I and 2/30 = 7% in group II. The rate of anastomotic leakages was significantly different in the two groups (5/27 in group I, 0 in group II). The monetary costs for given antibiotics and the duration of hospitalization were less in group II. Orthograde bowel lavage alone proved to be of no effect in reducing the rate of septic complications when used without antibiotic perioperative short-term-prophylaxis and therefore cannot be recommended to be used solely. The present study was designed to evaluate functional outcome of perineal repair with and without levatorplasty versus transanal repair of rectocele in obstructed defecation.
                A total of 48 multiparous women with obstructed defecation caused by a rectocele were randomly allocated to three groups: transperineal repair with levatorplasty (TPR-LP; n = 16); transperineal repair without levatorplasty (TPR; n = 16); and transanal repair (TAR; n = 16). The study included defecographic assessment, anal manometry, symptom improvement, sexual function, and score on a function questionnaire. Assessments were done preoperatively and 6 months postoperatively.
                Defecography showed significant reduction in size of rectocele in all groups. Constipation improved significantly in both groups with transperineal repair but not in the group with transanal repair. Significant reductions in mean anal resting pressure, maximum reflex volume, and urge-to-defecate volume were observed only with the transperineal approach (with and without levatorplasty). Functional score improved significantly in the transperineal groups (with levatorplasty, P < 0.001; without levatorplasty, P < 0.01), but not in the transanal group (P = 0.142). Levatorplasty added to transperineal repair significantly improved the overall functional score compared with transperineal repair alone (P < 0.01) and transanal repair TAR (P < 0.001).
                Rectocele repair appears to improve anorectal function by improving rectal urge sensitivity. Transperineal repair of rectocele is superior to transanal repair in both structural and functional outcome. Levatorplasty improves functional outcome, but potential effects on dyspareunia should be discussed with the patient. Our purpose was to determine whether a vaginal or abdominal approach is more effective in correcting uterovaginal prolapse.
                Eighty-eight women with cervical prolapse to or beyond the hymen or with vaginal vault inversion > 50% of its length and anterior vaginal wall descent to or beyond the hymen were randomized to a vaginal versus abdominal surgical approach. Forty-eight women underwent a vaginal approach with bilateral sacrospinous vault suspension and paravaginal repair, and 40 women underwent an abdominal approach with colposacral suspension and paravaginal repair. Ancillary procedures were performed as indicated. Detailed pelvic examination was performed postoperatively by the nonsurgeon coauthor yearly up to 5 years. The women were examined while standing during maximum strain. Surgery was classified as optimally effective if the woman remained asymptomatic, the vaginal apex was supported above the levator plate, and no protrusion of any vaginal tissue beyond the hymen occurred. Surgical effectiveness was considered unsatisfactory if the woman was symptomatic, the apex descended > 50% of its length, or the vaginal wall protruded beyond the hymen.
                Eighty women (vaginal 42, abdominal 38) were available for evaluation at 1 to 5.5 years (mean 2.5 years). The groups were similar in age, weight, parity, and estrogen status, and 56% had undergone prior pelvic surgery. There was no significant difference between the groups in morbidity, complications, hemoglobin change, dyspareunia, pain, or hospital stay. The vaginal group had longer catheter use, more urinary tract infections, more incontinence, decreased operative time, and lower hospital charge. Surgical effectiveness was optimal in 29% of the vaginal group and 58% of the abdominal group and was unsatisfactory leading to reoperation in 33% of the vaginal group and 16% of the abdominal group. The reoperations included procedures for recurrent incontinence in 12% of the vaginal and 2% of the abdominal groups. The relative risk of optimal effectiveness by the abdominal route is 2.03 (95% confidence interval 1.22 to 9.83), and the relative risk of unsatisfactory outcome using the vaginal route is 2.11 (95% confidence interval 0.90 to 4.94).
                Reconstructive pelvic surgery for correction of significant pelvic support defects was more effective with an abdominal approach. This study was designed to compare outcomes of transanal and vaginal techniques for rectocele repair.
                Thirty females with symptomatic rectocele were enrolled in a prospective, randomized study. Fifteen underwent transanal rectoceleplasty, the other 15 underwent vaginal posterior colporrhaphy. Patients were assessed by clinical interview and examination, defecography, colon transit study, and anorectal manometry before randomization and 12 months postoperatively. Patients with compromised anal sphincter function or other symptomatic prolapse were excluded.
                The study groups were comparable in terms of demographic factors and rectocelerelated symptoms and signs. Eleven (73 percent) patients in the vaginal group and 10 (66 percent) in the transanal group digitally assisted rectal emptying preoperatively. The mean depth of the rectocele was 6.0 +/- 1.6 cm vs. 5.6 +/- 1.8 cm (P = 0.53) in the respective groups. At follow-up, 14 (93 percent) patients in the vaginal group and 11 (73 percent) in the transanal group reported improvement in symptoms (P = 0.08). Need to digitally assist rectal emptying decreased significantly in both groups, to one (7 percent) for the vaginal group and four (27 percent) for the transanal group (P = 0.17 between groups). The respective recurrence rates of rectocele were one (7 percent) vs. six (40 percent) (P = 0.04), and enterocele rates were zero vs. four (P = 0.05). In the vaginal group defecography showed a significant decrease in rectocele depth whereas in the transanal group the difference did not reach statistical significance. None of the patients reported de novo dyspareunia, but 27 percent reported improvement.
                Patients' symptoms were significantly alleviated by both operative techniques. The transanal technique was associated with more clinically diagnosed recurrences of rectocele and/or enterocele. Adverse effects on sexual life were avoided by use of both techniques. The purpose of this study was to compare 2 anti-incontinence procedures in women who had severe genital prolapse and potential stress incontinence.
                In addition to vaginal reconstructive surgery, 50 patients with stage II or higher anterior defect and a positive stress test result with prolapse reduction received either tension-free vaginal tape or plication of the endopelvic fascia. Preoperative evaluation included history, physical examination, stress test, and urodynamic assessment. Data were analyzed with the Student t test, the Fisher's exact test, and the Wilcoxon signed-rank test.
                The median follow-up time was similar for both groups, 26 and 24 months. Subjective (96% vs 64%; P=.01) and objective (92% vs 56%; P<.01) continence rates were higher after the tension-free vaginal tape procedure. Time for the resumption of spontaneous voiding, rates of urinary retention, or de novo urge incontinence were similar in the 2 groups.
                Tension-free vaginal tape can be recommended for patients with prolapse and occult stress incontinence. To test the effectiveness of weekly postoperative pelvic floor muscle training (PFMT) versus supportive telephone contact by a urology nurse for men at 4 weeks after radical prostatectomy.
                This was a randomized controlled trial in three Canadian centers. At 4 weeks after surgery, standardized verbal and written instruction about PFMT was provided to all subjects. Randomization occurred after initial instruction. Continence was defined as 8 g or less of urine loss on a 24-hour pad test. Primary outcome was grams of urine loss on pad test; secondary outcomes were International Prostate Symptom Score (IPSS), Incontinence Impact Questionnaire (IIQ-7) score, cost, and perception of urine loss as a problem. Data were obtained at baseline (preoperatively) and at weeks 4, 8, 12, 16, and 28 and 1 year after surgery.
                A total of 216 men were enrolled; 11 were dry or withdrew at 4 weeks. Ninety-nine were randomized to the control group and 106 to the treatment group. There were no group differences at baseline for prostate-specific antigen level (mean [standard deviation] 8.4 [10.4] ng/mL; 7.6 [4.6] ng/mL), Gleason score (6.3 [0.86]), IPSS, IIQ-7 score, pad test, or voiding diary. At 8 weeks 23% of the control group and 20% of the treatment group were continent; at 12 weeks, 28% and 32%; 16 weeks, 40% and 44%; 28 weeks, 50% and 47%; and at 52 weeks, 64% and 60%, respectively. There were no significant differences between groups at any time point for the outcome variables.
                Verbal instruction and written information with telephone support seemed to be as effective as intensive PFMT. Less-intense therapy may be more cost-effective. The results of controlled-intermittent anal dilatation (CIAD) or lateral internal sphincterotomy (LIS) in the treatment of chronic anal fissures are presented.
                Forty patients who were randomized to two groups underwent CIAD or a LIS. The pre- and post-operative mean anal canal resting pressures (MACRPs) and symptoms were recorded and the results were compared.
                Two months post-operatively, 18 patients in the CIAD group and 17 patients in the LIS group had healed completely, and had no anal incontinence or other complications. The post-operative improvement in pain, bleeding, and constipation did not differ significantly between the two groups. In the CIAD and LIS groups, the pre-operative MACRPs were 89.7+/-16.5 and 87.6+/-12.3 mmHg, respectively; 2 months post-operatively, the MACRPs had significantly decreased to 76.9+/-13.7 and 78.1+/-11.3 mmHg in the CIAD and LIS groups, respectively. No statistical difference existed in the pre- or post-treatment MACRPs between the groups.
                CIAD applied with a standardized technique reduced anal canal resting pressure and provided symptomatic healing that was equivalent to a LIS. Since there were no findings of incontinence, or situations which resulted in sphincter damage, we conclude that CIAD is suitable for patients with chronic anal fissures because it is less invasive than LIS, with equivalent efficacy and safety. In addition, the CIAD method may be an alternative procedure in older and multiparous women who has a higher risk of incontinence. To determine under controlled conditions whether there are significant differences in the duration of hospitalization and recovery between abdominal and vaginal hysterectomy for indications other than uterovaginal prolapse.
                In a two-center prospective, double-blind randomized trial, 36 women with dysfunctional uterine bleeding, uterine fibroids or pelvic pain scheduled for hysterectomy were randomized to abdominal or vaginal hysterectomy. The primary outcome measure was the duration of hospital stay. Secondary outcome measures included analgesic requirements and return to normal health and function.
                There were no significant differences in peri-operative patient or surgical characteristics. Vaginal hysterectomy was associated with a reduction in hospital stay compared to abdominal hysterectomy (median stay 3 days vs. 5 days, p = 0.01). In addition, patients undergoing vaginal hysterectomy had reduced analgesic requirements (mean 75.4 mg vs. 131.4 mg morphine equivalent, p = 0.002), shorter need for intravenous hydration (mean 25.3 h vs. 32.7 h, p = 0.05), and faster return of bowel action (median 3 days vs. 4 days, p = 0.002). They also returned to normal domestic activities (mean 4.6 weeks vs. 8.5 weeks, p = 0.01) and work (mean 7.0 weeks vs. 13.9 weeks, p = 0.005), and completed their recovery (mean 7.9 weeks vs. 16.9 weeks, p = 0.008) more quickly.
                Vaginal hysterectomy was associated with significant benefits in terms of reduced hospital stay and improved patient recovery. Vaginal hysterectomy should be the route of choice not only for women with genital tract prolapse but also those without.
Without demonstrable benefit, preservation of anal continence should not be used as a criterion for choosing elective primary CD. The strength of this conclusion would be greatly strengthened if there were studies that randomised women with average risk pregnancies to CD versus VD.