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A randomized controlled trial comparing a modified Burch procedure and a suburethral sling: long-term follow-up.

The aim of this study was to compare the long-term results of a modified Burch procedure with a sling procedure for the treatment of stress incontinence with a low-pressure urethra. Thirty-six women with urodynamic stress incontinence, low-pressure urethra, urethral hypermobility and no significant pelvic organ prolapse were randomly assigned to undergo either a modified Burch procedure ( n=19) or a sling placement ( n=17). Cure of the stress incontinence (defined as a negative stress test and negative pad-weight test) was the primary long-term endpoint. Secondary endpoints included subjective cure of stress incontinence (defined as no incontinence episodes on a 1-week voiding diary) and voiding function studies. Comparisons of group means were performed with the Mann-Whitney U-test, pooled variance t-tests and separate variance t-tests. Proportions were compared with Fisher's exact test. A logistic regression analysis was performed to control for covariates that differed in our two groups despite randomization. Long-term follow-up (mean=72.6 months) was available for 82% (28/34) of the original study group. The objective cure rates for the Burch and sling groups were 84.6% and 100%, respectively ( P=0.17). Mean uroflowmetry rates for the Burch and sling groups were 7.38 and 6.8 ml/s, respectively ( P=0.58, 95%CI -2.5, 4.4). Mean postvoid residual volumes for both groups were 35 ml ( P=0.97, 95% CI -23.8, 65.9). Two sling patients (12%) required partial resection of their slings because of erosion. Both patients remained continent. In terms of voiding function and stress incontinence cure, there were no differences between groups undergoing modified Burch or sling procedures for treatment of urodynamic stress incontinence with low-pressure urethra.

Aged↗

TVT and Sparc suburethral slings: a case-control series.

Two midurethral slings, TVT and Sparc, are the subject of this case-control series aimed at assessing sling placement, voiding function, bladder symptoms and patient satisfaction. Thirty-seven Sparc and 69 TVT patients were matched for age, body weight, pre-existing urge incontinence, preoperative voiding, concomitant surgery and length of follow-up (mean 0.6, range 0.1-1.5 years). There were no significant differences for subjective cure/improvement, satisfaction or symptoms of incontinence. The clinical stress test was positive in 8/37 Sparc vs 4/69 TVT patients ( p=0.019). The TVT had a more negative effect ( p=0.001) on postoperative voiding. The Sparc was situated more cranially at rest and further from the symphysis pubis, and was more mobile ( p<0.001) on Valsalva. There are significant differences in medium-term outcomes after TVT and Sparc, affecting tape placement, mobility, effect on voiding function and objective stress continence. Patient satisfaction and subjective cure rates seem similar.

Case-Control Studies↗

Does the MONARC transobturator suburethral sling cause post-operative voiding dysfunction? A prospective study.

The aim of this study was to compare pre-operative and post-operative voiding parameters following insertion of the MONARC transobturator tape (TOT), for treating women with urodynamic stress incontinence. This prospective observational study was conducted at a tertiary referral urogynaecology unit, in North Queensland, involving 83 women who were prospectively assessed pre-operatively and at 6-8 weeks following the procedure. Information collected included patient demographics, concomitant surgery, pre-operative and post-operative symptomatology (using validated questionnaires), and pre-operative and post-operative urodynamic parameters. Parameters used to assess voiding function included symptoms of voiding difficulty (incomplete emptying and irritative symptoms) as well as objective parameters including maximum flow rate (Qmax), adjusted maximum flow rate (Qmaxadj) using the Liverpool nomogram (LN), maximal urethral pressure, and post-void residual (PVR). Pre-operative average Qmax was 23.7 ml/s compared to 21.1 ml/s post-operatively (p=0.064). When the Qmax was adjusted for voided volume using the LN, Qmaxadj was seen to decrease significantly from 26 ml/s to 18 ml/s (p<0.05). Women with PVR>50 ml did not differ significantly pre-operatively and post-operatively, 5/83(6%) vs 7/83 (8.4%) (p=0.75). The number of women with a flow rate <10th centile on LN was 22 (26.5%) pre-operatively vs 29 (34.9%) post-operatively (p=0.21). One (1.2%) post-operatively had voiding dysfunction diagnosed by an abnormal voiding pattern (p=0.728), which was not statistically significant. Objective voiding dysfunction as determined by adjusted flow rates <10th centile LN and >50 ml PVR was seen in four women (4.8%). Adjusted free flow rates are significantly reduced following insertion of the MONARC TOT, as are some symptoms related to voiding dysfunction. Despite this, satisfaction rates remain high with observed voiding dysfunction or objective measures of voiding dysfunction showing no statistical change in the short term. Long-term follow-up is planned at 1 year.

Female↗

Urethrovaginal fistula--a rare complication after the placement of a suburethral sling (IVS).

A sixty-year-old woman with stress urinary incontinence had undergone a placement of an IVS (Tyco Health Care UK) in another hospital in February 2003. Seventeen months after the procedure, she complained about a suppurative discharge from the vagina and a recurrent severe stress urinary incontinence. The gynecological examination revealed an erosion of the sling into the vagina and a large urethrovaginal fistula bordered by granuloma. After removal of the sling, the urethrovaginal fistula was closed using a vaginal flap. A subsequent conservative treatment regime with duloxetine and pelvic floor training improved the stress urinary incontinence to the patient's satisfaction.

Combined Modality Therapy↗

Suburethral sling using the transobturator approach: a quality-of-life analysis.

OBJECTIVE: The objective of the study was to determine the degree of benefit of a transobturator midurethral polypropylene sling in patients with stress urinary incontinence through a quality-of-life instrument and outcome analysis. STUDY DESIGN: Forty-seven patients completed the validated Individual Incontinence Impact Questionnaire both before and after treatment. Subjects also completed the validated Patient Satisfaction Questionnaire postoperatively to complete outcome analysis. Statistical analyses included a paired Student t test for intrapair comparisons and 2-sample t tests to compare mean differences between groups. RESULTS: Individual Incontinence Impact Questionnaire scores for the entire sample declined from a preoperative mean of 43.0 +/- 27.0% to a postoperative mean of 11.8 +/- 16.4 (P < .0001). On review of Patient Satisfaction Questionnaire responses, 45 patients (95.7%) were completely satisfied or somewhat satisfied, and 42 subjects (89.4%) stated their leakage was much better or better. CONCLUSION: The transobturator midurethral sling provides a significant improvement in quality-of-life and high postoperative patient satisfaction.

Adult↗

Suburethral sling inserted by the transobturator route in the treatment of female stress urinary incontinence: preliminary results in 117 cases.

OBJECTIVE: Assessment of the transobturator out-in technique in the treatment of female urinary incontinence. STUDY DESIGN: Obtape, a non-woven, 5% polypropylene tape was inserted via the transobturator route in patients suffering from stress or mixed urinary incontinence. From 1 February 2003 to 30 April 2004 117 patients have been operated. Mean age was 55 years (37-82). Follow-up range from 7 to 22 months (median follow-up time 16.3 months). All patients were assessed before surgery by clinical gynaecological examination and an urodynamic workup (post-void residual urine, flowmetry, voiding urgency thresholds and urethral profile). RESULTS: There were no major complications and no deaths. There were six (5.1%) minor intraoperative problems and three (2.5%) tape erosions. The subjective level of complete and partial patient satisfaction was 92.3% (108 patients) and 4.2% (5 patients), respectively. Four patients (3.4%) felt that the situation was unchanged. No patients felt that their situation had deteriorated (Table 4). There is a concern in operating the subgroup of patients suffering from low MUPC with dysuria as the cure rate is very low. CONCLUSIONS: Obtape transobturator tape is a safe, simple and rapid procedure for treating female stress urinary incontinence, avoiding the major risks of the retropubic approach. Evaluation of the results after a longer follow-up period is necessary to confirm the superiority of this technique.

Adult↗

Transvaginal paravaginal repair of high-grade cystocele central and lateral defects with concomitant suburethral sling: report of early results, outcomes, and patient satisfaction with a new technique.

Baden-Walker classification grade III-IV (pelvic organ prolapse quantification [POP-Q] system stage III-IV) cystocele is associated with a constellation of abnormalities including urethral hypermobility, lateral defect, central defect, and concomitant vault and posterior wall prolapse. We describe a new transvaginal paravaginal technique to correct this group of abnormalities and report on our early results. We prospectively evaluated patients with high-grade cystocele who underwent repair with the new transvaginal paravaginal repair. Preoperative evaluation included history and physical examination, dynamic pelvic magnetic resonance imaging, urodynamics, and symptom questionnaire. All patients first underwent a distal urethral polypropylene sling surgery. After repair of the central defect of the cystocele, a paravaginal repair of the lateral defect was performed by using a circular 5 cm x 5 cm soft polypropylene mesh attached proximally to the sacrouterine/cardinal ligament, distally to the bladder neck, and laterally to the infralevator obturator fascia. Postoperative evaluation at 3-month intervals included history and physical examination using the POP-Q system, a voiding dysfunction and incontinence symptom questionnaire, the validated short form of the Urogenital Distress Inventory (UDI-6), a validated global quality-of-life question, and a postvoid residual. We performed the repair in 98 patients with a mean age of 65 years (range, 40 to 86 years). Of these, 26% underwent concomitant vaginal hysterectomy, 45% had enterocele repair, and 94% had rectocele repair. There were 2 complications, including transient ureteral obstruction due to bladder wall hematoma and 1 patient who presented with a recurrent enterocele requiring surgical repair. No patient experienced urinary retention. De novo stress urinary incontinence was seen in 3 patients; de novo urge incontinence was seen in 2 patients. Postoperative POP-Q scores showed 85% of patients with stage 0-I, 13% with stage II, and 2% with stage III anterior vaginal wall prolapse. Of patients with preoperative stress urinary incontinence, 70% reported never experiencing symptoms under any circumstances. Quality of life improved from 4.7 to 1 (P < 0.005). Transvaginal paravaginal repair of grade III-IV cystocele using soft polypropylene mesh fixed to the obturator fascia, sacrouterine ligaments, and bladder neck area provides excellent support of the central defect repair as well as repair of the lateral defect. The operation is safe, simple, and outpatient based, and provides excellent anatomic results with minimal complications. Concomitant distal polypropylene sling did not increase the rate of complications and did not compromise results of stress urinary incontinence surgery.

Adult↗

[Suburethral sling for male urinary incontinence].

This article describe a new technique for treating post-prostatectomy urinary incontinence. We performed this procedure on 15 patients with a follow-up of 2 to 9 months. All of the patients had radical retropubic prostatectomies and a urodynamically confirmed stress urinary incontinence for more than one year; 3 of the 15 (20%) had detrusor instability. We used the exaggerated lithotomy position and a perineal approach. Three 5 mm titanium bone screw with pre-loaded No 1 polypropylene sutures (In fast Straight-In bone Screw Suture system) were placed on each side of the inner surface of the descending pubic ramus. To support the bulbar urethra was used a cadaveric fascia lata graft, reinforced with a piece of folded polypropylene mesh and tied to the pubic bone using the sutures attached to the bone anchors. Urethral resistance was increased to 45 cm H2O above baseline pressure. Thirteen patients (86.6%) are completely cured, i.g., do not require any pads. We have seen total failure in 1/15 patients (6.6%) and minimal improvement in 1/15 patients (6.6%). Urgency incontinence was reported in 3/15 patients (20%). All responded to the use of anticholinergic therapy. Two of the three patients with post-operative urgency incontinence had preoperative detrusor instability documented on urodynamic evaluation. This minimally invasive male sling procedure is efficacious. Long-term follow-up will be necessary before a final assessment of this new technique is rendered.

Follow-Up Studies↗

Modified rectus fascial suburethral sling.

Pubovaginal slings are being used more frequently for complicated stress urinary incontinence (SUI) secondary to impairment of the proximal sphincteric mechanism. The excellent long-term results of the sling surgery expands its role in genuine stress incontinence, especially high-risk groups. The modification described herein simplifies the surgery and avoids many of its potential complications, meanwhile maintains a high success rate.

Fasciotomy↗