Elisabetta Costantini

Updated Systematic Review and Meta-Analysis of the Comparative Data on Colposuspensions, Pubovaginal Slings, and Midurethral Tapes in the Surgical Treatment of Female Stress Urinary Incontinence

CONTEXT Burch colposuspension, pubovaginal sling, and midurethral retropubic tape (RT) and transobturator tape (TOT) have been the most popular surgical treatments for female stress urinary incontinence (SUI). Several randomized controlled trials (RCTs) have been published comparing the different techniques, with conflicting results. OBJECTIVE Our aim was to evaluate the efficacy, complication, and reoperation rates of midurethral tapes compared with other surgical treatments for female SUI. EVIDENCE ACQUISITION A systematic review of the literature was performed using the Medline, Embase, Scopus, Web of Science databases, and Cochrane Database of Systematic Reviews. EVIDENCE SYNTHESIS Thirty-nine RCTs were identified. Patients receiving midurethral tapes had significantly higher overall (odds ratio [OR]: 0.61; confidence interval [CI]: 0.46-0.82; p=0.00009) and objective (OR: 0.38; CI: 0.25-0.57; p<0.0001) cure rates than those receiving Burch colposuspension, although they had a higher risk of bladder perforations (OR: 4.94; CI: 2.09-11.68; p=0.00003). Patients undergoing midurethral tapes and pubovaginal slings had similar cure rates, although the latter were slightly more likely to experience storage lower urinary tract symptoms (LUTS) (OR: 0.31; CI: 0.10-0.94; p=0.04) and had a higher reoperation rate (OR: 0.31; CI: 0.12-0.82; p=0.02). Patients treated with RT had slightly higher objective cure rates (OR: 0.8;CI: 0.65-0.99; p=0.04) than those treated with TOT; however, subjective cure rates were similar, and patients treated with TOT had a much lower risk of bladder and vaginal perforations (OR: 2.5; CI: 1.75-3.57; p<0.00001), hematoma (OR: 2.62; CI: 1.35-5.08; p=0.005), and storage LUTS (OR: 1.35; CI: 1.05-1.72; p=0.02). Meta-analysis demonstrated similar outcomes for TVT-O (University of Liège, Liège, Wallonia, Belgium) and Monarc (AMS, Minnetonka, MN, USA). CONCLUSIONS Patients treated with RT experienced slightly higher continence rates than those treated with Burch colposuspension, but they faced a much higher risk of intraoperative complications. RT and pubovaginal slings were similarly effective, although patients with pubovaginal slings were more likely to experience storage LUTS. The use of RT was followed by objective cure rates slightly higher than TOT, but subjective cure rates were similar. TOT had a lower risk of bladder and vaginal perforations and storage LUTS than RT. The strength of these findings is limited by the heterogeneity of the outcome measures and the short length of follow-up.

Botulinum A toxin intravesical injection in patients with painful bladder syndrome: 1-year followup

PURPOSE We evaluated the 1-year efficacy and tolerability of botulinum A toxin intravesically injected in patients with painful bladder symptoms associated with increased urinary frequency, refractory to conventional treatments. MATERIALS AND METHODS Three men and 12 women were prospectively included in the study. Under short general anesthesia the patients were given injections of 200 U commercially available botulinum A toxin diluted in 20 ml 0.9% NaCl. Injections were performed submucosally in the bladder trigone and lateral walls under cystoscopic guidance. A voiding chart and the visual analog scale for pain were used, and urodynamics were performed before treatment, and 1, 3, 5 and 12 months later. RESULTS Overall 13 patients (86.6%) reported subjective improvement at the 1 and 3-month followups. The mean visual analog scale score, and daytime and nighttime urinary frequency were significantly decreased (p <0.05, <0.01 and <0.05, respectively). At the 5-month followup the beneficial effects persisted in 26.6% of cases but increased daytime and nighttime urinary frequency, and an increased visual analog scale score were observed compared to baseline. At 12 months after treatment pain recurred in all patients. Nine patients complained of dysuria 1 month after treatment. Dysuria persisted in 4 cases at the 3-month followup and in 2 at the 5-month followup. CONCLUSIONS Intravesically injected botulinum toxin A is effective for short-term management of refractory painful bladder syndrome. The beneficial effects decreased progressively within a few months after treatment. Thus, repeat injections of the neurotoxin are required for efficacious treatment in patients with the disease.

Colposacropexy with Gore-Tex Mesh in Marked Vaginal and Uterovaginal Prolapse

This study focusses on abdominal sacral colpopexy which appears to provide the most anatomically correct restoration and secure and durable support for advanced vaginal or uterovaginal prolapse. 21 patients underwent colposacropexy or hysterocolposacropexy using Gore-tex mesh. All patients referred symptoms of vaginal heaviness and urinary dysfunctions. Five presented with complete vaginal vault prolapse, 7 with third-degree anterior colpoceles and 9 with uterovaginal prolapse. Hydronephrosis was present in 4. Five patients had previously undergone total hysterectomy, and underwent only sacropexy; 9 underwent standard total abdominal hysterectomy before sacropexy; 7 underwent hysterocolposacropexy, preserving the uterus. In colposacropexy anchorage was designed to provide a large vagina-mesh contact area thus reducing the risk of suspension failure. Hysterocolposacropexy was performed using 3 stitches to anchor the synthetic mesh to the vagina and the uterine isthmus. Postoperative follow-up times range from 12 to 68 months. Overall results for 19/21 patients were satisfactory. In all 21 patients the descensus was markedly reduced. Hydronephrosis was completely resolved. Slight incontinence persisted in 3, but protection was not required. Slight dysuria persisted in 2. First-degree cystoceles recurred only in 3 patients who underwent hysterocolposacropexy. Sacropexy with synthetic mesh seems to be the most valid support of uterovaginal prolapse as the physiological vaginal axis is restored and vaginal function is preserved. Our success rate and the overall satisfaction expressed by 19/21 patients have encouraged us to continue in this surgical approach.

BIOFEEDBACK SUCCESSFULLY CURES DETRUSOR-SPHINCTER DYSSYNERGIA IN PEDIATRIC PATIENTS

PURPOSE We assessed the efficacy of voiding and bladder biofeedback for achieving perineal synergy and curing symptoms in children with detrusor-sphincter dyssynergia MATERIALS AND METHODS A total of 16 boys and 27 girls 4 to 14 years old with detrusor-sphincter dyssynergia diagnosed by uroflowmetry and electromyography underwent biweekly voiding biofeedback therapy consisting of perineal floor electromyography during uroflowmetry. The 6 patients with enuresis and an unstable bladder also underwent bladder biofeedback training during cystometry. Biofeedback continued until detrusor-sphincter dyssynergia resolved. Followup consisted of electromyography and uroflowmetry 1 month after completing biofeedback training, and telephone interviews after 2 and 4 years. RESULTS Biofeedback resolved detrusor-sphincter dyssynergia in all children, although the condition disappeared significantly sooner in girls (p <0.02). Secondary enuresis disappeared significantly earlier than primary enuresis (p <0.0001). The 2-year success rate of 87.18% for enuresis decreased to 80% at the 4-year followup. CONCLUSIONS Voiding and bladder biofeedback achieves perineal synergy and cures symptoms in children with detrusor-sphincter dyssynergia

Uterus preservation in pelvic organ prolapse surgery

Attitudes to sexuality and the psychological value of reproductive organs have changed in Western countries over the last few decades. Nevertheless, repair of pelvic support defects with concomitant hysterectomy is still considered the standard treatment for pelvic organ prolapse. Over the last 10 years, however, interest has been growing in uterus-sparing surgery, which can be divided into vaginal, abdominal, and laparoscopic procedures. The majority of studies on uterus-sparing surgery, with the exception of abdominal techniques, report few cases with short follow-up. Sacrospinous hysteropexy is the most studied vaginal technique for uterus preservation and favorable results have been demonstrated, although the majority of studies are flawed by selection and information bias, short follow-up and lack of adequate control groups. Abdominal and laparoscopic procedures are promising, providing similar functional and anatomical results to hysterectomy and sacrocolpopexy. Consensus is growing that the uterus can be preserved at the time of pelvic reconstructive surgery in appropriately selected women who desire it. The results of comparison trials and prospective studies confirm that uterus-sparing surgery is feasible and is associated with similar outcomes to hysterectomy, as well as shorter operating times. Surgeons should be ready to respond to the wishes of female patients who want to preserve vaginal function and the uterus.

Visually Directed Transrectal High Intensity Focused Ultrasound for the Treatment of Prostate Cancer: A Preliminary Report on the Italian Experience

PURPOSE High intensity focused ultrasound is a minimally invasive treatment option for prostate cancer. Data from the literature show promising early oncological outcomes and a favorable side effect profile. This study is a preliminary report of the Italian experience (Perugia and Turin) of patients treated with the Sonablate(R)500 high intensity focused ultrasound device. MATERIALS AND METHODS Between 2004 and 2007, 163 consecutive men with T1-T3 N0M0 prostate cancer underwent high intensity focused ultrasound with the Sonablate 500. Followup included prostate specific antigen tests at 1 month and then every 3 months after treatment, and a random prostate biopsy at 6 months. Failure was defined according to prostate specific antigen nadir, positive findings on followup biopsy and biochemical failure according to Phoenix criteria. RESULTS Median patient age was 72 years old, median baseline prostate specific antigen was 7.3 ng/ml, and disease stage was T1 in 44.1%, T2 in 42.5% and T3a in 13.4% of patients. Median followup was 23.8 months. After high intensity focused ultrasound treatment prostate specific antigen decreased to a median nadir of 0.15 ng/ml. Median prostate specific antigen at 3 and 6 months was 0.30 and 0.54 ng/ml, respectively. At 6 months the negative biopsy rate was 66.1%. There was no biochemical evidence of disease in 71.9% overall. On multivariate analysis prostate specific antigen nadir became the only independent predictor of no biochemical evidence of disease and positive biopsy at a cutoff of 0.40 ng/ml. CONCLUSIONS A favorable outcome of high intensity focused ultrasound is associated with lower baseline prostate specific antigen, lower prostate specific antigen nadir, lower Gleason score and lower tumor stage. As with any novel technology long-term data will be required before this technique gains widespread clinical acceptance.

Burch Colposuspension Does Not Provide Any Additional Benefit to Pelvic Organ Prolapse Repair in Patients With Urinary Incontinence: A Randomized Surgical Trial

PURPOSE We evaluated the impact of Burch colposuspension as an anti-incontinence measure in patients with urinary incontinence undergoing abdominal surgery for pelvic organ prolapse repair. MATERIALS AND METHODS A total of 47 women with pelvic organ prolapse and urinary incontinence were randomly assigned to abdominal pelvic organ prolapse repair and concomitant Burch colposuspension (24 patients, group A) or pelvic organ prolapse repair alone without an anti-incontinence procedure (23 patients, group B). They were followed up at 3, 6 and 9 months after surgery, and then annually. The primary outcome measures were anatomical outcome and changes in incontinence status as indicated by a bladder diary, the number of daily pads and the stress test. Secondary end points were changes in subjective symptoms and quality of life as measured by the Urogenital Distress Inventory and the Incontinence Impact Questionnaire. RESULTS In group A 13 of 24 patients (54.2%) were still incontinent after surgery compared with 9 of 23 (39.1%) in group B. The intragroup difference was significant (group A p = 0.003, group B p = 0.0001), but there was no significant intergroup difference (p = 0.459 for A vs B). No significant intergroup difference emerged in anatomical outcome. Urogenital Distress Inventory and Incontinence Impact Questionnaire scores improved in both groups (p = 0.0001) but the intergroup difference was not significant in either questionnaire (p = 0.769 and p = 0.327, respectively). CONCLUSIONS Burch colposuspension does not provide any additional benefit in pelvic organ prolapse repair in patients with urinary incontinence.

Pelvic Organ Prolapse Repair With and Without Prophylactic Concomitant Burch Colposuspension in Continent Women: A Randomized, Controlled Trial With 8-Year Followup

PURPOSE We reevaluated and brought up to date the 8-year followup of a previous published, randomized, controlled trial of the impact of Burch colposuspension as a prophylactic anti-incontinence procedure in patients without urinary incontinence who underwent abdominal pelvic organ prolapse repair. MATERIALS AND METHODS A total of 66 continent women with pelvic organ prolapse were randomly assigned to abdominal pelvic organ prolapse repair and concomitant Burch colposuspension in 34 (group 1) or pelvic organ prolapse repair alone without an anti-incontinence procedure in 32 (group 2). Primary study end points were the anatomical outcome and changes in incontinence status. Secondary end points were changes in subjective symptoms and quality of life. RESULTS Median followup was 97 months (range 72 to 134). Three group 1 and 1 group 2 patients were lost to followup. Three group 1 patients had a stage I rectocele and 1 had a stage I cystocele. Four group 2 patients had a stage I rectocele and 3 had a stage I cystocele. Nine of 31 group 1 patients (29%) were incontinent compared with 5 of 31 (16%) in group 2 (p = 0.553). In group 1 all except 1 patient were successfully treated for voiding dysfunction. Storage symptoms had disappeared in 1 patient and de novo storage symptoms had developed in 2 since the previous followup. De novo incontinence developed in 2 group 2 patients after midterm outcomes were reported. Median Urogenital Distress Inventory-6 and Incontinence Impact on Quality of Life-7 scores were improved in all groups at last followup (p 0.0001). CONCLUSIONS Long-term results cast doubt on whether Burch colposuspension should be done during pelvic organ prolapse repair in continent women.

Preoperative Valsava leak point pressure may not predict outcome of mid-urethral slings: analysis from a randomized controlled trial of retropubic versus transobturator mid-urethral slings

OBJECTIVE To test the hypothesis that preoperative Valsalva leak point pressure (VLPP) predicts long-term outcome of mid-urethra slings for female stress urinary incontinence (SUI). MATERIALS AND METHODS One hundred and forty-five patients with SUI were prospectively randomized to two mid-urethra sling treatments: Tension free vaginal tape (TVT) or transobturator tape (TOT). They were followed-up at 3, 6, 12 months post-operatively and then annually for the primary outcome variable, i.e. dry or wet and secondary outcome variables such as scores on the urogenital distress inventory (UDI-6) and the impact of incontinence on quality of life (IIQ-7) questionnaire as well as patient satisfaction as scored on a visual analogue scale (VAS). Preoperative VLPP was correlated with primary and secondary outcome variables. RESULTS Mean follow-ups were 32 +/- 12 months (range 12-55) for TVT and 31 +/- 15 months (range 12-61) for TOT. When patients were analyzed according to VLPP stratification, 95 (65.5%) patients showed a VLPP > 60 cm H2O and 50 (34.5%) patients had a VLPP < or = 60 cm H2O. The overall objective cure rates were 75.8% for patients with VLPP > 60 cm H2O and 72% for those with VLPP < or = 60 cm H2O (p < 0.619). No significant differences in objective cure rates emerged when patients were stratified for pre-operative VLPP and matched for TOT or TVT procedures: VLPP > 60 cm H2O (82% vs. 68.9% p < 0.172); VLPP < or = 60 cm H2O (68% vs. 76% p < 0.528). CONCLUSIONS When patients were stratified for preoperative VLPP (< or = or > of 60 cm H2O), preoperative VLPP was not linked to outcome after TVT or TOT procedures.

Lichen Sclerosus of the Male Genitalia and Urethral Stricture Diseases

Introduction: The true incidence of urethral involvement in patients with genital lichen sclerosus (LS) is unknown. We review the epidemiology and discuss the pathogenesis of LS and urethral stricture diseases. Materials and Methods: During the period 1991–2002, of 925 patients who underwent urethroplasty for anterior urethral stricture, 130 patients (14%) received the diagnosis of LS. In all patients with LS the histology was re-examined to confirm the clinical diagnosis. Retrograde and voiding urethrography was used to establish urethral involvement in the disease. Results: In 106 patients (82%) the histology provided the classical features of LS, and 24 patients (18%) showed some histological variations. In 49 patients (37%) the LS involved the pendolous urethra (meatus-navicularis-penile), and in 53 cases (41%) a panurethral stricture was evident. Conclusions: LS urethral involvement appears to be a much more common and extensive disease than previously reported, and requires particular care in its early diagnosis.