Andrea Braga

Tension-free Vaginal Tape for the Treatment of Urodynamic Stress Incontinence: Efficacy and Adverse Effects at 10-Year Follow-Up

BACKGROUND One of the most effective and popular current procedures for the surgical treatment of stress urinary incontinence (SUI) is tension-free midurethral slings. OBJECTIVE To evaluate the outcomes of women with retropubic tension-free vaginal tape (TVT) for urodynamic stress incontinence (USI) after 10-yr follow-up. DESIGN, SETTING, AND PARTICIPANTS This was a prospective observational study. Consecutive women with proven USI were treated with TVT. Patients with mixed incontinence and/or anatomic evidence of pelvic organ prolapse were excluded. INTERVENTION Standard retropubic TVT. MEASUREMENTS Patients underwent preoperative clinical and urodynamic evaluations. During follow-up examinations, women were assessed for subjective satisfaction and objective cure rates. Multivariable analyses were performed to investigate outcomes. RESULTS AND LIMITATIONS A total of 63 women were included. After 10 yr, 5 patients (8%) were lost or no longer evaluable. The 10-yr subjective, objective, and urodynamic cure rates were 89.7%, 93.1%, and 91.4%, respectively. These rates were stable across the whole study period (p>0.99). De novo overactive bladder was reported by 30.1% and 18.9% of patients at 3-mo and 10-yr follow-up, respectively (p for trend = 0.19). A total of 84.2% of women with detrusor overactivity received antimuscarinic drugs, but 43.8% were nonresponders 12 wk later. At multivariable analysis, maximum detrusor pressure during the filling phase >9cm H(2)O (hazard ratio [HR]: 16.2; p=0.01) and maximum detrusor pressure during the voiding phase ≤29cm H(2)O (HR: 8.0; p=0.01) were independent predictors for the recurrence of SUI, as well as obesity was for the recurrence of objective SUI (HR: 17.1; p=0.01) and of USI (HR: 8.9; p=0.02), respectively. Intraoperatively, bladder perforation occurred in two cases; no severe bleeding or other complications occurred. CONCLUSIONS The 10-yr results of this study seem to demonstrate that TVT is a highly effective option for the treatment of female SUI, recording a very high cure rate with low complications after a 10-yr follow-up.

Robot-assisted Sacrocolpopexy for Pelvic Organ Prolapse: A Systematic Review and Meta-analysis of Comparative Studies

CONTEXT Surgery represents the mainstay of treatment for pelvic organ prolapse (POP). Among different surgical procedures, abdominal sacrocolpopexy (SC) is the gold standard for apical or multicompartmental POP. Research has recently focused on the role of robot-assisted sacrocolpopexy (RASC). OBJECTIVE To conduct a systematic review on the outcomes of RASC. EVIDENCE ACQUISITION PubMed, Scopus, and Web of Science databases as well as ClinicalTrials.gov were searched for English-language literature on RASC. A total of 509 articles were screened; 50 (10%) were selected, and 27 (5%) were included. Studies were evaluated per the Grading of Recommendations, Assessment, Development, and Evaluation system and the European Association of Urology guidelines. EVIDENCE SYNTHESIS Overall, data on 1488 RASCs were collected from 27 studies, published from 2006 to 2013. Objective and subjective cures ranged from 84% to 100% and from 92% to 95%, respectively. Conversion rate to open surgery was <1% (range: 0-5%). Intraoperative, severe postoperative complications, and mesh erosion rates were 3% (range: 0-19%), 2% (range: 0-8%), and 2% (range: 0-8%), respectively. Surgical-related outcomes have improved with increased experience, with an estimated learning curve of about 10-20 procedures. Laparoscopic SC is less costly than RASC, although the latter has lower costs than abdominal SC. CONCLUSIONS RASC is a safe and feasible procedure for POP; it allows the execution of complex surgical steps via minimally invasive surgery without medium- and long-term anatomic detriments. Further prospective studies are needed to confirm these findings. PATIENT SUMMARY We looked at the outcomes of robotic sacrocolpopexy for prolapse. We found that the use of robotic technology is safe and effective for the treatment of prolapse in women.

TVT-O for the Treatment of Pure Urodynamic Stress Incontinence: Efficacy, Adverse Effects, and Prognostic Factors at 5-Year Follow-up

BACKGROUND Inside-out tension-free vaginal transobturator tape (TVT-O) is currently one of the most effective and popular procedures for the surgical treatment of female stress urinary incontinence (SUI), but data reporting long-term outcomes are scarce. OBJECTIVE To evaluate the efficacy and safety of TVT-O 5-yr implantation for management of pure SUI in women. DESIGN, SETTING, AND PARTICIPANTS A prospective observational study was conducted in four tertiary reference centers. Consecutive women presenting with urodynamically proven, pure SUI treated by TVT-O were included. Patients with mixed incontinence and/or anatomic evidence of pelvic organ prolapse were excluded. INTERVENTION TVT-O implantation without any associated procedure. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Data regarding subjective outcomes (International Consultation on Incontinence-Short Form [ICIQ-SF], Patient Global Impression of Improvement, patient satisfaction scores), objective cure (stress test) rates, and adverse events were collected during follow-up. Multivariable analyses were performed to investigate outcomes. RESULTS AND LIMITATIONS Of the 191 women included, 21 (11.0%) had previously undergone a failed anti-incontinence surgical procedure. Six (3.1%) patients were lost to follow-up. The 5-yr subjective and objective cure rates were 90.3% and 90.8%, respectively. De novo overactive bladder (OAB) was reported by 24.3% of patients at 5-yr follow-up. Median ICIQ-SF score significantly improved from 17 (interquartile range [IQR]:16-17) preoperatively to 0 (IQR: 0-2) (p<0.0001). Failure of a previous anti-incontinence procedure was the only independent predictor of subjective recurrence of SUI (hazard ratio [HR]: 4.4; p = 0.009) or objective (HR: 3.7; p = 0.02). No predictive factor of de novo OAB was identified. CONCLUSIONS TVT-O implantation is a highly effective option for the treatment of women with pure SUI, showing a very high cure rate and a low incidence of complications after 5-yr follow-up.

Urinary symptoms and urodynamic findings in women with pelvic organ prolapse: is there a correlation? Results of an artificial neural network analysis.

BACKGROUND International official guidelines recommend urodynamic (UDS) evaluation in patients with pelvic organ prolapse (POP). However, the real benefit of this examination is still the subject of heated and controversial debate. Therefore, we aimed to assess the correlation between urinary symptoms and UDS findings in women with POP through the implementation of a sophisticated computer-based technology in the outpatient workup. DESIGN, SETTING, AND PARTICIPANTS A prospective cohort study was performed in a single, tertiary, urogynaecologic referral department, enrolling consecutive women seeking care for pelvic floor dysfunctions. INTERVENTION Patients underwent clinical and urodynamic evaluation. Data regarding baseline characteristics, symptoms, anatomic, and urodynamic findings were gathered for each patient. Multiple linear regression (MLR) and artificial neural networks (ANNs) were performed to design predicting models. RESULTS AND LIMITATIONS A total of 802 women with POP were included. POP quantification stages and baseline data poorly correlated to final UDS findings. Stress urinary incontinence and overactive bladder were both independently associated to each UDS diagnosis, including detrusor overactivity (DO), urodynamic stress incontinence (USI), and mixed urinary incontinence (USI plus DO). Receiver operating characteristic comparison confirmed that ANNs were more accurate than MLR in identifying predictors of UDS diagnosis, but none of these methods could successfully overcome UDS. Case-control studies are needed to confirm our findings. CONCLUSIONS Despite the current debate based on the actual value of UDS in women with POP, even the implementation of ANN, a sophisticated computer-based technology, does not permit an accurate diagnosis just on the basis of symptoms or avoiding UDS. Therefore, in women with POP, especially if scheduled for surgery, UDS should be considered as mandatory, since misleading counselling could result in unpleasant unexpected events.

Urodynamic evaluation: can it prevent the need for surgical intervention in women with apparent pure stress urinary incontinence?

To identify how many patients with symptoms of pure stress urinary incontinence (SUI) do not require any surgical treatment on the basis of urodynamics (UDS) and how many patients still do not require surgery 1 year after UDS. To assess the outcomes of these patients at 12‐month follow‐up.

Deep endometriosis and bladder and detrusor functions in women without urinary symptoms: a pilot study through an unexplored world

OBJECTIVE To evaluate the impact of deep endometriosis (DE) on bladder function, focusing on detrusor pattern, in patients without preoperative urinary symptoms. DESIGN Prospective study. SETTING Academic research center. PATIENT(S) A total of 25 asymptomatic patients: 12 patients with DE (group 1) and 13 patients with ovarian endometriosis (group 2, control group). INTERVENTION(S) Preoperative urodynamic evaluation. MAIN OUTCOME MEASURE(S) The impact of DE on urodynamic parameters. RESULT(S) For the first time, a urodynamic diagnosis of detrusor overactivity was correlated with the presence of deep infiltrating endometriosis (group 1, 91.7% [11/12] vs. group 2, 7.7% [1/13]). All involuntary detrusor contractions were detected only during the filling phase. All cystometry parameters were found to be altered in group 1 and statistically different between the two groups. No pressure/flow study parameter significantly differed between the two groups, besides maximal detrusor pressure (46 cmH2O [33-79] vs. 29 cmH2O [15-40]), which was significantly higher in group 1. Therefore, all detrusor-related parameters are statistically different between the two groups. Postvoid residual does not reach a statistically significant difference. CONCLUSION(S) DE could significantly impair detrusor functions. A preoperative urodynamic evaluation allows the attainment of important functional information, even in asymptomatic patients.

TVT for the treatment of urodynamic stress incontinence: Efficacy and adverse effects at 13-year follow-up.

To assess long‐term subjective, objective, and urodynamic outcomes of retropubic mid‐urethral slings at 13‐year follow‐up.

Tension-free Vaginal Tape–Obturator for Treatment of Pure Urodynamic Stress Urinary Incontinence: Efficacy and Adverse Effects at 10-year Follow-up

BACKGROUND Inside-out transobturator tape (tension-free vaginal tape-obturator [TVT-O]) is currently one of the most effective and popular procedures for the surgical treatment of female stress urinary incontinence (SUI). However, data reporting long-term outcomes are lacking. OBJECTIVE To assess the efficacy and safety of TVT-O 10 yr after implantation for the treatment of female pure SUI. DESIGN, SETTING, AND PARTICIPANTS A multicenter, prospective study was conducted in five tertiary referral centers in three countries. All consecutive women with urodynamically proven pure SUI treated by TVT-O were included. Patients with mixed incontinence and/or anatomic evidence of pelvic organ prolapse were excluded. INTERVENTION TVT-O implantation. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Data regarding subjective outcomes (International Consultation on Incontinence Questionnaire-Short Form, Patient Global Impression of Improvement, and patient satisfaction scores), objective cure (stress test) rates, and adverse events were collected during follow-up. Univariable analysis was performed to investigate outcomes. RESULTS AND LIMITATIONS One hundred sixty-eight women had TVT-O implantation. At 10-yr follow-up, 160 patients (95%) were available for the evaluation. We did not find any significant change of the surgical outcomes during this time. At 10 yr after surgery, 155 of 160 patients (97%) declared themselves cured (p=0.7). Similarly, at 10-yr evaluation, 148 of 160 patients (92%) were objectively cured. No significant deterioration of objective cure rates was observed over time (p=0.4). The history of failure of previous anti-incontinence procedures (hazard ratio: 5.34; 95% CI, 2.61-11.9; p=0.009) was the only predictor of recurrence of SUI. The onset of de novo overactive bladder was reported by 23 of 160 patients (14%) at 10-yr follow-up. No other late complications were reported. CONCLUSIONS The 10-yr results of this study showed that TVT-O is a highly effective and safe option for the treatment of SUI. PATIENT SUMMARY At long-term follow up, tension-free vaginal tape-obturator is highly effective and safe for the treatment of stress urinary incontinence.

Solifenacin in women with de novo overactive bladder after tension-free obturator vaginal tape--is it effective?

PURPOSE To our knowledge no group has evaluated antimuscarinic efficacy in patients with de novo overactive bladder after mid urethral sling placement. We assessed solifenacin efficacy in women with de novo overactive bladder after obturator tension-free vaginal tape placement compared to a control group. MATERIALS AND METHODS We prospectively considered all women with de novo overactive bladder symptoms at a 3-month followup visit after placement of obturator tension-free vaginal tape. Patients with overactive bladder preoperatively and those with obstructive symptoms or signs were excluded from analysis. Women who satisfied inclusion and exclusion criteria (group 1) were compared with a series of consecutive naïve patients with overactive bladder symptoms without a previous surgical procedure for stress urinary incontinence (group 2). We prescribed 12-week antimuscarinic therapy with oral solifenacin 5 mg once daily. Objective outcomes included changes from baseline in 3-day voiding diary data. Subjective efficacy was evaluated using the Overactive Bladder Questionnaire Short Form, Urgency Severity Scale and Patient Global Impression of Improvement questionnaires. RESULTS A total of 110 patients with de novo overactive bladder after obturator tension-free vaginal tape placement completed solifenacin treatment and were included in group 1. They were compared with 120 consecutive naïve women with overactive bladder (group 2). Group 1 presented at the 3-month followup visit with significantly less benefit in the mean decrease in urgency and urgency urinary incontinence episodes daily (-1.1 vs -2.3 and -0.2 vs -1.1, respectively, each p <0.0001). In group 1 we also found a lower subjective solifenacin effect. Previous obturator tension-free vaginal tape placement was an independent predictor of failed solifenacin treatment. CONCLUSIONS Antimuscarinic treatment with solifenacin had significantly lower efficacy in women with de novo overactive bladder after mid urethral sling placement than in controls.

Benefit of Pelvic Floor Muscle Therapy in Improving Sexual Function in Women With Stress Urinary Incontinence: A Pretest–Posttest Intervention Study

Very few data are available on the effect of pelvic floor muscle training on sexual function in incontinent women. The authors used the Female Sexual Function Index to assess the effect of pelvic floor muscle training on female sexual function. Participants included women with stress urinary incontinence, without overactive bladder symptoms, who completed a 3-month pelvic floor muscle training. All patients completed the Female Sexual Function Index and the International Consultation on Incontinence Questionnaire–Short Form at baseline and at the 3-month follow-up. Thirty-four patients completed all of the questionnaires; 64.7% patients were referred with stress urinary incontinence without sexual disorders, while 35.3% complained of stress urinary incontinence and sexual symptoms. The International Consultation on Incontinence Questionnaire–Short Form score significantly decreased after 3 months of pelvic floor muscle training (p =.01). The Female Sexual Function Index score significantly improved after pelvic floor muscle training even in women with sexual disorders (12.5 ± 9.5 vs. 29.7 ± 3.7; p <.001). This study showed that pelvic floor muscle training may improve female sexual function in women with pure stress urinary incontinence.