Calin Ciofu

Mid-term evaluation of the transobturator male sling for post-prostatectomy incontinence: focus on prognostic factors.

Study Type – Therapy (outcomes research)

RESULTS OF THE TENSION-FREE VAGINAL TAPE PROCEDURE FOR THE TREATMENT OF TYPE II STRESS URINARY INCONTINENCE AT A MINIMUM FOLLOWUP OF 1 YEAR

PURPOSE We evaluated the safety and efficacy of the tension-free vaginal tape procedure for treating type II stress urinary incontinence in females. MATERIALS AND METHODS Between April 1998 and April 1999, 62 women 28 to 86 years old (mean age 62.8) were treated consecutively for stress urinary incontinence with the tension-free vaginal tape procedure. Preoperative evaluation included history, physical examination and multichannel video urodynamics. All patients had type II stress urinary incontinence, none had preoperative detrusor instability or significant pelvic prolapse and in 16 previous surgery for stress incontinence had failed. RESULTS All patients were followed at least 12 months after the procedure (median 16.2). A total of 42 and 20 women received spinal and local anesthesia, respectively. We noted 6 bladder perforations, including 5 in patients with a history of surgery for stress urinary incontinence. Blood loss was less than 200 cc in all cases. We observed no prolonged postoperative pain, infection or sling rejection. Post-void residual urine was less than 100 cc the day after surgery in 59 cases. Only 3 patients self-catheterized a maximum of 4 days. At followup 54 women (87.1%) were cured of stress urinary incontinence, 6 were improved (9.6%) and 2 had failure (3. 3%), while 4 (6.4%) had new onset detrusor instability without evidence of bladder outlet obstruction. CONCLUSIONS The tension-free vaginal tape procedure appears to be a minimally invasive, safe and effective treatment for type II stress urinary incontinence. A history of surgery for stress incontinence seems to be a risk factor for bladder perforation.

Urinary Incontinence in French Women: Prevalence, Risk Factors, and Impact on Quality of Life

BACKGROUND The lack of epidemiologic data on the prevalence of female urinary incontinence (UI) attending general practitioners (GPs) in France led us to conduct a cross-sectional study in our country. OBJECTIVES To determine the prevalence of UI and to assess its impact on the quality of life (QoL). DESIGN, SETTING, AND PARTICIPANTS This cross-sectional study of women aged >18 yr was conducted by attending GPs between June 2007 and July 2007. MEASUREMENTS The main outcome measures were urinary symptoms, functional impairment, International Consultation on Incontinence Questionnaire-Short Form score, and medical care seeking. RESULTS AND LIMITATIONS Overall, 241 GPs enrolled 2183 women seen during 1 d. The prevalence of UI was 26.8% (n=584) and increased with age, body mass index (BMI), and number of children delivered (p<0.0001). Among women with UI, 496 were included in a cross-sectional survey: 45.2% (n=224) had stress UI, 42.1% (n=209) had mixed UI, and 10.9% (n=53) had urge UI, while 2% (n=10) had UI of indeterminate type. Overall, 288 of 496 women (51.8%) stated that UI had a negative impact on their QoL; this effect remained mostly mild or moderate, and only 197 of 496 women (39.7%) had asked for medical help. Longer duration of symptoms, higher frequency of comorbid urinary symptoms, and altered QoL were most frequent among women with mixed UI (p<0.001). Misclassification may have occurred because the diagnosis of UI was based on self-reported data rather than on clinical or urodynamic examinations. CONCLUSIONS UI symptoms were found in almost one in four women attending GPs. Clinical and functional UI impairment were associated with age, BMI, and parity. UI caused distress to women, but only those who were severely affected sought help. The results emphasize the need for policy development for UI prevention and management in France.

A French Multicenter Clinical Trial of SPARC for Stress Urinary Incontinence

OBJECTIVE To evaluate the safety and efficacy of the SPARC procedure in women with genuine stress urinary incontinence. METHODS We conducted a prospective multicenter trial of a suprapubic approach to suburethral polypropylene (SPARC) taping for the treatment of genuine stress urinary incontinence. Between June 2001 and June 2002, 104 consecutive women (mean age 58.7 years) underwent SPARC in three centers. All the women had urethral hypermobility preoperatively. Detrusor instability was ruled out by cystometry. The women were evaluated 1, 3, 6 and 12 months postoperatively. The objective cure rate was evaluated by clinical and urodynamic examination, and the subjective cure rate was assessed using the Kings and Bristol questionnaire. RESULTS The mean follow-up time was 11.9+/-1.9 months (range 8 to 20 months). The mean operating time was 30 min (25-50 min). Most of the patients received general anesthesia (48%). The overall complication rate was 44.2% (46/104). The perioperative complication rate was 10.5%, including 11 bladder injuries. A significant difference in the bladder injury rate was observed between women with and without previous incontinence surgery (respectively 4/11, 36.3% versus 7/93, 7.5%; p<0.001). No hemorrhaging occurred. The early postoperative complication rate was 22.1%. The main complication was voiding disorders (11 patients), which necessitated intermittent self-catheterization for less than 15 days (1.3+/-1.1 days, range 1 to 10 days). The late postoperative complication rate was 11.5%, including de novo urge symptoms in 12 women. The objective cure rate was 90.4%. No difference was found between patients with genuine stress incontinence and those with mixed incontinence. The subjective cure rate was 72%. The objective and subjective cure rates differed significantly (p<0.05). The subjective cure rate among patients with de novo urge symptoms was 58%. CONCLUSION The SPARC procedure is a safe and effective treatment for women with stress urinary incontinence, despite a high incidence of de novo urge symptoms.

Results of the Tension-Free Vaginal Tape technique in the elderly

OBJECTIVES To assess the results of the Tension-Free Vaginal Tape (TVT) technique for the treatment of stress urinary incontinence (SUI) in the elderly. PATIENTS AND METHODS Between March 1998 and February 2001, 76 consecutive women more than 70 years old (median 76) and presenting with SUI were operated with the TVT technique. 28.9% (22/76) of the patients had previous surgery for SUI. 31% (24/76) of the patients had an overactive bladder and 4 patients had detrusor instability controlled by anticholinergic therapy. All patients had preoperative multichanel urodynamic evaluation. RESULTS No serious complication was noted intra- or postoperatively. At a mean follow up of 24.6 months (range 16-49 months), 67% of the patients were cured (51/76). Among the failures, 10 patients (13.7%) had persistent SUI, 14 patients (18.4%) had urge incontinence and 2 patients were lost to follow up. De novo urgency without incontinence was noticed in 21% of the patients but preoperative urgency symptoms were cured in 46% of the patients. Overall 82% of the patients were satisfied with the result of the surgery, 14% considered the result as incomplete and 4% considered they were worsened by surgery. CONCLUSION The TVT procedure is safe and efficient to treat SUI in the elderly population even if the rate of de novo urgency appeared to be significant.

Midterm Prospective Evaluation of TVT-Secur Reveals High Failure Rate

BACKGROUND TVT-Secur has been described as a new minimally invasive sling for womens stress urinary incontinence (SUI) management, showing promising results in short-term studies. OBJECTIVE Our goal was to evaluate the outcome of this procedure after a midterm follow-up. DESIGN, SETTING, AND PARTICIPANTS A prospective evaluation involved 45 consecutive patients presenting SUI associated with urethral hypermobility. Fourteen patients preoperatively reported overactive bladder (OAB) symptoms, but none had objective detrusor overactivity. Eight patients had low maximal urethral closure pressure (MUCP). Four patients had pelvic organ prolapse (POP). INTERVENTION Patients with POP were treated under general anesthesia by Prolift and TVT-Secur procedure. The 41 other patients received TVT-Secur under local anesthesia on an outpatient basis. All interventions were made by the same surgeon. MEASUREMENTS Postoperative assessment included pad count, bladder diary, clinical examination with stress test, evaluation of satisfaction with the Patient Global Impression of Improvement (PGI-I) scale, and evaluation of side effects. Patients were classified as cured if they used no pads, had no leakage, and had a PGI-I score < or = 2; as improved in case of reduction of SUI symptoms >50% and PGI-I score < or = 3; and as failure otherwise. RESULTS AND LIMITATIONS Mean postoperative follow-up was 30.2 +/- 9.8 mo (range: 11-40 mo). Short-term evaluation showed a 93.5% success rate, but, at last follow-up, only 18 (40%) patients were cured, while 8 (18%) were improved, and 19 (42%) failed. Twelve patients underwent implantation of TVT or transobturator tape during follow-up. Age, MUCP, or OAB were not associated with failure. Side effects were limited to five cases of de novo OAB and three cases of urinary tract infection. This work is limited by the absence of a comparison group. CONCLUSIONS Our experience shows that despite its good short-term efficacy, TVT-Secur is associated with a high recurrence rate of SUI. Therefore, TVT-Secur does not seem appropriate for SUI first-line management in women.

Duloxetine for Mild to Moderate Postprostatectomy Incontinence: Preliminary Results of a Randomised, Placebo-Controlled Trial

BACKGROUND Duloxetine is effective in the management of stress urinary incontinence (SUI) in women but has been poorly evaluated in the treatment of SUI following radical prostatectomy (RP). OBJECTIVE To establish the superiority of duloxetine over placebo in SUI after RP. DESIGN, SETTING, AND PARTICIPANTS We conducted a prospective, randomised, placebo-controlled, double-blind, monocentric superiority trial. After a placebo run-in period of 2 wk, patients with SUI after RP were randomised to receive either 80mg of duloxetine daily or matching placebo for 3 mo. MEASUREMENTS The primary outcome measure was the relative variation in incontinence episodes frequency (IEF) at the end of study compared to baseline. Secondary outcomes included quality of life (QoL) measures (Incontinence Impact Questionnaire Short Form [IIQ-SF], Urogenital Distress Inventory Short Form [UDI-SF], Incontinence Quality of Life [I-QoL]), symptom scores (Urinary Symptom Profile [USP] questionnaire, International Consultation on Incontinence/World Health Organisation Short Form questionnaire [ICIQ-SF], the Beck Depression Inventory [BDI-II] questionnaire), 1-h pad test, and assessment of adverse events. RESULTS AND LIMITATIONS Thirty-one patients were randomised to either the treatment (n=16) or control group (n=15). Reduction in IEF was significant with duloxetine compared to placebo (mean±standard deviation [SD] variation: -52.2%±38.6 [range: -100 to +46] vs +19.0%±43.5 [range: -53 to +104]; mean difference: 71.2%; 95% confidence interval [CI] for the difference: 41.0-101.4; p<0.0001). IIQ-SF total score, UDI-SF total score, SUI subscore of the USP questionnaire, and question 3 of the ICIQ-SF questionnaire showed improvement in the duloxetine group (p=0.006, p=0.02, p=0.0004, and p=0.003, respectively). Both treatments were well tolerated throughout the study period. CONCLUSIONS Duloxetine is effective in the treatment of incontinence symptoms and improves QoL in patients with SUI after RP.

Complications of urethral sling procedures.

Purpose of review To review the current literature on complications of suburethral slings used to treat stress urinary incontinence in the female. Recent findings The surgical treatment of female urinary incontinence has changed considerably since the development of the tension-free vaginal tape procedure, introduced by Ulmsten in 1995. As the follow-up for the first studies is now more than 5 years, the ‘long-term’ results of the technique can be evaluated. Furthermore, now that the learning phase has been completed and the technique can be considered to be well mastered, it is interesting to review the complications inherent in this technique, their frequency, including those rarer complications that are sometimes associated with severe morbidity, and to consider the ways in which these complications can be prevented or treated. The development of the tension-free vaginal tape procedure has not prevented the development of other types of suburethral sling, but on the contrary, has promoted the development of these alternatives by the use of various sling insertion techniques, and especially various types of materials. There has even been a renewed interest in materials that have been known for a long time (heterologous and autologous materials) in some recent papers, and new synthetic suburethral slings have been proposed with the objectives of combining low morbidity, safety and efficacy. Summary Monofilament polypropylene meshes can be used safely to perform suburethral slings and seems to be the most suitable material in this indication according to the existing literature.

PROSPECTIVE EVALUATION OF GENETIC ABNORMALITIES AND TELOMERASE EXPRESSION IN EXFOLIATED URINARY CELLS FOR BLADDER CANCER DETECTION

PURPOSE To evaluate alternative procedures to cytoscopic examination we prospectively compared noninvasive procedures for detecting bladder cancer namely cytology, loss of heterozygosity (LOH), microsatellite instability and human telomerase catalytic subunit reverse transcriptase (hTERT) messenger (m) RNA detection. MATERIALS AND METHODS Specificity and cutoff values were established in the blood and urine sediment of 50 controls. Sensitivity was analyzed in the urine and tissue samples of 50 patients with bladder cancer. The diagnosis was established by cystoscopic and histological examination. Genomic alterations were studied using a panel of 24 microsatellite markers to detect LOH events, while 3 additional mononucleotide repeats were analyzed for microsatellite instability detection. Telomerase expression was detected in urinary cells by nested RT-polymerase chain reaction amplification of hTERT mRNA. All techniques were compared by cytological examination. RESULTS Sensitivity and specificity were 31% and 100% for cytological testing, 96% and 100% for LOH, and 75% and 69% for RT-polymerase chain reaction of hTERT, respectively. No alteration was detected on microsatellite instability analysis in urine or tumor tissue cells. Using only the 5 markers most strongly associated with bladder cancer selected by logistic regression analysis, namely ABL1, IFNa, D9S12, MJD58 and D18S364, LOH test sensitivity slightly decreased to 90%. CONCLUSIONS Urinary LOH analysis was the most sensitive and specific method for bladder cancer detection and it appeared less dependent on urine sediment quality. The logistic regression score may be an interesting complement to cystoscopy. The specificity of hTERT mRNA detection was incomplete since false-positives were observed in 31% of cases. Absent microsatellite instability in our cohort showed that these genomic alterations are not present at the early step of bladder cancer.

In situ extracorporeal shock wave lithotripsy for acute renal colic due to obstructing ureteral stones

The purpose of the present study was to evaluate in situ extracorporeal shock wave lithotripsy (ESWL) for the treatment of obstructing ureteral stones causing acute renal colic. In situ ESWL with an EDAP LT-02 piezo-electric lithotriptor was used in a prospective study to treat 67 patients with obstructing ureteral stones causing acute renal colic. Patients were treated without anesthesia on an out-patient basis or during a one-day hospital stay. The overall one month stone-free rate was 94% (94% for proximal stones and 95% for distal stones). The overall success rate after a single ESWL session was 81%. Treatment was well tolerated in 90% (60/67) of patients. There was one case of non-obstructive pyelonephritis and one of ureteral edema. These rates compare well with published reports for delayed treatment in patients without renal colic. Immediate ESWL for cases of acute renal colic due to obstructing ureteral stones is an effective treatment strategy that warrants wider consideration.