Konrad Futyma

The Clinical Effectiveness of Retropubic (IVS-02) and Transobturator (IVS-04) Midurethral Slings: Randomized Trial

BACKGROUND Few series comparing the clinical efficacy of retropubic slings versus transobturator slings for the treatment of female stress urinary incontinence (SUI) are available. OBJECTIVE To compare clinical efficacy of retropubic tape operations and transobturator suburethral tape operations for the surgical treatment of female SUI. DESIGN, SETTING, AND PARTICIPANTS From January 2003 to December 2005, 611 patients underwent clinical and urodynamic evaluation before surgical treatment for SUI. Patients with advanced urogenital prolapse (pelvic organ prolapse-quantification scale [POP-Q] scale grade >1) were excluded, and 537 patients were included in this study. After 18 mo, 398 women were available for follow-up efficacy evaluation at a tertiary academic center. INTERVENTION All patients underwent either a retropubic sling procedure or a transobturator sling procedure. Patients were randomly allocated into two study groups at a ratio of 1:1. MEASUREMENTS After 18 mo all enrolled patients were clinically checked for clinical efficacy of both procedures. RESULTS AND LIMITATIONS Demographic and urodynamic parameters of patients were similar in both groups. No bladder injury occurred in the transobturator sling group (IVS-04), whereas 13 intraoperational bladder perforations (6.5%) occurred in the retropubic sling group (IVS-02) (p<0.001). The tape erosion rate was <2.5% in both groups (p=0.7). After 18 mo, 398 patients (201 in the IVS-02 group and 197 in the IVS-04 group) were evaluated in terms of clinical efficacy of the procedures. We found out that there was no statistically significant difference in clinical efficacy between these two procedures (chi(2)=1.88, p=0.39). In the IVS-02 group, 75.1% of patients (n=151) remained dry (cured), 16.9% of patients (n=34) reported significant improvement, and 8.0% of patients (n=16) were considered as failures. In the IVS-04 group, 74.1% of patients (n=146) remained dry, 14.2% of patients (n=28) reported significant improvement, and 11.7% (n=23) were considered as failures. CONCLUSIONS Based on an 18-mo follow-up, the efficacies of both techniques are comparable; however, the retropubic route appears to be more efficient in the intrinsic sphincter deficiency (ISD) group.

Transvaginal Prolift(®) mesh surgery due to advanced pelvic organ prolapse does not impair female sexual function: a prospective study.

OBJECTIVES To evaluate sexual function among women with advanced pelvic organ prolapse (POP) before and after Prolift(®) vaginal reconstructive mesh surgery. STUDY DESIGN Assessments were performed preoperatively and 12-18 months after the surgery, including physical examination using the Pelvic Organ Prolapse Quantification (POP-Q) scale as well as the Female Sexual Function Index (FSFI) questionnaire. RESULTS Fifty-nine sexually active patients who underwent vaginal reconstructive surgery due to advanced POP between June 2008 and January 2010 were included in the study. Analysis of the FSFI questionnaire showed no statistically significant differences after surgery, despite proper anatomical results. When comparing the group of women who underwent additional surgical restoration of the perineal body with patients without this procedure we also did not observe any differences in FSFI scores. CONCLUSIONS Surgical treatment of advanced POP with the Prolift(®) system does not negatively influence sexual function, but patients should not expect a significant improvement after this type of operation. Additionally performed surgical restoration of perineal body does not reduce sexual function, either.

Tape Fixation: An Important Surgical Step to Improve Success Rate of Anti-Incontinence Surgery

PURPOSE Mid urethral slings are effective surgical treatment for stress urinary incontinence. However, 5% to 20% of patients still experience surgical failure with clinically significant recurrent or persistent stress urinary incontinence. Since a subset of these failures may be caused by improper tape position, we elucidated whether additional paraurethral fixation of a tape to prevent displacement during tensioning could improve the transobturator sling outcome. MATERIALS AND METHODS The study was done in 463 patients with stress urinary incontinence who were randomly allocated to treatment with a standard transobturator intravaginal monofilament sling procedure (232) or to an intravaginal transobturator monofilament sling with additional 2-point tape fixation (231). Another 2 absorbable sutures parallel to the urethra were added to fix the tape and prevent displacement during tape tensioning. Outcome was assessed by a cough test and a 1-hour pad test at 12 months. RESULTS Clinical efficacy of the procedure with fixation was significantly higher with 195 women (95.12%) cured or improved compared to the 199 (88.73%) cured or improved with the standard sling (chi-square 5.71, p = 0.0169). There was no increase in intraoperative or postoperative complications. Also, among patients with intrinsic sphincter deficiency we noted a significantly better outcome in the fixation group than in the control group, that is 39 of 41 patients (95.1%) cured or improved vs 31 of 42 (73.8%) (chi-square 10.65, p = 0.0011). CONCLUSIONS Tape fixation significantly increases the clinical efficacy of the transobturator sling, especially in patients with intrinsic sphincter deficiency.

An Open Multicenter Study of Clinical Efficacy and Safety of Urolastic, an Injectable Implant for the Treatment of Stress Urinary Incontinence: One-Year Observation

The prevalence of stress urinary incontinence rises and affects up to 30% of women after 50 years of age. Midurethral slings are currently the mainstay of surgical anti-incontinence therapy. Some patients experience recurrent SUI (RSUI) which is defined as a failure of anti-incontinence surgery after a period of time or persistence of SUI after the procedure aimed at correcting it. The urethral bulking agent application decreases invasiveness of treatment and meets patients requirements. The objective of this study was to assess the safety and clinical efficacy of Urolastic injection. One hundred and five patients with SUI (including 91 patients with RSUI) were treated with Urolastic in three tertiary gynecological clinics. The efficacy of the procedure was assessed objectively at each follow-up visit by means of cough test and a standard 1-hour pad test. Objective success rate after 12 months after primary procedure in RSUI patients was found in 59.3% of patients. In 14 patients with primary SUI improvement after 1 year was found in 71.4% of patients. Although cure rates after MUS are up to 90% there is still place for less invasive treatment option like periurethral injection of bulking agents, especially in patients with previous SUI surgical management.

Use of uroflow parameters in diagnosing an overactive bladder—Back to the drawing board

The aim of our study was to analyze whether uroflowmetry parameters are helpful in diagnosing overactive bladder (OAB). The working hypothesis was that the flow curves of patients with OAB symptoms would appear as a sharp peak flow rate with a short duration and high amplitude, lasting only for a short period during urgency sensation, followed by reduced urine flow. We introduced a new parameter called flow index (FI) defined as an average divided by maximal urine flow rates as a potential marker for diagnosing OAB.

Expression of genes encoding extracellular matrix proteins: A macroarray study

Endometrial cancer (EC) is one of the most common gynecological malignancies in Poland, with well-established risk factors. Genetic instability and molecular alterations responsible for endometrial carcinogenesis have been systematically investigated. The aim of the present study was to investigate, by means of cDNA macroarrays, the expression profiles of genes encoding extracellular matrix (ECM) proteins in ECs. Tissue specimens were collected during surgical procedures from 40 patients with EC, and control tissue was collected from 9 patients with uterine leiomyomas. RNA was isolated and RT-PCR with radioisotope-labeled cDNA was performed. The levels of ECM protein gene expression in normal endometrial tissues were compared to the expression of these genes in EC specimens. Statistically significant differences in gene expression, stratified by clinical stage of the ECs, were detected for aggrecan, vitronectin, tenascin R, nidogen and two collagen proteins: type VIII chain α1 and type XI chain α2. All of these proteins were overexpressed in stage III endometrial carcinomas compared to levels in stage I and II uterine neoplasms. In conclusion, increased expression of genes encoding ECM proteins may play an important role in facilitating accelerated disease progression of human ECs.

Can botox improve night-time overactive bladder symptoms in women?

Despite the efficacy of intravesical onabotulinumtoxinA (Botox) therapy for urgency, urgency incontinence, and daytime frequency, its value in treatment of nocturia remains unclear. The aim of the prospective observational study was to assess the effect of onabotulinumtoxinA on night‐time symptoms in women with overactive bladder (OAB), including nocturia, night‐time urgency incontinence, and nocturnal voided volume as end‐points.

PROSPECT multicenter trial—a real milestone in prolapse surgery?

We were very enthusiastic when we found the results of the PROSPECT trial published by Glazener et al. Unfortunately, we found that it has some serious flaws, that could potentially have a negative influence on the final results and conclusions drawn. Our main concern is that the patients were wrongly assigned to the analyzed groups, because those who received different procedures than primarily planned should have been transferred to the appropriate patient groups, that is, if patients were in the mesh arm but received standard repair they should have been transferred to the standard procedure group. Combining patients after different procedures into one group will distort the analytical results within this particular group, see Figure: Trial profile; page 384. In the mesh arm out of 425 patients only 341 (80%) underwent mesh inlay procedure and nine patients from the other arms had mesh inlay procedures, so altogether 350 patients. Surprisingly, after 6 months, 1 and 2 years of follow-up 381, 389, and 343 patients, respectively, were available for analysis in this arm despite only 350 patients undergoing the procedure initially. It means that one fifth of the patients from the mesh arm were analyzed in this group but received a completely different procedure. This will have a clear and definite impact on the objective, anatomical, and subjective outcomes of the trail. The same issue is present in the GRAFT trial where 301 patients underwent biological graft procedure, but after 6 months, 1 and 2 years of follow-up 335, 337, and 300 patients, respectively, were available for analysis. The important question here is, why were the patients who actually had biological grafts inserted not analyzed in this group? The final issue is that such a large, multicenter (35 centers) study evaluated only subjective symptoms after 2 years of follow-up instead of being designed to properly evaluate anatomical outcomes. Examining more than 1300 patients is quite a challenge, however, with 35 centers this leaves only 38 patients per center. Information about the anatomical outcome after 2 years would answer the ultimate question: are mesh inlays really responsible for better outcomes or not? Moreover, to make the study more transparent, a table with the data presenting the number of procedures performed in each center should be included. This issue gives rise to another important question: what was the centers’ experience in performing the investigated procedures. It appears that monthly only 30.6 patients were enrolled throughout 35 centers; giving an average of 0.87 patients/month/center or 10.4 patients/year/center. Even when we look at the total number of women who were identified as those requiring prolapse surgery in all centers during the whole study recruitment period (4083 women), we can come to the conclusion that only 31.8 patients were operated per center per year. According to the American Urogynecologic Society’s Guidelines Development Committee, a minimum of 30 surgical cases for pelvic organ prolapse (any route, with or without transvaginal mesh) should be performed by each surgeon every year to maintain proficiency in pelvic reconstructive surgery. This gives reason to suspect that the centers which partook in the trail may not have had the optimal volume of experience in managing genitourinary prolapse. In the study, published by Kelly et al low-volume surgeons caused mesh-related complications requiring reoperation in 4.8% (145/3001) of cases, whereas very highvolume surgeons only had a 3.0% (73/2447) reoperation rate. This illustrates how important it is to provide information regarding the centers’ and surgeons’ operative volume, especially in a trail that aims to change the apprehension of urogynaecological procedures and have a wide-reaching impact on clinical practice. We hope that the Authors will clarify these issues and urogynaecologists will have no doubts about the conclusions that can be drawn from the PROSPECT trial results.

Impact of intravesical onabotulinumtoxinA on sexual function in women with OAB

Urgency urinary incontinence (UUI), and the symptoms of overactive bladder (OAB) have a negative impact on female sexual function. The aim of this study was to investigate the effect of intravesical onabotulinumtoxinA (Botox) injection on sexual function in women with OAB, using the multi domain Female Sexual Function Index (FSFI) questionnaire.

Biological markers with potential clinical value in endometrial cancer — review of the literature

Endometrial carcinoma (EC) is the most common malignancy of the female genital tract encountered in western countries, making it the fourth most common cancer in women. The incidence of uterine cancer is on the rise throughout the developed world where diagnosis is increasingly observed among younger patients. With regard to this, attention has been focused on conducting more studies to achieve a better understanding of the molecular genetics related to endometrial carcinogenesis. Over the years, EC has been classified into two broad histopathological subtypes based on the mechanism of development, and we can therefore observe specific biomarkers related to the respective subtype. Based on this idea, more research has been carried out in the last decade, using biotechnological methods, with the aim to identify new potential tumor markers. By translating these findings into clinical use one may facilitate accurate diagnosis and prognostic prediction, and contribute to individualized treatment. Without a doubt, there is a demanding need to identify biomarkers that can be adopted in clinical practice in order to reduce the time needed to obtain diagnosis. Such markers may be of great value in improving patient outcome. However, a number of problems remain to be solved before this becomes a reality. This paper briefly reviews the current status of rising biomarkers in EC.