Paweł Skorupski

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.

A randomized comparison between monofilament and multifilament tapes for stress incontinence surgery

Our objective was to compare monofilament and multifilament tapes positioned without tension at the midurethra for postoperative complications and cure rate. One hundred patients with stress urinary incontinence were randomly allocated into two study groups. Using identical surgical methodology, 50 patients had a monofilament tape inserted at the midurethra using the TVT delivery instrument, and another 50 a multifilament tape using the IVS delivery instrument. The only significant difference between the groups was in the incidence of postoperative urinary retention (p=0.023). Ten patients from the monofilament group required longer than normal (‘normal’ means to the morning of the next day) catheterization, in contrast to only two from the multifilament group. The clinical efficacy of both procedures was equally high. Conclusions were that both tapes appear to be equally effective in the surgical treatment of SUI. The higher incidence of postoperative urinary retention in the monofilament group was most likely caused by the elastic feature of this tape.

The Efficacy and Safety of the Tension-Free Vaginal Tape Procedure Do Not Depend on the Method of Analgesia

OBJECTIVE The original tension-free vaginal tape (TVT) method, described by Ulmsten et al., routinely uses local anaesthesia during the procedure. Since the anaesthetic effect after local application of lidocaine hydrochloride was not always satisfactory we decided to introduce the spinal anaesthesia during this operation. The aim of the present study was to compare local and spinal anaesthesia with respect to their efficacy and safety in the TVT procedure. METHODS 103 women, with objectively confirmed stress urinary incontinence, were randomised into the study. Sixty-seven women were anaesthetised locally and 36 patients spinally. All TVT procedures were performed as originally described. Objective assessment of the influence of anaesthesia on intra-abdominal pressure at rest and during the cough test was done using a rectal catheter and a central venous pressure manometer. The efficacy of the TVT procedure was based on a gynaecological examination with a cough test and a three-degree subjective scale: complete cure, improvement or failure. RESULTS The success of the TVT procedure performed under local anaesthesia is comparable with that achieved under spinal analgesia (p=0.42). The number of complications that occurred in the two groups does not differ significantly (p=0.57). CONCLUSIONS Spinal anaesthesia impairs the ability to cough effectively during the TVT procedure. However, the efficacy and safety of the operations performed under this type of anaesthesia are comparable with the efficacy and safety of operations done under local anaesthesia.

The polymorphisms of the MMP-1 and the MMP-3 genes and the risk of pelvic organ prolapse

Introduction and hypothesisTo investigate the associations between single nucleotide polymorphism (SNP) type 1G/2G at position −1607/−1608 of the matrix metalloproteinase (MMP)-1 gene and SNP type 5A/6A at position −1612/-1617 of the MMP-3 gene and the development of pelvic organ prolapse (POP) in women.Methods133 patients with symptomatic POP were included in the study group. The control group consisted of 132 women with a normal pelvic floor. 1G/2G MMP-1 and 5A/6A MMP-3 SNPs were determined by polymerase chain reaction (PCR) and restriction fragments length polymorphism analysis.ResultsWhen estimated individually none of the investigated SNPs were associated with POP. The combined MMP-1/MMP-3 SNP analysis showed that the following polymorphic pairs were overrepresented in women with POP: 1G/2G −5A/6A, 2G/2G −5A/6A, 2G/2G −5A/5A, 1G/1G −6A/6A, p = 0.005.ConclusionsThe combined effect of −1607/−1608 MMP-1 and −1612/−1617 MMP-3 SNPs may contribute to the development of POP in some women.

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.

Relationship between estrogen receptor-α polymorphism and serum levels of vascular cell adhesion molecule-1, intercellular adhesion molecule-1, C-reactive protein and homocysteine in postmenopausal women

Background and aim. Genetic variation in the estrogen receptor-α gene (ERα) may influence the risk of cardiovascular diseases in postmenopausal women. This effect, at least in part, may be dependent on the decrease in expression of injury and inflammatory markers in the vascular wall. The aim of the present study was to evaluate the relationship between ERα PvuII and XbaI polymorphisms and serum levels of soluble vascular cell adhesion molecule-1 (sVCAM-1), soluble intercellular adhesion molecule-1 (sICAM-1), C-reactive protein (CRP) and homocysteine in postmenopausal women. Subjects and methods. Subjects of the study were 64 postmenopausal women. PvuII and XbaI ERα gene polymorphisms were analyzed by polymerase chain reaction–restriction fragment length polymorphism. Results. Mean sVCAM-1 level was significantly higher in pp homozygotes in comparison with PP homozygotes and Pp heterozygotes, as well as higher in xx homozygotes in comparison with XX homozygotes and Xx heterozygotes. Levels of sVCAM-1 were also significantly higher in women with px haplotype compared with PX and Px haplotypes. There were no relationships between investigated genotypes or haplotypes and levels of sICAM-1, CRP and homocysteine. Conclusion. The results of our study suggest that genetic variation in ERα gene may influence blood levels of VCAM-1 in women after the menopause.

Interstitial collagenase (MMP-1) activity in human ovarian tissue.

The collagen content and collagenase activity were estimated in human ovarian interstitial tissue devoid of all visible follicles in menstruating, fertile as well as climacteric women. The mean total collagenase activity in ovarian specimens taken during both follicular (n = 10, 3.97 +/- 0.58 U/g wet weight, ww) and luteal phase (n = 10, 3.39 +/- 1.24 U/g ww) of the normal menstrual cycle along with total collagen concentration (184.8 +/- 41.0 vs. 194.4 +/- 30.5 micrograms/mg ww, respectively) did not differ. Total collagenase activity of climacteric gonads (n = 5, 1.55 +/- 0.71 U/g ww) was lower than in specimens collected during both follicular and luteal phase (p = 0.0002 and p = 0.017, respectively). About 23% of the total collagenase activity in follicular phase ovarian extracts and only about 1% in luteal phase ovarian preparations was found in the latent form. The percentage of latent collagenase in ovarian tissue during the follicular phase was negatively correlated with the day of the menstrual cycle (r = -0.93, p = 0.007). Extracellular matrix remodelling in the human ovary can be correlated with the functional status of the follicular unit.

Extracellular matrix remodelling within the normal human ovarian capsule

Collagen tissue content and both interstitial (MMP-1) and type IV collagenases (also known as gelatinases) activity within the normal human ovarian capsule were investigated. The apical tunica albuginea (n = 10) displayed a lower mean total collagen concentration than the ovarian capsule areas (n = 9) with no follicles underneath them (137.8 +/- 36.1 vs. 176.6 +/- 23.1 micrograms/mg wet weight tissue (ww), P = 0.004). This was accompanied by higher net interstitial collagenase activity (12.96 +/- 2.26 vs. 5.97 +/- 1.9 U/g ww, P = 0.016) which was present within the ovarian capsule in active form only. Zymography revealed the dominance of the 72-kDa over the 92-kDa gelatinase form regardless of the capsule area investigated. Our results indicate that extracellular matrix remodelling within human tunica albuginea is more strongly pronounced in the apical region.

Evaluation of matrix metalloproteinases-1 and -3 concentrations in the tunica albuginea, the apical wall of atretic follicles and the corpus luteum of normal human ovaries.

Matrix metalloproteinases-1 (MMP-1) and -3 (MMP-3) are proteolytic enzymes involved in remodelling the ovarian extracellular matrix throughout the menstrual cycle. The aim of the present study was to evaluate the tissue concentrations of MMP-1 and MMP-3 in the apical wall of atretic follicles (androstenedione/estradiol ratio > 4), tunica albuginea dissected from the ovarian surface overlying areas devoid of follicles, corpus luteum, and tunica albuginea covering the corpus luteum. After extraction of MMPs from the tissue samples, their concentrations in the extracts were measured by enzyme-linked immunosorbent assays (ELISA). Significantly less MMP-1 was detected in the apical wall of atretic follicles compared to tunica albuginea taken from sites devoid of follicles. These data indicate that atresia is associated with relatively low concentrations of MMP-1 in the apical wall of the follicle. Moreover, there was a negative correlation between the amount of MMP-3 and the diameter of follicle. These data suggest that both MMPs play an important role in the final step of atresia. The amount of MMP-1 in the corpus luteum was several times lower than in the other tissues. This is likely due to stabilization of the extracellular matrix during the period of the corpus luteum maintenance. The concentration of MMP-3 did not differ significantly among the examined tissues.