Comparison of Clinical Efficacy and Urodynamic Changes Using Single-incision Slings (MiniArc® vs. Solyx™) for the Treatment of Female Stress Urinary Incontinence.

OBJECTIVE: To compare the clinical efficacy and urodynamic parameter changes between the MiniArc and the Solyx sling for the treatment of female urodynamic stress incontinence (USI). MATERIALS AND METHODS: One-hundred and thirty (MiniArc n = 79, BS-Solyx n = 51) patients were included in this study. Cough stress test (ST), pad test (PT), Incontinence Impact short form Questionnaire (IIQ-7), Urogenital Distress Inventory six-item questionnaire (UDI-6), Sexual Questionnaire-Short Form (PIS-Q), and urodynamic parametric changes were assessed to determine objective and subjective outcomes following the procedure. Objective cure was defined as negative ST and PT <2 g and subjective cure was defined as "No" to the answer of UDI-6 Question #3. Predictors of surgical failure were also determined. RESULTS: All Solyx users, as opposed to 91.1% of MiniArc patients, obtained objective cure at postoperative 3 months (P = 0.042). No significant difference in subjective cure rates (93.7% vs. 90.2% at 3-months (P = 0.513); 89.9% vs. 80.4% at 1 year for Solyx and MiniArc patients, respectively (P = 0.126)) and improvement scores in UDI-6 and IIQ-7 were observed. The Solyx group incurred more de novo urgency (17.6% vs. 6.3% at 3 months (P = 0.042); 23.5% vs. 7.6% at 1 year (P = 0.01)). Both procedures yielded significant decrements in maximal urethral closure pressure (P < 0.001) and average flow rate (P = 0.015). The preoperative PT and sling type were strong predictors of surgical failure, where the Solyx tape reported lower odds (odds ratio = 0.174, P = 0.02) compared to the MiniArc sling. CONCLUSION: Single-incision mini-slings are safe and effective treatment for female USI. The Solyx SIS demonstrated superiority over the MiniArc in this study based on its higher objective cure rate and lower risk for surgical failure.

The efficacy and complications of using transvaginal mesh to treat pelvic organ prolapse in Taiwan: A 10-year review.

Transvaginal mesh (TVM) insertion for the treatment of pelvic organ prolapse (POP) is significantly associated with lower failure rates, although its use remains controversial due to the potential risk of mesh-related complications. In this review, we collected the published literature regarding the use of TVM to treat POP in an attempt to assess both the efficacy and complications related to TVM usage in Taiwan. We searched 25 English language articles using PubMed related to TVM in Taiwan from 2010 to 2019. The present article focuses on the efficacy and complications of TVM and analyzes the data. There were 25 studies on TVM selected for this review. Regarding their success rate, 21 out of the 22 studies (95.5%) had more than a 90% objective success rate. Twenty studies (90.9%) had less than 10% major complications of TVM. Twenty out of the 25 studies (80.0%) had 5% or less mesh exposure. For self-cut TVM and the later single-incision TVM, both the complication rates and exposure rates decreased. The rate of de novo dyspareunia ranged from 2.6% to 14.3%, and the incidence decreased yearly from 2011 to 2019. This review showed both the high treatment efficacy and low complication rate of TVM usage for the short-term treatment of POP in Taiwan. However, a longer-term study is needed to draw a conclusion regarding the safety of this treatment.

Changes in the PGC-1α and mtDNA copy number may play a role in the development of pelvic organ prolapse in pre-menopausal patients.

OBJECTIVE: The alternations of mtDNA may play an important role in the molecular pathogenesis and process of Pelvic Organ Prolapse (POP) formation in both pre-menopausal and post-menopausal women. The aim of the present study is to analyze the association between the mitochondrial biogenesis gene and development of POP in the uterosacral ligaments (UL) of pre-menopausal women. MATERIALS AND METHODS: Seventy one pre-menopausal women, all below 52 years of age, were enrolled in this study. UL biopsies were obtained from uterine specimens taken from 33 women with POP (n = 33, study group) and 38 myoma patients without POP (n = 38, control group). Quantitative Real-Time PCR was performed to measure mitochondrial DNA (mtDNA) copy number and mtDNA4977. Western blotting and immunohistochemistry were used to assess the protein expression of PGC-1α, TFAM, NRF-1 and NRF-2. Statistical analysis was performed using SPSS statistical software and the Mann-Whitney U test, and the continuous variables were analyzed using the Student's t-test in demographic data. RESULTS: There were no significant differences in the patient demographics between the two groups (p > 0.05). The mtDNA copy number in the UL of pre-menopausal patients with prolapse was significantly higher than that in the no prolapse group (p = 0.008). There were no significant differences between the mtDNA4977 of the POP and non-POP groups, but a significantly higher expression of PGC-1α in the POP group compared to the non-POP group (1.59 ± 1.30 v.s. 0.66 ± 0.53; p = 0.036). The expression of TFAM in the POP group was higher than in the non-POP group). There was no significant difference in the TFAM(p = 0.377), NRF-1 and NRF-2 expression between the POP and non-POP groups (p = 0.647; p = 0.682). CONCLUSIONS: Changes in the PGC-1α and mtDNA copy number may play a role in the development of Pelvic Organ Prolapse in pre-menopausal patients.

Prenatal Exposure to LPS Alters The Intrarenal RAS in Offspring, Which Is Ameliorated by Adipose Tissue-Derived Mesenchymal Stem Cells.

BACKGROUND: Prenatal lipopolysaccharide (LPS) exposure causes hypertension in rat offspring through an unknown mechanism. Here, we investigated the role of the intrarenal renin-angiotensin system (RAS) in hypertension induced by prenatal LPS exposure and also explored whether adipose tissue-derived mesenchymal stem cells (ADSCs) can ameliorate the effects of prenatal LPS exposure in rat offspring. METHODS: Sixty-four pregnant rats were randomly divided into 4 groups (n = 16 in each), namely, a control group and an LPS group, which were intraperitoneally injected with vehicle and 0.79 mg/kg LPS, respectively, on the 8th, 10th, and 12th days of gestation; an ADSCs group, which was intravenously injected with 1.8 × 107 ADSCs on the 8th, 10th, and 12th days of gestation; and an LPS + ADSCs group, which received a combination of the treatments administered to the LPS and ADSCs groups. RESULTS: Prenatal LPS exposure increased blood pressure, Ang II expression, Ang II-positive, monocyte and lymphocyte, apoptotic cells in the kidney, and induced renal histological changes in offspring; however, the LPS and control groups did not differ significantly with respect to plasma renin activity levels, Ang II levels, or renal function. ADSCs treatment attenuated the blood pressure and also ameliorated the other effects of LPS-treated adult offspring. CONCLUSIONS: Prenatal exposure to LPS activates the intrarenal RAS but not the circulating RAS and thus induces increases in blood pressure in adult offspring; however, ADSCs treatment attenuates the blood pressure increases resulting from LPS exposure and also ameliorates the other phenotypic changes induced by LPS treatment by inhibiting intrarenal RAS activation.

Changes in mitochondrial DNA copy number and extracellular matrix (ECM) proteins in the uterosacral ligaments of premenopausal women with pelvic organ prolapse.

OBJECTIVE: The study aimed to explore the changes in mitochondrial DNA (mtDNA) copy number, collagen, and matrix metalloproteinase (MMPs) expression with pelvic organ prolapse (POP) in the uterosacral ligaments of premenopausal women. MATERIALS AND METHODS: A group of 56 premenopausal women, all younger than 52 years of age, were enrolled in this study. Uterosacral ligament (UL) biopsies were obtained from uterine specimens taken from 22 women with POP (n = 22, study group) and 34 myoma patients without POP (n = 34, control group) during abdominal or vaginal hysterectomy. Quantitative real-time polymerase chain reaction (Q-PCR) and immunohistochemistry analysis were applied in the present study. RESULTS: The rate of high body mass index (BMI) (> 24 kg/m(2)) women was significantly higher in the POP group (81.8% vs. 35.3%, p = 0.001 *), and the BMI of the POP women was higher than that of the nonPOP women (p = 0.029 *). The mtDNA copy number (p = 0.001 *), collagen III alpha 1 (COL3α1) expression (p = 0.025 *), and MMP2 expression (p = 0.047 *) were significantly higher in the POP group when compared with the nonPOP group. The high BMI women had a higher mtDNA copy number (p = 0.002 *), COL3α1 (p = 0.028 *) gene expressions compared with the standard BMI women. CONCLUSION: In the premenopausal state, higher BMI may be a stronger associate factor than vaginal birth for the development of POP. The higher mtDNA copy number, COL3α1, and MMP2 gene expressions are highly associated with POP in the UL of premenopausal women.

Is single incision midurethral sling effective in patients with low maximal urethral closure pressure?

OBJECTIVE: To ascertain whether low preoperational maximal urethral closure pressure (MUCP) affects the outcomes of single incision sling (SIS) procedures and changes MUCP values postsurgery. MATERIAL AND METHODS: There were 112 (MUCP ≥ 40 cmH2O, n = 88; MUCP < 40 cmH2O, n = 24) consecutive women with urodynamic stress incontinence who had undergone SIS (MiniArc) procedures included in this study. The threshold of 40 cmH2O was used since it has been shown to be a significant risk factor for failed incontinence surgery. Clinical outcomes were assessed by the cough stress test, the 1-hour pad test, the Incontinence Impact Questionnaire-Short Form, the Urogenital Distress Inventory six-item questionnaire, the Sexual Questionnaire-SF, and postoperative changes in the urodynamic parameters. A comparison of the 1-year follow-up data is presented. RESULTS: Three months postsurgery, a significant decrease was observed in the 1-hour pad test, from 20.6 g preoperatively to 0.73 g postoperatively (p < 0.001). The objective cure rate was 82.1% without any significant differences between the two groups (p = 0.202). At 3 months and 1 year after surgery, significantly decreasing Urogenital Distress Inventory six-item questionnaire and Incontinence Impact Questionnaire-Short Form, and increasing Sexual Questionnaire-SF scores were observed in both groups, without any significant differences between the two groups. No statistically significant difference in the subjective cured rate was noted between the two groups at the 3-month and 18.4 month follow-ups. The postoperative MUCP was significantly decreased in the MUCP ≥ 40 group (p < 0.05) while significantly increased in the MUCP < 40 group (p = 0.006). CONCLUSIONS: These results suggest that SIS is a safe and highly effective treatment for urodynamic stress incontinence even in women with low MUCP at a mean follow-up of 18.4 months. Evaluation of the outcomes with more subjects after a longer follow-up period is necessary.

A life-threatening hematoma after the single-incision sling MiniArc procedure: a case report.

The newer generation of single-incision slings such as the MiniArc may minimize these risks by avoiding the passage of needles through the obturator foramen and muscles. However, they may still lead to severe vascular injuries. We report a case of a life-threatening obturator hematoma forming after a MiniArc procedure. We determined the exact location using a computed tomographic scan of the pelvis, and it was surgically managed. The patient's symptoms subsided, and her vital signs stabilized after the hematoma was removed using a transvaginal approach. Single-incision slings may be associated with life-threatening vascular complications.

A comparative study of a single-incision sling and a transobturator sling: clinical efficacy and urodynamic changes.

INTRODUCTION: In this retrospective study, a comparison is made of the clinical efficacy of two stress urinary incontinence treatment apparatuses, a single-incision sling and a transobturator sling. METHODS: Eighty-five (single-incision n=43, transobturator n=42) consecutive patients were included in this study. Clinical outcomes were assessed by the cough stress test (CST), the pad test, the Impact Questionnaire-Short Form (IIQ-7), the Urogenital Distress Inventory six-item questionnaire (UDI-6), the Sexual Questionnaire-SF (PIS-Q), the pain score, and the postoperative changes in urodynamic parameters. A comparison of the 1-year follow-up data is presented. RESULTS: Three months post-surgery, 81.8% of the single-incision sling group and 74.4% of the transobturator sling group had a negative cough test and a dry pad test. One year after surgery, significantly decreasing UDI-6, IIQ-7, and increasing PIS-Q scores were observed in both groups, while the complication rates remained similar. Postoperatively, the single-incision sling group seems to show a greater improvement in UDI-6 score, require less operation time, and experience less blood loss, less postoperative pain, and a smaller decrease in maximal urethral closure pressure (MUCP). CONCLUSIONS: These results suggest that the single-incision sling and the transobturator sling are equally as effective and safe for the treatment of stress incontinence, as evaluated during the 1-year follow-up. The insertion of a single-incision sling seems to be less painful than that of a conventional sling. One year after surgery, the MUCP and mean flow rate of the transobturator sling group had significantly decreased compared with that of the single-incision sling group.

Sustained release of transgenic human factor IX: preparation, characterization, and in vivo efficacy.

The current regimen of factor IX (FIX) injection is of an episodic format, which leads to limited efficacy. A sustained release dosage form is beneficial in terms of reducing the injection frequency and improving the therapeutic effectiveness. The aim of this study was to formulate a new microsphere form of a FIX-containing preparation to diminish these shortcomings. Using the water-in-oil-in-water (W/O/W) double emulsion technique, injectable long-acting FIX microspheres were prepared with transgenic recombinant human FIX (rhFIX) and poly(lactic-co-glycolic acid) (PLGA) polymer. The rhFIX microspheres prepared had diameters ranging between 25-350 µm and easily passed through a small-gauge-number needle for subcutaneous injection. In in vitro release testing, the microspheres had a sustained release profile featuring an initial burst and sustained release spanning a 5-day period. In in vivo pharmacodynamic testing, normalization of the bleeding of hemophilic mice was maintained for 5 days with microsphere injection as compared with 2 days with native rhFIX. Taken together, these results indicated that long-acting FIX microspheres were successfully prepared for potential use in hemophilic prophylaxis.

Is transobturator suburethral sling effective for treating female urodynamic stress incontinence with low maximal urethral closure pressure?

OBJECTIVE: To assess retrospectively the efficacy and safety of MONARC (American Medical Systems) transobturator suburethral slings in the treatment of female urodynamic stress incontinence with and without low maximal urethral closure pressure (MUCP). MATERIALS AND METHODS: Seventy-three women with urodynamic stress incontinence, fitted with the transobturator suburethral sling at a medical center in central Taiwan, participated in the study. Objective postoperative evaluations, including a 1-hour pad test, cough stress test, uroflowmetry, and residual urine volume, were conducted 6 months after operation. Subjective outcomes were evaluated by telephone interview. Charts were reviewed for perioperative complications, urinary retention, and requirements for postoperative medication for symptoms of urgency. The mean follow-up was 48 months. RESULTS: Objective cure rate was 80.8% (dry pad test and negative stress test), 82.4% for MUCP less than 30cmH(2)O, and 80.4% for MUCP greater than 30cmH(2)O (p=1.000). Mean pad weight gain changed from 25.8g preoperatively to 1.8g postoperatively (p<0.05). There was no significant change in urinary flow rate or residual volume. Subjectively, 98.6% of subjects experienced complete improvement; only one patient found no improvement. Very few perioperative complications occurred. Immediate postoperative difficulty in voiding occurred in 6.8% of patients. Postoperative de novo urgency was 2.7%. CONCLUSIONS: The MONARC transobturator suburethral sling is a safe and highly effective treatment for stress urinary incontinence even in women with low MUCP at a mean follow-up of 48 months. Evaluation of the outcomes after a longer follow-up period is necessary.

Optimal duration of urinary catheterization after anterior colporrhaphy.

INTRODUCTION AND HYPOTHESIS: The optimal duration of urethral catheterization during and after pelvic reconstructive surgery is not established. This study investigated the optimal duration of urinary catheterization in patients undergoing anterior vaginal repair with or without other vaginal surgeries. METHODS: A total of 90 patients were included from April 2007 to March 2008. They were randomly divided into 2, 3, and 4 days urinary catheterization groups based on the color of the questionnaire papers they blindly chose. After catheter removal, the amount of post-void residual urine was used to measure the efficacy of bladder emptying. Differences between groups were determined using Chi-square test, Fisher's exact test, or Kruskal-Wallis test, as appropriate. RESULTS: No significant differences were found in the amount of post-void residual urine between the three catheterization groups. CONCLUSIONS: Our findings suggest that the duration of urethral catheterization after anterior colporrhaphy need not exceed 2 days.

Low copy number and high 4977 deletion of mitochondrial DNA in uterosacral ligaments are associated with pelvic organ prolapse progression.

INTRODUCTION AND HYPOTHESIS: The pathophysiology of pelvic organ prolapse (POP) is related to aging in the pelvic organ support, and mitochondrial dysfunction is one of the major contributors to aging. Therefore, the objective of this study was to investigate the correlation between alternations of mitochondrial DNA and progression of POP. METHODS: Polymerase chain reaction (PCR) was applied in the present study. Uterosacral ligaments (UL) were obtained from 45 POP patients and 38 myoma patients without POP. Chi-square test, Student's t-test, Mann-Whitney U test, and Spearman correlation analysis were applied in the comparison between POP and non-POP patients. RESULTS: The results revealed that significant depletion of mitochondrial DNA (mtDNA) and an increase in the incidence of 4977 deletion of mtDNA (mtDNA(4977)) in the UL tissue of POP patients. CONCLUSIONS: The alternations of mtDNA may play an important role in the molecular pathogenesis and process of POP formation.

Comparison of suprapubic versus transobturator surgical treatments of female stress urinary incontinence.

OBJECTIVE: The aim of this study was to retrospectively compare surgical outcomes of the suprapubic arc sling (SPARC) and transobturator suburethral tape (MONARC) for treatment of stress urinary incontinence (SUI) in women. MATERIALS AND METHODS: A total of 74 women treated for SUI using MONARC were compared with 32 treated using SPARC. Postoperative evaluations were conducted at 3-6 months, including 1-hour pad test, cough stress test, uroflowmetry and residual urine volume. Subjective outcomes were evaluated using telephone interviews. Perioperative complications were investigated from chart records. RESULTS: No significant difference was found between the SPARC and MONARC treatment groups in terms of the objective cure rate at 3 months postoperatively (90.6% vs. 80.6%; p = 0.258). However, a significant difference was found between the subjective cure rates of the SPARC and MONARC groups (77.4% vs. 97.3%; p < 0.05). CONCLUSION: Both MONARC and SPARC are safe and effective for surgical treatment of SUI.

Duloxetine versus placebo for the treatment of women with stress predominant urinary incontinence in Taiwan: a double-blind, randomized, placebo-controlled trial.

BACKGROUND: This manuscript compares the efficacy and safety of duloxetine with placebo in Taiwanese women with SUI. METHODS: Taiwanese women with SUI were were randomly assigned to placebo (n = 61) or duloxetine 80 mg/day (n = 60) in this double-blind, 8-week, placebo-controlled study. Outcome variables included: incontinence episode frequency (IEF), Incontinence Quality of Life questionnaire (I-QOL) scores, and Patient Global Impression of Improvement rating (PGI-I). RESULTS: Decrease in IEF was significantly greater in duloxetine-treated than placebo-treated women (69.98% vs 42.56%, P < .001). No treatment differences in I-QOL scores were significant. There were significant differences in PGI-I rating. Treatment-emergent adverse events (TEAEs) were experienced by more duloxetine-treated than placebo-treated women (80.0% vs 44.3%; P < .001). Discontinuations due to adverse events were significantly greater for duloxetine-treated than placebo-treated women (26.7% vs 6.6%; P = .003). CONCLUSION: Data provide evidence for the safety and efficacy of duloxetine for the treatment for Taiwanese women with SUI. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00475358.

Obturator hematoma after the transobturator suburethral tape procedure.

BACKGROUND: Herein we report a case of obturator hematoma formation which occurred during our 25th case involving the transobturator suburethral tape procedure with the inside-to-out approach. CASE: A case of an obturator hematoma forming after a transobturator suburethral tape procedure is reported. The patient did not become infected and was managed conservatively. The hematoma spontaneously resorbed after 11 weeks and the patient was cured of her incontinence. CONCLUSION: The transobturator approach for suburethral tape placement may be associated with vascular complications.

Urgency is the core symptom of female overactive bladder syndrome, as demonstrated by a statistical analysis.

PURPOSE: We determined overactive bladder symptoms in combination with other lower urinary tract symptoms and illustrated their relationships using a statistical analysis. Furthermore, we also describe the potential contributory factors and adaptation strategies in patients that are associated with overactive bladder subtypes. MATERIALS AND METHODS: A total of 1,930 women with a mean age +/- SD of 46 +/- 15 years (range 15 to 91) with troubling lower urinary tract symptoms were successfully interviewed with a validated questionnaire at the urology and urogynecology clinics at 14 medical centers in Taiwan. The questionnaire was constructed to evaluate 6 lower urinary tract symptoms and 7 adaptation strategies. A log linear statistical model and multiple logistic regression analysis were used to assess the associations among lower urinary tract symptoms and the potential overactive bladder contributory factors, respectively. RESULTS: No single or isolated symptom presented in patients with overactive bladder. Most patients reported a combination with other lower urinary tract symptoms. These female patients can be categorized into 3 groups, including 1 is associated with dry symptoms (urgency, frequency and nocturia), 1 associated with wet symptoms (urgency, urge incontinence and mixed stress incontinence) and a small group that may have overactive bladder symptoms combined with voiding difficulty symptoms. in contrast to patients with dry overactive bladder (urgency associated with frequency and/or nocturia without urge incontinence), after multiple logistic regression analysis patients with wet overactive bladder (urgency with urge incontinence) had a greater average age and higher body mass index, and made more adaptation efforts (p <0.05). CONCLUSIONS: We used statistical analysis to determine and suggest that urgency is the core symptom of female overactive bladder syndrome and there are 3 distinctive overactive bladder subtypes, which differ in their symptom combinations. Different symptom combinations and patient characteristics affect female adaptation to overactive bladder syndrome.