European Urogynaecological Association Position Statement: The role of urodynamics in stress urinary incontinence evaluation and treatment decision.

Stress urinary incontinence (SUI) is defined as a condition characterized by the involuntary leakage of urine during activities that increase intra-abdominal pressure which may decrease quality of life with a significant economic impact on health systems, necessitating the implementation of cost-effective management plans. Urodynamics (UDS) has been considered during the last decades as the gold standard for assessment of lower urinary tract symptoms (LUTS) due to their high reproducibility. At the same time, concerns about the systematic use of UDS before SUI surgery were raised due to a limited evidenced base to recommend their routine use. In uncomplicated female patients with SUI, UDS can offer further insights into LUTS, potentially assisting the physician in determining the appropriate therapeutic approach. However, it has not been shown that preoperative UDS can directly impact the surgical outcome for continence. Indeed, evidence supports the conclusion that pre-operative UDS in women with uncomplicated, clinically demonstrable, SUI does not improve the outcome of surgery for SUI. Nevertheless, asymptomatic detrusor overactivity (DO) identified by urodynamic testing or pre-existing voiding dysfunction are associated with an increased occurrence of postoperative overactive bladder (OAB) and voiding dysfunction, respectively. The EUGA Working Group concluded that the evidence does not support the systematic preoperative use of UDS for uncomplicated cases. However, in cases where mixed symptoms, voiding dysfunction, previous surgery, or concomitant prolapse are present, preoperative UDS are advised as they can be beneficial in anticipating postoperative outcomes. This aids in conducting comprehensive and thorough preoperative counseling. The Group recommend performing preoperative UDS considering the patient's specific clinical situation and the surgeon's judgment, with consideration given to the potential benefits, risks, and impact on treatment decisions and patient outcomes.

Pre- versus Post-Menopausal Onset of Overactive Bladder and the Response to Vaginal Estrogen Therapy: A Prospective Study.

Background and Objectives: This study examined the utility of local estrogen therapy for improving urinary symptoms in women diagnosed with Overactive Bladder allied to the time of onset of urinary symptoms whether pre- or post-menopausal. Materials and Methods: Subject to informed consent, menopausal women diagnosed with Overactive Bladder (OAB) and Genitourinary Syndrome of Menopause (GSM) were enrolled at three urogynecological units. OAB symptoms were scored using the Global Pelvic Floor Symptoms Bother Questionnaire (GPFSBQ), with explicit attention to question number 3 that specifically addresses the presence or absence of urgency and the Patient Perception of Intensity of Urgency Scale (PPIUS). The Vaginal Health Index (VHI) was used to assess the vaginal mucosa trophism. Exclusion criteria included: Pelvic organ prolapse (POP) ≥ stage II, urinary tract infection or disease, diabetes, inflammatory diseases, use of diuretics, alcohol or drug addictions, neurological and/or psychiatric disorders, and other precluding conditions. Women were treated with local estrogens for 3 months and re-evaluated. Results: Forty-three post-menopausal women were enrolled. Of these, ten women developed OAB symptoms before menopause (Group I) and 33 developed symptoms after menopause (Group II). Following local estrogen therapy, based on the Global Pelvic Floor Symptoms Bother Questionnaire, improvement of OAB symptoms was reported by 20% of patients in Group I (p = 0.414) and 64% of patients in Group II, (p = 0.002). Based on the PPIUS scale, diminution in urinary urgency was experienced by 20% of patients in Group I (p = 0.68) and 66% of patients in Group II (p = 0.036). Improved VHI scores were graded statisticaly significant in both groups (Group I in 100% of women, p = 0.005 vs. 76% in Group II, p = 0.004). Conclusions: Our results indicate that local estrogen therapy is more effective in women who develop OAB after menopause.

Anterior/Apical single incision mesh (Elevate™): Surgical experience, anatomical and functional results, and long-term complications.

OBJECTIVE: Pelvic organ prolapse is a common condition among post-menopausal women, and surgery is often the standard treatment proposed. Native tissue vaginal surgery is burdened by a high rate of recurrence, and mesh vaginal surgery has become current practice. The purpose of this study was to evaluate the safety and the effectiveness of the vaginal kit Anterior/Apical single incision mesh Elevate™ for the correction of anterior and apical compartment prolapse. STUDY DESIGN: Data of patients with symptomatic anterior vaginal prolapse stage ≥ II, receiving mesh repair with the Anterior/Apical Elevate single incision system between January 2010 and January 2015 were retrieved. Prolapse was classified according to the POP-Q system. The main outcome measure was anatomical success, while subjective and safety outcomes were secondary outcomes. RESULTS: Anatomical success rate was 87.2 % for anterior compartment prolapse and 84.6 % for combined anterior and apical prolapse, while overall functional success rate was 96.2 % after a median follow-up of 33.6 months. The most frequent short-term complications were urinary bladder injury (3.0 %) and transient urinary retention (6.9 %). The most common long-term complications were de novo or persistent symptomatic stress urinary incontinence (10.8 %) and vaginal mesh extrusion (3.8 %). CONCLUSION: Mesh vaginal surgery with Anterior/Apical single incision mesh Elevate™ is a well-tolerated procedure with a very high anatomical and functional success rate. Short and long-term complications rate seem to be acceptable, and in most of cases, solvable. Further studies are needed to confirm our promising data.

When love hurts. A systematic review on the effects of surgical and pharmacological treatments for endometriosis on female sexual functioning.

INTRODUCTION: Endometriosis is associated with an increased risk of dyspareunia, therefore this chronic gynecologic disease should be considered as a major cause of sexual dysfunctions. The aims of this study were to review the literature on the effects of surgical and pharmacological treatments for endometriosis on female sexual functioning, and to provide suggestions for future treatment strategies. MATERIAL AND METHODS: We followed the PRISMA guidelines to conduct this systematic review, which involved an electronic database search of studies on the association between endometriosis and sexuality published between 2000 and 2016. RESULTS: As a result of the screening process, 22 studies were included in this systematic review. The 22 studies included were divided into two categories: (a) surgical intervention studies (n = 17), examining postoperative sexual outcomes of surgery for endometriosis; (b) pharmacological intervention studies (n = 5), evaluating the effects of pharmacological endometriosis treatments on sexual functioning. The studies considered showed that overall surgical and pharmacological interventions for endometriosis can lead to medium-/long-term improvement, but not necessarily to a definitive resolution of female sexual dysfunctions due to endometriosis. CONCLUSIONS: Sexual functioning is a multidimensional phenomenon and the ideal treatment for endometriosis-related sexual dysfunctions should be conducted by a multidisciplinary team that involves not only gynecologists, but also sexologists and psychologists/psychotherapists. Improving global sexual functioning, and not just reducing pain at intercourse, should be considered as a major clinical goal of endometriosis treatment.

"The first cut is the deepest": a psychological, sexological and gynecological perspective on female genital cosmetic surgery.

In recent years increased numbers of healthy women and girls have been seeking female genital cosmetic surgery for esthetic reasons and/or to enhance sexual functioning. This phenomenon is associated with the development of a new vulvovaginal standard due to Internet pornography and the increased exposure of female genitalia. This strict standard may negatively affect women's psychological health and cause increased insecurity, which may drive even teenagers to seek female genital cosmetic surgery. Psychological counseling is recommended to inform women that surgery is not a definitive solution to treat psychologically based pain or dysfunction. Moreover, there is no robust evidence supporting the effectiveness of female genital cosmetic surgery, especially regarding sexual enhancement, as underlined by major scientific societies. The importance of a definite regulation of female genital cosmetic surgery should be emphasized and be based on an ethically oriented, multidisciplinary model aimed at providing exhaustive information on all gynecological, sexological, and psychological concerns raised by this type of surgery.

Urethral bulking agents versus other surgical procedures for the treatment of female stress urinary incontinence: a systematic review and meta-analysis.

Bulking agents provide an alternative option in the management of women with stress urinary incontinence and they seem to have an important role in the management flow chart of SUI. However, evidence on this issue is scanty. The most important aspect is to understand whether bulking agents are comparable with the other first-line anti-incontinence surgical procedure (MUS, Burch colposuspension and pubovaginal slings). Hence, the primary aim of the current review was to assess the objective and subjective outcomes of bulking agents in comparison with the other surgical procedures for the treatment of SUI. PubMed and Medline were systematically searched and we included studies evaluating the use of bulking agents in comparison with other surgical approaches for either primary or recurrent treatment of female SUI. Three studies meeting the inclusion criteria were identified. Two of these studies were RCTs evaluating the use of bulking agents versus other surgical procedures for the treatment of primary female SUI; the remnant article was a retrospective cohort study that compared the effectiveness and safety of repeat midurethral sling with urethral bulking after failed midurethral sling. The combined results of all analyses showed that the objective recurrence rate of peri- or trans-urethral injections is significantly higher in comparison with the other surgical procedures. Similar findings were observed when considering separately the treatment for primary or recurrent SUI. Furthermore, lower subjective recurrence rate was observed among patients undergoing other surgical treatment in comparison with those undergoing bulking agents; however, this trend was not statistically significant. Moreover, patients undergoing injection of bulking agents experienced a lower rate of voiding dysfunctions in comparison to the control group. According to current evidence, bulking agents should not be proposed as first-line treatment in those women seeking permanent cure for both primary and recurrent SUI. However, the effectiveness of a procedure should be balanced with its invasiveness and patients' expectations. Bulking agents are a minimally invasive approach to treat SUI and their use should be considered as an alternative strategy particularly in special conditions: patients who are fragile, in those who do not wish to have surgery, or in whom surgical options are restricted (postoperatively, after irradiation).

Role of urodynamics before prolapse surgery.

The role of urodynamic studies (UDS) before prolapse surgery is contentious and a hotly debated topic in urogynaecology. Previous studies in women with prolapse and women with uncomplicated stress urinary incontinence (SUI) have focused on women without preoperative incontinence. Currently, it has not been possible to reach a universal consensus on the role of UDS before prolapse surgery in women with concomitant symptomatic or occult SUI. It is clear that UDS could add some information in women undergoing pelvic organ prolapse surgery and could facilitate counselling of patients. However, there is no evidence that the outcome of surgery is altered by prior UDS. New well-designed randomized studies are necessary to improve our understanding of this topic.

Acute post-partum urinary retention: analysis of risk factors, a case-control study.

PURPOSE: The aim of this retrospective case-control study was to assess clinical factors that can predict the occurrence of post-partum urinary retention (PPUR) and evaluate their influence as independent risk factors. METHODS: Between January 2008 and December 2010, 11,108 vaginal deliveries were performed. 105 women who suffered from PPUR were detected by retrospective data analysis. PPUR was defined as the inability to have spontaneous micturition within 6 h after vaginal delivery. RESULTS: Data analysis detected six risk factors for PPUR on-set: primiparity, vacuum-assisted delivery, uterine fundal pressure during the second stage of labor (Kristeller's maneuver), a longer second stage of labor, medio-lateral episiotomy, initial higher dose of epidural analgesia. Nevertheless, logistic regression showed that only vacuum-assisted delivery and Kristeller's maneuver were significant independent risk factors (P = 0.001 and 0.009, respectively). CONCLUSIONS: Our study identified these risk factors as the cause of mechanical and neurological damage, which can lead to post-partum urinary retention. By early diagnosis, a prompt and appropriate management of PPUR can be established in order to assure a rapid return to normal bladder function after vaginal delivery.

Single incision mid-urethral slings: impact of obesity on outcomes.

OBJECTIVES: To assess the potential impact of obesity on the success rate of single incision slings (SIS). STUDY DESIGN: This was a retrospective cohort study of women who underwent the SIS procedure for primary stress urinary incontinence. Women were divided into three different groups by body mass index (BMI) according to the WHO classification. The International Consultation on Incontinence-short form (ICIQ-SF), Women Irritative Prostate Symptoms Score (W-IPSS), Patient Global Impression of Severity (PGI-S) and Patient Global Impression of Improvement (PGI-I) questionnaires were used. Objective and subjective outcomes were the primary outcome measures of the study. SPSS software was used for data analysis. RESULTS: 206 patients who underwent the SIS procedure were reviewed. At 1 year follow-up there were 196 women available for the analysis: 69 were normal weight subjects, 91 overweight and 36 obese. Patients in all BMI groups reported a significant improvement in their condition. Nevertheless there was a trend towards lesser objective efficacy of SIS with increasing body weight, with a significant difference between obese women and normal subjects: 75% vs 91.3%, p=0.049; OR 3.74 (95% CI 1.19-11.76). Analysis of the ICIQ-SF and PGI-I showed significant lower mean ± SD improvement in obese women when compared with their normal or overweight counterparts, together with a significantly lower number of obese patients reporting themselves as very much improved or much improved. CONCLUSIONS: Single incision slings seem to be an effective treatment regardless of BMI, but obese women had nearly 4 times the odds of objective failure as compared to normal weight women.

Type I collagen and matrix metalloproteinase 1, 3 and 9 gene polymorphisms in the predisposition to pelvic organ prolapse.

AIM: To evaluate whether the presence of specific polymorphism in the gene promoter of collagen and some matrix metalloproteinases was associated with the risk of developing pelvic organ prolapse. METHODS: A case-control study was carried on 233 women: 137 were cases with ≥ stage II pelvic organ prolapse and 96 were matched controls without pelvic pathologies. Allele and genotype frequencies related to polymorphisms at the Sp1 site of type I collagen and some functional polymorphisms in the promoters of metalloproteinases-1, -3 and -9 have been compared between groups. It has been shown that these single-insertions/deletions polymorphisms located in the promoter region of the genes have a functional significance in the regulation of their transcriptional level and local expression. Genotypes were determined by polymerase chain reaction (PCR) amplification and sequence analysis. SPSS 14.0 software was used for data analysis. Probability values of <0.05 were considered statistically significant. RESULTS: No difference between groups was found in the genotype distribution polymorphisms for COL1A1, metalloproteinases-9 and -3, while the distribution of the polymorphism of metalloproteinases-1 was significantly increased in the cases when compared with controls (p = 0.04). CONCLUSIONS: Our findings suggest that the polymorphism of metalloproteinases-1 might have a role in mediating susceptibility to pelvic organ prolapse.

Short-term outcomes with the Ajust™ system: a new single incision sling for the treatment of stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: To evaluate the efficacy and safety of the minimally invasive Ajust™ system in the treatment of stress urinary incontinence. METHODS: This was a prospective multicentre study. All patients with primary urodynamic stress urinary incontinence were prospectively selected to receive the Ajust™ procedure. The International Consultation on Incontinence-Short Form (ICI-SF), Women Irritative Prostate Symptoms Score (W-IPSS), PGI-S, and PGI-I questionnaires were used to evaluate the impact of incontinence and voiding dysfunction on QoL and to measure patient's perception of incontinence severity and improvement. RESULTS: From January 2009 to October 2009, 111 consecutive subjects were enrolled in the study. At 6 months, 102 were available for outcomes analysis. The subjective and objective cure rates were 85.7% and 91.4%, respectively. The ICI-SF and W-IPSS questionnaires showed a statistical significant improvement in symptom scores. CONCLUSIONS: In the short-term follow-up, the Ajust™ system was effective in restoring continence in more than 85% of subjects with a highly significant improvement in QoL.

TVT-secur: a minimally invasive procedure for the treatment of primary stress urinary incontinence. One year data from a multi-centre prospective trial.

The objective of this study is to evaluate the efficacy and morbidity of the new minimally invasive TVT-secur procedure. This was a prospective multi-centre trial. All patients with primary urodynamic stress urinary incontinence were prospectively selected to receive the TVT-secur procedure. The International Consultation on Incontinence-Short Form (ICIQ-SF), Women Irritative Prostate Symptoms Score (W-IPSS), Patient Global Impression of Severity (PGI-S) and Patient Global Impression of Improvement (PGI-I) questionnaires were used to evaluate the impact of incontinence and voiding dysfunction on quality of life (QoL) and to measure patient's perception of incontinence severity and improvement. The SPSS software was used for data analysis. From November 2006 to September 2007, 95 consecutive patients were enrolled in the study. At 1 year, 91 patients were available for the analysis. The subjective and objective cure rates were 78% and 81%, respectively. The ICIQ-SF and W-IPSS symptoms score showed a statistically significant decrease. Post-operative complications included voiding difficulty, recurrent UTI, de novo urgency incontinence and dyspareunia. Our data show that TVT-secur is associated with an 80% success rate at 1 year.

Number of daytime micturitions and volume voided per micturition in the evaluation of efficacy of drugs for overactive bladder: findings from randomized clinical trials.

OBJECTIVE: To analyze the relationship between mean volume voided per micturition and number of daytime micturitions. METHODS: We reviewed data from randomized clinical trials on the medical treatment of overactive bladder published in the international literature between 1997 and 2004. Fourteen studies including data on these two parameters were identified. RESULTS: Six studies compared tolterodine with placebo, two tolterodine and oxybutynin with placebo, two tolterodine with oxybutynin, two solifenacin and tolterodine with placebo, one oxybutynin CR with oxybutynin IR, and one different doses of solifenacin. The correlation between the percent change in the mean voided volume and in the number of daytime micturitions was assessed using the Spearman rank correlation coefficient (r), with r=-0.67 for all the studies. For groups of patients treated with each drug, we found r=-0.09 for oxybutynin, r=-0.59 for tolterodine, r=-0.85 for solifenacin, and r=-0.34 for placebo. CONCLUSION: The results of this analysis suggest that in the evaluation of the efficacy of a drug for overactive bladder, the mean volume voided per micturition may be a useful measure of efficacy.

Peri-operative morbidity and early results of a randomised trial comparing TVT and TVT-O.

The aim of this study was to compare the morbidity and short-term efficacy of retro-pubic (TVT) and inside-out trans-obturator (TVT-O) sub-urethral sling in the treatment of stress urinary incontinence. This was a prospective multi-centre randomised trial; 231 women with primary stress urinary incontinence were randomised to TVT (114) or TVT-O (117). The International Consultation on Incontinence-Short Form (ICIQ-SF), Women Irritative Prostate Symptoms Score (W-IPSS) and Patient Global Impression of Severity (PGI-S) questionnaires were used to evaluate the impact of incontinence and voiding dysfunction on QoL and to measure the patient's perception of incontinence severity. The primary and secondary outcome measures were rates of success and complications. The SPSS software was used for data analysis. The TVT-O procedure was associated with significantly shorter operation time and with a more extensive use of general anaesthesia when compared with TVT. There were 5 (4%) bladder perforations in the TVT group compared with none in the TVT-O group. Rates of early post-operative urinary retention and voiding difficulty were similar for both groups and no difference was found in the average hospital stay. Six patients (5%) in the TVT-O group complained of thigh pain in the post-operative course. The median follow-up time was 6 months. Two hundred eighteen patients were available for the analysis of outcomes. Subjective and objective cure rates were 92% and 92% in the TVT group and 87% and 89% in the TVT-O group. The ICIQ-SF questionnaire symptoms score showed a highly statistical decrease in both groups, the W-IPSS on the contrary was unchanged. Our data show that both procedures were equally effective in the short-term for the treatment of stress urinary incontinence with a highly significant improvement in incontinence-related QoL.

Tension-free vaginal tape: analysis of risk factors for failures.

To investigate whether there are any demographic, clinical, or urodynamic variables associated with an increased risk of failure in women undergoing surgery with tension-free vaginal tape (TVT). We retrospectively analysed 325 consecutive patients who had been operated with the TVT procedure. Patients were assessed with a complete history, physical examination, and urodynamic testing. The operation was done under local or epidural anesthesia and any further surgical procedure was added as indicated. The postoperative evaluation included collection of data on intra- and postoperative complications and analysis of outcomes. The outcome of surgical treatment was evaluated subjectively and objectively. The Statistical Package for Social Sciences (SPSS, Chicago, Illinois, USA) was used for data analysis; P<0.05 was considered significant. The overall complication rate was 14%, voiding dysfunction being the most common. Three hundred and one women were available for the analysis of surgical outcome and the mean follow-up was 34+12 months (median 32 months). Subjectively, 269 women (89%) were cured by the procedure and 13 (4.3%) reported marked improvement. An objective cure was achieved in 263 (87%); 38 patients still having leakage while coughing during postoperative cystometry. Among the numerous presumed risk factors for failed antiincontinence surgery only urethral hypomobility and recurrent stress urinary incontinence were significantly associated with failure of the TVT procedure in our study. However, even in these complicated situations, the cure rate was more than 70%.

Porcine skin collagen implants to prevent anterior vaginal wall prolapse recurrence: a multicenter, randomized study.

PURPOSE: We evaluated the efficacy of the Pelvicol porcine collagen implant for preventing recurrent anterior vaginal wall prolapse in women undergoing primary surgery for pelvic organ prolapse. MATERIALS AND METHODS: This was a prospective, randomized, multicenter trial in 206 women with stage II or greater anterior vaginal wall prolapse (point Ba -1 or greater) according to the pelvic organ prolapse quantification system. The patients were randomly assigned to undergo anterior vaginal repair or the same procedure with Pelvicol implant reinforcement. SPSS software was used for data analysis. RESULTS: A total of 201 women were available for surgical outcome analysis, including 98 and 103 in the implant and no implant groups, respectively. All completed the 1-year followup visit. Most women were satisfied with the postoperative condition with a significant decrease in the visual analog scale score in each group (p <0.001). Anatomical anterior recurrence (point Ba greater than -1) was observed in 7 women (7%) in the implant group and in 20 (19%) in the other groups (OR 3.13, 95% CI 1.26-7.78, p = 0.019). Additionally, there were 11 women (3 and 8, respectively, or 5%) with posterior recurrence and 6 (3 per group or 3%) with unsatisfactory results at the upper vaginal segment. One patient who received a porcine implant had vaginal extrusion of the mesh 1 month after surgery. CONCLUSIONS: Our data show that the Pelvicol implant can be easily and readily used to augment and reinforce anterior colporrhaphy. The prolapse recurrence rate was considerably lower in the implant group compared with outcomes in patients treated with simple anterior repair.

Tension-free vaginal tape (TVT) and intravaginal slingplasty (IVS) for stress urinary incontinence: a multicenter randomized trial.

OBJECTIVE: This study was undertaken to compare the efficacy and morbidity of 2 minimally invasive procedures for stress urinary incontinence. STUDY DESIGN: This was a prospective randomized multicenter trial; 190 women with primary urodynamic stress incontinence were randomly assigned to tension-free vaginal tape (TVT) (n = 95) or intravaginal slingplasty (IVS) (n = 95). The primary and secondary outcome measures were rates of success and complications. SPSS software was used for data analysis. RESULTS: At 2 years 92 and 87 patients were available in the TVT and IVS group for outcomes analysis. Subjectively, 80 (87%) and 68 (78%) women were cured, respectively. Objectively, a 1-hour pad test was negative in 78 (85%) and 63 (72%) patients. Eight of the patients assigned to IVS (9%) had vaginal erosion/infection, compared with none in the TVT group (P < .01). CONCLUSION: Both procedures were effective for stress incontinence, but 9% of women treated with the IVS required removal of the tape for erosions.