Anatomical and functional outcomes after hysterectomy and bilateral sacrospinous ligament fixation for stage IV uterovaginal prolapse: a prospective case series.

BACKGROUND: Aim of this study is to examine pelvic floor symptoms, anatomical results and patients' satisfaction after sacrospinous vaginal fixation for stage 4 pelvic organ prolapse. METHODS: All patients with stage 4 pelvic organ prolapse were treated with vaginal hysterectomy, native tissue cystocele and rectocele repair and bilateral sacrospinous vaginal fixation. Anatomical and functional outcomes according to the POPq classification system and the German version of the Australian pelvic floor questionnaire were assessed. Changes between baseline, first follow-up and second follow-up were assessed by the paired Wilcoxon rank test using R, version 3.5.1. RESULTS: 20 patients were included in the study. Scores in all four domains of the pelvic floor symptom questionnaire (bladder, bowel, prolapse, sexual function) were significantly improved at 6 and 12-months follow-up. One patient presented with a symptomatic stage 3 cystocele that needed a second surgical intervention and two patients needed surgery due to a de novo stress urinary incontinence. There were no perioperative adverse events and all patients reported full satisfaction after surgery. CONCLUSIONS: The vaginal approach with hysterectomy, native tissue repair and bilateral sacrospinous vaginal fixation seems to be a safe and effective method for the treatment of advanced stage POP, offering excellent relief in all pelvic floor symptoms. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT02998216 ), December 20th, 2016. Prospectively registered.

Obstetrical and epidemiological factors influence the severity of anal incontinence after obstetric anal sphincter injury.

BACKGROUND: Obstetric anal sphincter injury (OASI) is one of the most severe obstetrical complications. Although risk factors for OASI have been identified, little is known about various parameters that can influence symptoms' severity. The aim of this study is to explore whether obstetrical and epidemiological factors can have an effect on the severity of symptoms after OASI. METHODS: 11.483 deliveries between January 2010 and December 2014 were reviewed, and data from 88 women with OASI are presented. RESULTS: The only statistically significant differences between symptomatic and asymptomatic women were age (p = 0.02), body mass index (p = 0.04) and the use of forceps (p = 0.04). Women with more severe symptoms were more likely to have received oxytocin during the second stage of labor (p = 0.03) and had shorter delivery to follow-up interval (p = 0.008). CONCLUSIONS: Modifiable factors such as use of forceps and oxytocin should be taken into consideration in clinical practice.

Perioperative adverse events associated with pelvic organ prolapse repair by nerve-preserving sacropexy: an analysis of 768 cases over a 10-year period.

OBJECTIVE: To report the perioperative adverse events associated with nerve-preserving sacropexy for pelvic organ prolapse (POP) repair and to identify risk factors that could predict possible adverse events. MATERIALS AND METHODS: A total of 768 women who underwent sacropexy for POP repair performed by one surgeon using the same technique, beyond the learning curve, over a 10-year period, between January 1st 2007 and December 31st 2016. METHODS: The medical records of 768 women were reviewed for age, body mass index (BMI), tobacco use, previous surgeries (for POP and incontinence, abdominal surgeries in general), operating time, duration of hospitalization and perioperative events at time of surgery and 6 weeks postoperatively. Additionally, the complications were classified according to the Clavien-Dindo grading system and the Charlson Age Comorbidity Index (CACI) was evaluated for the patients. RESULTS: Between January 1st 2007 and December 31st 2016, 768 patients underwent sacropexy for POP. 27 (3.5%) adverse events occurred intra- and post-operative within 6 weeks after surgery. In univariate and multivariate analyses, only comorbidity and concomitant posterior colporrhaphy are significantly associated with complications. CONCLUSIONS: Surgeon's experience and a standardized technique minimize the risk of perioperative adverse events. The data on complications we found can be used to guide effective consent.

Management of device-related complications after sacral neuromodulation for lower urinary tract disorders in women: a single center experience.

PURPOSE: This study is aimed at presenting and discussing the device-related complication management during a 5-year period, of the sacral nerve modulation (SNM), in a tertiary-care university unit. METHODS: This is a retrospective chart review of all women, who received SNM in our department between May 2011 and May 2016. All two-stage procedures were performed by the same experienced surgeon and according to our strict protocol of patients' selection and follow-up. Data of perioperative and postoperative complications and their management were collected. RESULTS: The test stimulation was positive in 59 out of 64 patients (92%), who then received the permanent implantation after a mean test phase duration of 9 days. Mean overall follow-up was 16.5 (±10.9) months. We recorded 20 complications (31%) in 15 patients, after a mean follow-up time of 160 days. These comprise: lead migration (13.8%), infection (8.6%), pain (5.2%), wound healing disorders (5.2%) and lead fibrosis (10%). The event/patient ratio was significantly reduced from 0.6 in the beginning of our experience with SNM to 0.2 at the second period of the study (p = 0.005). All complications could be successfully resolved after surgical intervention without influence on the treatment effect. CONCLUSION: Complications after SNM are common and may require additional surgical intervention for full resolution but without affecting the treatment effect. Also, due to a learning curve, a lower events/patient ratio over time is to be expected.

Long-term quality of life, satisfaction, pelvic floor symptoms and regret after colpocleisis.

PURPOSE: The aim of this study is to present long-term results including patients' satisfaction, pelvic floor symptoms, regret and change in body image in a long-term follow-up after colpocleisis. METHODS: All women who underwent colpocleisis between September 2001 and February 2014 were identified from the hospital operating lists. These women were contacted for a telephone survey up to 13 years after surgery and asked to complete a structured questionnaire to assess patients' satisfaction, Quality of Life (QoL) and pelvic floor symptoms. RESULTS: A total of 44 women underwent colpocleisis during the period from September 2001 to February 2014. Mean age was 78 years (range 65-91) years. Mean follow-up time was 41 months (range 10-120). Twenty women could be reached for the survey and were included in the analysis. 15 (75 %) reported a positive impact on QoL, 2 (10 %) a negative because of urinary problems, 2 (10 %) could not report any change in the QoL and 1 (5 %) could not answer this question. There was no recurrence of prolapse. The majority of patients (90 %) would undergo the same surgery again and no patient regretted the loss of her vaginal sexual function. CONCLUSIONS: Colpocleisis seems to be an effective treatment for pelvic organ prolapse. In the long term, impact on quality of life is positive, whilst urinary tract symptoms seem to be the most bothersome factor.

Pelvic Pain of Myofascial Origin in Women: Correlation with Lower Urinary Tract Symptoms.

Introduction: Women with lower urinary tract symptoms (LUTS) and high-tone pelvic floor often experience pain and have positive trigger points upon pelvic floor examination. However, the correlation of these findings has not yet been systematically examined and sufficiently understood. The aim of this cross-sectional study is to examine the correlation of pelvic myofascial pain with LUTS and pelvic floor tone. Materials and Methods: All participants filled a standardized pelvic floor questionnaire to assess LUTS, which consists of a total of 43 questions regarding bladder, bowel, and sexual function as well as prolapse symptoms. Myofascial trigger points in different muscle groups including pubococcygeus, iliococcygeus, and obturator as well as pelvic floor muscle tone were assessed using a standardized digital examination technique. Results: 110 women were included in the study. There was a significant correlation between pain in various muscle groups and LUTS as well as high-tone pelvic floor muscle. A significant correlation could also be found between high pelvic floor muscle tone and the overall questionnaire score (p < 0.001) as well as the bladder function score (p < 0.001) and various pain scores of the different groups. Individuals with high-tone pelvic floor were more likely to have more LUTS and higher pain scores. Conclusions: The existence of myofascial pelvic floor trigger points and high pelvic floor muscle tone seem to be reflective of pelvic floor symptoms, as assessed with a standardized pelvic floor questionnaire.

Pelvic floor muscle tenderness in asymptomatic, nulliparous women: topographical distribution and reliability of a visual analogue scale.

INTRODUCTION AND HYPOTHESIS: Aim of this study is to investigate pelvic floor muscle pain scores in a group of healthy, asymptomatic, nulliparous women using a simple visual analogue scale, and to examine the inter-rater and test-retest reliability of the digital palpation of the pelvic floor muscle. METHODS: Seventeen female volunteers were recruited. Different sites of their pelvic floor muscle were examined digitally according to the suggestions of the International Continence Society from two investigators blinded to the clinical data in two consecutive visits and pain scores were obtained. Level of agreement between investigators, inter-rater and intra-rater reliability were assessed. RESULTS: Overall pain scores were low. There were statistically significant differences between scores at different pelvic sites, with the levator ani showing the lowest scores. Reliability was heterogeneous among pelvic sites, varying from poor to excellent. CONCLUSIONS: Pain upon palpation of the pelvic floor muscle in asymptomatic, nulliparous women should be considered an uncommon finding.

Pelvic pain in urogynecology. Part II: treatment options in patients with lower urinary tract symptoms.

Therapeutic options for chronic pelvic pain in women offer only a limited symptom relief. Especially in the patient with lower urinary tract symptoms (LUTS), where overlap of pain, storage and voiding symptoms is common, data on the efficacy of treatment of pain are limited. We conducted a literature review to detect articles which pertained to female patients with LUTS and pelvic pain and we included articles which evaluated the efficacy of the treatment of pelvic pain. Forty-one articles were detected, which included nerve stimulation (sacral and pudendal), intravesical instillations and injections, oral pharmacological treatments, periurethral injections as well as physical and manual therapy as treatment options. Only five controlled trials were found, which did not show superiority of the active treatment versus placebo. Although some treatment options show promising results in the treatment of pelvic pain in patients with LUTS, more randomised controlled trials are needed to confirm these results.

How does colpocleisis for pelvic organ prolapse in older women affect quality of life, body image, and sexuality? A critical review of the literature.

Colpocleisis is a surgical treatment for pelvic organ prolapse that results in vaginal obliteration. This review aims to systematically evaluate the quality of life, changes in body image, regret, and impact on sexual activity in women after colpocleisis. A review was conducted using the PubMed and Scopus databases with search criteria specifying pelvic organ prolapse, colpocleisis, quality of life, body image, regret, sexuality, and their synonyms. For the selection of the eligible articles, we used the PRISMA reporting system. A total of 1285 articles were found. After removing duplicates and applying the inclusion and exclusion criteria, 30 articles were reviewed in full length. Quality of life after colpocleisis was evaluated in 22 articles, and 20 authors used validated questionnaires. All concluded that quality of life improved after surgical treatment. Twenty-one articles studied regret after obliterative treatment for pelvic organ prolapse. Most of the patients reported no regret. Regret was often due to bowel and bladder symptoms. A few patients reported regret because of loss of coital function. Body image was highlighted in six studies. Three articles assessed body image using the modified Body Image scale. The body image scores demonstrated a significant improvement after surgery. Women tended to remain sexually active and some also regained sexual activities after surgery. Colpocleisis remains a viable option for pelvic organ prolapse, without compromising quality of life, body image, or sexuality, but diligent patient selection is needed. Particular concern should be given to bladder and bowel symptoms since these are the main reason for dissatisfaction after colpocleisis.

Vibrational Spectroscopy in Urine Samples as a Medical Tool: Review and Overview on the Current State-of-the-Art.

Although known since the first half of the twentieth century, the evolution of spectroscopic techniques has undergone a strong acceleration after the 2000s, driven by the successful development of new computer technologies suitable for analyzing the large amount of data obtained. Today's applications are no longer limited to analytical chemistry, but are becoming useful instruments in the medical field. Their versatility, rapidity, the volume of information obtained, especially when applied to biological fluids that are easy to collect, such as urine, could provide a novel diagnostic tool with great potential in the early detection of different diseases. This review aims to summarize the existing literature regarding spectroscopy analyses of urine samples, providing insight into potential future applications.

An interdisciplinary team-training protocol for robotic gynecologic surgery improves operating time and costs: analysis of a 4-year experience in a university hospital setting.

Main aim of this study is to assess the effect of a structured, interdisciplinary, surgical, team-training protocol in robotic gynecologic surgery, with the gradual integration of an advanced nurse practitioner. Data from all robotic surgical procedures were prospectively acquired. The surgical team consisted of one experienced surgeon and two surgical fellows and the scrub nurse team from three advance nurse practitioners, specialized in robotic surgery. The training was performed in a four-phase manner over 4 years and included theoretical training, hands-on training and team-communication skills enhancement. Scrub nurses increasingly adopted an active role during surgery. For a period of 4 years, 175 patients could be included in the analysis. All of them underwent a robotic gynecologic procedure. Mean docking time decreased from 45.3 to 27.3 min (p < 0.001), mean operating time from 235 to 179 min (p = 0.0071) and costs per case from 17,891 to 14,731 Swiss Francs (p = 0.035). There were no statistically significant changes in perioperative complications and conversions to laparotomy. An interdisciplinary long-term training protocol for high specialized robotic surgery within a "fixed" team with the gradually addition of an advanced study nurse improves the efficacy of the procedure in terms of time and costs. Although the surgery is performed quicker, the same performance and quality of surgical care could be reached.

Pelvic pain in urogynaecology. Part I: evaluation, definitions and diagnoses.

Aim of this review is to summarise the available literature on the definitions and assessment of pelvic pain in the urogynaecological patient. A MEDLINE search and a hand search of conference proceedings of the International Continence Society and International Urogynecological Association were performed. Sixty-nine articles were reviewed. The site of pain was specified in 45% of the articles, 20% used the digital examination of pelvic myofascial trigger points for the diagnosis; 20%, the Pelvic Pain and Urgency/Frequency Symptom Scale; 26%, the Interstitial Cystitis Symptom and Problem Index and 39%, a simple visual analogue scale. The diagnosis was interstitial cystitis in 67% and chronic pelvic pain in 19% of the articles. Consensus on the diagnostic procedures and definition of pelvic pain in the urogynaecological patient should be achieved in order to provide exact diagnostic information which will lead to more satisfying treatment options.

Safety, immunogenicity, and preliminary clinical efficacy of a vaccine against extraintestinal pathogenic Escherichia coli in women with a history of recurrent urinary tract infection: a randomised, single-blind, placebo-controlled phase 1b trial.

BACKGROUND: Escherichia coli infections are increasing worldwide in community and hospital settings. The E coli O-antigen is a promising vaccine target. We aimed to assess the safety and immunogenicity of a bioconjugate vaccine containing the O-antigens of four E coli serotypes (ExPEC4V). METHODS: In this multicentre phase 1b, first-in-human, single-blind, placebo-controlled trial, we randomly assigned (1:1) healthy adult women with a history of recurrent urinary tract infection (UTI) to receive a single injection of either intramuscular ExPEC4V or placebo. The primary outcome was the incidence of adverse events among vaccine and placebo recipients throughout the study. Secondary outcomes included immunogenicity and antibody functionality, and the incidence of UTIs caused by E coli vaccine serotypes in each group. This study is registered with ClinicalTrials.gov, number NCT02289794. FINDINGS: Between Jan 20, 2014, and Aug 27, 2014, 93 women received target-dose ExPEC4V and 95 received placebo. The vaccine was well tolerated: no vaccine-related serious adverse events occurred. Overall, 56 (60%) target-dose vaccines and 47 (49%) placebo recipients experienced at least one adverse event that was possibly, probably, or certainly related to injection. Vaccination induced significant IgG responses for all serotypes: at day 30 compared with baseline, O1A titres were 4·6 times higher, O2 titres were 9·4 times higher, O6A titres were 4·9 times higher, and O25B titres were 5·9 times higher (overall p<0·0001). Immune responses persisted at 270 days but were lower than those at 30 days. Opsonophagocytic killing activity showed antibody functionality. No reduction in the incidence of UTIs with 103 or more colony-forming units per mL of vaccine-serotype E coli was noted in the vaccine compared with the placebo group (0·149 mean episodes vs 0·146 mean episodes; p=0·522). In post-hoc exploratory analyses of UTIs with higher bacterial counts (≥105 colony-forming units per mL), the number of vaccine serotype UTIs did not differ significantly between groups (0·046 mean episodes in the vaccine group vs 0·110 mean episodes in the placebo group; p=0·074). However, significantly fewer UTIs caused by E coli of any serotype were noted in the vaccine group compared with the placebo group (0·207 mean episodes vs 0·463 mean episodes; p=0·002). INTERPRETATION: This tetravalent E coli bioconjugate vaccine candidate was well tolerated and elicited functional antibody responses against all vaccine serotypes. Phase 2 studies have been initiated to confirm these findings. FUNDING: GlycoVaxyn, Janssen Vaccines.

The EpiNo® Device: Efficacy, Tolerability, and Impact on Pelvic Floor-Implications for Future Research.

Aims. The aim of this review is to provide a comprehensive overview of the available literature on preventing perineal trauma with the EpiNo. Methods. We perfomed a literature research in the MedLine and EMBASE databases for studies referring to EpiNo published between 1990 and 2014, without restrictions for language and study type. Results. Five published studies were identified, regarding the effect of EpiNo on the rate of episiotomy and perineal tears, pelvic floor muscle function, and fetal outcome. The device seems to reduce episiotomy and perineal tears' rate, as well as the risk for levator ani microtrauma and avulsion, though not always statistically significant. It does not seem to have an effect on duration of second stage of labour and fetal outcome. The device is well tolerated and the adverse events are rare and mild. However, design and reporting bias in the reviewed articles do not allow evidence based conclusions. Conclusions. The EpiNo device seems to be promising, with potential positive effects on natural birth, while being uncomplicated to use and without major complications. Well designed, randomized trials are needed in order to understand the effects of EpiNo on pelvic floor and make evidence based recommendations on its use.

Short and long-term urodynamic and quality of life assessment after nerve sparing radical hysterectomy: a prospective pilot study.

OBJECTIVE: The aim of this study was to compare pre- and postoperative bladder function and quality of life (QoL) in women diagnosed with gynecologic malignancy and treated with nerve sparing radical hysterectomy (NSRH). STUDY DESIGN: Before and after NSRH for uterine malignancy, bladder function was prospectively assessed in a small cohort of 12 women (39-72 years) suffering from uterine malignancy using urodynamic studies and a validated self-administered condition specific QoL questionnaire. Urodynamic studies were performed one day before (U0) as well as one week (U1) and 22 months (U2) after surgery. The questionnaire was applied at U0 and U2. RESULTS: Cystometry showed detrusor contractions leading to overactive bladder incontinence in six out of nine women at short-term, which persisted in three women at long-term follow-up leading to a significant impaired QoL. Voiding function and bladder sensation remained uncompromised after surgery. CONCLUSIONS: NSRH preserves voiding function and bladder sensation. However, short and long-term urodynamic detrusor overactivity and urge incontinence was observed in a significant number of women although symptoms improved over time. These data are important for counselling women and for the design of larger studies to assess the benefits of NSRH versus conventional radical hysterectomy (RH).

Foreign body reaction in vaginally eroded and noneroded polypropylene suburethral slings in the female: a case series.

INTRODUCTION AND HYPOTHESIS: Aim of this study was to investigate the pattern of the foreign body reaction of macroporous polypropylene mesh (MPPM) used in females for the treatment of stress urinary incontinence and to compare this pattern between eroded and noneroded tapes. METHODS: Ten explanted suburethral slings, five eroded and five noneroded, were examined immunohistochemically under light microscopy; the tissue reaction was compared between eroded and noneroded materials. RESULTS: Eroded material showed a significantly higher accumulation of macrophages around the filaments of the mesh. CONCLUSIONS: This is the first study comparing reaction around eroded and noneroded MPPMs and indicates a more intense tissue reaction around eroded mesh, when compared to noneroded material. More studies are needed to prove whether the detected foreign body reaction was the actual trigger for the erosion.