A novel combined transurethral and suprapubic approach for excision of mesh at the bladder neck.

INTRODUCTION AND HYPOTHESIS: Unrecognized bladder perforation of a tension-free sling is a rare situation. Removal of the intravesical sling has been done by laparotomy or transurethrally. With technique presented here we want to show a minimally invasive approach that allows complete removal of the intraluminal sling material, located at the bladder neck. METHODS: This video shows a novel combined transurethral and suprapubic approach for radical removal of the mesh. Two 3.5-mm trocars were placed suprapubically into a filled bladder. One site was used for an optic with camera and the other for a 3.5-mm grasping forceps to apply tension on the mesh to pull it out of the bladder wall while it was being excised transurethrally with a cystoscope and transurethral scissors. RESULTS: The patient's postoperative course was uneventful. At 1-month follow-up, the patient was free of dysuria and cystoscopy revealed complete healing of the mesh site. Because of recurrent stress urinary incontinence, another continence sling surgery has been performed (TVT exact). After a follow-up of 2 years, she is continent and free of dysuria. CONCLUSIONS: This novel technique provides an effective means of removing mesh perforated into the bladder, located at the bladder neck, using a combined transurethral and suprapubic approach. The technique is minimally invasive and the applied traction allows complete removal of the intraluminal part of the mesh.

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.

Long-term follow-up of laparoscopic sacrocolpopexy.

INTRODUCTION AND HYPOTHESIS: This study evaluates the long-term results of laparoscopic sacrocolpopexy. In a prior publication, we demonstrated that laparoscopic sacrocolpopexy is a safe method with excellent anatomical results and low recurrence rates after a 12-month follow-up. This study now evaluates the long-term objectives and subjective outcomes of laparoscopic sacrocolpopexy after 5 years (mean). METHODS: From 2003 to 2007, a prospective study enrolling 101 patients was conducted to evaluate laparoscopic sacrocolpopexy as a treatment for pelvic organ prolapse. The long-term results were assessed postoperatively after 5 years by gynecological examinations, including the Pelvic Organ Prolapse Quantification (POP-Q) system and quality of life assessments using validated questionnaires. RESULTS: A total of 68 patients received a full clinical follow-up exam between July and September 2011, and 17 patients were assessed by questionnaires only. Altogether, six anatomical recurrences in the anterior, four in the posterior, and one in the apical compartment were found during the 5 years after surgery; 83.8 % of patients had no prolapse in any compartment or stage 0 prolapse according to the International Continence Society (ICS) classification. The total reoperation rate was 3.5 %. Two mesh erosions into the bladder occurred, though no vaginal erosion occurred. The preoperative quality of life index improved from 5.6 to 9.1 (12 months) and 8.3 (60 months) postoperatively, resulting in a subjective cure rate of 95.3 %. CONCLUSIONS: Laparoscopic sacrocolpopexy has demonstrated excellent anatomical and functional long-term results. With the ongoing debate about the complications of vaginal mesh surgery, laparoscopic sacrocolpopexy should be considered a favorable treatment option for patients with pelvic organ prolapse.

Clean intermittent self-catheterization: a burden for the patient?

AIM: To assess patients' perception of clean intermittent self-catheterization (CISC) for voiding dysfunction. PATIENTS AND METHODS: A total of 101 patients performing CISC because of voiding dysfunction were invited to participate in this questionnaire survey. The response rate was 91% (92/101). RESULTS: The mean time over which CISC was performed was 5 years (standard deviation (SD) +/- 6.3) and the mean frequency of CISC per day was three times (SD +/- 2). Almost 80% (72/92) of the patients perceived CISC as easy or very easy and CISC did not interfere at all or interfered a little bit with work or other regular daily activities in more than 80% (76/92). Almost 90% (80/92) reported no or minimal pain while performing CISC. This did not interfere at all or interfered a little bit with work or other regular daily activities in almost 90% (80/92). Quality of life improved considerably due to CISC in more than 60% (56/92) and 12% (11/92) complained of a deterioration. In multivariable analysis, severe pain performing CISC (odds ratio 20.9, 95% confidence interval 1.7-259.9, P = 0.018) was the only factor that predicted poor quality of life. CONCLUSIONS: The majority of patients considered CISC to be an easy and painless procedure which did not interfere with daily activities. Consequently, quality of life improved in more than 60% of the patients. Therefore, CISC does not appear to be a burden for the patient and, from a patient's perspective, can be recommended.