Missing Data Frequency and Correlates in Two Randomized Surgical Trials for Urinary Incontinence in Women

INTRODUCTION AND HYPOTHESIS: Missing data is frequently observed in clinical trials; high rates of missing data may jeopardize trial outcome validity. PURPOSE: We determined the rates of missing data over time, by type of data collected and compared demographic and clinical factors associated with missing data among women who participated in two large randomized clinical trials of surgery for stress urinary incontinence, the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr) and the Trial of Midurethral Sling (TOMUS). METHODS: The proportions of subjects who attended and missed each follow-up visit were calculated. The chi-squared test, Fisher\u27s exact test and t test were used to compare women with and without missing data, as well as the completeness of the data for each component of the composite primary outcome. RESULTS: Data completeness for the primary outcome computation in the TOMUS trial (62.3%) was nearly double that in the SISTEr trial (35.7%). The follow-up visit attendance rate decreased over time. A higher proportion of subjects attended all follow-up visits in the TOMUS trial and overall there were fewer missing data for the period that included the primary outcome assessment at 12 months. The highest levels of complete data for the composite outcome variables were for the symptoms questionnaire (SISTEr 100 %, TOMUS 99.8%) and the urinary stress test (SISTEr 96.1%, TOMUS 96.7%). In both studies, the pad test was associated with the lowest levels of complete data (SISTEr 85.1%, TOMUS 88.3%) and approximately one in ten subjects had incomplete voiding diaries at the time of primary outcome assessment. Generally, in both studies, a higher proportion of younger subjects had missing data. This analysis lacked a patient perspective as to the reasons for missing data that could have provided additional information on subject burden, motivations for adherence and study design. In addition, we were unable to compare the effects of the different primary outcome assessment time-points in an identically designed trial. CONCLUSIONS: Missing visits and data increased with time. Questionnaire data and physical outcome data (urinary stress test) that could be assessed during a visit were least prone to missing data, whereas data for variables that required subject effort while away from the research team (pad test, voiding diary) were more likely to be missing. Older subjects were more likely to provide complete data

Recurrent urinary tract infection and estrogen shape the taxonomic ecology and function of the postmenopausal urogenital microbiome

Article describes how postmenopausal women are severely affected by recurrent urinary tract infection (rUTI). The authors perform shotgun metagenomics and advanced culture on urine from a controlled cohort of postmenopausal women to identify urogenital microbiome compositional and function changes linked to rUTI susceptibility

Long-term efficacy of fulguration of trigonitis for recurrent urinary tract infections in women

Objective: Women with a longstanding history of recurrent urinary tract infections (RUTIs) represent a challenging population because of gradual development of antibiotic resistance and frequent antibiotic allergies. We report on the long-term results of women with RUTIs and trigonitis who were treated using endoscopic fulguration and were prospectively followed. Materials and methods: Following institutional review board approval, charts of non-neurogenic women with RUTIs (defined as ≥3 UTIs/y), no voiding dysfunction or incontinence, and normal upper tracts by imaging, who underwent cystoscopy with fulguration of trigonitis (CFT) under anesthesia with 1 year minimum follow up after CFT, were reviewed. Trigonitis was defined as a condition of inflammation of the trigone region of the bladder. The primary outcome was complete resolution of trigonitis based on follow-up office cystoscopy 6 months after CFT. The secondary outcome was the total number of antibiotic courses (AC) prescribed for UTI-related symptoms and/or positive urine cultures (PUC) following CFT. We hypothesized that patients with complete trigonitis resolution after CFT fared best. Results: From 2004 to 2008, 33 women met the inclusion criteria with a mean follow up of 48 ± 19 months (range, 14–82 months). Resolution of trigonitis at 6 months was noted in 25 (76%) patients. This group averaged 0.51 ± 0.5 total AC and/or PUC/y compared with 2.03 ± 1.1 total AC and/or PUC/y for women with persistent trigonitis following CFT (p = 0.006). Conclusion: Patients with resolved trigonitis at 6 months after CFT did best; however, both groups benefited from the procedure over time

Total hysterectomy and anterior vaginal wall suspension for concurrent uterine and bladder prolapses: Long-term anatomical results of additional vault and/or posterior compartment prolapse repair

Objective: To review the long-term results of an intraoperative decision to repair or not repair associated vault and posterior compartment defects after total hysterectomy (TH) and anterior vaginal wall suspension (AVWS) for uterine and bladder prolapses. Methods: After gaining Institutional Review Board approval, the operative records of women receiving TH and AVWS concurrently with a minimum follow-up period of 6 months were reviewed. Two groups were identified: Group 1 (G1) underwent TH + AVWS and intraoperative apical and/or posterior repairs, and Group 2 (G2) had TH + AVWS alone. The definition of prolapse recurrence was Pelvic Organ Prolapse—Quantification ≥ Stage 2 and/or any reoperation for prolapse. Results: From 1998 to 2009, a total of 94 women were evaluated. At the mean 3 years follow-up, the rates of overall prolapse recurrence following initial surgeries between G1 and G2 were 30% and 24%, respectively. Additional operative repair for G1 and G2 was 18.5% and 16%, respectively. The progression rate for both groups was < 8%. The overall success for G1 and G2 was 70% and 76%, respectively. Conclusion: At long-term follow-up, nearly one in five apical recurrences in these two surgical groups was observed with stable results in the anterior compartment. The posterior compartment required the least surgical intervention

Risks of long-term use of nitrofurantoin for urinary tract prophylaxis in the older patient

Purpose: To review the current literature on reported pulmonary, liver, and nerve adverse reactions (ARs) of long-term Nitrofurantoin (NF) suppression in older patients treated for urinary tract infections (UTIs). Materials and methods: An extensive literature search was performed on PubMed for the search terms “Nitrofurantoin,” and “Nitrofurantoin and lung, pulmonary, liver, nerve or ARs”. Relevant cited papers were also analyzed. Articles not in English, or related to children, or pregnant women were excluded. Results: In 43 articles and other texts meeting the inclusion criteria from 1968 to 2014, rates of long-term NF-related pulmonary ARs compared to total NF prescriptions differed worldwide, but remained extremely small at 0.001% (USA) and 0.001% for pulmonary and hepatic ARs (France). Among all NF ARs, rates of pulmonary ARs differed across the literature from 2% (UK), 3% (Holland), 5% (Sweden), to 7% (Australia). Nerve ARs were reported as .0007% and liver ARs as .0003% of total prescriptions Conclusions: Pulmonary, nerve, or liver ARs resulting from long-term NF prophylaxis in older patients treated for UTIs are potentially serious but extremely rare, and should not deter from the cautious use of NF in this population

Hemorrhage Occluder™ Pin to control life-threatening bleeding during the removal of an infected sacrocolpopexy mesh: A case report

Vaginal mesh exposures and infections are recognized complications of open and laparoscopic sacrocolpopexy performed for vault prolapse. In severe cases, complete sacrocolpopexy mesh removal may be necessary. This case report presents a 72-year-old woman with previous mesh sacrocolpopexy who presented with infected mesh and recurrent vaginal bleeding despite multiple attempts at surgical transvaginal mesh excision. A life-threatening massive hemorrhage occurred intra-operatively. After several failed attempts to control bleeding, hemorrhage Occluder™ Pins were successfully placed by vascular surgery to control presacral veins. Although an exceedingly rare complication, anticipation and rapid management of life-threatening bleeding are critical to save life during complicated mesh removals

Macroplastique outcome in women with stress urinary incontinence secondary to intrinsic sphincteric deficiency

Objectives: To evaluate short-term outcomes of Macroplastique (MPQ) in women with stress urinary incontinence (SUI) using patient reported outcome and three-dimensional vaginal ultrasound (3DUS). Materials and methods: After obtaining institutional review board approval, a chart review of non-neurogenic women that received MPQ for intrinsic sphincter deficiency (ISD) was extracted from a prospective database. Patients were divided into three groups: naïve (Group I), prior incontinence surgery (Group II), and both prior incontinence surgery and bulking agent (Group III). Women with urethral hypermobility were excluded. Baseline evaluation included a history, physical examination to confirm SUI, and questionnaires [Urinary Distress Inventory-6 (UDI-6), 1 quality of life (QOL) global score based on visual analog scale], and in select patients urodynamic studies and/or standing voiding cystogram. Patient follow up included repeat questionnaires scores and 3DUS to objectively assess MPQ volume. Success was defined as sufficient improvement after one injection so that a subsequent reinjection/different SUI operation was not requested at the last follow-up visit. It was hypothesized that Group I would fare best. Results: Fifty-nine women met the inclusion criteria. Success rate was 83% for Group I, 70% for Group II, and 69% for Group III (p = 0.54) at 9 months mean follow up. Fifteen patients underwent a second 3DUS during follow up with a stable volume, compared to the first study (4.5 ± 1.5 vs. 4.4 ± 1.5, p = 0.70), which confirmed stable volumes over time. Among the failures (N = 15), nine patients proceeded with reinjection; four patients had fascial slings, and two patients had artificial sphincters. Conclusion: As confirmed by 3DUS, Macroplastique appears efficacious as a primary treatment and as a salvage treatment for SUI due to ISD in the short-term