Risk factors for explantation due to infection after sacral neuromodulation: a multicenter retrospective case-control study.

BACKGROUND: Sacral neuromodulation is an effective therapy for overactive bladder, urinary retention, and fecal incontinence. Infection after sacral neurostimulation is costly and burdensome. Determining optimal perioperative management strategies to reduce the risk of infection is important to reduce this burden. OBJECTIVE: We sought to identify risk factors associated with sacral neurostimulator infection requiring explantation, to estimate the incidence of infection requiring explantation, and identify associated microbial pathogens. STUDY DESIGN: This is a multicenter retrospective case-control study of sacral neuromodulation procedures completed from Jan. 1, 2004, through Dec. 31, 2014. We identified all sacral neuromodulation implantable pulse generator implants as well as explants due to infection at 8 participating institutions. Cases were patients who required implantable pulse generator explantation for infection during the review period. Cases were included if age ≥18 years old, follow-up data were available ≥30 days after implantable pulse generator implant, and the implant was performed at the institution performing the explant. Two controls were matched to each case. These controls were the patients who had an implantable pulse generator implanted by the same surgeon immediately preceding and immediately following the identified case who met inclusion criteria. Controls were included if age ≥18 years old, no infection after implantable pulse generator implant, follow-up data were available ≥180 days after implant, and no explant for any reason <180 days from implant. Controls may have had an explant for reasons other than infection at >180 days after implant. Fisher exact test (for categorical variables) and Student t test (for continuous variables) were used to test the strength of the association between infection and patient and surgery characteristics. Significant variables were then considered in a multivariable logistic regression model to determine risk factors independently associated with infection. RESULTS: Over a 10-year period at 8 academic institutions, 1930 sacral neuromodulator implants were performed by 17 surgeons. In all, 38 cases requiring device explant for infection and 72 corresponding controls were identified. The incidence of infection requiring explant was 1.97%. Hematoma formation (13% cases, 0% controls; P = .004) and pocket depth of ≥3 cm (21% cases, 0% controls; P = .031) were independently associated with an increased risk of infection requiring explant. On multivariable regression analysis controlling for significant variables, both hematoma formation (P = .006) and pocket depth ≥3 cm (P = .020, odds ratio 3.26; 95% confidence interval, 1.20-8.89) remained significantly associated with infection requiring explant. Of the 38 cases requiring explant, 32 had cultures collected and 24 had positive cultures. All 5 cases with a hematoma had a positive culture (100%). Of the 4 cases with a pocket depth ≥3 cm, 2 had positive cultures, 1 had negative cultures, and 1 had a missing culture result. The most common organism identified was methicillin-resistant Staphylococcus aureus (38%). CONCLUSION: Infection after sacral neuromodulation requiring device explant is low. The most common infectious pathogen identified was methicillin-resistant S aureus. Demographic and health characteristics did not predict risk of explant due to infection, however, having a postoperative hematoma or a deep pocket ≥3 cm significantly increased the risk of explant due to infection. These findings highlight the importance of meticulous hemostasis as well as ensuring the pocket depth is <3 cm at the time of device implant.

Use of Dynamic MRI of the Pelvic Floor in the Assessment of Anterior Compartment Disorders.

PURPOSE OF REVIEW: Approximately 25% of women in the USA suffer from pelvic floor disorders. Disorders of the anterior compartment of the pelvic floor, in particular, can cause symptoms such as incomplete urinary voiding, urinary incontinence, pelvic organ prolapse, dyspareunia, and pelvic pain, potentially negatively impacting a woman's quality of life. In some clinical situations, clinical exam alone may be insufficient, especially when patient's symptoms are in excess of their pelvic exam findings. In many of these patients, dynamic magnetic resonance imaging (dMRI) of the pelvic floor can be a valuable imaging tool allowing for comprehensive assessment of the entire pelvic anatomy and its function. RECENT FINDINGS: Traditionally, evaluation of the anterior compartment has been primarily through clinical examination with occasional use of urodynamic testing and ultrasound. In recent years, dMRI has continued to gain popularity due to its improved imaging quality, reproducibility, and ability to display the entire pelvic floor. Emerging evidence has also shown utility of dMRI in the postoperative setting. In spite of advances, there remains an ongoing discussion in contemporary literature regarding the accuracy of dMRI and its correlation with clinical examination and with patient symptoms. Dynamic pelvic MRI is a helpful adjunct to physical examination and urodynamic testing, particularly when a patient's symptoms are in excess of the physical examination findings. Evaluation with dMRI can guide preoperative and postoperative surgical management in many patients, especially in the setting of multicompartmental disorders. This review will summarize relevant pelvic floor anatomy and discuss the clinical application, imaging technique, imaging interpretation, and limitations of dMRI.

Prevalence of cognitive impairment in older women with pelvic floor disorders.

INTRODUCTION AND HYPOTHESIS: This study aimed to determine the prevalence of mild cognitive impairment (MCI) and early dementia among women >55 years seeking care for pelvic floor disorders (PFDs) and to describe the impact of cognitive impairment on condition-specific quality of life (QoL). We hypothesized that the prevalence of MCI would be at least 15% among this population. METHODS: This was a cross-sectional study of English-speaking women >55 years presenting for evaluation of PFDs. We assessed baseline demographics and administered the Short Test of Mental Status (STMS) to screen for cognitive impairment. We predicted a sample of 196 would be needed for a precision of ±5% of the estimated sample prevalence in participants with PFDs. Chi-square tests were used to compare categorical variables and Student's t tests and analysis of variance (ANOVA) for continuous variables. Multivariate regression analysis was used to assess for any independent association with cognitive impairment and condition-specific QoL. RESULTS: Between July 2013 and July 2014, 211 participants were enrolled. The prevalence of MCI and early dementia were 15% [95% confidence interval (CI) 10.9-20.6; n = 32)] and 17% (95% CI 11.9-22.1; n = 36], respectively. Patients with MCI and early dementia had higher Patient Heath Questionnaire scores indicating greater depressive symptoms (p = 0.006) and higher overall Pelvic Floor Impact Questionnaire scores indicating worse condition-specific QoL (p = 0.008). CONCLUSION: MCI and early dementia were prevalent in our population seeking care for PFDs. Women with cognitive impairment experienced worse condition-specific QoL.

Use of patient reported outcome questionnaires in the urogynecologic literature.

AIMS: We aimed to describe the current use of patient reported outcome questionnaires (PROQ) in the urogynecologic literature. METHODS: All articles from 2009 in 11 journals were reviewed and included if PROQ were used. PROQ were assigned the grades of recommendation used by the International Consultation on Incontinence (ICI). Data were collected by two independent reviewers (differences resolved by consensus). Fisher and χ(2) tests were used for statistics. RESULTS: Of the 212 articles included, 126 used multiple PROQ. Seventy-two percent used at least one grade A PROQ and 42% exclusively used grade A PROQ. Articles about urinary incontinence (UI) were more likely to use grade A PROQ than those pertaining to interstitial cystitis or anal incontinence. Eighty-three articles used PROQ in non-English languages. These articles were as likely to use ICI grade A PROQ as those using English PROQ. When translated questionnaires are used, 41.5% of articles did not provide references for a validation of the translated version. Eighty-seven different PROQ were identified and used 422 times. Of those, 75 were developed in English. Short versions were used more frequently. PROQ available online were used 9.4 times more frequently than those requiring payment. The more utilized PROQ were more often grade A than those rarely used (P < 0.001). CONCLUSIONS: Using multiple PROQ is common in the literature reviewed. 72.2% of articles used at least one PROQ with the highest ICI recommendation but only 42% used exclusively those. Short and easily available PROQ were used more often. Most PROQ are developed in English.

Spanish translation and validation of four short pelvic floor disorders questionnaires.

INTRODUCTION AND HYPOTHESIS: Globally, Spanish is the primary language for 329 million people; however, most urogynecologic questionnaires are available in English. We set out to develop valid Spanish translations of the Questionnaire for Urinary Incontinence Diagnosis (QUID), the Three Incontinence Questions (3IQ), and the short Pelvic Floor Distress Inventory (PFDI-20) and Pelvic Floor Impact Questionnaire (PFIQ-7). METHODS: The TRAPD method (translation, review, adjudication, pretesting, and documentation) was used for translation. Eight native Spanish-speaking translators developed Spanish versions collaboratively. These were pretested with cognitive interviews and revised until optimal. For validation, bilingual patients at seven clinics completed Spanish and English questionnaire versions in randomized order. Participants completed a second set of questionnaires later. The Spanish versions' internal consistency and reliability and Spanish-English agreement were measured using Cronbach's alpha, weighted kappa, and intraclass correlation coefficients. RESULTS: A total of 78 subjects were included; 94.9 % self-identified as Hispanic and 73.1 % spoke Spanish as their primary language. The proportion of per-item missing responses was similar in both languages (median 1.3 %). Internal consistency for Spanish PFDI-20 subscales was acceptable to good and for PFIQ-7 and QUID excellent. Test-retest reliability per item was moderate to near perfect for PFDI-20, substantial to near perfect for PFIQ-7 and 3IQ, and substantial for QUID. Spanish-English agreement for individual items was substantial to near perfect for all questionnaires (kappa range 0.64-0.95) and agreement for PFDI-20, PFIQ-7, and QUID subscales scores was high [intraclass correlation coefficient (ICC) range 0.92-0.99]. CONCLUSIONS: We obtained valid Spanish translations of the PFDI-20, PFIQ-7, QUID, and 3IQ. These results support their use as clinical and research assessment tools in Spanish-speaking populations.

Sexual activity and function in women with and without pelvic floor disorders.

INTRODUCTION AND HYPOTHESIS: We describe differences in sexual activity and function in women with and without pelvic floor disorders (PFDs). METHODS: Heterosexual women ≥40 years of age who presented to either urogynecology or general gynecology clinics at 11 clinical sites were recruited. Women were asked if they were sexually active with a male partner. Validated questionnaires and Pelvic Organ Prolapse Quantification (POP-Q) examinations assessed urinary incontinence (UI), fecal incontinence (FI), and/or pelvic organ prolapse (POP). Sexual activity and function was measured by the Female Sexual Function Index (FSFI). Student's t test was used to assess continuous variables; categorical variables were assessed with Fisher's exact test and logistic regression. Univariate and multivariate analyses were used to assess the impact of pelvic floor disorders (PFDs) on FSFI total and domain scores. RESULTS: Five hundred and five women met eligibility requirements and gave consent for participation. Women with and without PFDs did not differ in race, body mass index (BMI), comorbid medical conditions, or hormone use. Women with PFDs were slightly older than women without PFDs (55.6 + 10.8 vs. 51.6 + 8.3 years, P <0.001); all analyses were controlled for age. Women with PFDs were as likely to be sexually active as women without PFDs (61.6 vs. 75.5 %, P = 0.09). There was no difference in total FSFI scores between cohorts (23.2 + 8.5 vs. 24.4 + 9.2, P = 0.23) or FSFI domain scores (all P = NS). CONCLUSION: Rates of sexual activity and function are not different between women with and without PFDs.

Painful Bladder Syndrome/Interstitial Cystitis and High Tone Pelvic Floor Dysfunction.

This article provides an overview of 2 conditions that defy straightforward characterization and treatment: interstitial cystitis/painful bladder syndrome often coexists with high tone pelvic floor dysfunction. These conditions are common in gynecologic patients who present with chronic pelvic pain and are often misdiagnosed due to their syndromic nature and amorphous definitions. Clinicians should maintain a high level of suspicion for these processes in patients with chronic pelvic pain or recurrent urinary tract infection symptoms. Optimal treatment uses a multimodal approach to alleviate symptoms.

Prevalence of Screening High Risk of Obstructive Sleep Apnea Among Urogynecology Patients.

OBJECTIVES: There is limited knowledge on the prevalence of obstructive sleep apnea (OSA) among urogynecology patients. The aim of this study was to determine the prevalence of screening high risk of OSA (HR-OSA) in an ambulatory urogynecology clinic. METHODS: Women presenting for a new patient visit to a single outpatient urogynecology clinic for any indication were screened for eligibility. Patients were included if they were 18 years or older, English speaking, nonpregnant, and not using treatment for OSA. Participants completed the STOP-BANG questionnaire to screen for OSA and additional questionnaires to assess the presence and classification of nocturia and urinary incontinence. RESULTS: Among 130 participants, the prevalence of screening HR-OSA was 38.5%. Characteristics associated with screening HR-OSA included hypertension (P < 0.001), diabetes (P=0.003), untreated sleep apnea (P < 0.001), body mass index ≥30 kg/m (P < 0.001), and age >50 years (P < 0.001). Participants who screened HR-OSA were more likely to have bothersome bladder symptoms of nocturia (P < 0.001), nocturnal enuresis (P < 0.001), higher urinary distress inventory scores (P < 0.001), and incontinence severity index scores (P < 0.001). On multivariable analysis, age >50 years (odds ratio [OR], 7.54), hypertension (OR, 4.04), body mass index ≥30 kg/m (OR, 3.98), and nocturial enuresis (OR, 2.26) remained significantly associated with screening HR-OSA. Average time to complete the STOP-BANG was 1.2 minutes. CONCLUSIONS: The prevalence of OSA among urogynecology patients is high, and screening is not time prohibitive. Patients who screen HR-OSA have more bothersome bladder symptoms. Providers should consider screening urogynecology patients for OSA, especially patients who are 50 years or older, are obese, and have nocturnal enuresis.