Prospective follow-up of overactive bladder symptoms in patients with prior SARS-CoV-2 infection.

PURPOSE: SARS-CoV-2 infection can result in genitourinary symptoms, such as frequency, urgency, nocturia, and pain/pressure. In this study, we followed the progression of overactive bladder (OAB) symptoms in patients that reported new or worsening OAB symptoms after coronavirus disease-19 (COVID-19) diagnosis. MATERIALS AND METHODS: Individuals from a COVID-19 serology study were invited to participate in a follow-up study. Respondents were divided into three groups based on prior COVID-19 testing. Patients scored symptoms retrospectively before the pandemic, at study onset, and prospectively during 12-month follow-up. Genitourinary symptoms were assessed using international consultation on incontinence questionaire for OAB (ICIQ-OAB). Change in ICIQ-OAB scores from baseline were calculated. The minimal important difference of one on ICIQ-OAB is considered a significant change. RESULTS: 26.0% of participants previously had positive COVID polymerase chain reaction (PCR) test (PCR+), 5.6% a positive serology test only (Ser+), and 65.5% were COVID naïve (COVID-). 23.8% of participants reported a significant increase in ICIQ-OAB score at study onset compared to prepandemic. ICIQ-OAB scores were similar at prepandemic but significantly higher at study start (p < 0.001) in PCR+ group. During follow-up, change in ICIQ-OAB scores from baseline remained unchanged for COVID- group, but gradually reduced for PCR+, reaching similar levels as COVID- group by 12 months. By 12 months, 71.4% of PCR+, 42.9% of Ser+, and 68.8% of COVID- participants still reported significant increase in ICIQ-OAB scores. CONCLUSIONS: Most COVID-19 patients experienced return of symptoms to baseline, indicative of the potential resolution of COVID-associated cystitis. A subset of cases did not, raising questions about the underlying factors contributing to this outcome. Additional research is needed to assess long COVID on urological health.

Development of an implant technique and early experience using a novel implantable pulse generator with a quadripolar electrode array at the tibial nerve for refractory overactive bladder.

OBJECTIVES: Tibial nerve stimulation is an effective treatment for overactive bladder (OAB) and has been utilized as an in-person recurring session treatment option for many years. The primary objective of this study was to evaluate the safety and efficacy of a long-term implantable device and the method of utilizing a retrograde approach to place the device (a percutaneous implantable pulse generator [pIPG] with integrated quadripolar electrodes) at the tibial nerve (Protect PNS; Uro Medical Corp.). METHODS: A novel retrograde implant technique was developed through multiple cadaveric dissections to percutaneously implant a chronic, wireless, minimally invasive pIPG device with integrated quadripolar electrodes (now licensed to Uro Medical) at the tibial nerve. A proof-of-concept pIPG device approved as part of an FDA IDE was designed to gain early experience in subjects with refractory OAB. The pIPG was implanted in the office under local anesthesia using the novel retrograde approach, and stimulation was activated using an external wireless energy source called a transmitter. Initially, a pilot study was designed to compare outcomes in subjects randomized to either percutaneous tibial nerve stimulation (PTNS) or Protect PNS. However, due to the small sample sizes available at this time, it was not possible to compare the two groups. Thus, the purpose of this manuscript is to describe the outcome of subjects who underwent implantation of the Protect PNS system. Twelve-month safety and efficacy were evaluated. RESULTS: Nine subjects were enrolled in the randomized pilot study; 5 to the pIPG group and 4 to PTNS, and all completed the 13-week primary endpoint. Subsequently, two subjects in the PTNS group chose to cross over and have the pIPG implanted after 13 weeks. Outcomes of the seven subjects who underwent implantation of the pIPG are described. No complications related to the office procedure were noted. Two of the older model pIPG devices became nonresponsive at 1 and 4 weeks and were replaced. Six minor adverse events were reported and resolved. Subjects reported improvement in urge urinary incontinence (UUI) episodes, OAB symptoms, and quality of life. Subjects impanted with a pIPG reported a 50% reduction in UUI as early as 1 week. CONCLUSIONS: Results of this pilot study suggest that retrograde percutaneous implantation of a pIPG is a safe, minimally invasive one-stage office procedure for treatment for urge incontinence related OAB symptoms, without significant complications after 12 months follow-up. Future studies will be required to compare outcomes among treatment modalities.

Pudendal Neuromodulation is Feasible and Effective After Pudendal Nerve Entrapment Surgery.

BACKGROUND: Patients with intractable pain in the pudendal nerve distribution may benefit from pudendal neuromodulation; however, some may have previously undergone pudendal nerve entrapment surgery (PNES), potentially altering nerve anatomy and function. AIM: We examined pudendal neuromodulation outcomes in patients with prior PNES. METHODS: Patients with a history of PNES and quadripolar, tined pudendal lead placement for urogenital pain were reviewed. Symptoms and outcomes were collected from existing medical records. OUTCOMES: Patients with pudendal neuromodulation and prior PNES were compared to patients with no prior PNES who had pudendal lead placement. RESULTS: Fifteen patients with a history of 1, 2, or 3 prior PNES (n = 13, 1, and 1, respectively) were evaluated. Most (10; 67%) were female, with bilateral pain (9; 60%), and symptoms of 5-26 years. After trialing the lead, bladder symptoms and pain were improved in 8 of 12 and 9 of 14 patients, respectively, and 80% of patients (12/15) underwent permanent generator implantation. When prior PNES patients were compared to those with no prior PNES (n = 43), gender (67% vs 77% female; P = .50) and age (median 63 vs 58 years; P = .80), were similar; however, BMI differed (mean 24 vs 29; P = .008) and a lower proportion (12/15; 80% vs 42/43; 98%; P = .049) had generator implantation. Importantly, median lead implant time (48 vs 50 minutes; P = .65) did not differ between the 2 groups. CLINICAL IMPLICATIONS: Pudendal neuromodulation has the potential to provide pain relief for a very difficult-to-treat population; furthermore, it does not appear that prior PNES surgery made lead placement significantly more challenging. STRENGTHS & LIMITATIONS: Study strengths include being a tertiary referral center for urogenital pain and having a single surgeon perform all procedures in a regimented way. Limitations include the retrospective study design, small sample size and various approaches to PN CONCLUSION: Chronic pudendal neuromodulation can be a viable option even after prior PNES. Kristen M. Meier, Patrick M. Vecellio, Kim A. Killinger, Judith A. Boura, Kenneth M. Peters. Pudendal Neuromodulation is Feasible and Effective After Pudendal Nerve Entrapment Surgery. J Sex Med 2022;19:995-1001.

A novel approach to vulvodynia using targeted neuromodulation.

Vulvodynia is a debilitating disorder which can prove extremely difficult to treat. Neuromodulation is increasingly becoming a frontline therapy in various chronic pain syndromes. We present a relatively simple surgical technique utilizing targeted neuromodulation leading to the successful treatment of vulvodynia.

International Society for the Study of Women's Sexual Health (ISSWSH) Review of Epidemiology and Pathophysiology, and a Consensus Nomenclature and Process of Care for the Management of Persistent Genital Arousal Disorder/Genito-Pelvic Dysesthesia (PGAD/GPD).

BACKGROUND: Persistent genital arousal disorder (PGAD), a condition of unwanted, unremitting sensations of genital arousal, is associated with a significant, negative psychosocial impact that may include emotional lability, catastrophization, and suicidal ideation. Despite being first reported in 2001, PGAD remains poorly understood. AIM: To characterize this complex condition more accurately, review the epidemiology and pathophysiology, and provide new nomenclature and guidance for evidence-based management. METHODS: A panel of experts reviewed pertinent literature, discussed research and clinical experience, and used a modified Delphi method to reach consensus concerning nomenclature, etiology, and associated factors. Levels of evidence and grades of recommendation were assigned for diagnosis and treatment. OUTCOMES: The nomenclature of PGAD was broadened to include genito-pelvic dysesthesia (GPD), and a new biopsychosocial diagnostic and treatment algorithm for PGAD/GPD was developed. RESULTS: The panel recognized that the term PGAD does not fully characterize the constellation of GPD symptoms experienced by patients. Therefore, the more inclusive term PGAD/GPD was adopted, which maintains the primacy of the distressing arousal symptoms and acknowledges associated bothersome GPD. While there are diverse biopsychosocial contributors, there is a common underlying neurologic basis attributable to spontaneous intense activity of the genito-pelvic region represented in the somatosensory cortex and its projections. A process of care diagnostic and treatment strategy was developed to guide the clinician, whenever possible, by localizing the symptoms as originating in any of five regions: (i) end organ, (ii) pelvis/perineum, (iii) cauda equina, (iv) spinal cord, and (v) brain. Psychological treatment strategies were considered critical and should be performed in conjunction with medical strategies. Pharmaceutical interventions may be used based on their site and mechanism of action to reduce patients' symptoms and the associated bother and distress. CLINICAL IMPLICATIONS: The process of care for PGAD/GPD uses a personalized, biopsychosocial approach for diagnosis and treatment. STRENGTHS AND LIMITATIONS: Strengths and Limitations: Strengths include characterization of the condition by consensus, analysis, and recommendation of a new nomenclature and a rational basis for diagnosis and treatment. Future investigations into etiology and treatment outcomes are recommended. The main limitations are the dearth of knowledge concerning this condition and that the current literature consists primarily of case reports and expert opinion. CONCLUSION: We provide, for the first time, an expert consensus review of the epidemiology and pathophysiology and the development of a new nomenclature and rational algorithm for management of this extremely distressing sexual health condition that may be more prevalent than previously recognized. Goldstein I, Komisaruk BR, Pukall CF, et al. International Society for the Study of Women's Sexual Health (ISSWSH) Review of Epidemiology and Pathophysiology, and a Consensus Nomenclature and Process of Care for the Management of Persistent Genital Arousal Disorder/Genito-Pelvic Dysesthesia (PGAD/GPD). J Sex Med 2021;18:665-697.

Initial experience using a novel nerve stimulator for the management of pudendal neuralgia.

AIMS: In patients with pudendal neuralgia, prior studies have shown efficacy in chronic stimulation with Interstim® (Medtronic, Inc.). This feasibility study reports on the initial experience of using a wireless system to power an implanted lead at the pudendal nerve, StimWave®, to treat pudendal neuralgia. METHODS: Retrospective chart review identified patients with a lead placed at the pudendal nerve for neuralgia and powered wirelessly. Clinical outcomes were assessed at Postoperative visits and phone calls. Administered non-validated follow-up questionnaire evaluated the Global Response Assessment, percentage of pain improvement, satisfaction with device, and initial and current settings of the device (h/day of stimulation). RESULTS: Thirteen patients had the StimWave® lead placed at the pudendal nerve, 12 (92%) female and 1 (7.6%) male. Mean age was 50 years (range: 20-58). Failed prior therapies include medical therapy (100%), pelvic floor physical therapy (92%), pudendal nerve blocks (85%), pelvic floor muscle trigger point injections (69%), neuromodulation (30.7%), or surgeries for urogenital pain (23.1%). After the trial period, 10/13 (76.9%) had >50% improvement in pain with 6/13 (46.1%) reporting 100% pain improvement. Nine underwent permanent lead placement. At last postoperative visit (range, 6-83 days), 5/9 patients reported >50% pain improvement. Seven patients reached for phone calls (22-759 days) reported symptoms to be "markedly improved" (n = 2), "moderately improved" (n = 4), or "slightly improved" (n = 1). At follow up, complications included lead migration (n = 2), broken wire (n = 1), or nonfunctioning antenna (n = 2). CONCLUSION: Complex patients with pudendal neuralgia may benefit from pudendal nerve stimulation via StimWave®.

Safety, tolerability, and efficacy of LiRIS 400 mg in women with interstitial cystitis/bladder pain syndrome with or without Hunner lesions.

AIMS: Two phase 2 studies were conducted to assess the efficacy and safety of lidocaine-releasing intravesical system (LiRIS) in patients with interstitial cystitis/bladder pain syndrome (IC/BPS) with (Study 001; NCT02395042) or without, (Study 002; NCT02411110) Hunner lesions (HL). METHODS: Both were multicenter, randomized, double-blind, placebo-controlled, and enrolled women aged ≥18 years. In Study 001, patients were randomized 2:1:1 to LiRIS 400 mg/LiRIS 400 mg, placebo/LiRIS 400 mg, or placebo/placebo for a continuous 28 (2 × 14)-day period. In Study 002, patients were randomized 1:1 to LiRIS 400 mg or placebo for a continuous (single treatment) 14-day period. RESULTS: In total, 59 and 131 patients received treatment in Studies 001 and 002, respectively. There was no statistically significant difference in the primary endpoint, the change from baseline to Week 4 of follow-up post-removal in mean daily average bladder numeric rating scale (NRS) pain score in either study (Study 001: placebo/placebo, -1.6; LiRIS/LiRIS, -2.7, p = 0.142; placebo/LiRIS, -2.5, p = 0.319; Study 002: LiRIS -1.2; placebo, -1.5, p = 0.505). There was no statistically significant difference between groups in daily worst NRS pain score, number of micturitions/day or urgency episodes/day. There was no clear trend for reduction in number of HL for LiRIS vs placebo. The frequency of treatment-emergent adverse events was similar between treatment groups in both studies; most were mild or moderate intensity. CONCLUSION: These studies did not demonstrate a treatment effect of LiRIS 400 mg compared with placebo, either in patients with IC/BPS with HL, or in those without HL.

Proteomic analysis of bladder biopsies from interstitial cystitis/bladder pain syndrome patients with and without Hunner's lesions reveals differences in expression of inflammatory and structural proteins.

BACKGROUND: Interstitial cystitis/bladder pain syndrome is a bladder disease usually characterized by pain, urgency, and frequency. Interstitial cystitis is currently classified into two subtypes, with and without Hunner's lesions. However, the underlying etiology of interstitial cystitis and its subtypes are largely unknown. METHODS: To better understand the biological changes in the bladder of interstitial cystitis/bladder pain syndrome patients, we directly analyzed bladder tissue of interstitial cystitis patients, both those with Hunner's lesions and those without. Proteins in the bladder biopsies were analyzed using nanoscale high-performance liquid chromatography-tandem mass spectrometry. Disease subgroups were compared and significantly expressed proteins were mapped using STRING to determine protein associations and functions. RESULTS: We found that patients with Hunner's lesions had significant increases in inflammatory and endoplasmic reticulum stress proteins, with a decrease in cellular adhesive proteins, compared to patients without Hunner's lesions. These patients also exhibited a decrease in proteins associated with the Rap1 signaling pathway, which regulates cell proliferation and wound healing. When comparing diseased and non-disease-apparent tissue in patients with Hunner's lesions, diseased tissue exhibited a decrease in ubiquitination proteins. CONCLUSIONS: In summary, there are significant differences in protein expression found in the bladders of interstitial cystitis patients with and without Hunner's lesions, indicating a disturbance in proteins associated with cellular adhesion, proliferation, protein processing, and wound healing.

Targeting the SHIP1 Pathway Fails to Show Treatment Benefit in Interstitial Cystitis/Bladder Pain Syndrome: Lessons Learned from Evaluating Potentially Effective Therapies in This Enigmatic Syndrome.

PURPOSE: In this 12-week, randomized, double-blind, placebo controlled, multicenter, 3-arm, parallel group, phase 3 trial we assessed the effects of a novel SHIP1 activator on bladder pain and urinary symptoms in patients with interstitial cystitis/bladder pain syndrome. MATERIALS AND METHODS: Subjects with interstitial cystitis/bladder pain syndrome and a mean pain score of 5 or greater on an 11-point scale despite treatment were randomized to 100 or 200 mg of an oral SHIP1 activator or placebo once daily for 12 weeks. Maximum pain scores and urinary frequency were recorded in an e-diary. The ICSI (O'Leary-Sant Interstitial Cystitis Symptom Index) and BPIC-SS (Bladder Pain Interstitial Cystitis Symptom Score) questionnaires were administered. Safety was monitored through 12 weeks of treatment. RESULTS: A total of 298 female subjects with moderate to severe symptoms of interstitial cystitis/bladder pain syndrome were treated with 100 or 200 mg SHIP1 activator orally once daily for 12 weeks. Treatment demonstrated no difference in maximum daily bladder pain compared to placebo. There was no treatment benefit over that of placebo in the secondary end points of urinary voiding frequency, the BPIC-SS, the ICSI and a global response assessment. Exploratory analysis in 87 male subjects yielded a similar result, that is no difference from placebo. Treatment was generally well tolerated at both doses. CONCLUSIONS: SHIP1 activation is a safe but ineffective therapeutic approach to interstitial cystitis/bladder pain syndrome. Although this was a negative trial, the important lessons learned from this study in respect to inflammatory phenotype differentiation, including the potential importance of cystoscopy based classification, will improve current treatment in patients with interstitial cystitis/bladder pain syndrome and allow for better future trial design in those with this difficult urological chronic pain syndrome.

Coexisting depressive symptoms do not limit the benefits of chronic neuromodulation: A study of over 200 patients.

AIMS: To examine the relationship between coexisting depressive symptoms and outcomes after staged neuromodulation procedures for refractory urological symptoms. METHODS: Adults who enrolled in a prospective database and completed a Personal Health Questionnaire Depression Scale (PHQ-8) at baseline were reviewed. The PHQ-8 and Generalized Anxiety Disorder (GAD-7) assessed depressive/anxiety symptoms pre and 6 months post device implant. Urological symptoms were assessed with The Interstitial Cystitis Symptom Index/Problem Index (ICSI-PI) and Overactive Bladder Questionnaire (OAB-q) at baseline, 3 and 6 months, and Global Response Assessments (GRA) post implant. Subjects, grouped by PHQ <10 and PHQ ≥10, were compared with Pearson's Chi-square, Fisher's Exact or Wilcoxon rank test, and Spearman's correlations. RESULTS: In 117 PHQ <10 and 84 PHQ ≥10 patients, age differed (mean 59 vs 52 years; P = 0.001), and PHQ <10 had lower GAD-7, ICSI-PI, and OAB-q scores at baseline (P < 0.0001, P = 0.0003, and P < 0.0008, respectively). Implantation rates were similar between groups. Reoperation and complication rates within the first 6 months did not differ, similar proportions (majority) were improved on the GRA at each time point, and ICSI-PI and OAB-q scores improved significantly. PHQ scores only improved significantly for those with baseline PHQ ≥10. Baseline PHQ strongly correlated with GAD-7 at baseline and 6 months, and baseline ICSI-PI. Change in PHQ positively correlated with the change in GAD-7, 6 month ICSI-PI, and change in ICSI-PI from baseline to 6 months. CONCLUSIONS: Coexisting depressive symptoms do not limit the efficacy of neuromodulation and PHQ improvements correlate with improved anxiety and bladder symptoms.

The impact of prior back surgery on neuromodulation outcomes: A review of over 500 patients.

AIMS: To evaluate neuromodulation outcomes in patients with prior back surgery. METHODS: Adults in our prospective observational sacral/pudendal neuromodulation study were retrospectively evaluated. History and operative details were reviewed, and outcomes were measured at 3, 6, 12, and 24 months with overactive bladder questionnaire (OAB q) symptom severity (SS)/health related quality of life (HRQOL), interstitial cystitis symptom/problem indices (ICSI - PI), voiding diaries, and global response assessments (GRA). Data were examined with Pearson's χ2 , Fisher's exact, Wilcoxon rank sum tests, and logistic regression multivariate analysis. RESULTS: Five hundred and sixty patients were evaluated (mean age 58.8 ± 17 years; 83% female; 79% had a sacral lead placed), 109 (19%) had history of back surgery; 66 surgeries were lumbar. Back surgery patients were older (mean 63 ± 15 vs. 58 ± 17 years; P = 0.003) and a higher proportion had urge urinary incontinence (UUI) (64% vs. 50% P = 0.008). Generator implant rates were similar (94% vs. 91%; P = 0.34). OABq-SS and HRQOL and ICSI - PI composite scores did not differ between groups at any time point. On bladder diaries, median incontinence episodes daily at baseline and between stages were worse in the prior back surgery group but all bladder diary parameters improved significantly in both groups with the exception of mean voided volume which only improved significantly in the non-back surgery group. Most patients in both groups reported moderate/marked improvement in overall bladder symptoms. CONCLUSIONS: This study suggests that prior back surgery does not appear to impact clinical outcomes; therefore, neuromodulation may be offered in this patient population.

Predictors of reoperation after sacral neuromodulation: A single institution evaluation of over 400 patients.

AIMS: To explore factors that may predispose patients to reoperation after sacral neuromodulation (SNM). METHODS: Patients enrolled in our longitudinal neuromodulation database were reviewed. Medical records data, and voiding diaries, Interstitial Cystitis Symptom-Problem Indices (ICSI-PI), and Overactive Bladder Questionnaires (OAB-q) at baseline and 3 months were analyzed with Pearson's χ2 , Fisher's Exact test, Wilcoxon rank tests, and multivariable logistic regression. RESULTS: Of 407 patients, 134 (33%) had at least one reoperation over median 28.9 months follow-up (range 1.6-121.7); 78/407 (19%) were revised, and 56/407 (14%) were explanted. The most common reason for reoperation was lack of efficacy/worsening symptoms (n = 87). The reoperations group had a higher proportion of women (P = 0.049), lower mean body mass index (BMI; P = 0.010), more reprogramming events (P < 0.0001), longer median follow-up (P = 0.0008), and higher proportions with interstitial cystitis (P = 0.013), using hormone replacement therapy (P = 0.0004), and complications (P < 0.0001). Both reoperations/no reoperations groups had similar improvements in ICSI-PI (P < 0.0001 for both), OAB-q severity (P < 0.0001 for both) and quality of life (P < 0.0001 for both). On multivariate analysis, only longer follow-up (P = 0.0011; OR 1.048; CI 1.019, 1.078) and having a complication (P < 0.0001; OR 23.2; CI 11.47, 46.75) were significant predictors of reoperations. In women only, using HRT at time of implant was also predictive of reoperation (P = 0.0027; OR 3.09; CI 1.48, 6.46). CONCLUSIONS: In this largest known series to date, one third of the patients required reoperation and the most common reason was lack of efficacy/worsening symptoms. Ongoing study is needed as the technology continues to evolve. Neurourol. Urodynam. 36:354-359, 2017. © 2015 Wiley Periodicals, Inc.

Number of active electrodes at time of staged tined lead interstim implant does not impact clinical outcomes.

OBJECTIVES: To determine: (1) if obtaining motor response on <4 tined lead electrodes at time of placement affects subjective and objective clinical outcome and (2) voltage requirements to elicit motor response at implant and first postoperative visit number based on number of responding electrodes. METHODS: We reviewed our prospective neuromodulation database to identify patients with unilateral S3 lead placement and motor response (bellows ± toe flexion) on stimulation of 1-4 electrodes, then grouped by number of active electrodes at lead placement. Stage 1 success, reoperation and reprogramming rates, mean voltage at implant and first postoperative visit, and Interstitial Cystitis Symptom/Problem Indices (ICSI-PI) were analyzed using Pearson's Chi-square, Fisher's exact, Kruskal-Wallis or Wilcoxon rank tests. RESULTS: Two hundred forty four patients met inclusion criteria, categorized into 1-2 (n = 25), 3 (n = 48), and 4 active electrodes (n = 171). There were no significant differences between groups in terms of age, indications for neuromodulation, or stage 1 success. At implant, patients with <4 active electrodes required higher mean voltages for motor responses (5.9, 4.9, and 3.9 volts for each group respectively; P < 0.0001). Mean voltages for sensory threshold at first postoperative programming were 1.5 ± 1.5, 0.9 ± 1.0, and 0.8 ± 1.0, respectively (P = 0.08). Overall reoperation rates, and reprogramming sessions at 24 months did not differ (P = 0.72 and P = 0.50). ICSI-PI scores improved similarly in all groups. CONCLUSIONS: Motor response on four electrodes is not necessary for successful stage 1 trial. Despite higher voltage requirements in those with <4 active electrodes at implant, this difference was not observed at initial postoperative programming. Neurourol. Urodynam. 35:625-629, 2016. © 2015 Wiley Periodicals, Inc.

The role of social constraints and catastrophizing in pelvic and urogenital pain.

INTRODUCTION AND HYPOTHESIS: Pelvic and urogenital pain is complex and highly prevalent in women, and increased attention to psychosocial influences can guide more effective treatments. This study tested the hypothesis that social constraints (the perception that close others inhibit, discourage, or dissuade a person from disclosing one's feelings or talking about one's problems) would be associated with distress, pain, and problems with functioning, beyond the influence of the widely recognized risk factor of pain catastrophizing. METHODS: A total of 122 women completed psychosocial and pain questionnaires during an initial evaluation at a multidisciplinary urology center. Correlational and multiple regression analyses examined pain catastrophizing and social constraints in association with general distress, general pain severity, urogenital pain, and pain interference with functioning. RESULTS: In zero-order correlations, pain catastrophizing and social constraints were significantly associated with all pain measures (p < 0.05) and distress. In regressions, both pain catastrophizing and social constraints were simultaneously independent predictors of general distress (ß = 0.48 and 0.33, p < 0.001 respectively), general pain severity (ß = 0.55 and 0.21, p < 0.001 and 0.01 respectively), and pain interference with functioning (ß = 0.65, p < 0.001, and ß = 0.16, p < 0.05 respectively), and together explained a moderate portion of the variance in outcome variables. Pain catastrophizing (but not social constraints) also significantly predicted urogenital pain (ß = 0.43, p < 0.001). CONCLUSIONS: Both pain catastrophizing and social constraints are important to the experience of pelvic and urogenital pain, and effective pain treatment should include attention to these psychological and social factors.

Evaluating the Siebens Model in Geriatric-Stroke Inpatient Rehabilitation to Reduce Institutionalization and Acute-Care Readmissions.

BACKGROUND: The objective of the study is to evaluate the use of Siebens Domain Management Model (SDMM) in geriatric-stroke patients during inpatient rehabilitation (IR) to increase functional independence, and to reduce institutionalization and acute-care readmissions, which are quality indicators under the U.S. Affordable Care Act. METHODS: In 2010 (preintervention), 66 stroke patients aged more than 75 years were admitted to an IR facility, on average, 8.8 days postacute care. In 2012 (postintervention), 58 patients aged more than 75 years were admitted to the same IR facility, on average, 5.0 days postacute care. SDMM intervention involved weekly adjustments of clinical care focused on potential barriers to discharge home. Functional Independence Measure (FIM) efficiency, length of stay (LOS), and disposition rates to community or home, acute care, and long-term care were compared pre- and postintervention within facility, and facility data were compared to national case-mix-group-adjusted data from the Uniform Data System for Medical Rehabilitation for both years (2010/2012). RESULTS: Pre- and postintervention demographics and prestroke living support/setting were similar, but preintervention had on average 4 more days LOS in IR and 3.8 more days to IR onset. There were significantly more discharges to community in postintervention (79.3%) compared to preintervention (56.9%) (chi-square = 6.02, P < .013). The preintervention group did not significantly differ from 2010 national data whereas the postintervention/2012 group significantly differed from 2012 national data for higher FIM efficiency (t = -3.1, P < .002) and more discharges to community (chi-square = 19.7; P < .0001). From 2010 to 2012, there were 3.8 times more discharges to community (chi-square = 8535; P < .0001) and 6 times fewer acute-care dispositions postintervention than nationally (chi-square = 58.7; P < .0001).

Evaluating Siebens Domain Management Model for inpatient rehabilitation to increase functional independence and discharge rate to home in geriatric patients.

OBJECTIVE: To evaluate the Siebens Domain Management Model (SDMM) for geriatric inpatient rehabilitation (IR) to increase functional independence and dispositions to home. DESIGN: Before and after study. SETTING: IR facility. PARTICIPANTS: During 2010 (preintervention), 429 patients aged ≥75 years who were on average admitted to IR 8.2 days postacute care, and during 2012 (postintervention), 524 patients aged ≥75 years who were on average admitted to IR 5.5 days postacute care. Case-mix group (CMG) comorbidity tier severity, preadmission living setting, and living support were similar in both groups. INTERVENTION: The SDMM involving weekly adjustments of IR care focused on potential barriers to discharge home. MAIN OUTCOME MEASURES: FIM efficiency, length of stay (LOS), and disposition rates to community/home, acute care, and long-term care (LTC) to compare pre-/postintervention facility data and comparison of facility to national CMG-adjusted data from the Uniform Data System for Medical Rehabilitation for both years (2010/2012). RESULTS: Pre-/postintervention group admission FIM scores were similar (t=2.96, P<.003), but the preintervention group had on average 2.6 days greater LOS during IR and greater time to onset of IR (8.2 vs 5.5d) from acute care. Preintervention FIM efficiency was 2.1, whereas postintervention FIM efficiency was 2.76, a significant difference (t=4.1, P<.0001). There were significantly more discharges to the community in the postintervention group (74.4%) than the preintervention group (58.5%, χ(2)=26.2, P<.0001). There were significantly fewer patients discharged to LTC in the postintervention group (χ(2)=30.47, P<.0001). The preintervention group did not significantly differ from the 2010 national data, but the postintervention group significantly differed from the 2012 national data for both greater FIM efficiency (t=-5.5, P<.0001) and greater discharge to community (χ(2)=34, P<.0001). LOS decreased by 2.6 days in the postintervention group compared with the preintervention group, whereas LOS decreased by only 0.6 days nationally from 2010 to 2012, a significant difference with postintervention LOS lower than the national data (t=31.1, P<.0001). CONCLUSIONS: Use of the SDMM during IR in geriatric patients is associated with increased functional independence and discharges to home/community and reduced institutionalization.

Percutaneous tibial nerve stimulation and sacral neuromodulation: an update.

Neuromodulation is an important treatment modality for a variety of pelvic floor disorders. Percutaneous tibial nerve stimulation (PTNS) and sacral neuromodulation (SNM) are currently the two approved methods for delivering this therapy. Percutaneous tibial nerve stimulation is a minimally invasive office-based procedure that has shown efficacy in the treatment of overactive bladder, fecal incontinence, and pelvic pain. It has the advantage of minimal side effects but is limited by the need for patients to make weekly office visits to receive the series of treatments. Sacral neuromodulation uses an implanted device that stimulates the S3 nerve root and can improve symptoms of overactive bladder, non-obstructive urinary retention, fecal incontinence, and pelvic pain. This paper will review the most recent literature regarding this topic and discuss their advantages and limitations and recent innovations in their use.

Proof of concept trial on changes in current perception threshold after sacral neuromodulation.

OBJECTIVES: Sacral neuromodulation (SNM) is theorized to alter the neural pathways that mediate bladder and urethral sensation. We hypothesize that SNM affects current perception thresholds (CPTs) of afferent sensory nerve pathways. MATERIALS AND METHODS: Eight women were enrolled and completed pre and postoperative testing. A CPT device was used to measure CPT at 5 Hz (C-fibers), 250 Hz (Aδ-fibers), and 2000 Hz (Aß-fibers) on the urethra and bladder prior to and one month after SNM. Index finger readings at 2000 Hz served as controls. RESULTS: SNM had the greatest effect on the bladder at 250 and 2000 Hz, suggesting reduced bladder sensitivity. Significant changes in CPT were seen in the bladder at 2000 Hz with a decrease in sensitivity (p = 0.033). CPT testing was well tolerated, and no adverse events were identified. CONCLUSIONS: With a measurable change in CPT values for Aδ-fibers and Aß-fibers, these findings suggest that SNM modulates large myelinated afferent fibers in the bladder. Notably, little or no changes were found in the C-fiber CPT measurements. More research is needed with a larger sample size to determine the significance of these findings.