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1.
Neurourol Urodyn ; 2024 Jun 03.
Article in English | MEDLINE | ID: mdl-38828830

ABSTRACT

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.

2.
Am J Clin Exp Urol ; 12(2): 110-118, 2024.
Article in English | MEDLINE | ID: mdl-38736620

ABSTRACT

PURPOSE: Interstitial cystitis/bladder pain syndrome (IC/BPS) is a condition characterized in part by urinary urgency, frequency, and pain. There is a strong interest in gathering more data to compare and assess the differences in characteristics based on the presence of Hunner's lesions in patients with IC/BPS. MATERIALS AND METHODS: Using a nationwide crowdsource effort, we collected surveys and urine samples from patients with a history of IC/BPS. Participants completed the Interstitial Cystitis Symptom Index (ICSI) and Problem Index (ICPI), Overactive Bladder questionnaire (OABq SF), and pain scores. In addition, participants reported any co-morbidities and lifestyle modifications. Urinary cytokine levels were measured and compared to symptom severity. RESULTS: 491 participants enrolled: 119 with history of ulcerative Hunner's lesions (UIC), 372 reported no lesions (NHIC), and 2 unknowns. 96.3% were female, and prevalence of UIC was equal for both genders. Average age was higher for UIC vs. NHIC group (P = 0.011), as was the duration since diagnosis (P < 0.001). Symptom scores were elevated in UIC patients (P < 0.001). Both groups widely implemented lifestyle modifications, with dietary changes being most prevalent (70.1%), followed by prescription medication usage (63.1%). More UIC compared to NHIC participants experienced co-morbidities (P = 0.010). Urine samples were analyzed for GRO, IL-6, IL-8, and MCP-1. MCP-1 levels were significantly higher in UIC patients (P = 0.044). Weak positive correlation was found between cytokines and symptom scores. CONCLUSIONS: Patients with UIC and NHIC from across the United States displayed distinct phenotypic and urine biological characteristics. These findings contribute to increased understanding of IC/BPS and may aid in improving our knowledge of the condition.

3.
Adv Ther ; 41(7): 2635-2654, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38748331

ABSTRACT

The tibial nerve is an established target for neuromodulation in the management of overactive bladder (OAB) and its associated symptoms, including urge urinary incontinence (UUI). Technologies are currently available to deliver tibial nerve stimulation (TNS) through percutaneous devices or through implantable devices. The benefits and safety of percutaneous TNS have led to it as a guideline-recommended therapy. However, patient compliance is limited by the burden of weekly office visits and the need for maintenance treatments. Further, insurance often only covers a limited number of lifetime visits for percutaneous TNS. These factors and others have led to the development, study, and utilization of implantable TNS devices. Implantable TNS devices deliver the same therapeutic mechanism of action for nerve stimulation with a permanent implanted device that provides at-home stimulation rather than in-office therapy delivery. Additionally, there is an added potential for dynamic and patient-centered stimulation. There is a large body of high-quality evidence published for TNS, including numerous randomized controlled trials published on percutaneous TNS which have consistently demonstrated superior efficacy to sham and similar efficacy to that of anticholinergic medications. Percutaneous TNS also performs better than conservative therapy including pelvic floor muscle training. The percutaneous and implantable approaches deliver nerve stimulation to the same target nerve, using the same mechanism of action. Therefore, data from randomized trials of percutaneous TNS are informative for implantable TNS devices. At the time of this article's publication, at least two implantable TNS devices have received marketing authorization from the Food and Drug Administration (FDA). The objective of this review is to discuss the mechanism of action for TNS and summarize the published literature from clinical trials of percutaneous TNS as a foundation of high-quality evidence for implantable devices targeting the tibial nerve.


Subject(s)
Randomized Controlled Trials as Topic , Tibial Nerve , Urinary Bladder, Overactive , Urinary Incontinence, Urge , Humans , Urinary Bladder, Overactive/therapy , Urinary Incontinence, Urge/therapy , Transcutaneous Electric Nerve Stimulation/methods , Transcutaneous Electric Nerve Stimulation/instrumentation , Electric Stimulation Therapy/methods , Electric Stimulation Therapy/instrumentation , Treatment Outcome , Female
4.
Urology ; 2024 Apr 25.
Article in English | MEDLINE | ID: mdl-38677373

ABSTRACT

OBJECTIVE: To improve diagnosis of interstitial cystitis (IC)/bladder pain syndrome(IC) we hereby developed an improved IC risk classification using machine learning algorithms. METHODS: A national crowdsourcing resulted in 1264 urine samples consisting of 536 IC (513 female, 21 male, 2 unspecified), and 728 age-matched controls (318 female, 402 male, 8 unspecified) with corresponding patient-reported outcome (PRO) pain and symptom scores. In addition, 296 urine samples were collected at three academic centers: 78 IC (71 female, 7 male) and 218 controls (148 female, 68 male, 2 unspecified). Urinary cytokine biomarker levels were determined using Luminex assay. A machine learning predictive classification model, termed the Interstitial Cystitis Personalized Inflammation Symptom (IC-PIS) Score, that utilizes PRO and cytokine levels, was generated and compared to a challenger model. RESULTS: The top-performing model using biomarker measurements and PROs (area under the curve [AUC]=0.87) was a support vector classifier, which scored better at predicting IC than PROs alone (AUC=0.83). While biomarkers alone (AUC=0.58) did not exhibit strong predictive performance, their combination with PROs produced an improved predictive effect. CONCLUSION: IC-PIS represents a novel classification model designed to enhance the diagnostic accuracy of IC/bladder pain syndrome by integrating PROs and urine biomarkers. The innovative approach to sample collection logistics, coupled with one of the largest crowdsourced biomarker development studies utilizing ambient shipping methods across the US, underscores the robustness and scalability of our findings.

5.
Digit Health ; 9: 20552076231216280, 2023.
Article in English | MEDLINE | ID: mdl-38025103

ABSTRACT

Introduction: Interstitial cystitis/bladder pain syndrome (IC/BPS) manifests as urinary symptoms including urgency, frequency, and pain. The IP4IC Study aimed to establish a urine-based biomarker score for diagnosing IC/BPS. To accomplish this objective, we investigated the parallels and variances between patients enrolled via physician/hospital clinics and those recruited through online crowdsourcing. Methods: Through a nationwide crowdsource effort, we collected surveys from patients with history of IC/BPS. Study participants were asked to complete the validated instruments of Interstitial Cystitis Symptom Index (ICSI) and Interstitial Cystitis Problem Index (ICPI), as well as provide demographic information. We then compared the survey responses of patients recruited through crowdsourcing with those recruited from three specialized tertiary care urology clinics engaged in clinical research. Results: Survey responses of 1300 participants were collected from all 50 states of the USA via crowdsourcing and 319 from a clinical setting. ICSI and ICPI were similar for IC/BPS patients diagnosed by the physicians in clinic and self-reported by subjects via crowdsourcing stating they have a history of previous physician diagnosis of IC/BPS. Surprisingly, ICSI and ICPI were significantly lower in crowdsourced control than in-clinic control subjects. Conclusion: The IP4IC Study provides valuable insights into the similarities and differences between patients recruited through clinics and those recruited through online crowdsourcing. There were no significant differences in disease symptoms among these groups. Individuals who express an interest in digital health research and self-identify as having been previously diagnosed by physicians with IC/BPS can be regarded as reliable candidates for crowdsourcing research.

6.
Urol Case Rep ; 51: 102575, 2023 Nov.
Article in English | MEDLINE | ID: mdl-37829494

ABSTRACT

A 45-year-old male with diabetes, hypertension and hyperlipidemia was referred to urology due to persistent symptoms of urinary frequency, urgency, nocturia, erectile dysfunction, and constant pain localized to the bladder, pelvis, and perineal area, 3-4 months after SARS-CoV-2 infection. A bladder biopsy showed urothelial mucosa and submucosa with hemorrhage and fibrin microthrombi in blood vessels. Hydrodistention of the bladder and pelvic floor physical therapy resolved symptoms, though bladder and pain symptoms returned upon reinfection with SARS-CoV-2. Urinalysis revealed elevated urinary interleukin-8, which may indicate localized bladder inflammation.

8.
Urol Case Rep ; 46: 102307, 2023 Jan.
Article in English | MEDLINE | ID: mdl-36606098

ABSTRACT

This is a report of a women who failed 2 surgical repairs of vesicovaginal fistula secondary to refractory bladder spasms. After each surgical procedure - the hysterectomy and subsequent fistula repairs - the patient reported severe bladder spasms refractory to medical management. Our treatment was intradetrusor onabotuliniumtoxinA injections 4 weeks prior to a planned surgical fistula repair. The patient had successful vaginal approach fistula repair and has not required any subsequent overactive bladder (OAB) treatment.

9.
Neurourol Urodyn ; 42(2): 427-435, 2023 02.
Article in English | MEDLINE | ID: mdl-36573835

ABSTRACT

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.


Subject(s)
Transcutaneous Electric Nerve Stimulation , Urinary Bladder, Overactive , Humans , Urinary Bladder, Overactive/therapy , Transcutaneous Electric Nerve Stimulation/adverse effects , Transcutaneous Electric Nerve Stimulation/methods , Quality of Life , Pilot Projects , Urinary Incontinence, Urge/therapy , Treatment Outcome , Electrodes , Tibial Nerve
10.
Eur Urol Open Sci ; 46: 68-74, 2022 Dec.
Article in English | MEDLINE | ID: mdl-36245790

ABSTRACT

Background: Literature is sparse on COVID-19-associated cystitis (CAC), a novel condition comprising frequency, urgency, and nocturia after COVID-19 infection. Objective: To determine the incidence of CAC and correlation with SARS-CoV-2 antibody levels. Design setting and participants: This was a retrospective study in which urinary symptoms were scored using the International Consultation on Incontinence Questionnaire-overactive bladder (ICIQ-OAB) at three time points: before the pandemic (January 2020), 2 mo after COVID-19 infection (if applicable), and at the time of the study (May 2021). The setting was a regional health care system. The 18 785 healthcare employees who took part in the BLAST COVID study group were invited to participate, of whom 1895 responded. Outcome measurements and statistical analysis: The outcome measured was the percentage of COVID-positive patients with a significant change on ICIQ-OAB over time. Pearson's χ2 test was used for comparison of categorical data, and one-way analysis of variance for continuous data and multivariate analysis. A sample size of 618 was calculated for power of 80% and α = 0.05. Results and limitations: Of the 1895 participants, 31.9% (n = 605) were positive for COVID-19 according to positive serology or a polymerase chain reaction (PCR) test. Of these, 492 were PCR-positive and had 2-mo postinfection data, with 36.4% (179/492) reporting an increase of ≥1 point on the ICIQ-OAB compared to baseline (before the pandemic), with de novo OAB in 22% of these cases (40/179). Comparison of symptoms between baseline and the study time revealed that 27.4% (31/113) of those with positive serology only (asymptomatic COVID) and 37.8% (186/492) of those with PCR positivity (symptomatic COVID) had an increase of ≥1 point on the ICIQ-OAB, compared to 15.8% (n = 204) of uninfected patients, with odds ratios of 2.013 (95% confidence interval [CI] 1.294-3.138; p = 0.0015) and 3.236 (95% CI 2.548-4.080; p < 0.0001), respectively. The retrospective nature of the study and the volunteer sample are limitations. Conclusions: COVID-19 infection increases the risk of developing new or worsening OAB symptoms. Patient summary: We compared overactive bladder symptoms in a large group of participants between individuals with and without a previous COVID-19 infection. We found that symptomatic infection was associated with a three times greater risk of developing new or worsening overactive bladder symptoms among COVID-19 patients.

11.
Urol Case Rep ; 45: 102189, 2022 Nov.
Article in English | MEDLINE | ID: mdl-36033161

ABSTRACT

Post orgasmic illness syndrome (POIS) is increasingly being recognized as a debilitating cause of sexual dysfunction in males. It is often misdiagnosed due to its unfamiliarity to providers, resulting in numerous potentially unnecessary tests and treatments. Currently, there is no known single most effective treatment, but several case reports suggest desensitization, hormonal therapy, and other treatment modalities may be useful. However, these treatments are experimental in nature and have not been evaluated in placebo-controlled trials. We report on the use of a simple over-the-counter antihistamine in the management of POIS.

12.
J Sex Med ; 19(6): 995-1001, 2022 06.
Article in English | MEDLINE | ID: mdl-35459633

ABSTRACT

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.


Subject(s)
Pudendal Nerve , Pudendal Neuralgia , Female , Humans , Male , Middle Aged , Pelvic Pain/surgery , Pudendal Neuralgia/surgery , Retrospective Studies , Seizures
13.
Can J Urol ; 29(1): 11032-11035, 2022 02.
Article in English | MEDLINE | ID: mdl-35150228

ABSTRACT

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.


Subject(s)
Chronic Pain , Vulvodynia , Chronic Pain/therapy , Humans , Vulvodynia/therapy
14.
Urol Pract ; 9(6): 561-566, 2022 Nov.
Article in English | MEDLINE | ID: mdl-37145804

ABSTRACT

INTRODUCTION: Clinical research can be expensive and time consuming due to high associated costs and/or duration of the study. We hypothesized that urine sample collection using online recruitment and engagement of research participants via social medial has the potential to reach a large population in a small timeframe, at a reasonable cost. METHODS: We performed a retrospective cost analysis of a cohort study comparing cost per sample and time per sample for both online and clinically recruited participants for urine sample collection. During this time, cost data were collected based on study associated costs from invoices and budget spreadsheets. The data were subsequently analyzed using descriptive statistics. RESULTS: Each sample collection kit contained 3 urine cups, 1 for the disease sample and 2 for control samples. Out of the 3,576 (1,192 disease + 2,384 control) total sample cups mailed, 1,254 (695 control) samples were returned. Comparatively, the 2 clinical sites collected 305 samples. Although the initial startup cost of online recruitment was higher, cost per sample for online recruited was found to be $81.45 compared to $398.14 for clinic sample. CONCLUSIONS: We conducted a nationwide, contactless, urine sample collection through online recruitment in the midst of the COVID-19 pandemic. Results were compared with the samples collected in the clinical setting. Online recruitment can be utilized to collect urine samples rapidly, efficiently, and at a cost per sample that was 20% of an in-person clinic, and without risk of COVID-19 exposure.

15.
Neurourol Urodyn ; 40(7): 1730-1739, 2021 09.
Article in English | MEDLINE | ID: mdl-34288094

ABSTRACT

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.


Subject(s)
Cystitis, Interstitial , Adolescent , Adult , Cystitis, Interstitial/diagnosis , Cystitis, Interstitial/drug therapy , Double-Blind Method , Female , Humans , Lidocaine/adverse effects , Pelvic Pain , Treatment Outcome
16.
Neurourol Urodyn ; 40(6): 1670-1677, 2021 08.
Article in English | MEDLINE | ID: mdl-34196055

ABSTRACT

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®.


Subject(s)
Pudendal Nerve , Pudendal Neuralgia , Female , Humans , Male , Middle Aged , Pelvic Floor , Pelvic Pain/therapy , Pudendal Neuralgia/complications , Pudendal Neuralgia/therapy , Retrospective Studies
17.
J Sex Med ; 18(4): 665-697, 2021 04.
Article in English | MEDLINE | ID: mdl-33612417

ABSTRACT

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.


Subject(s)
Sexual Dysfunctions, Psychological , Sexual Health , Arousal , Consensus , Female , Genitalia , Humans , Paresthesia , Pelvis
18.
Female Pelvic Med Reconstr Surg ; 27(1): e18-e21, 2021 01 01.
Article in English | MEDLINE | ID: mdl-31697265

ABSTRACT

OBJECTIVES: This study aimed to evaluate changes in validated symptom scores at intake and discharge in women undergoing pelvic floor physical therapy (PFPT) for pain and other pelvic floor symptoms. METHODS: Consecutive women starting PFPT during 1 year were reviewed. History, demographics, and Pelvic Floor Distress Inventory Questionnaire - Short Form 20 (PFDI) total and domain scores (Pelvic Organ Prolapse Distress Inventory-6, Urogenital Distress Inventory-6, Colorectal-Anal Distress Inventory-8), Pelvic Floor Impact Questionnaire (PFIQ-7), and pain levels on a numeric rating scale (NRS) were collected at intake and discharge. Data were analyzed with descriptive statistics and sign tests. RESULTS: Of 474 women, mean age was 50.3 ± 16.7 years (range, 18-87 years) and the most common indication for PFPT was pelvic pain (208/474; 43.9%). In women with complete data, pretreatment to posttreatment median scores improved on the PFDI (77.3 vs 41.8; P < 0.0001), Urogenital Distress Inventory (37.5 vs 16.0; P < 0.0001), and PFIQ (58.0 vs 19.0; P < 0.0001), and the minimal clinically important difference was met for the PFDI, PFIQ, and Colorectal-Anal Distress Inventory. Women with primarily pelvic pain (n = 208) achieved significant improvements in PFDI, PFIQ, and NRS scores (P < 0.0001 for all) as well as the minimal clinically important difference for these measures. Pain patients with a history of pelvic surgery (n = 50) also had significant improvements in PFIQ and NRS but not PFDI scores. CONCLUSIONS: Most women referred to PFPT demonstrated symptom improvements as measured by validated instruments.


Subject(s)
Pelvic Floor Disorders/therapy , Pelvic Pain/therapy , Physical Therapy Modalities , Quality of Life , Adult , Aged , Female , Humans , Middle Aged , Prospective Studies , Surveys and Questionnaires , Treatment Outcome
19.
Female Pelvic Med Reconstr Surg ; 27(1): e91-e95, 2021 01 01.
Article in English | MEDLINE | ID: mdl-32217920

ABSTRACT

OBJECTIVE: This study aimed to determine whether small fiber polyneuropathy (SFPN) diagnosis differs between Hunner lesion interstitial cystitis/bladder pain syndrome (HL IC/BPS) and non-Hunner lesion IC/BPS (NHL IC/BPS). METHODS: This was a pilot study of 20 women with IC/BPS. Results from baseline questionnaires, such as Genitourinary Pain Index, Interstitial Cystitis Symptom Index/Interstitial Cystitis Problem Index (ICSI/ICPI), Patient Health Questionnaire-2, were collected.Two punch biopsies were performed on each patient: distal leg and thigh. The samples were evaluated for intraepidermal nerve fiber density. One intraepidermal nerve fiber density less than the fifth percentile, regardless of site, indicated a positive SPFN diagnosis. RESULTS: Twenty patients were enrolled; 10 HL IC/BPS and 10 NHL IC/BPS. The HL IC/BPS group was found to be significantly older than the NHL IC/BPS group (63 vs 48 years, P = 0.007). No significant differences were found in employment or relationship statuses, or in levels of education or comorbidities between the 2 groups.Sixty percent (6/10) of patients had SFPN in the NHL IC/BPS group compared with 40% (4/10) in the HL IC/BPS group. No significant differences were seen in SFPN positivity (P = 0.3) or Genitourinary Pain Index, Patient Health Questionnaire-2, or Interstitial Cystitis Symptom Index/Interstitial Cystitis Problem Index scores between the NHL and HL IC/BPS groups. CONCLUSIONS: Similar to previously published studies, 60% of NHL IC/BPS patients in this cohort were positive for SFPN compared with only 40% of the HL IC/BPS patients. Larger studies may be needed to realize the full impact of SFPN in IC/BPS.


Subject(s)
Cystitis, Interstitial/complications , Pelvic Pain/etiology , Small Fiber Neuropathy/complications , Female , Humans , Middle Aged , Pilot Projects , Severity of Illness Index , Small Fiber Neuropathy/diagnosis , Small Fiber Neuropathy/pathology , Surveys and Questionnaires , Syndrome
20.
Turk J Urol ; 47(5): 375-385, 2021 Sep.
Article in English | MEDLINE | ID: mdl-35118977

ABSTRACT

Neuromodulation has become a valid therapeutic option for patients with various lower urinary tract disorders. In clinical practice, the most used and recommended neuromodulation techniques are sacral neuromodulation (SNM), pudendal neuromodulation (PN), and percutaneous tibial nerve stimulation (PTNS). There are many theories concerning the mechanism of action of neuromodulation. Although SNM, PN, and PTNS show their activities through different nerve roots, all provide central and peripheral nervous system modulations. SNM has been approved for the treatment of overactive bladder (OAB), nonobstructive urinary retention, and fecal incontinence, while PTNS has been approved for OAB treatment. However, they are also used off-label in other urinary and nonurinary pelvic floor disorders, such as neurogenic lower urinary system disorder, interstitial cystitis, chronic pelvic pain, and sexual dysfunction. Minor and nonsurgical reversible complications are usually seen after neuromodulation techniques. In addition, in the last few years, there have been various developments in neuromodulation technology. Some of the examples of these developments are rechargeable batteries with wireless charging, improvements in programing, less invasive single-stage implantation in outpatient settings, and lower-cost new devices. We performed a literature search using Medline (PubMed), Cochrane Library, EMBASE, and Google scholar databases in the English language from January 2010 to February 2021. We included reviews, meta-analyses, randomized controlled trials, and prospective and retrospective studies to evaluate the activities and reliability of SNM, PN, and PTNS and the developments in this area in the last decade based on the current literature.

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