Prevalence of the use of oral nutritional supplements among acute inpatients at risk of malnutrition and associated patient characteristics.

AIM: To provide a snapshot of the current use of oral nutritional supplements, its association with inpatient characteristics, and with a focus on the role of nursing monitoring of food intake and implementing nutritional interventions for patients with low intake. DESIGN: Retrospective cohort study. METHODS: The study collected data from a hospital database regarding oral nutritional supplement initiation and variables of patients hospitalised in internal medicine departments, who did not receive enteral or parenteral nutrition. RESULTS: Of the 5155 admissions, 1087 fulfilled the inclusion criteria (47% female; mean age, 72.4 ± 14.6 years; mean length of stay, 14.6 ± 11.4 days). Sufficient food intake reporting was noted in 74.6% of the patients; of these 17% had decreased intake. Oral nutritional supplements and non-oral nutritional supplements groups did not differ in terms of sex, age, length of stay, Charlson Comorbidity Index, proportion of nursing reports, and absence of intake monitoring. Oral nutritional supplements were initiated in 31.9% of patients with a Malnutrition Universal Screening Tool score ≥2 and in 34.6% with decreased food intake. On multivariable analysis, hypoalbuminemia (adjusted odds ratio, 3.70), decreased food intake (adjusted odds ratio, 3.38), Malnutrition Universal Screening Tool score ≥2 (adjusted odds ratio, 2.10), and age <70 years (adjusted odds ratio, 1.56) were significantly associated with oral nutritional supplements use. CONCLUSION: The prevalence of oral nutritional intervention was suboptimal in patients at risk of malnutrition during acute hospitalisation, although decreased food intake and Malnutrition Universal Screening Tool score ≥2 independently increased the probability of oral nutritional supplements initiation. RELEVANCE IN CLINICAL PRACTICE: Understanding the clinical practice and nursing impact of care management in relation to nutritional intervention can assist in reviewing and improving patient care. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE IMPACT (ADDRESSING): This study informs clinical management and influences nursing practice standards related to assessing, monitoring, and managing malnutrition risk. IMPACT: The study impacts the quality of care for patients at risk of malnutrition. REPORTING METHOD: We adhered to the STROBE Checklist for cohort studies. PATIENT OR PUBLIC CONTRIBUTION: No Patient or Public Contribution.

A novel on-demand therapy for lifelong premature ejaculation using a miniature transperineal electrical stimulator-the vPatch: an as-treated analysis.

BACKGROUND: While premature ejaculation (PE) is a common and disturbing sexual dysfunction in men, current available treatment modalities have limited efficacy and low treatment adherence. AIM: To assess the feasibility, safety, and efficacy of the vPatch, a miniaturized on-demand perineal transcutaneous electrical stimulation device for treating PE. METHODS: This prospective bicenter international first-in-human clinical study consisted of 2 arms, was sham controlled, and had a randomized double-blind design. In terms of statistical power calculation, 59 patients aged 21 to 56 years (mean ± SD, 39.8 ± 9.28) with lifelong PE were included. During the initial visit, intravaginal ejaculatory latency time (IELT) was measured over a 2-week run-in period. Eligibility was confirmed in visit 2, based on IELT values, medical and sexual history, and patients' individualized sensory and motor activation thresholds during perineal stimulation with the vPatch. Patients were randomized to the active (vPatch) and sham device groups in a 2:1 ratio, respectively. The vPatch device's safety profile was determined by comparing the incidence of treatment-emergent adverse events. During visit 3, IELTs, Clinical Global Impression of Change scores, and Premature Ejaculation Profile questionnaire outcomes were recorded. Primary end points assessed vPatch device efficacy as mean change in geometric mean IELT; each person was compared with himself, with and without the device, and the sham group was compared with the active group. OUTCOMES: Outcomes included changes in IELT and Premature Ejaculation Profile before and after treatment, last visit Clinical Global Impression of Change scores, and vPatch safety profile. RESULTS: Of 59 patients, 51 completed the study: 34 in the active group and 17 in the sham group. The baseline geometric mean IELT significantly increased from 67 to 123 seconds (P < .01) in the active group, as compared with an insignificant increase from 63 to 81 seconds (P = .17) in the sham group. The increase in mean IELT in the active group was significantly higher than in the sham group (56 vs 18 seconds, P = .01). IELT significantly increased by 3.1 times in the active vs sham group. The mean ratio of fold change (active:sham) was 1.4, significantly different from 1.0 (P = .02). No serious adverse events were reported. CLINICAL IMPLICATIONS: Therapeutic use of the vPatch during coitus may become an on-demand, noninvasive, and drug-free treatment for PE. STRENGTHS AND LIMITATIONS: To our knowledge, this is the first rigorous study investigating whether transcutaneous electrical stimulation during coitus could improve the symptoms of men with lifelong PE. The study is limited by the small number of patients, the exclusion of patients with acquired PE, the short-term follow up, and the use of a device based on a theoretic mechanism of action. CONCLUSION: We demonstrated the possibility to treat lifelong PE by prolonging coitus on demand, using electric stimulation of ejaculation muscles with the vPatch.Clinical trial registration: NCT03942367 (ClinicalTrials.gov).

Maintenance Laser Treatment for Vaginal Looseness and Sexual Dysfunction: A Double-blinded Randomized Controlled Trial.

BACKGROUND: Vaginal looseness and decreased sensation during intercourse is prevalent in up to 30%-55% of premenopausal women. The efficacy and safety of CO2 laser have been demonstrated for these indications; however, the effect is temporary, up to 6-12 months. No studies regarding the efficacy and safety of adjuvant laser treatments have been conducted to date. AIM: To evaluate the efficacy and safety of a single maintenance CO2 laser treatment in women with vaginal looseness and a concurrent decline in sexual sensation during intercourse. METHODS: This prospective double-blinded randomized controlled trial included premenopausal women who experienced significant temporary improvement in symptoms following previous treatment with CO2 laser due to the abovementioned indications. Participants were randomized to either a single CO2 laser treatment or a single sham treatment. OUTCOMES: Treatment efficacy evaluated with the female sexual function index (FSFI) and the vaginal health index (VHI). RESULTS: Overall, 119 women were included in the study. Mean VHI and FSFI scores were significantly higher in the study group compared to the control group at three months post-treatment (17.34±1.39 vs 12.86±2.23, P = .023 and 30.93±1.79 vs 25.78±1.87, P = .044, respectively). In the study group, both VHI and FSFI returned to baseline at six months post-treatment. The median rate of sexual intercourse per month was increased in the study group at three months post-treatment (8 vs 4, P = .011), and returned to baseline at six months post-treatment. CLINICAL IMPLICATIONS: Maintenance laser treatment provides a temporary non-surgical alternative for women with vaginal looseness and associated sexual dysfunction, though treatment effect seems to be limited to less than 6 months, requiring additional maintenance sessions. STRENGTHS AND LIMITATIONS: The strengths of the current study include a randomized-sham controlled design. Furthermore, VHI was used as an objective evaluation tool, in addition to the FSFI, and assessment of the rate of sexual intercourse. The homogeneity and the relatively small sample size of the cohort is a limitation, and calls for caution in interpretation of the results, and the use of CO2 laser treatment in different age groups and populations. CONCLUSION: A single maintenance laser treatment in women who previously underwent successful treatment with laser is an effective, well-tolerated, and safe procedure for treating symptoms of vaginal looseness and sexual dysfunction, though effects are temporary. Lauterbach R, Aharoni S, Farago N, et al. Maintenance Laser Treatment for Vaginal Looseness and Sexual Dysfunction: A Double-blinded Randomized Controlled Trial. J Sex Med 2022;19:1404-1411.

The efficacy and safety of a single maintenance laser treatment for stress urinary incontinence: a double-blinded randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: To evaluate the efficacy and safety of a single carbon dioxide (CO2) laser maintenance treatment in women previously treated successfully with laser for stress urinary incontinence (SUI), who have demonstrated a decline in treatment effect. METHODS: Women aged 40-70 years who experienced temporary significant improvement in symptoms following CO2 laser treatments for SUI were randomized to either the treatment group or the sham treatment control group. Cough test results, 1-h pad weights and scores on the Urogenital Distress Inventory (UDI6), the International Consultation of Incontinence Questionnaire (ICIQ-UI) and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) were obtained at baseline and 3 and 6 months. RESULTS: Of 183 women screened, 131 were included in the final analysis. Demographic characteristics and baseline measures in the outcome tests were similar between the groups. Statistically significant improvements were demonstrated in the study compared to the control group at 3 months post-treatment in positive cough test (44.4% vs. 79.4%, P = 0.002), mean pad weight test (2.3 g ± 1.3 vs. 5.6 ± 1.1, P < 0.001), mean UDI-6(24.7 ± 12.1 vs. 45.1 ± 13.6 SD, P = 0.004), mean ICIQ-UI (16.5 ± 4.3 vs. 10.3 + 3.8, P = 0.003) and mean PISQ-12 (21.3 ± 6.8 vs. 36.6 ± 7.5, P = 0.003). However, values at 6 months post-treatment were similar to those at baseline. CONCLUSIONS: Our results suggest that a single maintenance laser treatment for reducing symptoms of SUI is transiently effective, well tolerated and safe. This treatment modality provides alternative non-surgical therapy for women with SUI.

In Vitro Fertilization Entails a High Prevalence of Erectile and Male Sexual Dysfunction: A Prospective Case-Control Study.

PURPOSE: We evaluated the effect of in vitro fertilization (IVF) on sexual function in men, particularly for erectile dysfunction. MATERIALS AND METHODS: A prospective case-control study at a tertiary medical center. The study group comprised men of infertile couples that required IVF to conceive. The control group comprised men of couples who conceived spontaneously. The effects of IVF on sexual and erectile function were assessed based on the International Index of Erectile Function (IIEF-15) and the Self-Esteem and Relationship (SEAR) questionnaires. Participants were followed up to 1 year postpartum. RESULTS: Compared to the control group (378), for the IVF group (356), mean IIEF-15 scores were significantly lower: prior to pregnancy (31.7±4.5 vs 64.4±7.2, p <0.0001), at mid-pregnancy (37.3±5.1 vs 66.4±5.5, p <0.0001) and up to one year postpartum (42.3±4.9 vs 68.6±4.3, p <0.0001). Compared to the control group, in the IVF group, mean SEAR scores were significantly lower at these 3 respective time points (29.9±6.3 vs 66.5±8.3; 34.1±5.8 vs 66.9±7.2; and 40.9±6.7 vs 67.3±5.6; p <0.0001). At the 3 time points, for the IVF compared to the control group, the median monthly sexual intercourse rate was lower; and both the use of phosphodiesterase-5 inhibitor and psychologist/sexologist care were higher. CONCLUSIONS: The prevalence of erectile dysfunction among men participating in IVF in order to conceive is significantly higher compared to couples that conceived spontaneously, thus leading to an extremely high rate of phosphodiesterase-5 inhibitor use.

Low-Intensity Shockwave for Treatment of Vestibulodynia: A Randomized Controlled Therapy Trial.

BACKGROUND: Provoked vestibulodynia (PVD) is an exhausting pain syndrome that immensely affects quality of sexual life and consequently negatively affects quality of life. Low-intensity shock wave therapy produces physical forces that lead to pain relief. AIM: The aim of this study was to evaluate the feasibility, safety, and efficacy of low-intensity shockwave therapy in patients with provoked vestibulodynia. METHODS: This is a double-blinded, randomized, sham-controlled, prospective study of 32 women. The treatment protocol included a series of treatments, performed twice a week for 6 weeks. Each treatment consisted of 500 pulses of low intensity shockwaves (0.09 mJmm2) using the Medispec, ED-1000 shockwave generator or sham. Participants were assessed at the baseline, and at 1 and 3 months after completing all treatments. OUTCOMES: Pain was assessed by both subjective and objective measures. The primary outcome was a change in dyspareunia, as assessed by scores on the 10-point visual analog scale. Secondary outcome measures were changes in pain threshold and tolerance, assessed by a quantitative validated algometer test, the Wong-Baker pain FACES scale, the Female Sexual Function Index and the Patients' Global Impression of Change scale. RESULTS: From the baseline to 1 month and 3 months after completion of treatment, visual analog scale scores for dyspareunia decreased (8.0 ± 1.4, 5.7 ± 2.3, and 4.4 ± 2.5, respectively, P < .005). For these respective time points, Wong-Baker scores decreased (4.0 ± 0.6, 2.9 ± 1.2, 2.5 ± 1.3, respectively, P < .05); and total Female Sexual Function Index increased (17.9 ± 6.3, 20.9 ± 6.2, 22.5 ± 8, respectively, P < .002). Pain threshold and tolerance measured by the algometer were increased 3 months after completion of the treatment compared with the baseline (69.8 mmHg ± 11.8 vs 22.9 mmHg ± 9.0, P < .01 and 87.7 mmHg ± 35.7 vs 43.3 mmHg ± 14.7, P < .0001, respectively). No changes were observed in any of the measures assessed in the sham group. CLINICAL IMPLICATIONS: We found a new effective treatment for alleviating the most bothersome symptom in PVD, pain during penetration and intercourse. This resulted in improved sexual function. STRENGTHS & LIMITATIONS: The strengths of this study are the randomized controlled design, the correlated subjective questionnaires, and the use of semiquantitative algometer methodology. The limitations are the relative low number of participants in a single center. CONCLUSION: For women with PVD, low-intensity shockwave therapy applied at the introitus is a feasible, safe, and effective treatment option that may have a beneficial effect in pain relief and in sexual function. Gruenwald I, Gutzeit O, Petruseva A, et al. Low-Intensity Shockwave for Treatment of Vestibulodynia: A Randomized Controlled Therapy Trial. J Sex Med 2021;18:347-352.

The Efficacy and Safety of CO2 Laser Treatment for Sexual Function and Vaginal Laxity Improvement in Pre-Menopausal Women.

BACKGROUND AND OBJECTIVES: Vaginal laxity lacks standardized diagnosis and severity criteria. It is considered as a subjective complaint that reflects decreased sexual satisfaction due to vaginal loosening. Treatment modalities have included physiotherapy and plastic surgery. Recently, laser treatments have also gained popularity as a means of relieving gynecological complaints such as pelvic organ prolapse, stress urinary incontinence, and genitourinary syndrome of menopause. The aim of the current study was to evaluate the efficacy of CO2 laser treatment in women for whom a decrease in sexual sensation during intercourse and vaginal loosening were their primary complaints. STUDY DESIGN/MATERIALS AND METHODS: For this prospective study, women with reported vaginal laxity and decreased sensation during intercourse were recruited from the Sexual Dysfunction Clinic in our health care campus. Each participant received three outpatient treatments with laser therapy, according to the same protocol. Treatment efficacy was assessed by changes in the Vaginal Health Index (VHI) and Female Sexual Function Index (FSFI). RESULTS: Overall, 84 pre-menopause women, with a mean age of 47.7 years, were included in the study. Mean VHI and FSFI were increased significantly at 3 months post-treatment and decreased again at 6 months post-treatment: 11.8 ± 1.6, 13.5 ± 1.1, and 11.8 ± 1.2, respectively, P = 0.013; and 21.3 ± 1.7, 29.9 ± 1.6, and 22.5 ± 1.8, respectively, P = 0.022. The rate of sexual intercourse doubled during the period of maximal treatment effect (P < 0.0001). CONCLUSIONS: CO2 laser treatment has both a statistically and clinically significant effect on participants' complaints and sex-life, which wanes by 6 months post-treatment. Laser therapy seems to be safe in the short term, with no serious adverse events reported in the current study. Further studies are warranted to determine the long-term safety and the efficacy of maintenance laser treatments. Lasers Surg. Med. © 2020 Wiley Periodicals LLC.

Vaginal Fractional Carbon Dioxide Laser Treatment and Changes in Vaginal Biomechanical Parameters.

BACKGROUND AND OBJECTIVES: Vaginal fractional carbon dioxide (CO2 ) laser treatment has emerged in the past two decades as a non-surgical option for vaginal tightening. Mounting evidence supports the effectiveness and safety of this treatment for female sexual dysfunction. A newly developed vaginal tactile imaging (VTI) technique accurately evaluates the biomechanical parameters of the female pelvic floor and vagina, including tissue elasticity, pelvic support, and pelvic muscle function in high definition. In the current study, we evaluated changes in objective biomechanical parameters using VTI, following vaginal CO2 laser treatment for vaginal tightening and sexual dysfunction. STUDY DESIGN/MATERIALS AND METHODS: We conducted a prospective cohort between June 2018 and January 2020. Inclusion criteria were vaginal looseness, decreased local sensation during sexual intercourse, and sexual dysfunction. All the participants were treated with a vaginal carbon dioxide laser. They underwent a gynecological evaluation based on the Vaginal Health Index (VHI) and sexual function assessment according to the Female Sexual Function Index (FSFI). Vaginal biomechanical parameters were assessed by VTI. Initial evaluations were performed at the pre-treatment consult visit, 1 week prior to the first treatment and at a 6-month post-treatment follow-up visit. RESULTS: Twenty-five women were included in the final analysis. Compared with baseline, the post-treatment mean scores for vaginal elasticity and tightening were higher (54.8 ± 5.2 vs. 41.5 ± 6.3, P = 0.0027 and 1.97 ± 0.25 vs. 1.32 ± 0.31, P = 0.0014, respectively). Post-treatment increases were demonstrated in pelvic muscle contraction strength (25.9 ± 3.5 vs. 16.5 ± 4.2, P = 0.0011) and in reflex pelvic muscle contraction (2.93 ± 0.44 vs. 2.12 ± 0.47, P = 0.0022); the mean FSFI and VHI scores were higher following treatment (28.47 ± 1.73 vs. 21.12 ± 1.58, P = 0.036 and 19.15 ± 1.27 vs. 11.6 ± 0.97, P = 0.0032). CONCLUSIONS: The quantification of vaginal biomechanical parameters using VTI technology offers objective evidence of the beneficial effect of vaginal CO2 laser treatment. Lasers Surg. Med. © 2020 Wiley Periodicals LLC.

Female Sexual Orgasmic Dysfunction and Genital Sensation Deficiency.

INTRODUCTION: Most studies on female sexual dysfunction (FSD), and female sexual orgasmic disorder (FSOD) in particular, have qualitatively examined cultural and educational factors; only few have quantitatively examined physiological factors. AIM: The aim of this study was to compare quantitative sensory testing (QST) between women for whom FSOD was their primary complaint and other women with FSD. METHODS: In this retrospective study of women who visited a sexual dysfunction clinic, the study group comprised women for whom FSOD was their primary complaint, and the control group comprised other women with FSD. Sexual dysfunction was assessed by the Female Sexual Function Index (FSFI). QST was performed with a thermal and vibration Genito-Sensory Analyzer (GSA; Medoc Ltd, Israel) aimed at the clitoral and vaginal areas. MAIN OUTCOME MEASURE: The main outcome was clitoral and vibratory sensory thresholds in accordance with the presence of FSOD. RESULTS: The study group comprised 89 (45%) women, with a mean age of 37.6 ± 1.9 years; and the control group comprised 110 (55%) women, with a mean age of 37.5 ± 11.3 years. Both mean FSFI-FSOD and total FSFI scores were significantly lower in the study group than in the control group (0.97 ± 0.94 vs 1.91 ± 1.3, P < 0.001) and (11.9 ± 3.2 vs 15.6 ± 3.6, P < 0.001), respectively. Mean clitoral vibratory sensory thresholds were higher in the study group than in the control group: 2.02 confidence interval (CI) 1.12-2.64 vs 1.55 CI 1.12-2.41, P < 0.001. No statistically significant difference was found between the groups in vaginal vibratory thresholds: 3.7 CI 2.6-6.6 vs 3.4 CI 1.9-5.4, P = 0.14. CLINICAL IMPLICATIONS: The findings support the role of the clitoris in obtaining sexual orgasm, thus inferring a possible physiologic cause of FSOD in otherwise healthy women, beyond established psychological causes. STRENGTH & LIMITATIONS: Assessments using an objective quantitative measure (QST) and a subjective tool (FSFI) in both the FSOD and control groups are strengths of this study. The retrospective design is a limitation. CONCLUSION: QST showed a direct correlation between vibratory clitoral stimulation and FSOD; Compared with the control group, women with FSOD are relatively insensitive to clitoral stimulation, but not to vaginal stimulation. Gruenwald I, Lauterbach R, Gartman I, et al. Female Sexual Orgasmic Dysfunction and Genital Sensation Deficiency. J Sex Med 2020; 17:273-278.

The safety and efficacy of CO2 laser in the treatment of stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: Conservative treatment is recommended as first-line therapy for stress urinary incontinence (SUI). We hypothesized that CO2 laser treatment would demonstrate safety and efficacy for women with SUI. METHODS: A prospective, open-label, cohort study of 33 women (mean age 43 years) referred from a continence clinic after urologist/urogynecologist assessment, with a verified stress urinary incontinence diagnosis based on urodynamic testing. The participants completed three outpatient treatments with laser therapy and were subsequently evaluated at 1, 3 and 6 months. The independent t and chi-square tests were used to assess changes in sanitary pad usage and SUI symptoms. RESULTS: Sanitary pad usage decreased from a median of 12 per day at baseline to 7 at 1-3 months post-treatment (P < 0.0001) and returned to 12 at 6 months post-treatment. Scores on the Urogenital Distress Inventory and the International Consultation of Incontinence Questionnaire decreased (improved) significantly at 1-3 months post-treatment: from 45 ± 2 and 16 ± 4, respectively, to 29.3 ± 14.7 and 8.15 ± 3.1, respectively (P < 0.0001). The scores returned to levels similar to baseline at 6 months after treatment. Participants reported mild and transient side effects, with significant improvement in quality of life. CONCLUSIONS: Laser therapy can be an optional conservative treatment for women who seek minimally invasive non-surgical treatment for the management of SUI. No serious adverse effects were reported though the sample size was not large, a possible limitation of the study. Further large randomized control trials are needed to appraise the efficacy and safety of laser therapy for stress urinary incontinence and to demonstrate the ultimate utility of this modality.

Low-Intensity Shock Wave Therapy in Sexual Medicine-Clinical Recommendations from the European Society of Sexual Medicine (ESSM).

INTRODUCTION: Low-intensity shockwave therapy (LISWT) has been investigated for the treatment of uroandrological disorders including erectile dysfunction (ED), Peyronie's disease (PD) and chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) with controversial findings. AIM: To review the evidence on LISWT for ED, PD, and CP/CPPS and provide clinical recommendations on behalf of the European Society of Sexual Medicine. METHODS: Medline and Embase databases were searched for randomized clinical trials (RCTs), meta-analyses and open-label prospective or retrospective studies investigating the effect of LISWT on ED, PD, or CP/CPPS. OUTCOMES: The panel provided statements on clinically relevant questions concerning LISWT: (i) treatment efficacy, (ii) treatment protocol, (iii) clinical indications, and (iv) safety. The level of evidence was provided according to the Oxford 2011 criteria and graded using the Oxford Centre for Evidence-Based Medicine recommendations. RESULTS: 11 RCTs and 5 meta-analyses investigated LISWT for ED. RCTs provided controversial results on the efficacy of LISWT and were affected by high heterogeneity and the small number of patients included. Pooled-data analysis showed an overall positive effect in terms of erectile function improvement but reported small estimates and included a largely heterogeneous cohort of patients. 4 RCTs and 1 meta-analysis assessed LISWT for PD. All trials showed positive findings in terms of pain relief but no effect on penile curvature and plaque size. Inclusion criteria vary widely among studies, and further investigation is needed. 5 RCTs investigated LISWT for CP/CPPS. Data showed a possible effect on pain relief, although there is no evidence supporting that pain relief was maintained or any improvement in pain over time. CLINICAL IMPLICATIONS: LISWT needs to be further investigated in the context of sexual medicine and is almost but not yet ready for clinical practice. STRENGTHS AND LIMITATIONS: All studies have been evaluated by a panel of experts providing recommendations for clinical practice. CONCLUSIONS: LISWT is a safe and well-tolerated procedure but its efficacy for the treatment of ED is doubtful and deserves more investigation. Patients reporting pain associated with PD may benefit from LISWT, although no effect is expected on disease progression. LISWT is not a primary treatment for CP/CPPS, but it may be considered as an option to relieve pain. Capogrosso P, Frey A, Jensen CFS, et al. Low-Intensity Shock Wave Therapy in Sexual Medicine-Clinical Recommendations from the European Society of Sexual Medicine (ESSM). J Sex Med 2019;16:1490-1505.

Low Intensity Shock Wave Treatment for Erectile Dysfunction-How Long Does the Effect Last?

PURPOSE: We studied the long-term efficacy of penile low intensity shock wave treatment 2 years after an initially successful outcome. MATERIALS AND METHODS: Men with a successful outcome of low intensity shock wave treatment according to the minimal clinically important difference on the IIEF-EF (International Index of Erectile Function-Erectile Function) questionnaire were followed at 6, 12, 18 and 24 months. Efficacy was assessed by the IIEF-EF. Failure during followup was defined as a decrease in the IIEF-EF below the minimal clinically important difference. RESULTS: We screened a total of 156 patients who underwent the same treatment protocol but participated in different clinical studies. At 1 month treatment was successful in 99 patients (63.5%). During followup a gradual decrease in efficacy was observed. The beneficial effect was maintained after 2 years in only 53 of the 99 patients (53.5%) in whom success was initially achieved. Patients with severe erectile dysfunction were prone to earlier failure than those with nonsevere erectile dysfunction. During the 2-year followup the effect of low intensity shock wave treatment was lost in all patients with diabetes who had severe erectile dysfunction at baseline. On the other hand, patients with milder forms of erectile dysfunction without diabetes had a 76% chance that the beneficial effect of low intensity shock wave treatment would be preserved after 2 years. CONCLUSIONS: Low intensity shock wave treatment is effective in the short term but treatment efficacy was maintained after 2 years in only half of the patients. In patients with milder forms of erectile dysfunction the beneficial effect is more likely to be preserved.

[POSITION STATEMENT FOR INTERMITTENT CATHETERIZATION OF URINARY BLADDER].

INTRODUCTION: A position paper presents the standpoint of the Israeli Urological Association on clean intermittent catheterization (CIC) for all physicians and nurses. The position paper is based on international guidelines and professional literature and is adapted to medical activities in Israel. CIC is indicated for the treatment of temporary/permanent disability in the emptying of the bladder, which is expressed by large post-voided urine/urine retention and related complications. There are a few contra-indications for CIC (low bladder volume or compliance, pressure sores/external infection of the urethra, anatomical, functional or cognitive disorder that does not allow to perform CIC, recurrent macrohematuria or urethrorrhagia, urethral pain that does not allow frequent catheterization, patient unwillingness to perform CIC by himself or by another person). There are alternatives to performing CIC permanent urethral or suprapubic catheter, urinary tract diversion, sphincterotomy. Before starting to perform CIC, the patient should be verified as being able to perform CIC and adhere to a predetermined schedule. It is recommended to perform the CIC at regular intervals during the day. During training and early stages of the CIC, it is recommended to catheter every 4-6 hours to assess bladder volume at these time intervals (urinary volume per catheterization). It is recommended to record drinking volumes, voiding volumes, and catheterization volumes for adjusting and timing the CIC. In order to determine the right number of catheterizations, several factors should be taken into account, such as the patient's ability to void, bladder capacity, and various urodynamic variables. In some cases additional therapy might be administered to reduce bladder pressure. If a patient cannot perform CIC on his own, a caregiver or a family member may be instructed to perform the procedure. The Committee described the methods and techniques to perform CIC and described possible complications (although rare) such as urinary tract infections (UTI), urethral and/or bladder damage, and the difference between a condition of asymptomatic bacteriuria and UTI. The Committee recommends that preventive antibiotic treatment should not be given to CIC patients. Antibiotic treatment should be given only in the case of UTI. The Committee recommends active participation of medical, nursing, social workers, family members and direct caregivers to improve the quality of life of CIC patients. Long-term follow-up is needed to diagnose and prevent complications of CIC/underlying disease leading to CIC. Different follow-up tests should be performed based on underlying disease, complications or changes in patient symptoms. The Committee described different types of catheters and recommends that the use of single-use catheters is preferable. Pre-shielding should be used before using the catheters without external coating.

Standards for Clinical Trials in Male and Female Sexual Dysfunction: IV. Unique Aspects of Clinical Trials in Female Sexual Dysfunction.

The focus of this article, the fourth in the series, Standards for Clinical Trials in Male and Female Sexual Dysfunction, is on aspects of clinical trial design and measurement that are specific to clinical trials for treatments of female sexual dysfunction. Challenges in this area include the limited extent of treatment development and clinical trial research across the spectrum of female sexual dysfunctions, changing regulatory considerations, changing diagnostic criteria for female sexual dysfunction, and the need to articulate assessment procedures to these changes. Discussion focuses on approaches to addressing these challenges in clinical trials in female sexual dysfunction.

Standards for Clinical Trials in Male and Female Sexual Dysfunction: III. Unique Aspects of Clinical Trials in Male Sexual Dysfunction.

This series of articles, Standards for Clinical Trials in Male and Female Sexual Dysfunction, began with the discussion of a common expected standard for clinical trial design in male and female sexual dysfunction, a common rationale for the design of phase I to IV clinical trials, and common considerations for the selection of study population and study duration in male and female sexual dysfunction. The second article in this series discussed fundamental principles in development, validation, and selection of patient- (and partner-) reported outcome assessment. The third and present article in this series discusses selected aspects of sexual dysfunction that are that are unique to male sexual dysfunctions and relevant to the conduct of clinical trials of candidate treatments for men.

Penile Low Intensity Shock Wave Treatment is Able to Shift PDE5i Nonresponders to Responders: A Double-Blind, Sham Controlled Study.

PURPOSE: We performed sham controlled evaluation of penile low intensity shock wave treatment effect in patients unable to achieve sexual intercourse using PDE5i (phosphodiesterase type 5 inhibitor). MATERIALS AND METHODS: This prospective, randomized, double-blind, sham controlled study was done in patients with vasculogenic erectile dysfunction who stopped using PDE5i due to no efficacy. All patients had an erection hardness score of 2 or less with PDE5i. A total of 58 patients were randomized, including 37 treated with low intensity shock waves (12 sessions of 1,500 pulses of 0.09 mJ/mm(2) at 120 shock waves per minute) and 18 treated with a sham probe. In the sham group 16 patients underwent low intensity shock wave treatment 1 month after sham treatment. All patients were evaluated at baseline and 1 month after the end of treatment using validated erectile dysfunction questionnaires and the flow mediated dilatation technique for penile endothelial function. Erectile function was evaluated while patients were receiving PDE5i. RESULTS: In the low intensity shock wave treatment group and the sham group 54.1% and 0% of patients, respectively, achieved erection hard enough for vaginal penetration, that is an EHS (Erection Hardness Score) of 3 (p <0.0001). According to changes in the IIEF-EF (International Index of Erectile Function-Erectile Function) score treatment was effective in 40.5% of men who received low intensity shock wave treatment but in none in the sham group (p = 0.001). Of patients treated with shock waves after sham treatment 56.3% achieved erection hard enough for penetration (p <0.005). CONCLUSIONS: Low intensity shock wave treatment is effective even in patients with severe erectile dysfunction who are PDE5i nonresponders. After treatment about half of them were able to achieve erection hard enough for penetration with PDE5i. Longer followup is needed to establish the place of low intensity shock wave treatment in these challenging cases.

Effect of Midurethral Sling Surgery on Vaginal Sensation.

INTRODUCTION: Previous studies have reported changes in the sensory functioning of the vagina in women with pelvic floor disorder. AIM: To evaluate vaginal and clitoral sensation before and after surgery with trans-obturator tape (TVT-O, Ethicon Johnson & Johnson). METHODS: Quantitative sensory thresholds for warm, cold, and vibratory sensations were measured at the vagina and clitoris 1 day before and 12 ± 4 months after surgery. MAIN OUTCOME MEASURES: Differences in thresholds to warm, cold, and vibratory sensations at a predetermined anatomic area of the genital region. RESULTS: Twenty-two women were admitted for midurethral sling surgery, and four were lost to follow-up. For the remaining 18 (mean age = 52 years, range = 37-65), we found a significant sensory decrease at the clitoral region to cold, warm, and vibratory stimuli after surgery. In contrast, in the anterior vaginal wall, there was a significant decrease only to warm stimuli after surgery. CONCLUSION: TVT-O can cause sensory loss in the clitoral and anterior vaginal wall region that can be measured and quantified. The effect of such sensory loss on sexual function and quality of sexual life needs further investigation.

Standards for Clinical Trials in Male and Female Sexual Dysfunction: I. Phase I to Phase IV Clinical Trial Design.

This series of articles outlines standards for clinical trials of treatments for male and female sexual dysfunctions, with a focus on research design and patient-reported outcome assessment. These articles consist of revision, updating, and integration of articles on standards for clinical trials in male and female sexual dysfunction from the 2010 International Consultation on Sexual Medicine developed by the authors as part of the 2015 International Consultation on Sexual Medicine. We are guided in this effort by several principles. In contrast to previous versions of these guidelines, we merge discussion of standards for clinical trials in male and female sexual dysfunction in an integrated approach that emphasizes the common foundational practices that underlie clinical trials in the two settings. We present a common expected standard for clinical trial design in male and female sexual dysfunction, a common rationale for the design of phase I to IV clinical trials, and common considerations for selection of study population and study duration in male and female sexual dysfunction. We present a focused discussion of fundamental principles in patient- (and partner-) reported outcome assessment and complete this series of articles with specific discussions of selected aspects of clinical trials that are unique to male and to female sexual dysfunction. Our consideration of standards for clinical trials in male and female sexual dysfunction attempts to embody sensitivity to existing and new regulatory guidance and to address implications of the evolution of the diagnosis of sexual dysfunction that have been brought forward in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. The first article in this series focuses on phase I to phase IV clinical trial design considerations. Subsequent articles in this series focus on the measurement of patient-reported outcomes, unique aspects of clinical trial design for men, and unique aspects of clinical trial design for women.

Standards for Clinical Trials in Male and Female Sexual Dysfunction: II. Patient-Reported Outcome Measures.

The second article in this series, Standards for Clinical Trials in Male and Female Sexual Dysfunction, focuses on measurement of patient-reported outcomes (PROs). Together with the design of appropriate phase I to phase IV clinical trials, the development, validation, choice, and implementation of valid PRO measurements-the focus of the present article-form the foundation of research on treatments for male and female sexual dysfunctions. PRO measurements are assessments of any aspect of a patient's health status that come directly from the patient (ie, without the interpretation of the patient's responses by a physician or anyone else). PROs are essential for assessing male and female sexual dysfunction and treatment response, including symptom frequency and severity, personal distress, satisfaction, and other measurements of sexual and general health-related quality of life. Although there are some relatively objective measurements of sexual dysfunction (ie, intravaginal ejaculatory latency time, frequency of sexual activity, etc), these measurements do not comprehensively assess the occurrence and extent of sexual dysfunction or treatment on the patient's symptoms, functioning, and well-being. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient's perspective.

The effect of pelvic organ prolapse repair on vaginal sensation.

INTRODUCTION AND HYPOTHESIS: The objective was to evaluate vaginal and clitoral sensation before and after robotic sacrocolpopexy for the repair of pelvic organ prolapse. METHODS: Twenty-two women, mean age 63 years (range 41-77), were admitted for robotic sacrocolpopexy repair of pelvic organ prolapse; 4 were lost to follow-up. Quantitative sensory thresholds for warm, cold, and vibratory sensations were measured at the vagina (anterior and posterior areas) and clitoris 1 day before and a mean of 12 ± 4 months following surgery. Student's paired t test was used to compare sensory thresholds before and after surgery. RESULTS: For the 18 women who completed follow-up, sensitivity was significantly higher after surgery (sensory threshold decreased) at the clitoral and vaginal regions, to cold and warm stimuli. In contrast, the vaginal and clitoral vibratory sensory thresholds did not change significantly following surgery. CONCLUSION: The repair of pelvic organ prolapse by robotic sacrocolpopexy could potentially play a role in restoring clitoral and vaginal wall sensation. The effects of these sensory changes on sexual function and the quality of sexual life need further investigation.