Evaluation of the effect of multipoint intra-mucosal vaginal injection of a specific cross-linked hyaluronic acid for vulvovaginal atrophy: a prospective bi-centric pilot study

Abstract Background Vulvo-vaginal atrophy (VVA) is one of the common consequences of estrogen deficiency especially after the menopause. Several studies have assessed the effects of Hyaluronic acid (HA) on physical and sexual symptoms associated with VVA with promising results. However, most of these studies have focused on subjective assessment of symptom response to topically administered preparations. Nonetheless, HA is an endogenous molecule and it is logical that its effects are best realized if injected in the superficial epithelial layers. Desirial® is the first crosslinked HA that is administered by injection in the vaginal mucosa. The aim of this study was to explore the effect of multipoint vaginal intra-mucosal injections of specific cross-linked hyaluronic acid (DESIRIAL®, Laboratoires VIVACY) on several clinical and patient reported core outcomes. Methods A cohort bi-centric pilot study. The chosen outcomes included change in vaginal mucosa thickness, biological markers for collagen formation, vaginal flora, vaginal pH, vaginal health index, vulvo-vaginal atrophy symptoms and sexual function 8 weeks post Desirial® injection. Patients’ satisfaction was also assessed using the patient global impression of improvement (PGI-I) scale. Results A total of 20 participants were recruited between 19/06/2017 and 05/07/2018. At the end of the study, there was no difference in the median total thickness of the vaginal mucosa or in procollagen I, III or Ki67 fluorescence. However, there was a statistically significant increase in COL1A1 and COL3A1 gene expression (p = 0.0002 and p = 0.0010 respectively). There was also a significant reduction in reported dyspareunia, vaginal dryness, vulvar pruritus, vaginal chafing and significant improvement in all female sexual function index dimensions. Based on PGI-I, 19 patients (95%) reported varying degrees of improvement where, 4 (20%) felt slightly better; 7 (35%) better and 8 (40%) much better. Conclusions Multi-point vaginal intra-mucosal injections, of Desirial® (a crosslinked HA) was significantly associated with the expression of CoL1A1 and CoL3A1 suggesting stimulation of collagen formation. Furthermore, there was a significant reduction in VVA symptomatology and a significant improvement in patient satisfaction and sexual function scores. However, there was no demonstrable change in the total vaginal mucosal thickness. Study registration ID-RCB: 2016-A00124-47, Protocol code number: LOCAL/2016/PM-001.

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Predictors of sexual function among men after myocardial infarction: a pilot study

British Journal of Cardiac Nursing ◽

10.12968/bjca.2021.0056 ◽

2021 ◽

pp. 1-11

Author(s):

Asa B Smith ◽

Debra L Barton ◽

Elizabeth A Jackson ◽

Daniela Wittmann ◽

Jacqui Smith ◽

...

Keyword(s):

Myocardial Infarction ◽

Pilot Study ◽

Problem Solving ◽

Sexual Function ◽

Coping Strategies ◽

Longitudinal Research ◽

Post Myocardial Infarction ◽

Measurement Information ◽

Patient Reported ◽

Support Seeking

Background/Aims Sexual dysfunction often persists among men who have had a myocardial infarction. While some cross-sectional and longitudinal research has been conducted, there are still no known modifiable targets for intervention. This pilot study aimed to model hypothesised predictive factors of higher sexual function in a cohort of men post myocardial infarction. Methods Using a longitudinal study design, data on sexual function, sexual fear, anxiety and depressive symptoms, and use of coping strategies were collected using the Male Sexual Function Index, Multidimensional Sexuality Questionnaire, Patient-Reported Outcomes Measurement Information System and Coping Strategy Indicator respectively. Spearman correlations were estimated to examine associations between factors at 2 weeks and 3 months following myocardial infarction. Linear regression models were conducted for sexual function while controlling for age. Results The data for 14 men were analysed. Sexual fear and use of problem-solving and support-seeking coping strategies were moderately correlated with sexual function at 3 months post myocardial infarction. Increased use of problem-solving and support-seeking coping strategies was associated with increased sexual function at 3 months. Conclusions Use of coping strategies may predict increased sexual function 3 months post myocardial infarction. However, additional studies are needed to further examine these hypothesised relationships with a larger and more diverse sample.

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Treating Knee Osteoarthritis With Platelet-Rich Plasma and Hyaluronic Acid Combination Therapy: A Systematic Review

The American Journal of Sports Medicine ◽

10.1177/0363546521998010 ◽

2021 ◽

pp. 036354652199801

Author(s):

Michael R. Baria ◽

W. Kelton Vasileff ◽

James Borchers ◽

Alex DiBartola ◽

David C. Flanigan ◽

...

Keyword(s):

Systematic Review ◽

Hyaluronic Acid ◽

Combination Therapy ◽

Knee Osteoarthritis ◽

Platelet Rich Plasma ◽

Case Series ◽

Final Analysis ◽

Preparation Technique ◽

Randomized Studies ◽

Patient Reported

Background: Platelet-rich plasma (PRP) and hyaluronic acid (HA) are injectable treatments for knee osteoarthritis. The focus of previous studies has compared their efficacy against each other as monotherapy. However, a new trend of combining these 2 injections has emerged in an attempt to have a synergistic effect. Purpose: To systematically review the clinical literature examining the combined use of PRP + HA. Design: Systematic review. Methods: A systematic review was performed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines using PubMed and Embase. The following search terms were used: knee osteoarthritis AND platelet rich plasma AND hyaluronic acid. The review was performed by 2 independent reviewers who applied the inclusion/exclusion criteria and independently extracted data, including methodologic scoring, PRP preparation technique, HA composition, and patient-reported outcomes (PROs). Results: A total of 431 articles were screened, 12 reviewed in full, and 8 included in the final analysis: 2 case series, 3 comparative, and 3 randomized studies. Average follow-up was 9 months. The modified Coleman Methodology Score was 38.13 ± 13.1 (mean ± SD). Combination therapy resulted in improved PROs in all studies. Of the comparative and randomized studies, 2 demonstrated that combination therapy was superior to HA alone. However, when PRP alone was used as the control arm (4 studies), combination therapy was not superior to PRP alone. Conclusion: Combination therapy with PRP + HA improves PROs and is superior to HA alone but is not superior to PRP alone.

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Protocol for a feasibility study of smoking cessation in the surgical pathway before major lung surgery: Project MURRAY

BMJ Open ◽

10.1136/bmjopen-2019-036568 ◽

2020 ◽

Vol 10 (11) ◽

pp. e036568

Author(s):

Sebastian T Lugg ◽

Amy Kerr ◽

Salma Kadiri ◽

Alina-Maria Budacan ◽

Amanda Farley ◽

...

Keyword(s):

Smoking Cessation ◽

Pilot Study ◽

Thoracic Surgery ◽

Elective Surgery ◽

Primary Objective ◽

Pulmonary Complications ◽

University Hospitals ◽

Patient Reported ◽

Ethical Approval ◽

Surgical Pathway

IntroductionSmoking prior to major thoracic surgery is the biggest risk factor for development of postoperative pulmonary complications, with one in five patients continuing to smoke before surgery. Current guidance is that all patients should stop smoking before elective surgery yet very few are offered specialist smoking cessation support. Patients would prefer support within the thoracic surgical pathway. No study has addressed the effectiveness of such an intervention in this setting on cessation. The overall aim is to determine in patients who undergo major elective thoracic surgery whether an intervention integrated (INT) into the surgical pathway improves smoking cessation rates compared with usual care (UC) of standard community/hospital based NHS smoking support. This pilot study will evaluate feasibility of a substantive trial.Methods and analysisProject MURRAY is a trial comparing the effectiveness of INT and UC on smoking cessation. INT is pharmacotherapy and a hybrid of behavioural support delivered by the trained healthcare practitioners (HCPs) in the thoracic surgical pathway and a complimentary web-based application. This pilot study will evaluate the feasibility of a substantive trial and study processes in five adult thoracic centres including the University Hospitals Birmingham NHS Foundation Trust. The primary objective is to establish the proportion of those eligible who agree to participate. Secondary objectives include evaluation of study processes. Analyses of feasibility and patient-reported outcomes will take the form of simple descriptive statistics and where appropriate, point estimates of effects sizes and associated 95% CIs.Ethics and disseminationThe study has obtained ethical approval from NHS Research Ethics Committee (REC number 19/WM/0097). Dissemination plan includes informing patients and HCPs; engaging multidisciplinary professionals to support a proposal of a definitive trial and submission for a full application dependent on the success of the study.Trial registration numberNCT04190966.

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Malignant Pleural Effusions Impact on Fatigue (IMPE-F): A Prospective Observational Cohort Pilot Study

Journal of Respiration ◽

10.3390/jor1020011 ◽

2021 ◽

Vol 1 (2) ◽

pp. 98-104

Author(s):

Avinash Aujayeb ◽

Donna Wakefield

Keyword(s):

Pilot Study ◽

Health Research ◽

Patient Reported Outcome ◽

Pleural Effusions ◽

Inclusion Criteria ◽

Malignant Pleural Effusions ◽

Cancer Related Fatigue ◽

Patient Reported ◽

Observational Cohort ◽

Respondent Fatigue

Introduction: Cancer-related fatigue is well described. Fatigue in patients with a malignant pleural effusion (MPE) has not been directly studied. Methods: A prospective observational cohort pilot study ‘Do Interventions for Malignant Pleural Effusions (MPE) impact on patient reported fatigue levels (IMPE-F study)’ is planned to determine whether pleural interventions reduce fatigue in MPE. Fatigue will be assessed with a validated patient reported outcome measure, FACIT-F. Discussion: MPE-F has funding from Rocket Medical Plc, and is part of a Masters in Clinical Research at Newcastle University. Respondent fatigue will be addressed by the investigators going through the questionnaire with the participants. Inclusion criteria are all patients above 18 years of age with a presumed MPE undergoing a procedure and able to consent. The expected number of participants is 50. Trial registration: The IMPE-F study has Research Ethics Committee (REC) [20/YH/0224] and Health Research Authority (HRA) and Health and Care Research Wales (HCRW) approvals [IRAS project ID: 276451]. The study has been adopted on National Institute for Health Research portfolio [CPMS ID 46430].

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83 A Medication Self-Management Intervention to Improve Medication Adherence For Older People with Multimorbidity: A Pilot Study

Age and Ageing ◽

10.1093/ageing/afab030.44 ◽

2021 ◽

Vol 50 (Supplement_1) ◽

pp. i12-i42

Author(s):

C Yang ◽

Z Hui ◽

S Zhu ◽

X Wang ◽

G Tang ◽

...

Keyword(s):

Medication Adherence ◽

Pilot Study ◽

Older People ◽

Intervention Group ◽

Self Management ◽

Control Group ◽

Medication Knowledge ◽

Management Intervention ◽

Patient Reported

Abstract Introduction Medication self-management support has been recognised as an essential element in primary health care to promote medication adherence and health outcomes for older people with chronic conditions. A patient-centred intervention empowering patients and supporting medication self-management activities could benefit older people. This pilot study tested a newly developed medication self-management intervention for improving medication adherence among older people with multimorbidity. Method This was a two-arm randomised controlled trial. Older people with multimorbidity were recruited from a community healthcare centre in Changsha, China. Participants were randomly allocated to either a control group receiving usual care (n = 14), or to an intervention group receiving three face-to-face medication self-management sessions and two follow-up phone calls over six weeks, targeting behavioural determinants of adherence from the Information-Motivation-Behavioural skills model (n = 14). Feasibility was assessed through recruitment and retention rates, outcome measures collection, and intervention implementation. Follow-up data were measured at six weeks after baseline using patient-reported outcomes including medication adherence, medication self-management capabilities, treatment experiences, and quality of life. Preliminary effectiveness of the intervention was explored using generalised estimating equations. Results Of the 72 approached participants, 28 (38.89%) were eligible for study participation. In the intervention group, 13 participants (92.86%) completed follow-up and 10 (71.42%) completed all intervention sessions. Ten participants (71.42%) in the control group completed follow-up. The intervention was found to be acceptable by participants and the intervention nurse. Comparing with the control group, participants in the intervention group showed significant improvements in medication adherence (β = 0.26, 95%CI 0.12, 0.40, P < 0.001), medication knowledge (β = 4.43, 95%CI 1.11, 7.75, P = 0.009), and perceived necessity of medications (β = −2.84, 95%CI -5.67, −0.01, P = 0.049) at follow-up. Conclusions The nurse-led medication self-management intervention is feasible and acceptable among older people with multimorbidity. Preliminary results showed that the intervention may improve patients’ medication knowledge and beliefs and thus lead to improved adherence.

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Safety and efficacy of faecal microbiota transplantation by Anaerobic Cultivated Human Intestinal Microbiome (ACHIM) in patients with systemic sclerosis: study protocol for the randomised controlled phase II ReSScue trial

BMJ Open ◽

10.1136/bmjopen-2020-048541 ◽

2021 ◽

Vol 11 (6) ◽

pp. e048541

Author(s):

Anna-Maria Hoffmann-Vold ◽

Håvard H Fretheim ◽

Vikas K Sarna ◽

Imon Barua ◽

Maylen N Carstens ◽

...

Keyword(s):

Systemic Sclerosis ◽

Pilot Study ◽

Phase Ii ◽

Intestinal Microbiome ◽

Induction Phase ◽

Inflammatory Disorder ◽

Faecal Microbiota ◽

Safety And Efficacy ◽

Faecal Microbiota Transplantation ◽

Patient Reported

IntroductionIn the multisystem inflammatory disorder systemic sclerosis (SSc), gastrointestinal tract (GIT) affliction is highly prevalent. There are no known disease modifying therapies and the negative impact is substantial. Aiming for a new therapeutic principle, and inspired by recent work showing associations between gut microbiota changes and GIT symptoms in SSc, we performed a pilot study on faecal microbiota transplantation (FMT) with the single-donor bacterial culture ‘Anaerobic Cultivated Human Intestinal Microbiome (ACHIM)’. Motivated by positive pilot study signals, we designed the ReSScue trial as a phase II multicentre, placebo-controlled, randomised 20-week trial to evaluate safety and efficacy on lower GIT symptoms of FMT by ACHIM in SSc.Methods and analysesWe aim to include 70 SSc participants with moderate to severe lower GIT symptoms, defined by the validated patient-reported University of California Los Angeles Scleroderma Clinical Trial Consortium GIT 2.0 2.0 questionnaire. The trial includes three parts. In part A1 (induction phase) lasting from week 0 to week 12, participants will be randomised 1:1 to repeat infusions of 30 mL ACHIM or placebo at week 0 and 2 by gastroduodenoscopy. In part A2, which is an 8-week subsequent maintenance phase, all study participants will receive 30 mL ACHIM at week 12 and followed until week 20 on continued blind. In part B, which will last until the last participant completes part A2, the participants will be followed through a maximum 16-week extended monitoring period, for longer-term data on safety and intervention effects. Primary endpoint is change from baseline to week 12 in UCLA GIT subscale scores of diarrhoea or bloating, depending on the worst symptom at baseline evaluated separately for each patient. Secondary endpoints are safety measures and changes in UCLA GIT scores (total, diarrhoea and bloating).Ethics and disseminationThis protocol was approved by the Northern Norwegian Committee for Medical Ethics. Study findings will be published.Trial registration numberNCT04300426; Pre-results.Protocol versionV.3.1.

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