Evaluation of immediate and short-term efficacy of DualStim therapy with and without intracavernosal umbilical cord-derived Wharton's jelly in patients with erectile dysfunction: Study protocol for a randomized controlled trial

Abstract Background Erectile Dysfunction (ED) affects a significant portion of the U.S. population and causes negative psychological burdens that affects men and their partner’s quality of life and satisfaction. Extracorporeal shock therapy (ESWT) utilizing focused ESWT (fESWT) and radial ESWT (rESWT) in Low-intensity shock wave therapy (LSIWT) has been used to treat ED with some success. Wharton’s Jelly (WJ) is a biologic substance with large amounts of stem cells, growth factors, cytokines and extracellular components. The use of simultaneous fESWT and rESWT (DualStim Therapy) combined with WJ have potential uses in ED that may have advantages over current treatments. Methods A randomized, single-blinded, controlled clinical trial will be conducted to evaluate the efficacy and safety of DualStim Therapy and ICIs of WJ in moderate to severe ED. A total of 60 patients with moderate to severe ED will be enrolled and treated with DualStim Therapy with intracavernosal injection (ICIs) of WJ or saline for a period of 7 weeks. The International Index of Erectile Function – Erectile Function (IIEF-EF) score will be used to gauge the treatment related changes in relation to the subject’s baseline. The scores will be recorded at baseline and compared to follow-ups 1,3 and 6 months post-treatment. Any Adverse events (AEs) or severe AEs will be recorded in the corresponding case report forms (CRFs). Sexual Encounter Profile (SEP), as well as the Global Assessment Questionnaire (GAQ) and the Erection Hardness Score (EHS) will be used to determine the sexual activity improvement from baseline leading to optimal penetration at follow-ups 1,3 and 6 months post-treatment.Discussion This clinical trial is a feasibility study to determine the immediate and short-term efficacy of DualStim Therapy, with and without ICIs of formulated umbilical cord-derived WJ to improve and/or restore erectile function in patients with moderate to severe ED. This study will also provide insight into the safety and efficacy of WJ. We anticipate clinically significant improvement in patients suffering from moderate and severe ED treated with DualStim therapy with WJ compared to their baseline and DualStim with saline.Trial registration Registered on ClinicalTrials.gov; the trial number is NCT04424394

Download Full-text

Evaluation of the short-term efficacy of local analgesic (lidocaine) and opioid analgesic (sufentanil) on patients with centrally mediated abdominal pain syndrome: a randomized controlled trial

Therapeutic Advances in Gastroenterology ◽

10.1177/17562848211021783 ◽

2021 ◽

Vol 14 ◽

pp. 175628482110217

Author(s):

Hang Yang ◽

Honglin Chen ◽

Bing Hu

Keyword(s):

Randomized Controlled Trial ◽

Abdominal Pain ◽

Rating Scales ◽

Rating Scale ◽

Controlled Trial ◽

Opioid Analgesic ◽

Pain Syndrome ◽

Short Term ◽

Randomized Controlled ◽

Term Efficacy

Background: Centrally mediated abdominal pain syndrome (CAPS) is characterized by continuous or frequently recurring abdominal pain and can result in functional loss across several life domains. The efficacy of the present management methods has not been established yet. We performed a prospective randomized controlled trial to explore the short-term efficacy of local analgesic (lidocaine) and opioid analgesic (sufentanil) in patients with CAPS. Methods: We consecutively enrolled 130 patients who met the Rome IV CAPS criteria and divided them into the sufentanil + lidocaine (S + L) group and sufentanil (S) group. Patients completed the pain rating scales, including the numeric rating scale (NRS) and verbal rating scale (VRS), 60 min before colonoscopy. All the patients were initially administered sufentanil. In the S + L group, we sprayed a 5 ml solution of lidocaine on the surface of ascending, transverse, descending, and sigmoid colon during colonoscope withdrawal, while 5 ml saline was sprayed in the S group. Follow up was performed 1 day, 3 days, 1 week, 2 weeks, 1 month, and 3 months after colonoscopy, to complete the pain scaling. Results: A comparison of the NRS and VRS showed that there were no significant differences between the S + L and S groups and within each group ( p > 0.05). Conclusions: Local analgesic lidocaine and opioid analgesic sufentanil showed negative efficacy during short-term observation. The opioid receptor blocker sufentanil did not worsen symptoms in patients with CAPS after colonoscopy under general anesthesia in the short term. [chictr.org.cn, Chinese Clinical Trial Identifier, ChiCTR-IOR-16008187]

Download Full-text