Evaluation of tadalafil in combination with Low-Intensity Pulsed Ultrasound (LIPUS) for erectile dysfunction: a protocol for a randomized controlled trial (SPIRIT Compliant)
Abstract
Abstract Background Erectile dysfunction (ED) is characterized by a persistent inability to achieve and maintain sufficient penile erection for satisfactory sexual performance persisting for at least six months. Low-intensity pulsed ultrasound (LIPUS), a noninvasive therapy, has shown potential in improving ED by promoting the regeneration of connective tissue, blood vessels, and cavernous nerves, as well as reducing inflammation. This study aims to evaluate the clinical efficacy and histological changes in the corpus cavernosum of patients with ED treated with tadalafil combined with LIPUS through a randomized controlled trial. Methods This study will enroll 114 patients diagnosed with ED who will be randomly assigned to either the treatment group or the control group in a 1:1 ratio using simple random sampling. The treatment group will first receive 5 mg of tadalafil daily combined with twice-weekly LIPUS therapy for 4 weeks. Following a 4-week interval with daily 5 mg tadalafil alone (no LIPUS treatment), the same combined treatment regimen will be repeated. The control group will receive only 5 mg of tadalafil daily. The primary outcome will be assessed using the minimal clinically important difference (MCID) based on the International Index of Erectile Function-5 (IIEF-5) at each follow-up visit. Additional assessments will include the Erection Hardness Score (EHS), penile blood flow parameters, and elasticity values for a comprehensive evaluation. Discussion The study…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 114 participants or records.
Read the paper
Related studies
- Antioxidant efficacy and the upregulation of Nrf2-mediated HO-1 expression by (+)-lariciresinol, a lignan isolated from Rubia philippinensis, through the activation of p38
- Anti-influenza virus activity of green tea by-products in vitro and efficacy against influenza virus infection in chickens
- Therapeutic Potential of Mesenchymal Stem Cells (MSCs) and MSC-Derived Extracellular Vesicles for the Treatment of Spinal Cord Injury
- The intratumoral administration of ferucarbotran conjugated with doxorubicin improved therapeutic effect by magnetic hyperthermia combined with pharmacotherapy in a hepatocellular carcinoma model
- Enhanced anticancer efficacy of TRAIL-conjugated and odanacatib-loaded PLGA nanoparticles in TRAIL resistant cancer
- In vivo tracking of bioorthogonally labeled T-cells for predicting therapeutic efficacy of adoptive T-cell therapy
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.