Study on the Effects of Drugs That Modulate the Endocannabinoid System on Spontaneous and Induced Contractility of the Human Detrusor Muscle
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study ID
- NCT07545694
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
The goal of this observational, in vitro study is to evaluate the effects of drugs that modulate the endocannabinoid system on spontaneous and neuronally induced contractility of the human detrusor. The study will include adult patients undergoing elective radical cystectomy for bladder cancer. The main questions it aims to answer are whether modulation of endocannabinoid receptors, enzymes involved in endocannabinoid synthesis and degradation, and endocannabinoid transport mechanisms alters basal detrusor contractility and modifies excitatory motor responses induced by neuronal activation. Participants undergoing radical cystectomy will provide written informed consent for the collection of a small sample of macroscopically healthy bladder tissue from the surgical specimen. Detrusor muscle strips will be prepared and studied in vitro using organ bath techniques. Contractile activity will be recorded under baseline conditions and after electrical field stimulation, as well as following exposure to pharmacological modulators of the endocannabinoid system. Demographic, clinical, and pathological data will also be collected for descriptive analysis.
Key Dates
- First listed
- Apr 22, 2026
- Start date
- Nov 12, 2025
- Status verified
- Nov 2025
- Primary completion
- May 31, 2028
- Completion
- May 31, 2028
Study Design
- Enrollment
- 65 participants (estimated)
Primary Outcome Measure
Effects of CB receptor agonists, antagonists and allosteric modulators, endocannabinoid synthesis/catabolism enzyme inhibitors, and EMT transporter inhibitors on EFS-induced submaximal contractions of detrusor preparations [ Time Frame: Time of in vitro organ bath pharmacological assessment (during the 30-month study period, post-tissue collection) ]
Central Contacts
- MARIA CHIARA SIGHINOLFI, DR0039 3921329216
Find similar trials
Related Studies
- Evaluation for NCI Surgery Branch Clinical Research ProtocolsRecruiting · National Cancer Institute (NCI) · Bethesda, Maryland
- Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant DiseaseRecruiting · National Cancer Institute (NCI) · Bethesda, Maryland
- Integrated Cancer Repository for Cancer ResearchRecruiting · University of Nebraska · Greenwood Village, Colorado
- Care of the Urothelial Cancer Patient and Prospective Procurement of Urothelial Cancer TissueRecruiting · National Cancer Institute (NCI) · Bethesda, Maryland