Study on the Effects of Drugs That Modulate the Endocannabinoid System on Spontaneous and Induced Contractility of the Human Detrusor Muscle

NCT07545694 | Recruiting

• 1 other identifier: 8157
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  Evaluate the change in amplitude on submaximal contractions induced by electrical field stimulation (EFS) in human detrusor tissue strips mounted in organ baths following exposure to specified drugs

  Time of in vitro organ bath pharmacological assessment (during the 30-month study period, post-tissue collection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with bladder cancer scheduled for elective resection surgery at the reference center, specifically the U.O.C. di Clinica Urologica at Fondazione Policlinico Universitario A. Gemelli in Rome, will be enrolled

You may qualify if:

• Age ≥ 18 years.
• Patients with bladder carcinoma at any stage of disease, undergoing upfront surgery or neoadjuvant therapy for more than 6 weeks, scheduled for surgery with curative/demolitive intent.
• Signed written informed consent to participate in the study.

You may not qualify if:

• Age \< 18 years.
• Procedures performed on an urgent/emergency basis.
• Patients treated with corticosteroid therapy for immunorheumatic diseases.
• Patients treated with radio-chemotherapy and undergoing surgery less than 6 weeks prior.
• Refusal to sign written informed consent to participate in the study.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo A. Gemelli, 100168 - Roma

Rome, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

bladder tissue

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Maria Chiara Sighinolfi

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MARIA CHIARA SIGHINOLFI, DR

CONTACT

0039 3921329216; mariachiara.sighinolfi@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 22, 2026
• Study Start: November 12, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 22, 2026

Record last verified: 2025-11

Locations

IT (1)