How drugs that affect the endocannabinoid system change bladder muscle contractions.
Official title: Study on the Effects of Drugs That Modulate the Endocannabinoid System on Spontaneous and Induced Contractility of the Human Detrusor Muscle
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT07545694 · Data updated 2026-11-12
This work will test whether drugs that alter the endocannabinoid system change spontaneous and nerve‑driven contractions of bladder muscle using tissue from adults having radical cystectomy for bladder cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 65 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rome) |
| Status | Recruiting |
| Started | November 12, 2025 |
| Main results expected | May 2028 |
| Study ends | May 2028 |
| Registry record updated | April 22, 2026 |
| Trial ID | NCT07545694 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with bladder carcinoma scheduled for elective radical cystectomy who can give written informed consent and meet the timing criteria for any prior therapy are ideal candidates.
✕Probably not a fit
Patients not undergoing planned radical cystectomy, those having urgent/emergency procedures, minors, or patients with recent radio‑chemotherapy (<6 weeks) or certain corticosteroid/immunosuppressive treatments are unlikely to participate or benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single‑center, observational in vitro project using detrusor muscle taken from elective radical cystectomy specimens. Small strips of macroscopically healthy bladder detrusor will be mounted in organ baths to record baseline motor activity and responses to electrical field (neuronal) stimulation. Preparations will then be exposed to pharmacological modulators of endocannabinoid receptors, enzymes that synthesize or degrade endocannabinoids, and transport mechanisms to see how those interventions alter spontaneous and evoked contractility. Results will be compared to baseline responses to identify effects on neurotransmission and smooth muscle tone and to inform potential therapeutic targets for disorders such as detrusor overactivity.
Why it matters
Potential benefit: If successful, the findings could point to new molecular targets in the endocannabinoid pathway for treating detrusor overactivity or overactive bladder symptoms.
How similar studies have gone: Preclinical animal studies have shown cannabinoid modulation can alter bladder function, but human tissue data are limited and sometimes inconsistent, so this human in vitro approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where it's running
-
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo A. Gemelli, 100168 - Roma
Rome, Italy Recruiting
Study contacts
- Principal investigator: Maria Chiara Sighinolfi — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Maria Chiara Sighinolfi, Dr
- Email: mariachiara.sighinolfi@policlinicogemelli.it
- Phone: 0039 3921329216
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.