topical nifedipine 0.3% plus lidocaine 1.5%: Transrectal and perianal application of nifedipine 0.3% plus lidocaine 1.5% cream twice daily for at least 21 days in patients with acute, uncomplicated hemorrhoidal disease
Study summary
The goal of this observational study is to evaluate the effectiveness of topical nifedipine 0.3% plus lidocaine 1.5% for uncomplicated hemorrhoidal disease. The main question it aims to answer is:
Does topical nifedipine 0.3% plus lidocaine 1.5% lower symptoms in patients with uncomplicated acute hemorrhoidal disease? Participants already taking nifedipine 0.3% plus lidocaine 1.5% as part of their regular medical care for hemorrhoidal disease will undergo four visits over a 30-day period, including two telephone contacts and two in-person visits.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Male and female patients aged 18-75 years.
* Clinical or anoscopic diagnosis of acute hemorrhoidal disease with prolapse severity between Grade II and IV (Goligher), possibly associated with external congestion.
* Patients who started treatment with nifedipine 0.3% + lidocaine 1.5% within the past 5 days.
* Availability of clinical evaluations at treatment initiation (proctologic visit and HDSS, SHS-HD, VAS scales).
* Ability to understand the informed consent.
* Signed informed consent.
Exclusion Criteria:
* Acute hemorrhoidal disease complicated by thrombosis or strangulation.
* Coagulopathies.
* Active neoplastic disease.
* Treatment with anticoagulants and/or chemotherapeutic agents.
* Hypersensitivity to active substances, especially lidocaine (and other amide-type local anesthetics) or excipients.
* Severe hypotensive states or cardiovascular insufficiency.
* Pregnancy or breastfeeding.
* Participation in clinical trials involving investigational drugs.
Primary outcome measure(s)
Change in HDSS (hemorrhoidal disease symptom score) questionnaire, analyzed using paired t-test or Wilcoxon signed-rank test according to data distribution. The total HDSS ranges from 0 to 20, with higher scores indicating greater symptom severity. — From enrollment to the 30-day follow-up
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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