In this study researcher wanted to learn more about the changes of biggest twisted and bulging veins in the rectal area (hemorrhoids) and changes of symptoms during a treatment period with the cream Relief Pro and suppositories Relief Pro. The study collected information on the treatment satisfaction of patients and their physicians with the prescribed treatment by using questionnaires. There were 3 visits at the physician's clinic for this study: one initial visit and 2 follow-up visits over a period of 2 weeks.
Study Type
OBSERVATIONAL
Enrollment
1,000
Relief Pro cream:1.0 mg/gm Fluocortolone + 20 mg/gm Lidocaine; Administration according to clinical practice.
Relief Pro rectal suppositories: 1.0 mg Fluocortolone + 40 mg Lidocaine; Administration according to clinical practice
State Scientific Center of Coloproctology
Moscow, Russia
Severity of pain (VAS: Visual Analogue Scale)
Pain was measured on a Visual Analogue Scale (VAS) from 0 (No Pain) to 10 (Maximal Pain).
Time frame: Up to 14 days
Severity of bleeding (according to 4-point Likert scale)
4-point Likert scale consisting of: 1 (None), 2 (Minimal), 3 (Moderate) and 4 (Significant).
Time frame: Up to 14 days
Severity of pruritus (according to 4-point Likert scale)
Time frame: Up to 14 days
Severity of swelling (according to 4-point Likert scale)
Time frame: Up to 14 days
Severity (amount) of discharge (according to 4-point Likert scale)
Time frame: Up to 14 days
Severity of sense of discomfort (according to 4-point Likert scale)
Time frame: Up to 14 days
Overall patient satisfaction with treatment (according to 5-point Likert scale)
Likert scale: 1 (Very satisfied), 2 (Satisfied), 3 (Neither satisfied nor dissatisfied), 4 (Dissatisfied) and 5 (Very dissatisfied).
Time frame: Up to 14 days
Time to onset of analgesic effect after the first use of the drug
Time frame: Up to 14 days
Duration of analgesic effect after the first use of the drug
Time frame: Up to 14 days
Patient's adherence to recommendations of the Investigator by PRO
PRO: Patient Reported Outcome
Time frame: Up to 14 days
Information obtained in the course of questioning about the consumer properties of the study product by PRO
Time frame: Up to 14 days
Severity of hemorrhoids symptoms according to the Sodergren score
Standardized answer options are given (4 and 5 Likert boxes) and each question gets a score from 0 to 4.
Time frame: Up to 14 days
Size of the largest hemorrhoid node measured during a routine examination
Time frame: Up to 14 days
Severity of swelling when assessed as part of routine examination (according to 4-point Likert scale)
Time frame: Up to 14 days
Severity of bleeding when assessed as part of routine examination (according to 4-point Likert scale)
Time frame: Up to 14 days
Amount of ReliefPro used based on information provided by the patient to the Investigator
Time frame: Up to 14 days
Overall satisfaction of Investigator with treatment with Relief Pro according Likert scale from 1 to 5 points as measured on Visits 2 and 3
Time frame: Up to 14 days
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