Effect of Pregabalin Administration on Catheter- Related Bladder Discomfort in Urological Surgical Operations

Saint Savvas Anticancer Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Pregabalin on Catheter Related Bladder Discomfort

Treatments: Drug: Placebo oral capsule; Drug: Pregabalin Oral Capsule [Lyrica] 75mg; Drug: Pregabalin Oral Capsule [Lyrica] 150 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03229668

CRBD urologic operations

Details and patient eligibility

About

The aim of this study is to assess the effect of pregabalin administration on catheter-related bladder discomfort (CRBD). The study group includes patients that are about to be subjected to urological operations because of the high incidence of CRBD observed in this kind of surgical population.

Enrollment: 78 patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients about to be subjected to urinary operations
• Signed informed consent

Exclusion criteria

• Preoperative urinary bladder/kidney dysfunction as a result of spinal cord pathology
• History of overactive ((urinary frequency>3 times at night and >8 times in 24 hours), neurogenic bladder
• End stage renal failure
• Central nervous system dysfunction
• Mental illness/ substance abuse
• Sensitivity to pregabalin
• Preoperative administration of pregabalin for other indications
• Recent bladder catheterization <3 months

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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78 participants in 3 patient groups, including a placebo group

Group I

Placebo Comparator group

Description:

Administration of a placebo capsule 1 hour prior to the surgical operation

Treatment:

Drug: Placebo oral capsule

Group II

Experimental group

Description:

Administration of 75mg of pregabalin 1 hour prior to the surgical operation

Treatment:

Drug: Pregabalin Oral Capsule [Lyrica] 75mg

Group III

Experimental group

Description:

Administration of 150mg of pregabalin 1 hour prior to the surgical operation

Treatment:

Drug: Pregabalin Oral Capsule [Lyrica] 150 mg