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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-28

Study Completion Date

2020-02-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Pregabalin on Catheter Related Bladder Discomfort

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, double-blind,randomized, placebo controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group I

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

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

Placebo oral capsule administered 1 hour prior to the surgical operation

Group II

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

Group Type EXPERIMENTAL

Pregabalin Oral Capsule [Lyrica] 75mg

Intervention Type DRUG

Pregabalin Oral Capsule \[Lyrica\] 75 mg administered 1 hour prior to the surgical operation

Group III

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

Group Type EXPERIMENTAL

Pregabalin Oral Capsule [Lyrica] 150 mg

Intervention Type DRUG

Pregabalin Oral Capsule \[Lyrica\] 150 mg administered 1 hour prior to the surgical operation

Interventions

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Placebo oral capsule

Placebo oral capsule administered 1 hour prior to the surgical operation

Intervention Type DRUG

Pregabalin Oral Capsule [Lyrica] 75mg

Pregabalin Oral Capsule \[Lyrica\] 75 mg administered 1 hour prior to the surgical operation

Intervention Type DRUG

Pregabalin Oral Capsule [Lyrica] 150 mg

Pregabalin Oral Capsule \[Lyrica\] 150 mg administered 1 hour prior to the surgical operation

Intervention Type DRUG

Other Intervention Names

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Pregabalin Pregabalin

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No