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Rigid Versus Flexible Cystoscopy in Women

NCT ID: NCT00214045

Last Updated: 2019-05-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2009-06-30

Brief Summary

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The study will help define the best tolerated approach to cystoscopy in women by randomly comparing flexible to rigid cystoscopy. Previous randomized studies evaluated rigid cystoscopy under general anesthesia versus flexible cystoscopy under local anesthesia. As a result of these studies, flexible cystoscopy is performed in the clinic setting generally in males. However, many women have rigid cystoscopy performed in the clinic while the men have flexible cystoscopy. No studies to date have evaluated whether flexible cystoscopy is better tolerated in women compared to rigid cystoscopy in women in the clinic setting.

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Detailed Description

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Conditions

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Hematuria Urination Disorders Voiding Dysfunction Recurrent Urinary Tract Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Flexible Cystoscopy

Flexible Cystoscopy

Group Type ACTIVE_COMPARATOR

Flexible Cystoscopy

Intervention Type DEVICE

Rigid Cystoscopy

Rigid Cystoscopy

Group Type ACTIVE_COMPARATOR

Rigid Cystoscopy

Intervention Type DEVICE

Interventions

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Flexible Cystoscopy

Intervention Type DEVICE

Rigid Cystoscopy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Female

Exclusion Criteria

* Minors
* Incarcerated individuals
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen Nakada, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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H-2004-0254

Identifier Type: -

Identifier Source: org_study_id

NCT00590733

Identifier Type: -

Identifier Source: nct_alias

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