NCT00945594

Brief Summary

The primary purpose of this study to assess patient pain scores comparing rigid to flexible cystoscopy in females; to assess post procedural complications, including frequency, urgency, infection and time to resolution of these symptoms between the two procedures; to assess physician perception of patient pain or discomfort with flexible or rigid cystoscopy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Jul 2009

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
7.6 years until next milestone

Results Posted

Study results publicly available

June 6, 2019

Completed
Last Updated

June 6, 2019

Status Verified

June 1, 2019

Enrollment Period

2.3 years

First QC Date

July 22, 2009

Results QC Date

May 20, 2014

Last Update Submit

June 5, 2019

Conditions

Pain

Keywords

flexible cystoscopyrigid cystoscopybladderoutcome assessmentpain measurement

Outcome Measures

Primary Outcomes (2)

  • Post Procedural Complications, Including Frequency, Urgency, Infection and Time to Resolution of These Symptoms Between the Two Procedures.

    Post procedural complications, including frequency, urgency, infection and time to resolution of these symptoms between the two procedures. Patients were asked to report frequency or urgency as a "yes" or "no"

    1 week after procedure

  • Duration of Post-procedure Complications

    Duration of post-procedure complications, surveyed 1 week post procedure

    1 week after procedure

Secondary Outcomes (1)

  • Visual Analog Pain Scale

    Immediately after procedure

Study Arms (2)

Flexible cystoscopy

EXPERIMENTAL

16F flexible cysto urethroscope (Storz, Culver city, CA)

Device: Cystoscopy

Rigid cystoscopy

EXPERIMENTAL

17F, 70° scope (Storz, Culver city, CA)

Device: Cystoscopy

Interventions

CystoscopyDEVICE

A 16 F flexible cysto urethroscope (Storz, Culver city, CA) is used for flexible cystoscopy. When rigid cystoscopy is performed, a 17F, 70° scope (Storz, Culver city, CA)

Flexible cystoscopyRigid cystoscopy

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with the following indications for outpatient cystourethroscopy:
  • Microscopic hematuria or
  • Voiding dysfunction, or recurrence of urinary incontinence, or
  • History of recurrent bacterial cystitis
  • Age \>18
  • Patient willingness to enroll
  • Patient able to read and understand an English language self- administered questionnaire.

You may not qualify if:

  • Severe detrussor overactivity
  • Interstitial cystitis or chronic urethral or bladder pain
  • Acute urinary tract infection
  • Urinary retention defined as a post void residual \>120cc
  • Pregnancy or planning pregnancy within the next 3 months
  • Prior urethral surgery
  • Dementia or inability to complete questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Cystoscopy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, UrologicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical Procedures

Results Point of Contact

Title
Lieschen Quiroz, MD
Organization
University of Oklahoma Health Sciences Center
lieschen-quiroz@ouhsc.edu
405-271-8787

Study Officials

  • Lieschen H Quiroz, MD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2009

First Posted

July 24, 2009

Study Start

July 1, 2009

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

June 6, 2019

Results First Posted

June 6, 2019

Record last verified: 2019-06

Locations

US(1)