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Pain Outcomes During Rigid Cystoscopy in Females With and Without Cystoscopic Sheath Obturator

NCT05152199 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2022-04-07

No results posted yet for this study

Summary

Rigid cystoscopy is a common procedure to evaluate lower urinary tract symptoms in females. This procedure can be done with or without an instrument called a sheath obturator. Both techniques are used by surgeons and are considered safe, but have never been studied to see if one technique leads to less discomfort with the patient's first void after the procedure. The obturator's use may potentially reduce urethral irritation and bothersome postprocedural symptoms, primarily dysuria. The investigators aim to determine whether there is a difference in dysuria outcomes postoperatively when cystoscopy is performed with or without an obturator.

Conditions

  • Dysuria

Interventions

PROCEDURE

Cystoscopy - with use of obturator sheath

The intervention arm will include the use of the obturator sheath upon entry into the urethra during rigid cystoscopy.

PROCEDURE

Cystoscopy - without use of obturator sheath

The intervention arm will not include the use of the obturator sheath upon entry into the urethra during rigid cystoscopy, but will consist of using the telescope under direct visualization.

Sponsors & Collaborators

  • Todd Moyerbrailean DO FACOG

    lead OTHER

Principal Investigators

  • Todd Moyerbrailean, DO, FACOG · Michigan State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-22
Primary Completion
2022-03-29
Completion
2022-03-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05152199 on ClinicalTrials.gov