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

NCT ID: NCT05152199

Last Updated: 2022-04-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-22
• Study Completion Date: 2022-03-29

Brief 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.

Detailed Description

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 (or obturator for short). There are two acceptable insertion techniques for performing cystoscopy in women. Surgeons can perform cystoscope without the use of the obturator by using a "visual" technique where a telescope with a sheath is inserted for entry into the bladder (referred to as cystoscopy without the obturator). Surgeons can also perform cystoscopy by using an obturator with a sheath allowing for smooth entry without needing the telescope (referred to as cystoscopy with the 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cystoscopy with use of obturator sheath

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

Group Type: OTHER

Cystoscopy - with use of obturator sheath

Intervention Type: PROCEDURE

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

Cystoscopy without use of obturator sheath

This 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.

Group Type: ACTIVE_COMPARATOR

Cystoscopy - without use of obturator sheath

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Female patients scheduled for gynecological procedures where cystoscopy is indicated
• Ability to comprehend and participate in the study

Exclusion Criteria

• < 18 years
• Pregnancy
• Current pelvic mesh erosion
• Exposure or pain complications from mesh
• Genitourinary malignancy;
• History of recurrent urinary tract infection (e.g., 2 in 6 months)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Todd Moyerbrailean DO FACOG

OTHER

Sponsor Role: lead

Responsible Party

Todd Moyerbrailean DO FACOG

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Todd Moyerbrailean, DO, FACOG

Role: PRINCIPAL_INVESTIGATOR

Michigan State University

Locations

Michigan State University

East Lansing, Michigan, United States

Countries

United States

References

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Other Identifiers

STUDY00005662

Identifier Type: -

Identifier Source: org_study_id