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

Todd Moyerbrailean DO FACOG

Status: Terminated

Conditions: Dysuria

Treatments: Procedure: Cystoscopy - without use of obturator sheath; Procedure: Cystoscopy - with use of obturator sheath

Study type: Interventional

Funder types: Other

Identifiers

NCT05152199

STUDY00005662

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups

Cystoscopy with use of obturator sheath

Other group

Description:

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

Treatment:

Procedure: Cystoscopy - with use of obturator sheath

Cystoscopy without use of obturator sheath

Active Comparator group

Description:

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.

Treatment:

Procedure: Cystoscopy - without use of obturator sheath