Dysuria
Conditions
Keywords
Rigid Cystoscopy, Obturator Sheath, Urogynecology
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.
Interventions
PROCEDURECystoscopy - with use of obturator sheath
The intervention arm will include the use of the obturator sheath upon entry into the urethra during rigid cystoscopy.
PROCEDURECystoscopy - 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
Todd Moyerbrailean DO FACOG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-Procedure Dysuria | Post intervention pain scale assessment within 10 minutes following first void after the procedure. | The participant will be asked to void within 10 minutes of the completed procedure. The participant will then complete a Visual Analog Numeric Pain Scale, where 1 = no pain and 10 = worst possible pain, within 10 minutes of voiding. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bladder pain | Within 10 minutes following the first post-procedure void. | A 6 item questionnaire will be completed within 10 minutes following the first post-procedure void and include a yes/no question Do you have pain in your bladder? |
| Hesitancy | Within 10 minutes following the first post-procedure void. | A 6 item questionnaire will be completed within 10 minutes following the first post-procedure void and include a yes/no question Was there a delay before you started to urinate? |
| Strength of stream | Within 10 minutes following the first post-procedure void. | A 6 item questionnaire will be completed within 10 minutes following the first post-procedure void and include a multiple choice question assessing the participants strength of stream as: 1 - not reduced, 2 - reduced a little, 3 - quite reduced, 4 - reduced a great deal, 5 - I had no stream |
| Incomplete Emptying | Within 10 minutes following the first post-procedure void. | A 6 item questionnaire will be completed within 10 minutes following the first post-procedure void and include a yes/no question Did you feel that your bladder was empty after urinating? |
| Post-procedure pain | Within 10 minutes following completion of the procedure | The participant will be asked to complete a Visual Analog Numeric Pain Scale, where 1 = no pain and 10 = worst possible pain, within 10 minutes of procedure completion. |
| Straining | Within 10 minutes following the first post-procedure void. | A 6 item questionnaire will be completed within 10 minutes following the first post-procedure void and include a yes/no question Did you have to strain to start urinating? |
Countries
United States
Outcome results
None listed