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

March 29, 2022 updated by: Todd Moyerbrailean DO FACOG

The Assessment of Pain Outcomes During Rigid Cystoscopy in Females With and Without the Use of the Rigid Cystoscope Obturator: A Randomized Control Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • East Lansing, Michigan, United States, 48824
        • Michigan State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-Procedure Dysuria
Time Frame: 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.
Post intervention pain scale assessment within 10 minutes following first void after the procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Strength of stream
Time Frame: 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
Within 10 minutes following the first post-procedure void.
Bladder pain
Time Frame: 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?"
Within 10 minutes following the first post-procedure void.
Hesitancy
Time Frame: 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?"
Within 10 minutes following the first post-procedure void.
Straining
Time Frame: 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?"
Within 10 minutes following the first post-procedure void.
Incomplete Emptying
Time Frame: 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?"
Within 10 minutes following the first post-procedure void.
Post-procedure pain
Time Frame: 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.
Within 10 minutes following completion of the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Todd Moyerbrailean DO FACOG

Investigators

  • Principal Investigator: Todd Moyerbrailean, DO, FACOG, Michigan State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2021

Primary Completion (Actual)

March 29, 2022

Study Completion (Actual)

March 29, 2022

Study Registration Dates

First Submitted

November 23, 2021

First Submitted That Met QC Criteria

December 7, 2021

First Posted (Actual)

December 9, 2021

Study Record Updates

Last Update Posted (Actual)

April 7, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00005662

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual participant data will be shared with members of the investigation team.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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