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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Todd Moyerbrailean DO FACOG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 22, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 29, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 29, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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