PainHYDRUDSNCT03330483
Do Hydrophilic Catheters Decrease Pain and Discomfort of a Patient During Urodynamic Study
An observational study of Pain and Discomfort, run by Meir Medical Center at 1 site in Israel.
Trial summary
This study attempts to verify whether different types of catheters could impact on patients' feelings at the first-time catheter insertion at urodynamic study. Each patient will undergo an insertion of only one type of a catheter and will rate his/her pain and discomfort feelings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Discomfort
- How many people
- 2 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are referred to Urodynamic Suite at Meir Medical Center and comply with inclusion criteria
Who may be able to join
- Male and female patients
- Age 18 and above
- Scheduled and consented for urodynamic study
- Able to sign an informed consent and agree to be included to a study.
Who cannot join
- indwelling catheter
- use of pain killers in 24 hours prior to urodynamic study
- persistent abdominal, perineal or pelvic pain or discomfort prior to a study
- prior or suspected urethral stricture
- urinary tract infection
- positive asymptomatic urine culture prior to urodynamic study
- scheduled for a transurethral cystoscopic examination at the same day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do Hydrophilic Catheters Decrease Pain and Discomfort of a Patient During Urodynamic Study: Single-blinded Randomized Study
This study attempts to verify whether different types of catheters could impact on patients' feelings at the first-time catheter insertion at urodynamic study.
Each patient will undergo an insertion of only one type of a catheter and will rate his/her pain and discomfort feelings.
Read the detailed description
Urodynamic study usually starts with non-invasive uroflowmetry following by insertion of a urethral catheter (nelathon or tiemann tip) for measuring of post-void residual of urine. Insertion of a urethral catheter is usually accompanied by a discomfort and sometimes even a pain. In order to minimize these unpleasant feelings urodynamic technician uses gel with anesthetic agents.
Single-use sterile catheters without any equipment and no coating can be used with lubricants and nowadays are the standard equipment at urodynamic study. Non-coated standard catheters are widely considered in the literature to cause an increase in urethral irritation, poor patient satisfaction, increased bacteriuria, and long-term urethral complications. Single-use sterile catheters with hydrophilic coatings, ready-to-use solution, with gel on the surface of the catheter or gel in the wrapping. Hydrophilic-coated catheters are characterized by having a layer of polymer coating, which absorbs and binds water to the catheter up to 10 times its own weight. This results in a thick, smooth and slippery surface reducing friction between the catheter surface and the urethral mucosa during insertion. The coating layer remains intact upon introduction into the urethra and ensures lubrication of the urethra in its entire length. Coloplast Speedicath hydrophylic catheters are designed for single use and are pre-coated to allow ease of insertion and removal, thereby reducing the risk of urethral mucosal irritation that can be more prevalent in an non-coated product.
Up today, there are no studies to verify whether a patient has different feelings with different type of catheters during the first-time urethral cauterization at urodynamic study.
- Conditions
- Pain, Discomfort
- Keywords
- pain, discomfort, hydrophylic catheter, urodynamic study
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Female Speedicath nelathon | Evaluation of pain or discomfort in female patients at/during/after Speedicath nelathon-tip catheter insertion | |
| Female nelathon | Evaluation of pain or discomfort in female patients at/during/after standard nelathon-tip catheter insertion | |
| Male Speedicath tiemann | Evaluation of pain or discomfort in male patients at/during/after Speedicath tiemann-tip catheter insertion | |
| Male tiemann | Evaluation of pain or discomfort in male patients at/during/after standard tiemann-tip catheter insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain and discomfort level from a baseline
Change in Visual Analogue Scale (VAS) questionnaire score from a baseline. VAS questionnaire score assesses pain and discomfort of a patient from 0 to 10 where 0 is no pain and discomfort and 10 is a maximal pain and discomfort.
Measured: 0, 2, 15, 30 minutes
Secondary outcomes (1)
Change in pulse rate
Pulse rate/minute
Measured: 0, 2, 15, 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Nov 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Why it stopped: Difficulty in recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330483
- Sponsor's protocol ID
- 0246-16-MMC
- Acronym
- HYDRUDS
- Status last verified
- Mar 2019
- First submitted
- 4 Oct 2017
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Hydrophilic Catheters Decrease Pain and Discomfort of a Patient During Urodynamic Study: Single-blinded Randomized Study
- ClinicalTrials.gov ID
- NCT03330483
- Acronym / sponsor ID
- HYDRUDS / 0246-16-MMC
- Conditions
- Pain, Discomfort
- Keywords
- pain, discomfort, hydrophylic catheter, urodynamic study
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulty in recruiting patients
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study attempts to verify whether different types of catheters could impact on patients' feelings at the first-time catheter insertion at urodynamic study.
Each patient will undergo an insertion of only one type of a catheter and will rate his/her pain and discomfort feelings.
Detailed description
Urodynamic study usually starts with non-invasive uroflowmetry following by insertion of a urethral catheter (nelathon or tiemann tip) for measuring of post-void residual of urine. Insertion of a urethral catheter is usually accompanied by a discomfort and sometimes even a pain. In order to minimize these unpleasant feelings urodynamic technician uses gel with anesthetic agents.
Single-use sterile catheters without any equipment and no coating can be used with lubricants and nowadays are the standard equipment at urodynamic study. Non-coated standard catheters are widely considered in the literature to cause an increase in urethral irritation, poor patient satisfaction, increased bacteriuria, and long-term urethral complications. Single-use sterile catheters with hydrophilic coatings, ready-to-use solution, with gel on the surface of the catheter or gel in the wrapping. Hydrophilic-coated catheters are characterized by having a layer of polymer coating, which absorbs and binds water to the catheter up to 10 times its own weight. This results in a thick, smooth and slippery surface reducing friction between the catheter surface and the urethral mucosa during insertion. The coating layer remains intact upon introduction into the urethra and ensures lubrication of the urethra in its entire length. Coloplast Speedicath hydrophylic catheters are designed for single use and are pre-coated to allow ease of insertion and removal, thereby reducing the risk of urethral mucosal irritation that can be more prevalent in an non-coated product.
Up today, there are no studies to verify whether a patient has different feelings with different type of catheters during the first-time urethral cauterization at urodynamic study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Female Speedicath nelathon | – | –Evaluation of pain or discomfort in female patients at/during/after Speedicath nelathon-tip catheter insertion |
| Female nelathon | – | –Evaluation of pain or discomfort in female patients at/during/after standard nelathon-tip catheter insertion |
| Male Speedicath tiemann | – | –Evaluation of pain or discomfort in male patients at/during/after Speedicath tiemann-tip catheter insertion |
| Male tiemann | – | –Evaluation of pain or discomfort in male patients at/during/after standard tiemann-tip catheter insertion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are referred to Urodynamic Suite at Meir Medical Center and comply with inclusion criteria
Key inclusion criteria (4 listed)
- Male and female patients
- Age 18 and above
- Scheduled and consented for urodynamic study
- Able to sign an informed consent and agree to be included to a study.
Key exclusion criteria (7 listed)
- indwelling catheter
- use of pain killers in 24 hours prior to urodynamic study
- persistent abdominal, perineal or pelvic pain or discomfort prior to a study
- prior or suspected urethral stricture
- urinary tract infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Pain and discomfort level from a baseline
Time frame: 0, 2, 15, 30 minutes
Change in Visual Analogue Scale (VAS) questionnaire score from a baseline. VAS questionnaire score assesses pain and discomfort of a patient from 0 to 10 where 0 is no pain and discomfort and 10 is a maximal pain and discomfort.
1 secondary outcome
Change in pulse rate
Time frame: 0, 2, 15, 30 minutes
Results and safety
The study was stopped early (reason given: Difficulty in recruiting patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Discomfort, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty in recruiting patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain and discomfort level from a baseline (time frame: 0, 2, 15, 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2019.