Urinary IncontinenceNCT01663181
Pain-perception During Outpatient cystoscopy-a Prospective Controlled Study
An observational study of Urinary Incontinence and Overactive Bladder, run by Medical University of Vienna at 1 site in Austria.
Trial summary
At an academic tertiary referral center, patients with pelvic floor dysfunction, scheduled for outpatient cystoscopy or urodynamic testing will be asked to participate in the study. Patients will be called one day after the examination and will be asked about pain and their general state of health. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Overactive Bladder, Pelvic Organ Prolapse
- How many people
- 109 participants
- Where
- 1 siteAustria
- Study dates
- May 2009to Apr 2010
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: women, aged >= 18 years with pelvic floor dysfunction, undergoing diagnostic work-up at a tertiary referral center for urogynecologic conditions
Who may be able to join
- women undergoing cystoscopy or urodynamic testing at an academic tertiary referral center.
Who cannot join
- age ≤ 18 years
- insufficient ability to understand German
- pregnancy
- participation in another clinical study at the same time
Trial locations and contacts
1 site in 1 country.
About this study
At an academic tertiary referral center, patients with pelvic floor dysfunction, scheduled for outpatient cystoscopy or urodynamic testing will be asked to participate in the study. Patients will be called one day after the examination and will be asked about pain and their general state of health.
The purpose of this study it to investigate pain perception in urogynecologic patients during outpatient cystoscopy and compare it with pain perception during outpatient urodynamic. The investigators will also investigate the difference between anticipated and actual pain perception. The investigators will test the null hypothesis that there is no difference in patients´ pain perception between outpatient cystoscopy and urodynamic testing. The secondary hypothesis will be that there is no difference between patients´ anticipated amount of pain and the actually experienced pain during cystoscopy and urodynamic testing.
Read more
According to power calculation, a sample size of 52 patients per group will be needed to detect a 2 cm difference in pain scores on the VAS - judged as a clinically significant difference - with 95% power and a two-sided significance level of 0.05.
Exclusion criteria are: age ≤ 18 years, insufficient ability to understand German, pregnancy and the participation in another clinical study at the same time.
- Conditions
- Urinary Incontinence, Overactive Bladder, Pelvic Organ Prolapse, Recurrent Urinary Tract Infections
- Medical subject headings
- Urinary Incontinence, Urinary Bladder, Overactive, Pelvic Organ Prolapse, Urinary Tract Infections
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 |
|---|---|---|
| urogynecologic patients undergoing outpatient cystoscopy | Not described | |
| urogynecologic patients undergoing outpatient-urodynamics | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
subjective pain perception immediately after examination as measured by a standard visual analog scale
patients are assessed at three points in time:
- zero to ten minutes before undergoing examination
- zero to ten minutes after undergoing examination
- 24 hours after undergoing examination
Measured: immediately after examination (zero to ten minutes after completing cystoscopy or urodynamics)
Secondary outcomes (1)
difference between anticipated pain and actual pain perception
Measured: immediately before and immediately after the examination (zero to ten minutes after undergoing examination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2012 (estimated)
- Study startMay 2009
- Primary completionFeb 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wolfgang Umek, MD, Medical University of Vienna
- Investigators
- Wolfgang Umek, Prof, Principal investigator, Medical University Vienna Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01663181
- Sponsor's protocol ID
- 413/2009
- Status last verified
- Apr 2022
- First submitted
- 5 Aug 2012
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain-perception During Outpatient cystoscopy-a Prospective Controlled Study
- ClinicalTrials.gov ID
- NCT01663181
- Acronym / sponsor ID
- 413/2009
- Conditions
- Urinary Incontinence, Overactive Bladder, Pelvic Organ Prolapse, Recurrent Urinary Tract Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 13 Aug 2012 (estimated)
- 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.
At an academic tertiary referral center, patients with pelvic floor dysfunction, scheduled for outpatient cystoscopy or urodynamic testing will be asked to participate in the study. Patients will be called one day after the examination and will be asked about pain and their general state of health.
The purpose of this study it to investigate pain perception in urogynecologic patients during outpatient cystoscopy and compare it with pain perception during outpatient urodynamic. The investigators will also investigate the difference between anticipated and actual pain perception. The investigators will test the null hypothesis that there is no difference in patients´ pain perception between outpatient cystoscopy and urodynamic testing. The secondary hypothesis will be that there is no difference between patients´ anticipated amount of pain and the actually experienced pain during cystoscopy and urodynamic testing.
According to power calculation, a sample size of 52 patients per group will be needed to detect a 2 cm difference in pain scores on the VAS - judged as a clinically significant difference - with 95% power and a two-sided significance level of 0.05.
Exclusion criteria are: age ≤ 18 years, insufficient ability to understand German, pregnancy and the participation in another clinical study at the same time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| urogynecologic patients undergoing outpatient cystoscopy | – | – |
| urogynecologic patients undergoing outpatient-urodynamics | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women, aged >= 18 years with pelvic floor dysfunction, undergoing diagnostic work-up at a tertiary referral center for urogynecologic conditions
Key inclusion criteria (1 listed)
- women undergoing cystoscopy or urodynamic testing at an academic tertiary referral center.
Key exclusion criteria (4 listed)
- age ≤ 18 years
- insufficient ability to understand German
- pregnancy
- participation in another clinical study at the same time
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
subjective pain perception immediately after examination as measured by a standard visual analog scale
Time frame: immediately after examination (zero to ten minutes after completing cystoscopy or urodynamics)
patients are assessed at three points in time: 1. zero to ten minutes before undergoing examination 2. zero to ten minutes after undergoing examination 3. 24 hours after undergoing examination
1 secondary outcome
difference between anticipated pain and actual pain perception
Time frame: immediately before and immediately after the examination (zero to ten minutes after undergoing examination)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
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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.
Wolfgang Umek, Prof principal investigator
Medical University Vienna Austria
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 Urinary Incontinence and Overactive Bladder, run by Medical University of Vienna at 1 site in Austria.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 12 Apr 2022. 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 Austria. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
subjective pain perception immediately after examination as measured by a standard visual analog scale (time frame: immediately after examination (zero to ten minutes after completing cystoscopy or urodynamics)). 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 12 Apr 2022.