Stress Urinary IncontinenceVUSIS 2NCT00814749
Value of Urodynamics Prior to Stress Incontinence Surgery 2
A study testing midureteral sling and surgical therapy or conservative in people with Stress Urinary Incontinence, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
To test the value of preoperatively performed urodynamics with regard to outcome of surgery for stress urinary incontinence (SUI) and to examine whether not performing urodynamics preoperatively is more cost effective than performing urodynamics preoperatively using the non-inferiority assumption. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- midureteral sling and surgical therapy or conservative
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2008to Jan 2011
- Phase
- Interventional
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Symptoms of stress urinary incontinence and/or mixed urinary incontinence, predominantly stress incontinence
- Signs of stress urinary incontinence on physical examination or voiding-diary
- Patient is a candidate for surgical treatment (as based on history and physical examination)
- Patient has attended at least 3 months of physiotherapy
- Patient accepts randomisation
- Patient is capable to fill out bladder diary's, pad tests and questionnaires
- Patient understands the Dutch written and spoken language
- ASA 1 or 2
Who cannot join
- Previous incontinence surgery
- Mixed urinary incontinence, urge component is predominant
- Prolapse >= 1cm beyond the hymen on Valsalva in supine position
- Postvoid urinary residual > 150ml
- Present urinary tract infection
- The need for additional pelvic surgery (prolapse and/or hysterectomy)
- Patient is or wants to become pregnant
- Prior pelvic radiotherapy
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center St. Radboud
Nijmegen, Gelderland
Sanne van Leijsen, MD, +31641520114, sannevanleijsen@hotmail.com
About this study
Official title: a Multicentered Randomised Controlled Trial to Test the Cost Effectiveness of Urodynamics in Women With Symptoms of Stress Urinary Incontinence in Whom Surgical Treatment is Considered
To test the value of preoperatively performed urodynamics with regard to outcome of surgery for stress urinary incontinence (SUI) and to examine whether not performing urodynamics preoperatively is more cost effective than performing urodynamics preoperatively using the non-inferiority assumption.
- Conditions
- Stress Urinary Incontinence
- Being tested
- midureteral sling, surgical therapy or conservative
- Keywords
- stress urinary incontinence, urodynamics, randomized clinical trial, surgery
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
midureteral slingProcedure or surgery
midureteral sling
surgical therapy or conservativeOther
midureteral sling or conservative; medication, physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| surgical therapy | Active comparator | Not described Receives: Procedure: midureteral sling |
| individual management | Active comparator | Not described Receives: Other: surgical therapy or conservative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non inferiority of the improvement of the urinary distress inventory one year after treatment.
Measured: one year
Secondary outcomes (1)
Cure of incontinence as measured with voiding diary. Complications of surgery for stress urinary incontinence, in particular re-operations and overactive bladder symptoms. Quality of life as measured by RAND-36, Euroqol and IIQ.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionJan 2010 (estimated)
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Investigators
- Mark Vierhout, MD, PhD, Principal investigator, Radboud University Medical CenterJohn Heesakkers, MD, PhD, Principal investigator, University Medical Center St. RadboudKirsten Kluivers, MD, PhD, Principal investigator, University Medical Center St. RadboudSanne van Leijsen, MD, Principal investigator, University Medical Center St. RadboudBen Willem Mol, MD, PhD, Principal investigator, Academic Medical Centre Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00814749
- Sponsor's protocol ID
- 2006/197
- Acronym
- VUSIS 2
- Status last verified
- Dec 2008
- First submitted
- 24 Dec 2008
- Last updated
- 25 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van Leijsen SAL, Kluivers KB, Mol BWJ, Hout J', Milani AL, Roovers JWR, Boon JD, Vaart CHV, Langen PH, Hartog FE, Dietz V, Tiersma ESM, Hovius MC, Bongers MY, Spaans W, Heesakkers JPFA, Vierhout ME; Dutch Urogynecology Consortium*. Value of urodynamics before stress urinary incontinence surgery: a randomized controlled trial. Obstet Gynecol. 2013 May;121(5):999-1008. doi: 10.1097/AOG.0b013e31828c68e3.
PubMed 23635736van Leijsen SA, Kluivers KB, Mol BW, Broekhuis SR, Milani FL, van der Vaart CH, Roovers JP, Bongers MY, den Boon J, Spaans WA, de Leeuw JW, Dietz V, Kleinjan JH, Brolmann HA, Roos EJ, Schaafstra J, Heesakkers JP, Vierhout ME. Protocol for the value of urodynamics prior to stress incontinence surgery (VUSIS) study: a multicenter randomized controlled trial to assess the cost effectiveness of urodynamics in women with symptoms of stress urinary incontinence in whom surgical treatment is considered. BMC Womens Health. 2009 Jul 21;9:22. doi: 10.1186/1472-6874-9-22.
PubMed 19622153
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Multicentered Randomised Controlled Trial to Test the Cost Effectiveness of Urodynamics in Women With Symptoms of Stress Urinary Incontinence in Whom Surgical Treatment is Considered
- ClinicalTrials.gov ID
- NCT00814749
- Acronym / sponsor ID
- VUSIS 2 / 2006/197
- Conditions
- Stress Urinary Incontinence
- Keywords
- stress urinary incontinence, urodynamics, randomized clinical trial, surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Nov 2008
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 25 Dec 2008 (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.
To test the value of preoperatively performed urodynamics with regard to outcome of surgery for stress urinary incontinence (SUI) and to examine whether not performing urodynamics preoperatively is more cost effective than performing urodynamics preoperatively using the non-inferiority assumption.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgical therapy | Active comparator | Procedure: midureteral sling |
| individual management | Active comparator | Other: surgical therapy or conservative |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Symptoms of stress urinary incontinence and/or mixed urinary incontinence, predominantly stress incontinence
- Signs of stress urinary incontinence on physical examination or voiding-diary
- Patient is a candidate for surgical treatment (as based on history and physical examination)
- Patient has attended at least 3 months of physiotherapy
- Patient accepts randomisation
Key exclusion criteria (8 listed)
- Previous incontinence surgery
- Mixed urinary incontinence, urge component is predominant
- Prolapse >= 1cm beyond the hymen on Valsalva in supine position
- Postvoid urinary residual > 150ml
- Present 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| midureteral slingmidureteral sling | Procedure or surgery | surgical therapy |
| surgical therapy or conservativemidureteral sling or conservative; medication, physiotherapy | Other | individual management |
Primary outcome
Non inferiority of the improvement of the urinary distress inventory one year after treatment.
Time frame: one year
1 secondary outcome
Cure of incontinence as measured with voiding diary. Complications of surgery for stress urinary incontinence, in particular re-operations and overactive bladder symptoms. Quality of life as measured by RAND-36, Euroqol and IIQ.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2008.
- Derived from this study: PubMed 23635736van Leijsen SAL, Kluivers KB, Mol BWJ, Hout J', Milani AL, Roovers JWR, Boon JD, Vaart CHV, Langen PH, Hartog FE, Dietz V, Tiersma ESM, Hovius MC, Bongers MY, Spaans W, Heesakkers JPFA, Vierhout ME; Dutch Urogynecology Consortium*. Value of urodynamics before stress urinary incontinence surgery: a randomized controlled trial. Obstet Gynecol. 2013 May;121(5):999-1008. doi: 10.1097/AOG.0b013e31828c68e3.
- Derived from this study: PubMed 19622153van Leijsen SA, Kluivers KB, Mol BW, Broekhuis SR, Milani FL, van der Vaart CH, Roovers JP, Bongers MY, den Boon J, Spaans WA, de Leeuw JW, Dietz V, Kleinjan JH, Brolmann HA, Roos EJ, Schaafstra J, Heesakkers JP, Vierhout ME. Protocol for the value of urodynamics prior to stress incontinence surgery (VUSIS) study: a multicenter randomized controlled trial to assess the cost effectiveness of urodynamics in women with symptoms of stress urinary incontinence in whom surgical treatment is considered. BMC Womens Health. 2009 Jul 21;9:22. doi: 10.1186/1472-6874-9-22.
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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.
Mark Vierhout, MD, PhD principal investigator
Radboud University Medical Center
John Heesakkers, MD, PhD principal investigator
University Medical Center St. Radboud
Kirsten Kluivers, MD, PhD principal investigator
University Medical Center St. Radboud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing midureteral sling and surgical therapy or conservative in people with Stress Urinary Incontinence, run by Radboud University Medical Center at 1 site in Netherlands.
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 8 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 25 Dec 2008. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanne van Leijsen, M.D. (+31-6-41520114, sannevanleijsen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non inferiority of the improvement of the urinary distress inventory one year after treatment. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00814749, which also lists 2 linked publications.
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 25 Dec 2008.