Surgical Treatment of Urge IncontinencePhase 1/2URGE-IINCT01737918
Treatment of Urge Urinary Incontinence in Women After Failure of Cesa or Vasa
A Phase 1/2 study testing TOT and solifenacin in people with Surgical Treatment of Urge Incontinence, run by Klinikum der Universität Köln at 2 sites in Germany.
Trial summary
Urge urinary incontinence can be a disorder caused by destroyed pelvic structures. We repaired the uteri-sacral ligaments (USL) by cesa or vasa. The study evaluates if solifenacin can lead to continence after surgery or if also the pubo-urethral ligaments (PUL) need to be repaired. Read more about this study
- Who is it for?
- Ages 40 to 85 years, women only
- Conditions the study is for
- Surgical Treatment of Urge Incontinence
- What is being tested?
- TOT and solifenacin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2013to Jul 2018
- Phase
- Phase 1/2
- 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 40 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- prior vasa or cesa operation as part of the URGE I study
- stress urinary incontinence
- mixed urinary incontinence
Who cannot join
- previous urogynecological surgery
- avulsion of cesa or vasa tape
- pregnancy
- neurologic/psychological reasons for incontinence
- body weight >100kg
- syndrome of dry overactive bladder
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Abt. Beckenbodenchirurgie der Universitäts-Frauenklinik Köln
Cologne, North Rhine-Westphalia, 50931
Wolfram H Jager, PhD, 0049221478 ext. 4900, wolfram.jaeger@uk-koeln.de
- Recruiting
Abt. Beckenbodenchirurgie der Universitäts-Frauenklinik Köln
Cologne, North Rhine-Westphalia, 50931
Wolfram H Jager, PhD, 0049221478 ext. 4900, wolfram.jaeger@uk-koeln.de
Peter Mallmann, PhD, 0049221478 ext. 4940, peter.mallmann@uk-koeln.de
About this study
Official title: Phase 1/2 Study of the Effect of TOT or Solifenacin After Cesa or Vasa on Urge Urinary Incontinence
Urge urinary incontinence can be a disorder caused by destroyed pelvic structures. We repaired the uteri-sacral ligaments (USL) by cesa or vasa. The study evaluates if solifenacin can lead to continence after surgery or if also the pubo-urethral ligaments (PUL) need to be repaired.
Read the detailed description
It was hypothesized that urge urinary incontinence in women is based on the destruction of the uteri-sacral ligaments (USL)and the pubourethral ligaments (PUL). In a preliminary study (URGE I) we repaired the USL by cesa or vasa. Those patients who are still incontinent after cesa and vasa get the repair of the PUL by means of trans-obturator tapes (TOT). That treatment is compared to conservative medical treatment. Cross over after completion of three months is possible if no continence is achieved.
- Conditions
- Surgical Treatment of Urge Incontinence
- Being tested
- TOT, solifenacin
- Keywords
- urge urinary incontinence, cesa, vasa, TOT, solifenacin
- Medical subject headings
- Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOTProcedure or surgery
Also called trans obturatorial tape
solifenacinDrug
Also called VESICUR 10mg per day
| Study group | Role | What they receive |
|---|---|---|
| trans obturatorial tape (TOT) | Experimental | placement of a sub-urethral tape Receives: Procedure: TOT |
| solifenacin | Active comparator | 10 mg per day Receives: Drug: solifenacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
cure of incontinence
Measured: 3 months
Secondary outcomes (1)
improvement of urge symptoms
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionDec 2017 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Treatment of Urge IncontinenceStudies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinikum der Universität Köln
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Dr. Wolfram Jäger, Klinikum der Universität Köln
- Investigators
- Wolfram H Jager, PhD, Principal investigator, Study Supervisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737918
- Sponsor's protocol ID
- URGE-II
- Acronym
- URGE-II
- Status last verified
- Apr 2015
- First submitted
- 28 Nov 2012
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Study of the Effect of TOT or Solifenacin After Cesa or Vasa on Urge Urinary Incontinence
- ClinicalTrials.gov ID
- NCT01737918
- Acronym / sponsor ID
- URGE-II / URGE-II
- Conditions
- Surgical Treatment of Urge Incontinence
- Keywords
- urge urinary incontinence, cesa, vasa, TOT, solifenacin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Klinikum der Universität KölnUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 30 Nov 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.
Urge urinary incontinence can be a disorder caused by destroyed pelvic structures. We repaired the uteri-sacral ligaments (USL) by cesa or vasa. The study evaluates if solifenacin can lead to continence after surgery or if also the pubo-urethral ligaments (PUL) need to be repaired.
Detailed description
It was hypothesized that urge urinary incontinence in women is based on the destruction of the uteri-sacral ligaments (USL)and the pubourethral ligaments (PUL). In a preliminary study (URGE I) we repaired the USL by cesa or vasa. Those patients who are still incontinent after cesa and vasa get the repair of the PUL by means of trans-obturator tapes (TOT). That treatment is compared to conservative medical treatment. Cross over after completion of three months is possible if no continence is achieved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trans obturatorial tape (TOT) | Experimental | Procedure: TOTplacement of a sub-urethral tape |
| solifenacin | Active comparator | Drug: solifenacin10 mg per day |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- prior vasa or cesa operation as part of the URGE I study
- stress urinary incontinence
- mixed urinary incontinence
Key exclusion criteria (6 listed)
- previous urogynecological surgery
- avulsion of cesa or vasa tape
- pregnancy
- neurologic/psychological reasons for incontinence
- body weight >100kg
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 |
|---|---|---|
| TOTAlso: trans obturatorial tape | Procedure or surgery | trans obturatorial tape (TOT) |
| solifenacinAlso: VESICUR 10mg per day | Drug | solifenacin |
Primary outcome
cure of incontinence
Time frame: 3 months
1 secondary outcome
improvement of urge symptoms
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
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.
Wolfram H Jager, PhD principal investigator
Study Supervisor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TOT and solifenacin in people with Surgical Treatment of Urge Incontinence, run by Klinikum der Universität Köln at 2 sites in Germany.
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 3 inclusion and 6 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 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Wolfram H Jager, PhD (0049221478 ext. 4900, wolfram.jaeger@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cure of incontinence (time frame: 3 months). 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 7 Apr 2015.