Urge Urinary IncontinencePhase 1/2URGE-INCT01737411
Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women
A Phase 1/2 study testing solifenacin and cesa/vasa in people with Urge Urinary Incontinence, run by Klinikum der Universität Köln at 1 site in Germany.
Trial summary
The purpose of this study is to determine if pelvic surgery can improve urge urinary incontinence in women more than standard medical treatment. Read more about this study
- Who is it for?
- Ages 40 to 80 years, women only
- Conditions the study is for
- Urge Urinary Incontinence
- What is being tested?
- solifenacin and cesa/vasa
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2013to Jun 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- urge urinary incontinence
Who cannot join
- stress urinary incontinence
- cancer disease of the females genital tract
- pregnancy
- neurologic/psychological reasons for incontinence
- body weight >100kg
- previous urogynecological surgery (TVT)
- syndrome of dry overactive bladder (>20 micturitions within 24 hours)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Abt. Beckenbodenchirugie der Universitäts-Frauenklinik Köln
Cologne, North Rhine-Westphalia, 50931
Wolfram H Jager, 0049221478 ext. 4900, wolfram.jaeger@uk-koeln.de
Wolfram H Jager, PhD
About this study
The purpose of this study is to determine if pelvic surgery can improve urge urinary incontinence in women more than standard medical treatment.
Read the detailed description
Urge Urinary Incontinence affects 30% of postmenopausal women. The etiology is unknown therefore treatment is symptomatic. For that purpose the nerval stimulation of the bladder muscle is interfered by several drugs, e.g. solifenacin.
We observed that the surgical repair of critical pelvic structures, i.e. the uteri-sacral ligaments (USL) can restore continence in a considerable number of patients.
In this study the surgical treatment is compared with the solifenacin treatment. According to outcome after three months patients who are still incontinent are referred to the opposite treatment group.
Outcome will be differentiated in cure (primary aim) and improvement of symptoms (secondary aim).
- Conditions
- Urge Urinary Incontinence
- Being tested
- solifenacin, cesa/vasa
- Keywords
- surgery, solifenacin, urge urinary incontinence
- 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.
solifenacinDrug
Also called VESICUR
cesa/vasaProcedure or surgery
surgical repair of USL
| Study group | Role | What they receive |
|---|---|---|
| solifenacin | Active comparator | 10 mg solifenacin per day for three months Receives: Drug: solifenacin |
| cesa/vasa | Experimental | repair of USL Receives: Procedure: cesa/vasa |
What is being measured
The primary outcome is the main question the study is designed to answer.
cure from urge urinary symptoms
At the start of the study urge symptoms are categorized from 0 (no symptom for the specific item) to 2 (worst expression of symptom). Cure is defined when sum of category points is 0, improvement is defined when category points are less after than before treatment
Measured: 12 months
Secondary outcomes (1)
cure from urge urinary symptoms
When the assigned first line treatment did not cure patients receive the treatment of the other arm (cross-over). Before cross-over urge symptoms of each patient are categorized from 0 (no symptom for the specific item) to 2 (worst expression of symptom). Cure is defined when sum of category points is 0, improvement is defined when category points are less after than before treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionDec 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urge Urinary 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, Study director, Study Supervisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737411
- Sponsor's protocol ID
- URGE-I
- Other IDs
- URGE-I, URGE-I, 11-016
- Acronym
- URGE-I
- Status last verified
- Apr 2015
- First submitted
- 27 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
- Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women
- ClinicalTrials.gov ID
- NCT01737411
- Acronym / sponsor ID
- URGE-I / URGE-I
- Conditions
- Urge Urinary Incontinence
- Keywords
- surgery, solifenacin, urge urinary incontinence
- 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
- Jun 2018 (estimated)
- First posted
- 29 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.
The purpose of this study is to determine if pelvic surgery can improve urge urinary incontinence in women more than standard medical treatment.
Detailed description
Urge Urinary Incontinence affects 30% of postmenopausal women. The etiology is unknown therefore treatment is symptomatic. For that purpose the nerval stimulation of the bladder muscle is interfered by several drugs, e.g. solifenacin.
We observed that the surgical repair of critical pelvic structures, i.e. the uteri-sacral ligaments (USL) can restore continence in a considerable number of patients.
In this study the surgical treatment is compared with the solifenacin treatment. According to outcome after three months patients who are still incontinent are referred to the opposite treatment group.
Outcome will be differentiated in cure (primary aim) and improvement of symptoms (secondary aim).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| solifenacin | Active comparator | Drug: solifenacin10 mg solifenacin per day for three months |
| cesa/vasa | Experimental | Procedure: cesa/vasarepair of USL |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- urge urinary incontinence
Key exclusion criteria (7 listed)
- stress urinary incontinence
- cancer disease of the females genital tract
- 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 |
|---|---|---|
| solifenacinAlso: VESICUR | Drug | solifenacin |
| cesa/vasasurgical repair of USL | Procedure or surgery | cesa/vasa |
Primary outcome
cure from urge urinary symptoms
Time frame: 12 months
At the start of the study urge symptoms are categorized from 0 (no symptom for the specific item) to 2 (worst expression of symptom). Cure is defined when sum of category points is 0, improvement is defined when category points are less after than before treatment
1 secondary outcome
cure from urge urinary symptoms
Time frame: 12 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.
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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.
Wolfram H Jager, PhD study director
Study Supervisor
1 site 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 solifenacin and cesa/vasa in people with Urge Urinary Incontinence, run by Klinikum der Universität Köln at 1 site 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 1 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: 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 1 site 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, wolframjaeger@gmx.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cure from urge urinary symptoms (time frame: 12 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.