Overactive BladderPhase 2/3NCT00648310
Topical Oestrogens and Antimuscarinics In The Treatment Of Detrusor Overactivity
A Phase 2/3 study testing Tolterodine 4 mg and arm 2: Tolterodine 4 mg + local oestrogens once daily for 12 weeks in people with Overactive Bladder, run by Università degli Studi dell'Insubria at 1 site in Italy.
Trial summary
Despite the great number of reports about the efficacy of oestrogens or antimuscarinics on OAB symptoms, so far no author has tried to investigate whether the concomitant administration of these two drugs, acting on two different pathophysiological mechanisms, could have a synergic effect reducing the rate of… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Tolterodine 4 mg and arm 2: Tolterodine 4 mg + local oestrogens once daily for 12 weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Jan 2004to Dec 2007
- Phase
- Phase 2/3
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All post-menopausal women with symptoms of overactive bladder and urodynamically proven pure detrusor overactivity
Who cannot join
- concomitant urodynamic stress incontinence
- documented recurrent urinary tract infections
- previous antimuscarinic treatment
- previous pelvic surgery
- concomitant systemic HRT
- history of breast or endometrial cancer
Show all 9Show fewer
- neurological disease
- clinical contraindications to treatment with oestrogen or antimuscarinics
- patients included in other ongoing clinical trials
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Gynecology and Obstetrics - Università dell'Insubria
Varese, 21100
About this study
Official title: Is There A Synergic Effect Of Topical Oestrogens When Associated To Antimuscarinics In The Treatment Of Symptomatic Detrusor Overactivity
Despite the great number of reports about the efficacy of oestrogens or antimuscarinics on OAB symptoms, so far no author has tried to investigate whether the concomitant administration of these two drugs, acting on two different pathophysiological mechanisms, could have a synergic effect reducing the rate of non-responders to treatment.
- Conditions
- Overactive Bladder
- Being tested
- Tolterodine 4 mg, arm 2: Tolterodine 4 mg + local oestrogens once daily for 12 weeks
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tolterodine 4 mgDrug
arm 2: Tolterodine 4 mg + local oestrogens once daily for 12 weeksDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | arm 1: Tolterodine 4 mg once daily for 12 weeks Receives: Drug: Tolterodine 4 mg |
| 2 | Experimental | arm 2: Tolterodine 4 mg + local oestrogens once daily for 12 weeks Receives: Drug: arm 2: Tolterodine 4 mg + local oestrogens once daily for 12 weeks |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startJan 2004
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies 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 2/3
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00648310
- Sponsor's protocol ID
- local oestrogens 9/2003
- Status last verified
- Mar 2008
- First submitted
- 27 Mar 2008
- Last updated
- 1 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Serati M, Salvatore S, Uccella S, Cardozo L, Bolis P. Is there a synergistic effect of topical oestrogens when administered with antimuscarinics in the treatment of symptomatic detrusor overactivity? Eur Urol. 2009 Mar;55(3):713-9. doi: 10.1016/j.eururo.2008.06.051. Epub 2008 Jun 20.
PubMed 18584946
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There A Synergic Effect Of Topical Oestrogens When Associated To Antimuscarinics In The Treatment Of Symptomatic Detrusor Overactivity
- ClinicalTrials.gov ID
- NCT00648310
- Acronym / sponsor ID
- local oestrogens 9/2003
- Conditions
- Overactive Bladder
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- Dec 2007 (actual)
- First posted
- 1 Apr 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.
Despite the great number of reports about the efficacy of oestrogens or antimuscarinics on OAB symptoms, so far no author has tried to investigate whether the concomitant administration of these two drugs, acting on two different pathophysiological mechanisms, could have a synergic effect reducing the rate of non-responders to treatment.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Tolterodine 4 mgarm 1: Tolterodine 4 mg once daily for 12 weeks |
| 2 | Experimental | Drug: arm 2: Tolterodine 4 mg + local oestrogens once daily for 12 weeksarm 2: Tolterodine 4 mg + local oestrogens once daily for 12 weeks |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All post-menopausal women with symptoms of overactive bladder and urodynamically proven pure detrusor overactivity
Key exclusion criteria (9 listed)
- concomitant urodynamic stress incontinence
- documented recurrent urinary tract infections
- previous antimuscarinic treatment
- previous pelvic surgery
- concomitant systemic HRT
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 |
|---|---|---|
| Tolterodine 4 mg | Drug | 1 |
| arm 2: Tolterodine 4 mg + local oestrogens once daily for 12 weeks | Drug | 2 |
Primary outcome
Not reported in the source record.
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 1 Apr 2008.
- Derived from this study: PubMed 18584946Serati M, Salvatore S, Uccella S, Cardozo L, Bolis P. Is there a synergistic effect of topical oestrogens when administered with antimuscarinics in the treatment of symptomatic detrusor overactivity? Eur Urol. 2009 Mar;55(3):713-9. doi: 10.1016/j.eururo.2008.06.051. Epub 2008 Jun 20.
Related trials for Overactive Bladder
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
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?
A Phase 2/3 study testing Tolterodine 4 mg and arm 2: Tolterodine 4 mg + local oestrogens once daily for 12 weeks in people with Overactive Bladder, run by Università degli Studi dell'Insubria at 1 site in Italy.
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 9 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 1 Apr 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 Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00648310, which also lists 1 linked publication.
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 1 Apr 2008.