Topical Oestrogens and Antimuscarinics In The Treatment Of Detrusor Overactivity

This study has been completed.

Sponsor:

Information provided by:

Università degli Studi dell'Insubria

ClinicalTrials.gov Identifier:

NCT00648310

First received: March 27, 2008

Last updated: NA

Last verified: March 2008

History: No changes posted

Tracking Information
First Received Date ^ICMJE	March 27, 2008
Last Updated Date	March 27, 2008
Start Date ^ICMJE	January 2004
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Topical Oestrogens and Antimuscarinics In The Treatment Of Detrusor Overactivity
Official Title ^ICMJE	Is There A Synergic Effect Of Topical Oestrogens When Associated To Antimuscarinics In The Treatment Of Symptomatic Detrusor Overactivity
Brief 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 non-responders to treatment.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2 Phase 3
Study Design ^ICMJE	Not Provided
Condition ^ICMJE	Overactive Bladder
Intervention ^ICMJE	Drug: Tolterodine 4 mg Drug: arm 2: Tolterodine 4 mg + local oestrogens once daily for 12 weeks
Study Arm (s)	Active Comparator: 1 arm 1: Tolterodine 4 mg once daily for 12 weeks Intervention: Drug: Tolterodine 4 mg Experimental: 2 arm 2: Tolterodine 4 mg + local oestrogens once daily for 12 weeks Intervention: Drug: arm 2: Tolterodine 4 mg + local oestrogens once daily for 12 weeks
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. Epub 2008 Jun 20.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	December 2007
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: All post-menopausal women with symptoms of overactive bladder and urodynamically proven pure detrusor overactivity Exclusion Criteria: concomitant urodynamic stress incontinence documented recurrent urinary tract infections previous antimuscarinic treatment previous pelvic surgery concomitant systemic HRT history of breast or endometrial cancer neurological disease clinical contraindications to treatment with oestrogen or antimuscarinics patients included in other ongoing clinical trials
Gender	Female
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Italy

Administrative Information
NCT Number ^ICMJE	NCT00648310
Other Study ID Numbers ^ICMJE	local oestrogens 9/2003
Has Data Monitoring Committee	No
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Università degli Studi dell'Insubria
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Università degli Studi dell'Insubria
Verification Date	March 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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