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Topical Oestrogens and Antimuscarinics In The Treatment Of Detrusor Overactivity

NCT ID: NCT00648310

Last Updated: 2008-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2007-12-31

Brief Summary

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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

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Conditions

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Overactive Bladder

Study Groups

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1

arm 1: Tolterodine 4 mg once daily for 12 weeks

Group Type ACTIVE_COMPARATOR

Tolterodine 4 mg

Intervention Type DRUG

2

arm 2: Tolterodine 4 mg + local oestrogens once daily for 12 weeks

Group Type EXPERIMENTAL

arm 2: Tolterodine 4 mg + local oestrogens once daily for 12 weeks

Intervention Type DRUG

Interventions

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Tolterodine 4 mg

Intervention Type DRUG

arm 2: Tolterodine 4 mg + local oestrogens once daily for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi dell'Insubria

OTHER

Sponsor Role lead

Locations

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Department of Gynecology and Obstetrics - Università dell'Insubria

Varese, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 18584946 (View on PubMed)

Other Identifiers

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local oestrogens 9/2003

Identifier Type: -

Identifier Source: org_study_id