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Topical Oestrogens and Antimuscarinics In The Treatment Of Detrusor Overactivity

Sponsor
Università degli Studi dell'Insubria (Other)
Overall Status
Completed
CT.gov ID
NCT00648310
Collaborator
(none)
1
Location
2
Arms
47
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tolterodine 4 mg
  • Drug: arm 2: Tolterodine 4 mg + local oestrogens once daily for 12 weeks
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Official Title:
Is There A Synergic Effect Of Topical Oestrogens When Associated To Antimuscarinics In The Treatment Of Symptomatic Detrusor Overactivity
Study Start Date :
Jan 1, 2004
Actual Study Completion Date :
Dec 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

arm 1: Tolterodine 4 mg once daily for 12 weeks

Drug: Tolterodine 4 mg
Experimental: 2

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

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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Gynecology and Obstetrics - Università dell'Insubria Varese Italy 21100

    Sponsors and Collaborators

    • Università degli Studi dell'Insubria

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00648310
    Other Study ID Numbers:
    • local oestrogens 9/2003
    First Posted:
    Apr 1, 2008
    Last Update Posted:
    Apr 1, 2008
    Last Verified:
    Mar 1, 2008
    Additional relevant MeSH terms:
    Urinary Bladder, Overactive
    Tolterodine Tartrate
    Estrogens

    Study Results

    No Results Posted as of Apr 1, 2008