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Topical Oestrogens and Antimuscarinics In The Treatment Of Detrusor Overactivity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00648310
First Posted: April 1, 2008
Last Update Posted: April 1, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Università degli Studi dell'Insubria
  Purpose
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 Intervention Phase
Overactive Bladder Drug: Tolterodine 4 mg Drug: arm 2: Tolterodine 4 mg + local oestrogens once daily for 12 weeks Phase 2 Phase 3

Study Type: Interventional
Official Title: Is There A Synergic Effect Of Topical Oestrogens When Associated To Antimuscarinics In The Treatment Of Symptomatic Detrusor Overactivity

Resource links provided by NLM:


Further study details as provided by Università degli Studi dell'Insubria:

Study Start Date: January 2004
Study Completion Date: December 2007
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00648310


Locations
Italy
Department of Gynecology and Obstetrics - Università dell'Insubria
Varese, Italy, 21100
Sponsors and Collaborators
Università degli Studi dell'Insubria
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00648310     History of Changes
Other Study ID Numbers: local oestrogens 9/2003
First Submitted: March 27, 2008
First Posted: April 1, 2008
Last Update Posted: April 1, 2008
Last Verified: March 2008

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Estrogens
Tolterodine Tartrate
Muscarinic Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents