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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
  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:

U.S. FDA Resources

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

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00648310

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

No publications provided by Università degli Studi dell'Insubria

Additional 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
Study First Received: March 27, 2008
Last Updated: March 27, 2008
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on May 16, 2013