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

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.

Study Type: Interventional

Study Design: N/A

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • arm 1: Tolterodine 4 mg once daily for 12 weeks
• Experimental: 2
  • arm 2: Tolterodine 4 mg + local oestrogens once daily for 12 weeks

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 Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Università degli Studi dell'Insubria

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00648310

Study ID Number: local oestrogens 9/2003

ClinicalTrials.gov Identifier: NCT00648310

Health Authority: Italy: Ethics Committee