Topical Oestrogens and Antimuscarinics In The Treatment Of Detrusor Overactivity

Phase 2

Completed

• Conditions: Overactive Bladder
• Interventions: Drug: Tolterodine 4 mg

• Registration Number: NCT00648310
• Lead Sponsor: Università degli Studi dell'Insubria

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Study Completion: 2007-12
• Status Verified: 2008-03
• Study First Submitted: 2008-03-27
• Study First Submitted QC: 2008-03-27
• Last Update Submitted: 2008-03-27
• Study First Posted: 2008-04-01
• Last Update Posted: 2008-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Tolterodine 4 mg	arm 1: Tolterodine 4 mg once daily for 12 weeks

Trial Locations

Locations (1)

Department of Gynecology and Obstetrics - Università dell'Insubria; 🇮🇹 Varese, Italy