Topical Oestrogens and Antimuscarinics In The Treatment Of Detrusor Overactivity

Università degli Studi dell'Insubria

Status and phase: Completed; Phase 3; Phase 2

Conditions: Overactive Bladder

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00648310

local oestrogens 9/2003

Details and patient eligibility

About

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.

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

1

Active Comparator group

Description:

arm 1: Tolterodine 4 mg once daily for 12 weeks

Treatment:

Drug: Tolterodine 4 mg

2

Experimental group

Description:

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

Treatment:

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