Topical Oestrogens and Antimuscarinics In The Treatment Of Detrusor Overactivity

NCT00648310 | Completed Phase 2

• 1 other identifier: local oestrogens 9/2003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder

Study Arms (2)

1

ACTIVE COMPARATOR

arm 1: Tolterodine 4 mg once daily for 12 weeks

Drug: Tolterodine 4 mg

2

EXPERIMENTAL

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

Interventions

Tolterodine 4 mg DRUG

1

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

2

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All post-menopausal women with symptoms of overactive bladder and urodynamically proven pure detrusor overactivity

You may not qualify if:

• 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

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead

Study Sites (1)

Department of Gynecology and Obstetrics - Università dell'Insubria

Varese, 21100, Italy

Location

Related Publications (1)

• Serati M, Salvatore S, Uccella S, Cardozo L, Bolis P. Is there a synergistic effect of topical oestrogens when administered with antimuscarinics in the treatment of symptomatic detrusor overactivity? Eur Urol. 2009 Mar;55(3):713-9. doi: 10.1016/j.eururo.2008.06.051. Epub 2008 Jun 20.

  PMID: 18584946 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Tolterodine Tartrate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Study Design

• Study Type: interventional
• Phase: phase 2
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 27, 2008
• First Posted: April 1, 2008
• Study Start: January 1, 2004
• Study Completion: December 1, 2007
• Last Updated: April 1, 2008

Record last verified: 2008-03

Locations

IT (1)