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Topical Oestrogens and Antimuscarinics In The Treatment Of Detrusor Overactivity

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Tolterodine 4 mg
arm 2: Tolterodine 4 mg + local oestrogens once daily for 12 weeks
Sponsored by
Università degli Studi dell'Insubria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Overactive Bladder

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Department of Gynecology and Obstetrics - Università dell'Insubria

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

arm 1: Tolterodine 4 mg once daily for 12 weeks

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 27, 2008
Last Updated
March 27, 2008
Sponsor
Università degli Studi dell'Insubria
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1. Study Identification

Unique Protocol Identification Number
NCT00648310
Brief Title
Topical Oestrogens and Antimuscarinics In The Treatment Of Detrusor Overactivity
Official Title
Is There A Synergic Effect Of Topical Oestrogens When Associated To Antimuscarinics In The Treatment Of Symptomatic Detrusor Overactivity
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Università degli Studi dell'Insubria

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder

7. Study Design

Study Phase
Phase 2, Phase 3

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
arm 1: Tolterodine 4 mg once daily for 12 weeks
Arm Title
2
Arm Type
Experimental
Arm Description
arm 2: Tolterodine 4 mg + local oestrogens once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Tolterodine 4 mg
Intervention Type
Drug
Intervention Name(s)
arm 2: Tolterodine 4 mg + local oestrogens once daily for 12 weeks

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Department of Gynecology and Obstetrics - Università dell'Insubria
City
Varese
ZIP/Postal Code
21100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
18584946
Citation
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.
Results Reference
derived

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Topical Oestrogens and Antimuscarinics In The Treatment Of Detrusor Overactivity

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