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CompletedNCT01503580Updated Oct 31, 2013

Studies of Psychiatric Predisposing Factors, Treatment-related Cardiovascular Effects, and Prognostic Factors Associated With Antimuscarinic Drug (Tolterodine) for Female Overactive Bladder Syndrome

An interventional study of tolterodine, solifenacin in Antimuscarinic Drug, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-10-31.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
155
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

Overactive bladder syndrome (OAB) affects around 17 % of female population. However, the etiology of OAB was complicated and unclear in many aspects. In particular, the research about psychiatric aspect of etiology in OAB was paucity. Besides, research about prognostic factors and impact of cardiovascular system of OAB treatment was also paucity. Therefore the aims of the investigators study were (1) to analyze the etiology of OAB in psychiatric aspects; (2) to analyze the prognostic factors associated with tolterodine treatment; (3) to analyze the differences of cardiac conduction and heart rate variability before and after tolterodine treatment; (4) to analyze the differences of arterial stiffness between non-OAB and OAB female patients, and before and after tolterodine treatment.

02

Conditions studied

  • Antimuscarinic Drug
03

In context

Urinary Bladder, Overactive

855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.

This study's enrollment of 155 is above the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.

Browse Urinary Bladder, Overactive studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • all cases are female patients with lower urinary tract symptoms
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
155 participants (actual)

Study arms

  • Experimental
    antimuscarinic drug

    Drug: tolterodine, solifenacin

Interventions

  • Drugtolterodine, solifenacin

    The enrolled women before March 2009 were treated with tolterodine 4 mg slow-release, and after March 2009 were treated with solifenacin 5 mg once a day for 12 weeks.

06

What researchers measure

Primary outcomes

  1. Changes of heart rate variability after antimuscarinics

    Changes of heart rate variability after 3-months' antimuscarinics treatment

    Time frame: 3 months

Secondary outcomes

  1. Changes of arterial stiffness after antimuscarinics treatment

    Changes of arterial stiffness after 3-months antimuscarinics' treatment

    Time frame: 3 months

  2. Changes of psychologic distress after antimuscarinics treatment

    Changes of psychologic distress after 3-months' antimuscarinics treatment

    Time frame: 3 months

07

Study locations

1 site
  • Department of Gynecology,National Taiwan University Hospital
    Taipei, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01503580
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Jan 4, 2012
Start date
Aug 2008
Primary completion
Jul 2010
Completion
Oct 2013
Last update
Oct 31, 2013

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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