The Long Term Outcomes of Rehabilitation and Drug Treatment for in Urgency Urinary Incontinence
Condition: Urge Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Urge
Study type: Interventional

Summary: 
      -  Urinary Urge Incontinence (UUI) is the involuntary urine loss associated with a strong
           sensation to void.

        -  UUI usually associated with reduced bladder capacity.

        -  The pathophysiology is unclear.

        -  Pelvic floor muscle dysfunction and detrusor instability have been suggested as possible
           mechanisms.

        -  Standard treatment includes anticholinergic medication and behavior modification.

        -  The study aims to compare the long term effectiveness of 4 different approaches to the
           treatment of women with Urge Urinary Incontinence (UUI):

             1. Pelvic Floor Rehabilitation (includes muscle training+behavioral
                intervention+bladder training)

             2. Pelvic Floor muscle training alone

             3. Bladder Training alone

             4. Drug treatment with Tolterodine.

        -  Study variables will include: impairment ratings, quality of life, and
           cost-effectiveness.

        -  This study addresses three issues:

             1. The long term efficacy and cost-effectiveness of the various treatment options.

             2. To identify the factors involved in determining the effectiveness of drug or
                behavioral therapy.

             3. The pathophysiology of UUI. By subdividing the rehabilitation group into 3 arms, we
                hope to shed light on the mechanism of dysfunction. A better response in one group
                will help localize the problem to pelvic floor muscles or to detrusor instability.
    

Detailed description: 
      The study has 3 phases: Before treatment (phase I), immediately after 3 months of treatment
      (phase II), and 1 year post-entry (phase III)

      Women with UUI will be divided randomly into one of the four treatment groups. Every subject
      will participate in 4 visits. The drug group treatment consists of administration of
      tolterodine SR 4 mg daily for 3 months. Subjects who assigned to the pelvic floor
      rehabilitation, pelvic floor muscle training, and bladder training groups will be treated via
      4 visits to a physical therapist, who is trained in the procedures. The chief researcher (RK)
      will be blinded to the treatment groups and will perform the outcome measures in all phases.

      Study variables will include impairment ratings, quality of life, and cost-effectiveness
    

Intervention name(s): tolterodine; bladder training; pelvic floor muscle training; pelvic floor rehabilitation
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): Detrusitol SR 4 mg, 1 capsule for a day, 3 months.; Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for educate and schedule voiding regimen.; Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for reinforced pelvic floor muscles.; The Pelvic floor rehabilitation protocol based on bladder training protocol and PFMT and lifestyle advice and information about good bladder and bowel habits. Four visits in 3 months was made with pelvic floor physical therapist, who is trained in the procedure.
Intervention MeSH terms: Tolterodine Tartrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: urge urinary incontinence; rehabilitation; anticholinergic