The Long Term Outcomes of Rehabilitation and Drug Treatment for in Urgency Urinary Incontinence

NCT00498888 | Completed DMC

• 1 other identifier: 2007030
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief 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):
• Pelvic Floor Rehabilitation (includes muscle training+behavioral intervention+bladder training)
• Pelvic Floor muscle training alone
• Bladder Training alone
• Drug treatment with Tolterodine.
• Study variables will include: impairment ratings, quality of life, and cost-effectiveness.
• This study addresses three issues:
• The long term efficacy and cost-effectiveness of the various treatment options.
• To identify the factors involved in determining the effectiveness of drug or behavioral therapy.
• 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.

Conditions

Urge Urinary Incontinence

Keywords

urge urinary incontinence; rehabilitation; anticholinergic

Outcome Measures

Primary Outcomes (1)

• Number of micturitions in a 24 hour bladder diary and number of urge urinary incontinence episodes by subjects' reports per week.

  Phase I, II, and III

Secondary Outcomes (14)

• cost-effectiveness

  1 year

• Health service utilization

  1 year

• underclothing pad use

  Phase I, II, and III

• change in physical activity and smoking

  Phase I, II, and III

• missed days at work

  1 year

Study Arms (4)

1

ACTIVE COMPARATOR

Women were prescribed a 3 month supply of Tolterodine SR 4 mg (Detrusitol SR 4 mg, Pfizer Pharmaceuticals Israel LTD) . After the randomization she needs to get the first prescription from her doctor, and followed this protocol every three weeks. Her doctor how already knows this research were explained how to take the drug. After finished this protocol she get the money she pay after sending the receipts and the empty boxes.

Procedure: tolterodine

2

ACTIVE COMPARATOR

The Bladder training protocol aims o to increase the time interval between voids, either by a mandatory or self-adjustable schedule, so that incontinence is ultimately avoided and continence regained. It is generally comprised of three components: 1) patient education that includes information about bladder and how continence is usually maintained, 2) scheduled voiding- a 'timetable for voiding' which may fixed or flexible to suit the participant's rate of increase in interval between voids, commonly the aim is to achieve an interval of three to four hours between voids and 3) positive reinforcement- - psychological support and encouragement is generally considered important and usually provided by health care professional . Frequency volume chart (FVC) records the time and volumes of voided for 24 hours by the women between the appointments. Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for educate and schedule voiding regimen.

Procedure: bladder training

3

ACTIVE COMPARATOR

The Pelvic floor muscle training (PFMT) protocol based on National Institute for health and clinical excellence (NICE clinical guideline 40, 2006), that the PFMT programs should comprise at least eight contractions performed three times per day, and the trial of supervised PFMT of at least 3 months' duration . Each appointment the women maid three sets of eight to 12 slow maximal contractions sustained for 6-8 second, and asked to made this protocol every day, and taught to contract these muscle to suppress urge filling. Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for reinforced pelvic floor muscles.

Procedure: pelvic floor muscle training

4

ACTIVE COMPARATOR

Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for pelvic floor muscle training and bladder training and lifestyle advice and information about good bladder and bowel habits.

Procedure: pelvic floor rehabilitation

Interventions

tolterodine PROCEDURE

Detrusitol SR 4 mg, 1 capsule for a day, 3 months.

1

bladder training PROCEDURE

Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for educate and schedule voiding regimen.

2

pelvic floor muscle training PROCEDURE

Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for reinforced pelvic floor muscles.

3

pelvic floor rehabilitation PROCEDURE

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.

4

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• complaints of urinary leakage \> 3 in last month (not stress incontinence)
• functionally independent subjects

You may not qualify if:

• urinary tract infection
• urogenital prolapse
• unstable diabetes
• neurological or psychiatric disease
• narrow angle glaucoma
• after colposuspension or sling surgery
• Mini Mental State Examination \<24

Sponsors & Collaborators

• Assuta Hospital Systems: lead

Study Sites (1)

Rehabilitation and Physical Therapy Center, Maccabi Healthcare Services

Rishon LeZiyyon, 75429, Israel

Location

Related Publications (1)

• Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2.

  PMID: 37811598 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Urge

Interventions

Tolterodine Tartrate

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; 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 Officials

• Rachel Kafri, MSc PT

  Maccabi Healthcare Services, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maccabi Healthcare Services

Study Record Dates

• First Submitted: July 10, 2007
• First Posted: July 11, 2007
• Study Start: June 1, 2007
• Primary Completion: January 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 29, 2012

Record last verified: 2012-11

Locations

IL (1)