Condition category
Urological and Genital Diseases
Date applied
26/03/2012
Date assigned
12/06/2012
Last edited
30/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Urinary incontinence (UI) is one of the major problems in older adults with a high impact on quality of life, especially among older women in long-term care facilities. Although conservative treatment for UI, such as pelvic floor muscle training (PFMT) and bladder training (BT), have been proven effective in independent older adults, current practice for women in homes for the elderly focuses on managing the consequences by providing incontinence pads and toileting assistance instead of treating underlying conditions or causes of UI such as reduced mobility. Strategies such as prompted voiding (participants urinate according to a schedule) and individual physical training have been shown to have a positive effect on frail nursing home residents. These interventions significantly reduce the frequency of incontinence episodes and improve mobility endurance even in people with mental and physical impairments. The main disadvantages of these interventions are the increased workload for nursing staff and high costs which could obstruct large-scale implementation. For these reasons it would be worthwhile to develop a strategy that targets the main causes and risk factors of UI without increasing the workload for nursing staff in long-term care facilities. To evaluate such a strategy, we developed a group-based physical exercise program to be delivered by physical therapists. It consists of exercises that target the functional causes of UI both directly by strengthening of the pelvic floor muscles and bladder training, and indirectly by improving physical performance relevant to continence behavior. The aim of this study was to evaluate the effectiveness of this group-based program by improving functional performance in older women living in homes for the elderly.

Who can participate?
Older women with or without UI and physically and mentally capable of participating in the exercise program.

What does the study involve?
The Incondition program consisted of weekly, 1-hour training sessions for groups of 6–10 women over a period of 22 weeks. Each session consisted of behavioral instructions and physical exercises. The behavioral element aimed to improve the control of micturition (urination) by improving knowledge about continence, improving toilet behavior (position, relaxation etc.), BT, and PFMT including relaxation and breathing. The aim of the physical exercises was to increase the functional ability to use the toilet independently and in time. Exercises were kept functional and pleasant, and used materials to enhance compliance. The 30-minute exercise session included warming up, exercises to improve the mobility of the upper extremities, hand function, standing up and sitting down on a chair or bed, walking, and cooling down. Participants received a written leaflet containing guidelines on good toilet behavior and micturition. After each session, homework exercises were given, if possible on an individual basis, and evaluated at the start of the following session. The intervention was delivered by physical therapists specialized in PFMT and experienced in group training and affinity with older adults. The physical therapists received special training to carry out the intervention correctly. Taking part in this program for 1 year was compared with receiving care as usual (in most cases prescribing incontinence pads). Ten homes carried out the new program, ten provided care as usual.

What are the possible benefits and risks of participating?
Benefits included better physical performance to use the toilet independently and reduction of UI. Possible risks were minimal as the program was adapted to the current physical level of participants. In order to avoid the taboo surrounding UI in homes both women with and without UI could participate so it was not publicly known who had UI. If successful the program will be implemented in other homes.

Where is the study run from?
Twenty homes for the elderly will be contacted to join in this study. The Netherlands organization for applied sciences (TNO) will carry out the development and evaluation.

When is study starting and how long is it expected to run for?
The study started in February 2002 and recruitment started in 2003. The program ran for 6 months.

Who is funding the study?
It was funded by the Netherlands Health Research and Development Council, The Hague, The Netherlands.

Who is the main contact?
Erwin Tak
erwin.tak@tno.nl

Trial website

Contact information

Type

Scientific

Primary contact

Prof Marijke Hopman-Rock

ORCID ID

Contact details

Wassenaarseweg 56
Leiden
2301 CE
Netherlands
-
marijke.hopman@tno.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

001

Study information

Scientific title

Incondtion: a RCT into the effectiveness of a group based exercise program to reduce urinary incontinence in institutionalized older women

Acronym

Study hypothesis

Reduction in the number of participants with urinary incontinence (UI) and the frequency of UI episodes in participants of the exercise program compared to those with those receiving usual care; improvement in performance relevant to continence behavior (mobility, dexterity etc).

Ethics approval

TNO Medical Ethics Committee, 17/12/2002, ref: METC 99/02

Study design

Multilevel randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Physiscal performance and urinary incontinence

Intervention

Intervention: a group-based physical exercise program to be delivered by physical therapists consisting of exercises that target the functional causes of UI both directly by strengthening of the pelvic floor muscles and bladder training, and indirectly by improving physical performance relevant to continence behavior. The Incondition program consisted of weekly, 1-hour training sessions for groups of 6-10 women over a period of 22 weeks.

Control: care as usual (mainly incontinence materials)

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. UI status
2. Severity of UI
3. Physical performance

Secondary outcome measures

Quality of life (physical, mental and incontinence-related)

Overall trial start date

01/02/2002

Overall trial end date

01/06/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female
2. Having sufficient cognitive and physical function to allow them to participate in the intervention (participants with a score higher than 9.6 on the Cognitive Screening Test (CST)
3. Use of toilet independently (as measured by the Barthel Index)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

206

Participant exclusion criteria

Currently using catheterization

Recruitment start date

01/01/2003

Recruitment end date

01/06/2004

Locations

Countries of recruitment

Netherlands

Trial participating centre

Wassenaarseweg 56
Leiden
2301 CE
Netherlands

Sponsor information

Organisation

Netherlands Health Research and Development Council (Netherlands)

Sponsor details

Laan van Nieuw Oost-Indië 334
The Hague
2593 CE
Netherlands
+31 (0) 70 349 51 11
info@zonmw.nl

Sponsor type

Government

Website

http://www.zonmw.nl

Funders

Funder type

Government

Funder name

Netherlands Health Research and Development Council (Netherlands) ref: 2010096440

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22953994

Publication citations

  1. Results

    Tak EC, van Hespen A, van Dommelen P, Hopman-Rock M, Does improved functional performance help to reduce urinary incontinence in institutionalized older women? A multicenter randomized clinical trial., BMC Geriatr, 2012, 12, 51, doi: 10.1186/1471-2318-12-51.

Additional files

Editorial Notes