Plain English Summary
Background and study aims
Involuntary urinary leakage is a very common problem, especially amongst elderly women.
The primary aim of this study was to study the effect of a new comprehensive conservative treatment program in elderly woman with involuntary urinary leakage.
Who can participate?
Chinese women aged 65 years or older with a clinical diagnosis of stress, urge or mixed urinary incontinence.
What does the study involve?
Participants were randomly allocated to either the intervention group or the control group. The intervention group attended a standardised comprehensive treatment program, which lasted for 12 weeks. A 30-minute individual training session was given at the same time of the day, once weekly for the first 4 weeks and then once every fortnight for the remaining 8 weeks. The three major components of the program were education, pelvic floor muscle training and bladder training. The control group only received an educational pamphlet with information about management of urinary incontinence. Participants were given an appointment for a follow-up visit in 12 weeks.
What are the possible benefits and risks of participating?
There are minimal reported risks in previous studies with a similar nature. However, subjects with an unreported latex allergy might suffer an allergic reaction.
Where is the study run from?
Hong Kong Polytechnic University (Hong Kong).
When is the study starting and how long is it expected to run for?
This study was carried out between September 2006 and August 2007.
Who is funding the study?
This study was jointly funded by the Hong Kong Polytechnic University and the Department of Health (Hong Kong).
Who is the main contact?
Dr Nicola Mok
Department of Rehabilitation Sciences, Hong Kong Polytechnic University
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effectiveness of an urinary continence physiotherapy program (UCPP) for Chinese elderly women in a community setting: a randomised controlled trial
Acronym
Study hypothesis
A comprehensive program consisting of education, behavioural modification, and specific therapeutic exercise is more effective than education alone in the management of urinary incontinence in the Chinese elderly female population
Ethics approval
1. Departmental Research Committee, Department of Rehabilitation Sciences, Hong Kong Polytechnic University, 09/02/2007
2. Ethics Committee, Department of Health, The Government of the Hong Kong Special Administrative Region of the People's Republic of China, 28/11/2006, ref: L/M 376/2006 in DHHQ/5030/5/5
Study design
Single-centre randomised single-blind interventional clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Urinary incontinence in elderly women
Intervention
Trial period: 12 weeks
Intervention:
1. A 30-minute individual training session was given at the same time of the day, once weekly for the first 4 weeks and then once every fortnight for the remaining 8 weeks
2. A total of eight treatment sessions were given to each recipient
3. Three major components in the UCPP:
3.1. Education, includes anatomy of the pelvic floor muscle and urinary tract, urinary continence mechanism and bladder care
3.2. Pelvic floor muscle training (PFMT) with the aid of vaginal palpation. PFMT included Kegel exercise program and neuromuscular re-education (the knack)
3.3. Bladder training (BT). BT involved strategies to increase the time interval between voids by a combination of progressive void schedules, urge suppression, distraction, self-monitoring and reinforcement.
4. For the control group, only an educational pamphlet with information about management of urinary incontinence was given at the baseline.
5. Participants were given an appointment for a follow-up visit in 12 weeks.
Joint Sponsor details:
Department of Health
The Government of the Hong Kong Special Administrative Region of the People's Republic of China
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. The number of urinary incontinence (UI) episodes in the last 7 days (UI7)
2. Subjective perception of improvement was assessed with a 10 cm Visual Analogue Scale (VAS), with 0 being 'no improvement' to 10 being 'complete relief' at the end of the intervention period
Secondary outcome measures
1. Subjects satisfaction with treatment, assessed by a 10 cm VAS, with 0 being 'totally dissatisfied' and 10 being 'totally satisfied'
2. Quality of life - assessed by the Incontinence Impact Questionnaire (IIQ) Chinese version
Overall trial start date
09/02/2007
Overall trial end date
31/12/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Chinese females, aged 65 years or older
2. Had clinical diagnosis of stress, urge or mixed urinary incontinence by a medical practitioner, with reference to a guideline (Lagro-Janssen et al 1991)
Participant type
Patient
Age group
Senior
Gender
Female
Target number of participants
55
Participant exclusion criteria
1. Concurrent active urinary tract infection
2. On diuretic medication
3. Co-existing bladder pathology or dysfunction due to genitourinary fistula, tumor, pelvic irradiation, neurological or other chronic conditions (e.g. diabetes mellitus, Parkinsons disease)
4. Previous anti-incontinence surgery
5. Significant cognitive impairment (assessed by the Cantonese Version of Mini-Mental State Examination Score (CMMSE))
6. Obesity (body mass index > 30 kg/m2)
7. Use of concomitant treatments during the trial
Recruitment start date
09/02/2007
Recruitment end date
31/12/2007
Locations
Countries of recruitment
Hong Kong
Trial participating centre
Department of Rehabilitation Sciences
Hung Hom
N/A
Hong Kong
Funders
Funder type
University/education
Funder name
Hong Kong Polytechnic University (Hong Kong)
Alternative name(s)
Hong Kong PolyU, PolyU
Funding Body Type
government organisation
Funding Body Subtype
Local government
Location
Hong Kong
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
Basic results (scientific)
Publication list