Effectiveness of an urinary incontinence program for Chinese elderly women in a community setting

ISRCTN ISRCTN62679410
DOI https://doi.org/10.1186/ISRCTN62679410
Secondary identifying numbers N/A
Submission date
30/06/2011
Registration date
11/07/2011
Last edited
14/08/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Nicola Mok
Scientific

Department of Rehabilitation Sciences
Hong Kong Polytechnic University
Hung Hom
N/A
Hong Kong

Study information

Study designSingle-centre randomised single-blind interventional clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEffectiveness of an urinary continence physiotherapy program (UCPP) for Chinese elderly women in a community setting: a randomised controlled trial
Study objectivesA 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(s)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
Health condition(s) or problem(s) studiedUrinary incontinence in elderly women
InterventionTrial 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 typeOther
Primary outcome measure1. 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 measures1. 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 study start date09/02/2007
Completion date31/12/2007

Eligibility

Participant type(s)Patient
Age groupSenior
SexFemale
Target number of participants55
Key inclusion criteria1. 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)
Key exclusion criteria1. 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, Parkinson’s 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
Date of first enrolment09/02/2007
Date of final enrolment31/12/2007

Locations

Countries of recruitment

  • Hong Kong

Study participating centre

Department of Rehabilitation Sciences
Hung Hom
N/A
Hong Kong

Sponsor information

Department of Rehabilitation Sciences (Hong Kong)
University/education

Hong Kong Polytechnic University
Hung Hom
N/A
Hong Kong

ROR logo "ROR" https://ror.org/0030zas98

Funders

Funder type

University/education

Hong Kong Polytechnic University (Hong Kong)
Government organisation / Universities (academic only)
Alternative name(s)
The Hong Kong Polytechnic University, 香港理工大学所有, Hong Kong PolyU, Government Trade School, Hong Kong Technical College, Hong Kong Polytechnic, PolyU, HKPU
Location
Hong Kong

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan