Condition category
Urological and Genital Diseases
Date applied
30/06/2011
Date assigned
11/07/2011
Last edited
14/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Nicola Mok

ORCID ID

Contact details

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

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 measures

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

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, 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

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

Sponsor information

Organisation

Department of Rehabilitation Sciences (Hong Kong)

Sponsor details

Hong Kong Polytechnic University
Hung Hom
N/A
Hong Kong

Sponsor type

University/education

Website

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

government non-federal

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes