An evaluation of pelvic floor muscle exercises and electrical muscle stimulation in patients with stress incontinence

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

JA Oldham
Scientific

Centre for Rehabilitation Science
University of Manchester
Central Manchester Healthcare Trust
Oxford Road
Manchester
M13 9WL
United Kingdom

Phone	+44 (0)161 276 6672
Email	jackie.oldham@man.ac.uk

Primary study design	Interventional
Study design	Randomised double-blind controlled trial
Secondary study design	Randomised controlled trial
Scientific title	An evaluation of pelvic floor muscle exercises and electrical muscle stimulation in patients with stress incontinence: a randomised, double-blind, controlled trial
Study objectives	To evaluate a new pattern of electrical of electrical stimulation as a treatment for stress incontinence.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Stress incontinence
Intervention	Women will be randomly allocated to one of the following groups: 1. Pelvic floor exercises alone 2. The new pattern of electrical stimulation alone 3. Pelvic floor exercises and the new pattern of electrical stimulation
Intervention type	Other
Primary outcome measure(s)	Patients were assessed pre, mid and post-treatment using: 1. Digital vaginal assessment of pelvic floor muscle strength using the modified Oxford Grading Scale 2. Assessment of vaginal muscle strength and endurance using the PRS 9300 perineometer (Incare Medical Products, USA) 3. One-hour pad test as recommended by the International Continence Society (ICS)
Key secondary outcome measure(s)	The following were only used pre- and post-treatment: 1. Seven-day frequency/volume chart 2. 36-item Short Form Health Survey (SF-36) 3. The Incontinence Impact Questionnaire 4. The Urogenital Distress Inventory
Completion date	31/12/2000

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	70 Years
Sex	Female
Target sample size at registration	27
Key inclusion criteria	1. Females with stress incontinence between the ages of 18 and 70. Added 12/01/2009: 2. Urodynamically proven stress incontinence 3. No neurological conditions diagnosed by consultant
Key exclusion criteria	Added 12/01/2009: 1. Previous electrical stimulation for stress incontinence 2. Prolapse 3. Pregnancy 4. Pacemakers and cardiomyopathy 5. Abnormal urological/gynaecological findings 6. Urinary tract/vaginal infection 7. Recent pelvic floor surgery (within the last six months)
Date of first enrolment	01/01/2000
Date of final enrolment	31/12/2000

Centre for Rehabilitation Science

Manchester
M13 9WL
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2000		Yes	No