Home versus clinic pelvic floor exercises for women with urine leakage
| ISRCTN | ISRCTN14610179 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14610179 |
| Sponsor | University Malaya Medical Centre |
| Funder | University Malaya Medical Centre |
- Submission date
- 26/01/2026
- Registration date
- 03/02/2026
- Last edited
- 03/02/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Many women experience urine leakage during everyday activities such as coughing, sneezing, laughing, or exercising. This condition is known as stress urinary incontinence. It happens when the pelvic floor muscles, which support the bladder and help control urine flow, become weak.
Pelvic floor muscle exercises are commonly recommended as a first treatment. These exercises help strengthen the pelvic floor muscles and can reduce or stop urine leakage. Pelvic floor exercises can be done under the supervision of a physiotherapist in a clinic or independently at home.
Clinic-based exercises may work well, but regular hospital visits can be difficult for some women because of work commitments, childcare responsibilities, travel distance, or cost. Home-based exercises are more convenient, but some women may not be sure if they are performing the exercises correctly.
Vaginal weights (also called vaginal cones) are small devices that are placed into the vagina during exercise. They provide physical feedback that helps women identify and contract the correct muscles. This may help women perform pelvic floor exercises more effectively at home.
The aim of this study is to compare two ways of performing pelvic floor muscle exercises in women with urine leakage:
1. Exercises performed at home using vaginal weights, and
2. Exercises performed under the supervision of a physiotherapist in a clinic.
The study aims to find out whether home-based exercises using vaginal weights are acceptable to women and whether they work as well as supervised clinic-based exercises in improving urine leakage and pelvic floor muscle strength.
Who can participate?
Women aged between 18 and 70 years who have stress-related urine leakage
What does the study involve?
Women who agree to take part will be randomly assigned to one of two groups. Random assignment means that each participant has an equal chance of being placed in either group.
One group will perform pelvic floor muscle exercises at home using vaginal weights. These participants will attend a training session where a clinician explains how to identify and correctly contract the pelvic floor muscles. They will receive written instructions and a set of vaginal weights. The weight used will be chosen based on what is suitable for each individual. Participants will perform the exercises at home for 2 months and will record their exercise sessions in a diary.
The second group will perform pelvic floor muscle exercises under the supervision of a physiotherapist in a clinic. These participants will attend regular clinic sessions over 2 months and perform pelvic floor exercises following standard care practice.
All participants will have assessments before starting the exercises and again after 2 months. These assessments include:
1. A short questionnaire about urinary symptoms
2. A simple test to measure how much urine leaks over 1 hour
3. An examination to assess pelvic floor muscle strength
4. A question about how satisfied they are with their assigned exercise method
What are the possible benefits and risks of participating?
Participants may benefit from improved bladder control, reduced urine leakage, and stronger pelvic floor muscles. They may also gain a better understanding of how to perform pelvic floor exercises correctly, which could help them continue exercising after the study ends.
The risks of taking part are low. Some women may feel mild discomfort when using vaginal weights or during pelvic examination. Temporary muscle soreness or vaginal discomfort may occur, especially when starting the exercises. There is a small risk of minor irritation. Participants can stop the exercise at any time if they feel uncomfortable and can contact the research team if they have concerns.
Where is the study run from?
The study is run from the University Malaya Medical Centre (UMMC) in Kuala Lumpur, Malaysia. Participants are recruited from the Gynaecology clinic and the Women’s Health physiotherapy clinic at UMMC.
When is the study starting and how long is it expected to run for?
February 2026 to August 2026
Who is funding the study?
University Malaya Medical Centre (Malaysia)
Who is the main contact?
Dr Nurafiqah Binti Mohd Shah, afiqah.shah@ummc.edu.my
Contact information
Principal investigator, Public
Obstetrics and Gynaecology department
Universiti Malaya Medical Centre
Jln Professor Diraja Ungku Aziz
Seksyen 13
50603 Petaling Jaya
Kuala Lumpur
50603
Malaysia
| Phone | +60 (0)163697821 |
|---|---|
| fiqashah00@gmail.com |
Scientific
Obstetrics and Gynaecology department
Universiti Malaya Medical Centre
Jln Professor Diraja Ungku Aziz
Seksyen 13
50603 Petaling Jaya
Kuala Lumpur
50603
Malaysia
| Phone | +60 (0)127440731 |
|---|---|
| maherah@um.edu.my |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Open (masking not used) | |
| Control | Active | |
| Assignment | Parallel | |
| Purpose | Treatment | |
| Scientific title | A randomised comparative trial of self-performed pelvic floor muscle exercise (PFME) with vaginal cone vs supervised pelvic floor muscle exercise in women with stress urinary incontinence | |
| Study acronym | CONE-PFME | |
| Study objectives | To compare the patient satisfaction and effectiveness of self-performed PFME using vaginal cones versus supervised PFME in improving urinary symptoms among women with stress urinary incontinence. | |
| Ethics approval(s) |
Approved 26/12/2025, Medical Research Ethics Committee, University Malaya Medical Centre (Universiti Malaya Medical Centre, Jln Professor Diraja Ungku Aziz, Seksyen 13, 50603 Petaling Jaya, Kuala Lumpur, 50603, Malaysia; +60 (0)3 7949 8473; iresearch@ummc.edu.my), ref: 202565-15143 | |
| Health condition(s) or problem(s) studied | Stress urinary incontinence | |
| Intervention | This study is a prospective, randomised comparative interventional trial involving women diagnosed with stress urinary incontinence. Eligible participants are recruited from gynaecology and women’s health physiotherapy clinics after providing written informed consent. Participants are randomly allocated into one of two study arms using a sequentially numbered, opaque, sealed envelope system to ensure allocation concealment. Intervention arm: Self-performed pelvic floor muscle exercise (PFME) with vaginal cone Participants receive a single structured training session conducted by a clinician. This session includes verbal instruction and written educational materials on identifying and correctly contracting pelvic floor muscles. Vaginal cones are introduced as a biofeedback tool. An individual starting cone weight is determined for each participant based on the maximum weight that cannot be held comfortably for 10 minutes. Three progressively heavier cones are prescribed. Participants perform PFME at home for a total duration of 90–120 minutes per week for 2 months. Exercises may be completed in continuous or divided sessions. Each session begins with vaginal cone use for up to 15 minutes, followed by continued pelvic floor muscle exercises with or without the cone. Participants record exercise frequency and duration in an exercise diary. Control arm: Supervised pelvic floor muscle exercise (PFME) Participants attend supervised pelvic floor muscle exercise sessions with a physiotherapist every 2 weeks for a period of 2 months, in accordance with standard clinical practice. Exercises include fast and slow pelvic floor muscle contractions and adjunct core muscle exercises. Exercise performance and adherence are monitored and documented by the physiotherapist. Baseline assessments are conducted prior to intervention and include a 1-hour pad test, Urinary Distress Inventory-6 (UDI-6) questionnaire, and pelvic floor muscle strength assessment using the Modified Oxford Score. All assessments are repeated at two months following completion of the intervention. | |
| Intervention type | Behavioural | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) |
| |
| Completion date | 30/08/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Female |
| Target sample size at registration | 108 |
| Key inclusion criteria | 1. Women aged 18 to 70 years 2. Diagnosed with stress urinary incontinence 3. Able to understand instructions and willing to perform pelvic floor muscle exercises 4. Willing to attend scheduled follow-up sessions |
| Key exclusion criteria | 1. Current urinary tract infection 2. Pelvic organ prolapse (stage 3 or above) 3. Previous pelvic floor surgery or incontinence surgery 4. Neurological conditions affecting bladder or pelvic floor function (e.g., spinal cord injury, multiple sclerosis) 5. Contraindications to using a vaginal device (e.g., active vaginal infection, recent vaginal surgery) |
| Date of first enrolment | 01/02/2026 |
| Date of final enrolment | 30/06/2026 |
Locations
Countries of recruitment
- Malaysia
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
03/02/2026: Study's existence confirmed by the Medical Research Ethics Committee, University Malaya Medical Centre.
