Urinary Incontinence (UI)IncontinenceNCT07795931
Comparison of Home Versus Clinic Kegel Rehabilitation in Women With Urinary Incontinence in the Tabuk Region
A study testing Home -Based Kegel Trainer Exercises (Kegel Trainer Application) will be used by the participants at home for training the pelvic floor muscles over 9 levels. and Clinic-Based Rehabilitation Program will consist of physiotherapist supervised pelvic floor strengthening exercises for the participant , 2 times per week for 3 months in people with Urinary Incontinence (UI), run by University of Tabuk at 1 site in Saudi Arabia.
Trial summary
Urinary incontinence is a common condition among women that significantly affects physical health, emotional well-being, social participation, and overall quality of life. Pelvic floor muscle training recommended as the first-line conservative treatment for urinary incontinence. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Urinary Incontinence (UI)
- What is being tested?
- Home -Based Kegel Trainer Exercises (Kegel Trainer Application) will be used by the participants at home for training the pelvic floor muscles over 9 levels. and Clinic-Based Rehabilitation Program will consist of physiotherapist supervised pelvic floor strengthening exercises for the participant , 2 times per week for 3 months
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Oct 2026to 1 Mar 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female participants aged 20-50 years.
- Diagnosed with urinary incontinence.
- Able to understand study instructions.
- Willing to provide informed consent
Who cannot join
- Delivery within the previous 3 months.
- Gynecological surgery during the previous 3 months.
- Lower urinary tract surgery during the previous 3 months.
- Postmenopausal women.
- Contraindications to pelvic floor muscle training.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site
Maternity and Children Hospital in Tabuk
Tabuk, Tabuk Region
Enas ES Abutaleb, PhD, 0536346062, eabutaleb@ut.edu.sa
About this study
Official title: A Comparison of Home-Based Kegel Exercises Versus Clinic-Based Rehabilitation in Women With Urinary Incontinence in the Tabuk Region: A Randomized Controlled Trial
Urinary incontinence is a common condition among women that significantly affects physical health, emotional well-being, social participation, and overall quality of life. Pelvic floor muscle training recommended as the first-line conservative treatment for urinary incontinence. While clinic-based rehabilitation provides direct supervision by healthcare professionals, home-based Kegel exercise programs offer greater convenience and accessibility. However, limited evidence exists regarding the comparative effectiveness of these approaches among women in Saudi Arabia.
The study aims to compare the effectiveness of home-based Kegel exercises and clinic-based rehabilitation programs in improving pelvic floor muscle strength, reducing urinary incontinence symptoms, and enhancing quality of life among women with urinary incontinence in the Tabuk region.
Read more
This study will employ a randomized controlled trial (RCT) design. Eligible women diagnosed with urinary incontinence will be recruited from the Maternity and Children Hospital, Tabuk. Participants will be randomly assigned to one of two groups:
- Group A: Home-based Kegel exercise program.
- Group B: Supervised clinic-based pelvic floor rehabilitation program. Both interventions will be conducted over a 12-week period. Outcome Measures
The effectiveness of the interventions will be evaluated using:
- Perineometer measurements to assess pelvic floor muscle strength.
- Pad Test to assess urinary leakage severity.
- King's Health Questionnaire (KHQ) to evaluate quality of life.
- Adherence records to monitor compliance with the exercise program. The assessments will be conducted at baseline, week 8, and week 12.
Read the detailed description
Background Urinary incontinence (UI) is a common condition among women that significantly affects physical health, emotional well-being, social participation, and overall quality of life. Pelvic floor muscle training (PFMT) is widely recommended as the first-line conservative treatment for urinary incontinence. While clinic-based rehabilitation provides direct supervision by healthcare professionals, home-based Kegel exercise programs offer greater convenience and accessibility. However, limited evidence exists regarding the comparative effectiveness of these approaches among women in Saudi Arabia.
Aim The study aims to compare the effectiveness of home-based Kegel exercises and clinic-based rehabilitation programs in improving pelvic floor muscle strength, reducing urinary incontinence symptoms, and enhancing quality of life among women with urinary incontinence in the Tabuk region.
Objectives
- To evaluate the effectiveness of home-based Kegel exercises in women with urinary incontinence.
- To evaluate the effectiveness of clinic-based pelvic floor rehabilitation.
- To compare outcomes between both intervention approaches.
- To compare the outcomes of both interventions regarding pelvic floor muscle strength, urinary leakage, and quality of life.
- To assess participants' adherence to the prescribed exercise programs. Methodology
This study will employ a randomized controlled trial (RCT) design. Eligible women diagnosed with urinary incontinence will be recruited from the Maternity and Children Hospital, Tabuk. Participants will be randomly assigned to one of two groups:
- Group A: Home-based Kegel exercise program.
- Group B: Supervised clinic-based pelvic floor rehabilitation program. Both interventions will be conducted over a 12-week period. Outcome Measures
The effectiveness of the interventions will be evaluated using:
- Perineometer measurements to assess pelvic floor muscle strength.
- Pad Test to assess urinary leakage severity.
- King's Health Questionnaire (KHQ) to evaluate quality of life.
- Adherence records to monitor compliance with the exercise program. Assessments will be conducted at baseline, week 8, and week 12. Data Analysis Data will be analyzed using SPSS software. Descriptive statistics, independent t-tests, Chi-square tests, and repeated-measures ANOVA will be used to compare outcomes between groups. Statistical significance will be set at p < 0.05.
Ethical Considerations Ethical approval will be obtained prior to study commencement. Written informed consent will be obtained from all participants. Participation will be voluntary, confidentiality will be maintained, and participants will have the right to withdraw from the study at any time without affecting their healthcare services.
Expected Outcomes The study is expected to demonstrate improvements in pelvic floor muscle strength, urinary continence, and quality of life in both groups. The findings will provide evidence regarding whether home-based Kegel exercises can achieve outcomes comparable to supervised clinic-based rehabilitation, thereby informing future physiotherapy practice and healthcare policy.
Significance This research will contribute to the growing body of evidence on pelvic floor rehabilitation and may support the implementation of accessible, cost-effective, and evidence-based treatment options for women with urinary incontinence in Tabuk region in Saudi Arabia. The results may also guide clinicians and healthcare decision-makers in optimizing rehabilitation services and improving patient outcomes.
- Conditions
- Urinary Incontinence (UI)
- Being tested
- Home -Based Kegel Trainer Exercises (Kegel Trainer Application) will be used by the participants at home for training the pelvic floor muscles over 9 levels., Clinic-Based Rehabilitation Program will consist of physiotherapist supervised pelvic floor strengthening exercises for the participant , 2 times per week for 3 months
- Keywords
- Urinary incontinence, Pelvic floor muscles, Kegel Exrecises
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home -Based Kegel Trainer Exercises (Kegel Trainer Application) will be used by the participants at home for training the pelvic floor muscles over 9 levels.Other
Also called Kegel Trainer, Pelvic floor muscle exercises
Kegel exercises are designed to focus on strengthening the weak pelvic floor muscles by using Kegel Trainer Application over 9 levels.
Clinic-Based Rehabilitation Program will consist of physiotherapist supervised pelvic floor strengthening exercises for the participant , 2 times per week for 3 monthsOther
Clinic-Based Rehabilitation Program will consist of physiotherapist supervised pelvic floor strengthening exercises for the participant , 2 times per week for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Home-Based Kegel Exercises | Experimental | Women diagnosed with urinary incontinence in this arm attending the Women's Department of Maternity and Children Hospital will use an AI trainer called Kegel trainer for 12 weeks focusing on strengthening the pelvic floor muscles. They will join a telegram group supervised by the caregiver to follow their interactions during the whole period. Receives: Other: Home -Based Kegel Trainer Exercises (Kegel Trainer Application) will be used by the participants at home for training the pelvic floor muscles over 9 levels. |
| Clinic-Based Rehabilitation Program | Experimental | Women diagnosed with urinary incontinence in this arm attending the Women's Department of Maternity and Children Hospital will be supervised by the Physiotherapist at the department for two times per week during the Kegel training for pelvic floor muscles training for 12 weeks . Receives: Other: Clinic-Based Rehabilitation Program will consist of physiotherapist supervised pelvic floor strengthening exercises for the participant , 2 times per week for 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perineometer
Pelvic floor muscle strength will be measured using a perineometer min 0 cmH₂O and max 300 cmH₂O. Higher scores indicate greater pelvic floor muscle strength
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (2)
long-term Pad Test
Urinary leakage severity will be measured using the long-term Pad Test. Minimum value of 0 g. Higher values indicate greater urinary leakage and therefore worse urinary incontinence. Lower values indicate less urinary leakage and better outcome.
Measured: From enrollment to the end of treatment at 12 weeks
King's Health Questionnaire
- Quality of life will be measured using the King's Health Questionnaire with min score 0 and max score 100 for each domain. Lower scores indicate better quality of life.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence (UI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tabuk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enas Elsayed Mohamed Abutaleb, University of Tabuk
- Investigators
- Enas ES Abutaleb, Associate Professor, Principal investigator, University of Tabuk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795931
- Sponsor's protocol ID
- University of Tabuk (UTabuk)
- Acronym
- Incontinence
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No