NCT07795931

Brief 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. 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Oct 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Oct 2026Mar 2027

First Submitted

Initial submission to the registry

August 26, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2027

Expected
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

5 months

First QC Date

August 26, 2026

Last Update Submit

September 23, 2026

Conditions

Keywords

Urinary incontinence, Pelvic floor muscles, Kegel Exrecises

Outcome Measures

Primary Outcomes (1)

  • 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

    From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (2)

  • long-term Pad Test

    From enrollment to the end of treatment at 12 weeks

  • King's Health Questionnaire

    From enrollment to the end of treatment at 12 weeks

Study Arms (2)

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.

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 .

Other: Clinic-Based Rehabilitation Program will consist of physiotherapist supervised pelvic floor strengthening exercises for the participant , 2 times per week for 3 months

Interventions

Kegel exercises are designed to focus on strengthening the weak pelvic floor muscles by using Kegel Trainer Application over 9 levels.

Also known as: Kegel Trainer, Pelvic floor muscle exercises
Home-Based Kegel Exercises

Clinic-Based Rehabilitation Program will consist of physiotherapist supervised pelvic floor strengthening exercises for the participant , 2 times per week for 3 months

Clinic-Based Rehabilitation Program

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Details* Female participants aged 20-50 years. * Diagnosed with urinary incontinence. * Able to understand study instructions. * Willing to provide informed consent
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female participants aged 20-50 years.
  • Diagnosed with urinary incontinence.
  • Able to understand study instructions.
  • Willing to provide informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maternity and Children Hospital in Tabuk

Tabuk, Tabuk Region, Saudi Arabia

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Enas ES Abutaleb, Associate Professor

    University of Tabuk

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Physical Therapy-University of Tabuk,Professor of Physical Therapy- Cairo University,

Study Record Dates

First Submitted

August 26, 2026

First Posted

August 31, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

February 15, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

September 25, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations