NCT06835309

Brief Summary

This study will be conducted to investigate the impact of isokinetic strengthening of hip muscles on pelvic floor muscles function in women experiencing stress urinary incontinence Does isokinetic strengthening of hip muscles impact pelvic floor muscles function in women experiencing stress urinary incontinence?

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

First Submitted

Initial submission to the registry

January 23, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

January 23, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 19, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2025

Completed
Last Updated

February 19, 2025

Status Verified

January 1, 2025

Enrollment Period

3 months

First QC Date

January 23, 2025

Last Update Submit

February 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pelvic floor muscle strength

    Perineometry to measure vaginal squeeze pressure (in mm hg) the more the grade, the better the muscle strength and so the less the stress urinary incontinence

    12 weeks

Secondary Outcomes (1)

  • Stress urinary incontinence.

    12 weeks

Study Arms (2)

Control arm

ACTIVE COMPARATOR

Pelvic floor muscles exercises

Other: Pelvic floor muscles exercises

Treatment arm

EXPERIMENTAL

Pelvic floor muscles exercises and isokinetic strengthening of hip muscles

Other: Pelvic floor muscles exercises and isokinetic strengthening of hip muscles

Interventions

The exercises for strengthening the PFM were 10 contractions of 5 seconds, 15 contractions of 3 seconds, 20 contractions of 2 seconds, 20 contractions of 1 second (equal rest time between contractions), and 5 repetitions of maximum contractions while coughing (1-minute interval).25 The level of difficulty of the exercises throughout the 20 sessions was determined by the patient's position, starting in a supine position, then progressing to a sitting position and, finally, to a standing position

Control arm

The hip muscle strengthening exercise was executed on Biodex multi-joint system isokinetic dynamometer. Muscle tension of the lower limbs was relieved by executing 5-minute warm-up exercises using a cycle ergometer before execution of the isokinetic exercise For each hip muscle group, eight repetitions per set for 4 sets were carried out for a single exercise with a 30 second break between each set. The patient's position were the same positions used in the testing procedure. The exercises were carried out 3 times a week and the hip muscles strength evaluation was conducted after the end of the program intervention

Treatment arm

Eligibility Criteria

Age30 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients diagnosed with stress urinary incontinence
  • age between 30 and 50 years

You may not qualify if:

  • low back pain
  • lower limb muscle pathology and/or joint degeneration
  • cardiovascular, metabolic or pulmonary disease
  • body mass index (BMI) \> 30 kg/m2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

British University in Egypt

Cairo, 4914058, Egypt

Location

Related Links

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2025

First Posted

February 19, 2025

Study Start

January 23, 2025

Primary Completion

April 23, 2025

Study Completion

May 23, 2025

Last Updated

February 19, 2025

Record last verified: 2025-01

Locations