NCT06269016

Brief Summary

this study will investigate effect of hip strengthening exercises and pelvic floor exercises on stress urinary incontinence in postnatal women. Clinical practice guidelines recommend PFMT as the first-line treatment for female SUI . Also, it has been speculated that the hip muscles are involved in the continence mechanism and that their deficiency could destabilize the normal function of the system. The addition of hip muscle exercises, regardless of PFM contractions, aimed to improve muscular condition for the motor or synergic strategies in PFM contraction. Secondary effects of these techniques, such as the influence of passive lumbar rotational mobilization in improving hip flexor strength, have been of high interest in physiotherapy in general

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
active not 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 Start

First participant enrolled

February 20, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2024

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

6 months

First QC Date

January 27, 2024

Last Update Submit

February 17, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • hip muscles strengthening exercise.

    measure the muscle power and endurance for pelvic floor muscles by using bio feedback device to measure maximum vaginal squeeze

    3 months

Study Arms (4)

control group no intervention

EXPERIMENTAL

no intervention for 3 months with assessment for maximum vaginal squeeze pre and post experiment using bio feedback device and urinary distress inventory UDI-6 short form.

Other: expremental pre and post test

study group hip muscles strengthening exercise.

EXPERIMENTAL

hip muscles exercises (hip abductors, adductors and gluteus maximus) for 3 months with assessment for maximum vaginal squeeze pre and post experiment using bio feedback device and urinary distress inventory UDI-6 short form.

Other: expremental pre and post test

study group hip muscles strengthening exercise combined with pelvic floor muscles exercise.

EXPERIMENTAL

hip muscles exercises (hip abductors, adductors and gluteus maximus) combined with pelvic floor muscles exercises for 3 months with assessment for maximum vaginal squeeze pre and post experiment using bio feedback device and urinary distress inventory UDI-6 short form.

Other: expremental pre and post test

study group pelvic floor muscles exercise.

EXPERIMENTAL

pelvic floor muscles exercises for 3 months with assessment for maximum vaginal squeeze pre and post experiment using bio feedback device and urinary distress inventory UDI-6 short form.

Other: expremental pre and post test

Interventions

effect of strengthening exercise of combined hip strengthening exercises and pelvic floor exercises

control group no interventionstudy group hip muscles strengthening exercise combined with pelvic floor muscles exercise.study group hip muscles strengthening exercise.study group pelvic floor muscles exercise.

Eligibility Criteria

Age30 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsstress urinary incomitance post-natal common problem in multiparas' females due to the effect of pregnancy hormones and increase intra-abdominal pressure during pregnancy also normal vaginal delivery increase the weakness of pelvic floor muscles.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Their ages will be ranged from 30 to 35 years old.
  • Their BMI will not exceed 35 Kg/m2.
  • All patients will be multipara women.
  • Their deliveries were normal vaginal delivery.
  • All patients will be diagnosed by gynecologist as mild or moderate degree of SUI.
  • All patients will have the same medical treatment and free from any pathological conditions that might affect the result.

You may not qualify if:

  • Recurrent urinary tract infections.
  • Hypertension.
  • Diabetes mellitus.
  • Intra uterine device.
  • Hysterectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mai Mohamed Sherif Mohamed Hassan

Cairo, Egypt

Location

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
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD researcher

Study Record Dates

First Submitted

January 27, 2024

First Posted

February 21, 2024

Study Start

February 20, 2023

Primary Completion

August 25, 2023

Study Completion

April 20, 2024

Last Updated

February 21, 2024

Record last verified: 2024-02

Locations