NCT06376903

Brief Summary

• This study will be conducted to determine the effect of pilates exercises on stress urinary incontinence in postmenopausal women

Trial Health

35
At Risk

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 Apr 2024

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

April 17, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

April 20, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2024

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

April 17, 2024

Last Update Submit

April 17, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • • Revised urinary incontinence scale

    : It is considered one of the tools which used to diagnose SUI. It takes the five best items which loaded on the urinary leakage. The items comprising this revised scale include urine leakage related to the feeling of urgency, urine leakage related to physical activity, coughing or sneezing, small amounts of urine leakage \[drops\]) as well as two items related to frequency and amount of incontinence Scoring is by simple summation and the range of the total score is between zero and 12(0= no incontinence , 1-2= slight incontinence , 3-6= moderate incontinence , 7-9= severe incontinence , 12= very severe incontinence)

    6 weeks

Secondary Outcomes (1)

  • • Quality of Life Questionnaire (QOL) for stress urinary incontinence

    6 weeks

Study Arms (2)

Study group ; of pilates exercises,Kegel exercises,and home care advices.advices

ACTIVE COMPARATOR

•study group : It will be consisted of thirty postmenopausal women suffering from mild and moderate stress urinary incontinence, will perform program of pilates exercises, 3 sessions/week (30 minutes a session ) for 12 weeks in addition to Kegel exercises (15min/three times per week/ for 12 weeks) and home care advices.

Other: Pilates exercise - pelvic floor exercise - home advices

Controlled group;Kegel exercises,and home care advices.

ACTIVE COMPARATOR

Controlled group : It will be consisted of thirty postmenopausal women suffering from mild and moderate stress urinary incontinence, will perform kegel exercises (15min/three times per week/ for 12 weeks) and home care advices as in group (A).

Other: Pilates exercise - pelvic floor exercise - home advices

Interventions

Group (A) (Study group): It will be consisted of thirty postmenopausal women suffering from mild and moderate stress urinary incontinence, will perform program of pilates exercises, 3 sessions/week (30 minutes a session ) for 12 weeks in addition to Kegel exercises (15min/three times per week/ for 12 weeks) and home care advices. • Group (B) (Controlled group): It will be consisted of thirty postmenopausal women suffering from mild and moderate stress urinary incontinence, will perform kegel exercises (15min/three times per week/ for 12 weeks) and home care advices as in group (A).

Also known as: Pelvic floor exercise - home care advices
Controlled group;Kegel exercises,and home care advices.Study group ; of pilates exercises,Kegel exercises,and home care advices.advices

Eligibility Criteria

Age50 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Details* Postmenopausal women (at least 12months after menstrual cessation), diagnosed with SUI by the gynecologist. * Their ages will range from 50-60 years old .
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Their ages will range from 50-60 years old .
  • Their BMI will be less than 30kg/m2 .
  • All of them suffer from mild to moderate degree of SUI .
  • All of them delivered vaginally.
  • All are multipara with 2 or more children.
  • All are of sedentary life style.

You may not qualify if:

  • Previous bladder surgery.
  • Post pelvic radiotherapy.
  • Vaginal/abdominal hysterectomy.
  • Vaginal infection.
  • Severe urinary tract infection.
  • Uterine Prolapse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Central Study Contacts

MANAL AHMED EL-SHAFEI, PHD

CONTACT

AZZA BARAMOUD kASSAB, PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cairo university

Study Record Dates

First Submitted

April 17, 2024

First Posted

April 22, 2024

Study Start

April 20, 2024

Primary Completion

August 20, 2024

Study Completion

September 20, 2024

Last Updated

April 22, 2024

Record last verified: 2024-04