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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06376903
Other study ID # P.T.REC/012/004860
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 20, 2024
Est. completion date September 20, 2024

Study information

Verified date April 2024
Source Cairo University
Contact MANAL AHMED EL-SHAFEI, PHD
Phone +201220664518
Email Manalpt1989@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

Pilates exercises help in the controlled movement of the core, that act as a corset and it activates both core muscle and synergistically the PFM. (Trantafylidis, 2009). There is limited evidence regarding the use of Pilates exercises for the management of stress urinary incontinence (SUI) in older women (Keri, 2013; Pyria et al, 2021). So this study will be conducted to determine the effect of Pilates exercises on SUI in postmenopausal women which provide an insight about the benefits of such exercise on postmenopausal SUI.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date September 20, 2024
Est. primary completion date August 20, 2024
Accepts healthy volunteers No
Gender Female
Age group 50 Years to 60 Years
Eligibility Inclusion Criteria:Postmenopausal women (at least 12months after menstrual cessation), diagnosed with SUI by the gynecologist. - 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. Exclusion Criteria:Women will be excluded from the study if they have: - Previous bladder surgery. - Post pelvic radiotherapy. - Vaginal/abdominal hysterectomy. - Vaginal infection. - Severe urinary tract infection. - Uterine Prolapse

Study Design


Intervention

Other:
Pilates exercise - pelvic floor exercise - home advices
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).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary • 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 • Quality of Life Questionnaire (QOL) for stress urinary incontinence : it has been developed to provide detailed information on how urinary incontinence affects patients' lives. It is a valid and reliable instrument for assessing QOL in women with voiding symptoms, including urinary incontinence. It includes questions that evaluate the distress and impact of urinary incontinence in three domains: avoidance and limiting behavior, social embarrassment and psychosocial impact 6 weeks
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