Effect of Pilates Exercises on Stress Urinary Incontinence in Posmenopausal Women

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

Study Overview

• Status: Not yet recruiting
• Conditions: Urinary Stress Incontinence
• Intervention / Treatment: Other: Pilates exercise - pelvic floor exercise - home advices

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MANAL AHMED EL-SHAFEI, PHD; Phone Number: +201220664518 +201220664518; Email: Manalpt1989@gmail.com
• Study Contact Backup: Name: AZZA BARAMOUD kASSAB, PHD; Phone Number: +201008410312; Email: drazzakassab@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Study group ; of pilates exercises,Kegel exercises,and home care advices.advices; •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; 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).; Other Names: Pelvic floor exercise - home care advices
Active Comparator: Controlled group;Kegel exercises,and home care advices.; 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; 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).; Other Names: Pelvic floor exercise - home care advices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
• 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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): April 20, 2024
• Primary Completion (Estimated): August 20, 2024
• Study Completion (Estimated): September 20, 2024

Study Registration Dates

• First Submitted: April 17, 2024
• First Submitted That Met QC Criteria: April 17, 2024
• First Posted (Actual): April 22, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: P.T.REC/012/004860

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No