Investigation of The Effect of Pelvic Floor Exercise Programme in Elderly.

Investigation of The Effect of Pelvic Floor Exercise Programme Related to Sexual Dysfunction, Incontinence, Physical Activity Level and Quality of Life in Elderly.

Alteration of hormonal structure and decreasing of muscle tissue with aging causes pelvic floor dysfunction. Over age of 65 so many factors such as decrease in volume of muscle tissue, decrease in the amount of estrogen / testosterone, and low level of physical activity cause problems such as incontinence, prolapse, constipation and sexual dysfunction The aim of this study is to investigate the effectiveness of pelvic floor exercise program on sexual dysfunction, incontinence, quality of life and physical activity level in elderly.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Sexual Dysfunction; Pelvic Floor Muscle Weakness; Urinary Incontinence in Old Age
• Intervention / Treatment: Other: Exercise

Detailed Description

Pelvic floor problems including prolapse, voiding and defecation dysfunction have been seen in approximately 37% of women aged 60-79 years and incontinence is the leading pelvic floor dysfunction. The International Incontinence Society (ICS)defines that all types of involuntarily urinary leakage as urinary incontinence. The incidence of urinary incontinence is 26.6% in women aged 65-74 and 41.8% in patients aged 75 and over. Sexual dysfunction is also frequently encountered problem in pelvic floor disorders in people older than 65 years. The aim of this study is to investigate the effectiveness of pelvic floor exercise program on sexual dysfunction, incontinence, quality of life and physical activity level in elderly. Pelvic floor exercises programme contains different contractions of pelvic floor muscle. Each exercises have slow and fast twitch muscle exercise contraction.

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Antalya, Turkey, 07070
    • Akdeniz University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 75 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

To be aged over 65 To attend all exercise class Not to be communication problem

Exclusion Criteria:

To have neurogenic bladder To have metastatic prostate or ovary cancer To have enfection in urinary tractus To have pelvic organs malign diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group of pelvic floor exercise; Group of pelvic floor exercise include 47 elderly people which contains contraction and repetition of pelvic floor muscle exercises during twice a week for 8 weeks performed by an expert pelvic health physiotherapist.	Other: Exercise; Pelvic floor exercise programme include repetition of pelvic floor muscle contraction during twice a week for 8 weeks performed by an expert pelvic health physiotherapist. Pelvic floor education programme include pelvic floor anatomy, information about pelvic floor dysfunction and behavioral changes.; Other Names: Education
No Intervention: Group of pelvic floor education; Group of pelvic floor education include 47 elderly people which contains anatomy of pelvic floor and dysfunction during once a week for 8 weeks performed by an expert pelvic health physiotherapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Female Sexual Dysfunction Index	The FSFI is a brief questionnaire measure of sexual functioning in women. It was developed for the specific purpose of assessing domains of sexual functioning (e.g. sexual arousal, orgasm, satisfaction, pain) in clinical trials.	8 weeks
International Index of Erectile Function Questionnaire	The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi- dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials.	8 weeks
International Consultation on Incontinence Questionnaire- Short Form (ICIQ-SF)	The ICIQ-UI Short Form is a brief and psychometrically robust patient-completed questionnaire for evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence in men and women in research and clinical practice across the world. It is scored on a scale from 0-21.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SEAPI-QMM	The SEAPI incontinence questionnaire includes 5 data points that rate severity of specific urinary symptoms. The SEAPI-QMM Incontinence Classification System was developed in the early 1990s as a system that could quantify urinary incontinence and its impact without special equipment or time-consuming procedures.	8 weeks
Physical Activity Scale for the Elderly (PASE)	Physical Activity Scale for the Elderly (PASE) is a brief (5 minutes) and easily scored survey designed specifically to assess physical activity in epidemiological studies of persons age 65 years and older[6]. The PASE score combines information on leisure, household and occupational activity[7]. The PASE assesses the types of activities typically chosen by older adults (walking, recreational activities, exercise, housework, yard work, and caring for others. It uses frequency, duration, and intensity level of activity over the previous week to assign a score, ranging from 0 to 793, with higher scores indicating greater physical activity. PASE was initially developed in early 90s to provide an instrument to investigate specifically older people with an age-specific physical activity questionnaire, filling what was an important need in epidemiological research at that time	8 weeks

Collaborators and Investigators

• Sponsor: Akdeniz University
• Investigators: Study Chair: Mehmet Sakıncı, Assos.Prof., Akdeniz University

Publications and helpful links

General Publications

• Engberg S, Sereika SM. Effectiveness of Pelvic Floor Muscle Training for Urinary Incontinence: Comparison Within and Between Nonhomebound and Homebound Older Adults. J Wound Ostomy Continence Nurs. 2016 May-Jun;43(3):291-300. doi: 10.1097/WON.0000000000000227.
• Serati M, Braga A, Di Dedda MC, Sorice P, Peano E, Biroli A, Torella M, Cromi A, Uccella S, Salvatore S, Ghezzi F. Benefit of pelvic floor muscle therapy in improving sexual function in women with stress urinary incontinence: a pretest-posttest intervention study. J Sex Marital Ther. 2015;41(3):254-61. doi: 10.1080/0092623X.2014.889052. Epub 2014 Mar 20.

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2019
• Primary Completion (Actual): May 30, 2019
• Study Completion (Actual): June 2, 2019

Study Registration Dates

• First Submitted: July 26, 2019
• First Submitted That Met QC Criteria: July 26, 2019
• First Posted (Actual): July 30, 2019

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Urinary incontinence; Pelvic floor exercise; Sexual dysfunction
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Nervous System Diseases; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Urination Disorders; Neuromuscular Manifestations; Elimination Disorders; Urinary Incontinence; Muscle Weakness; Enuresis
• Other Study ID Numbers: 2012-KAEK-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We have used SPSS for participant data after interventions

Drug and device information, study documents

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