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NCT Number: NCT04036604

Investigation of The Effect of Pelvic Floor Exercise Programme 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.

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Key information

Conditions

Pelvic Floor Muscle Weakness Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Quality of Life Sexual Dysfunction Sexual Dysfunction, Physiological Signs and Symptoms Urinary Incontinence Urinary Incontinence in Old Age Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

65 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akdeniz University

Antalya, 07070, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

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

Primary outcomes

  1. Female Sexual Dysfunction Index

    Time frame: 8 weeks

    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.

  2. International Index of Erectile Function Questionnaire

    Time frame: 8 weeks

    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.

  3. International Consultation on Incontinence Questionnaire- Short Form (ICIQ-SF)

    Time frame: 8 weeks

    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.

Secondary outcomes

  1. SEAPI-QMM

    Time frame: 8 weeks

    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.

  2. Physical Activity Scale for the Elderly (PASE)

    Time frame: 8 weeks

    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

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 30, 2019
Registry last updated
Jul 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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