NCT04036604

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2019

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

4 months

First QC Date

July 26, 2019

Last Update Submit

July 29, 2019

Conditions

Keywords

Pelvic floor exerciseUrinary incontinenceSexual dysfunction

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • SEAPI-QMM

    8 weeks

  • Physical Activity Scale for the Elderly (PASE)

    8 weeks

Study Arms (2)

Group of pelvic floor exercise

EXPERIMENTAL

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

Group of pelvic floor education

NO INTERVENTION

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.

Interventions

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.

Also known as: Education
Group of pelvic floor exercise

Eligibility Criteria

Age65 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, 07070, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Sexual Dysfunction, PhysiologicalUrinary Incontinence

Interventions

ExerciseEducational Status

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaSocioeconomic FactorsPopulation Characteristics

Study Officials

  • Mehmet Sakıncı, Assos.Prof.

    Akdeniz University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 groups Study Group and Control Group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assos.Prof.

Study Record Dates

First Submitted

July 26, 2019

First Posted

July 30, 2019

Study Start

January 21, 2019

Primary Completion

May 30, 2019

Study Completion

June 2, 2019

Last Updated

July 31, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

We have used SPSS for participant data after interventions

Locations