Effects of Group-based and Individual Pelvic Floor Muscle Training on Elderly Individuals With Urinary Incontinence

NCT ID: NCT06547580

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2024-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to asses the effects of 12-week group-based and individually planned pelvic floor muscle training on individuals aged 65 and over with urinary incontinence.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The research was conducted on participants over the age of 65 with urinary incontinence living in a nursing home. After these participants were informed about the content of the study, a signed informed consent form will be obtained. This study is an assessor-blinded, randomized controlled trial. Participants with incontinence aged 65 and over living in a nursig home were randomly assigned to intervention (IG) and control group (CG). The intervention group attended an exercise program that individualized pelvic floor muscle with Emg biofeedback training (individualized-PFMT). The control group was included in the group-based PFMT program. Duration of exercise for both groups was 45-60 minutes per session three times a week for 12 weeks. Incontinence symptoms and severity (Pelvic Floor Distress Inventory-20, bladder diary), PFM and abdominal muscle function (superficial electromyography), balance (Berg Balance Scale), functional status (Senior Fitness Test), hand grip strength, knee extansor, ankle dorsi-plantar flexion muscle srength, sleep quality and fear of falling (Falls Efficacy Scale) was measured at baseline and after the intervention.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urinary Incontinence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group-based PFMT

A group-based Pelvic floor muscle training was practiced under the supervision of an experienced physiotherapist, 2 sessions a week, 30-45 minutes each, for 12 weeks.

Group Type EXPERIMENTAL

Group-based PFMT

Intervention Type OTHER

Under the supervision of an experienced physiotherapist, group-based pelvic floor muscle training was applied for 12 weeks, 2 sessions per week, 30-45 minutes each session.

Individualized PFMT

Individualized Pelvic floor muscle training with Electromyography Biofeedback was practiced under the supervision of an experienced physiotherapist, 2 sessions a week, 30-45 minutes each, for 12 weeks.

Group Type EXPERIMENTAL

Individualized PFMT

Intervention Type OTHER

Under the supervision of an experienced physiotherapist, individualized pelvic floor muscle training was performed using the Emg Biofeedback device, 2 sessions a week, 30-45 minutes each session, in 12 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Group-based PFMT

Under the supervision of an experienced physiotherapist, group-based pelvic floor muscle training was applied for 12 weeks, 2 sessions per week, 30-45 minutes each session.

Intervention Type OTHER

Individualized PFMT

Under the supervision of an experienced physiotherapist, individualized pelvic floor muscle training was performed using the Emg Biofeedback device, 2 sessions a week, 30-45 minutes each session, in 12 weeks.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Having signed the informed volunteer consent form
* Being 65 years or older
* Having urinary incontinence
* Ability to walk unaided and not use any walking aids

Exclusion Criteria

* Having severe walking and balance problems
* Severe cognitive impairment (Mini mental state assessment test score below
* Having a serious neurological problem
* Having serious heart diseases
* Having a genito-urinary infection
* Having pelvic organ prolapse
* Six months ago he received medication for incontinence
* Having had incontinence and abdominal surgery
* Having metastatic cancer
* Having any vision problems
Minimum Eligible Age

65 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Celal Bayar University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Özge ÇELİKER TOSUN

Role: STUDY_DIRECTOR

Dokuz Eylul University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Melda BAŞER SEÇER

Manisa, Yunusemre, Turkey (Türkiye)

Site Status

Melda BAŞER SEÇER

Manisa, Yunusemre, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CelalBayarU1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.