Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06331039
Other study ID # CelalBayarU-5
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 5, 2023
Est. completion date September 30, 2023

Study information

Verified date May 2024
Source Celal Bayar University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Pelvic floor muscle weakness is one of the most important causes of incontinence. There are many studies supporting that pelvic floor muscle training prevents incontinence and reduces symptom severity, and with A level of evidence, it is among the first in the conservative treatment of incontinence. Functional status and balance problems are common in elderly people with incontinence, and it is known that functional type incontinence is common. Elderly people with incontinence most often fall while trying to get to the toilet. Balance exercises are recommended for falls and balance problems. The aim of this study is to examine whether pelvic floor muscle training (PFMT) combined with Otago exercises is effective on symptoms, balance and functional status in elderly people with UI living in nursing homes, compared to PFMT alone.


Description:

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 included Otago exercises combined with pelvic floor muscle training (PFMT). The control group was included in the PFMT program with different positions. 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 muscle function (superficial electromyography), balance (Berg Balance Scale), functional status (Senior Fitness Test) and fear of falling (Falls Efficacy Scale) was measured at baseline and after the intervention.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date September 30, 2023
Est. primary completion date August 5, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 100 Years
Eligibility Inclusion Criteria: 1. Having signed the informed volunteer consent form 2. Being 65 years or older 3. Having urinary incontinence 4. Ability to walk unaided and not use any walking aids Exclusion Criteria: 1. Having severe walking and balance problems 2. Severe cognitive impairment (Mini mental state assessment test score below 23) 3. Having a serious neurological problem 4. Having serious heart diseases 5. Having a genito-urinary infection 6. Having pelvic organ prolapse 7. Six months ago he received medication for incontinence 8. Having had incontinence and abdominal surgery 9. Having metastatic cancer 10. Having any vision problems

Study Design


Intervention

Other:
PFMT
PFM exercises were done. Each session were 45 minutes, 2 days a week on a group basis with the physiotherapist, and 1 day a week as a home program, for 12 weeks.
PFMT+Otago
It were done by combining Otago exercises and PFM exercises. Each session were 45 minutes, 2 days a week on a group basis with the physiotherapist, and 1 day a week as a home program, for 12 weeks.

Locations

Country Name City State
Turkey Melda BASER SEÇER Mani?sa Yunusemre

Sponsors (4)

Lead Sponsor Collaborator
Celal Bayar University Dokuz Eylul University, Hacettepe University, Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary incontinence symptoms and severity SPSS 29 is validated. Pelvic Floor Distress Inventory-20 (PFDI-20) instrument scores were recorded at the baseline and after the intervention. Pelvic Floor Distress Inventory-20 Scale evaluates pelvic organ prolapse, urinary and colorectoanal problems that may develop due to pelvic floor dysfunction, and the degree of complaints about them; It is the short form of the Pelvic Floor Distress Inventory Scale; It consists of 3 subheadings: Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6), Urinary Distress Inventory-6 (ÜDI-6) and Colorectoanal Distress Inventory-8 (KRADE-8) and a total of 20 questions. Each subheading score ranges from 0-100, and the total score ranges from 0-300. While the best score for each subheading is 0 and the worst score is 100, the best score in total is 0 and the worst score is 300.
Change: Week 12- baseline
baseline and week 12 (after intervention)
Primary balance SPPS 29 is validated. Berg Balance Scale score will be recorded at baseline and after the intervention. It consists of fourteen items. The proficiency level in the activity for each item is 0; "cannot", 4; It is indicated with 5 points (0-4), "makes it independent and safe". The 14 functional parameters included in Berg Balance Scale. The maximum score that participants can get from the test is 56 and reflects an excellent balance function. (0-20 points; severe fall risk, 21-40 points; moderate fall risk, 41-56; mild fall risk). The fall risk limit for this test is 45 points.
Change: Week 14- baseline
baseline and week 14 (after intervention)
Primary bladdery diary SPPS 29 is validated. Bladdery diary were recorded at the baseline and after the intervention.
The patient records the type and amount of fluid he/she takes, the frequency of urinary incontinence, the urination volume, the frequency of urination at night, and the situations in which he/she leaks urine, along with the times in a 24-hour voiding diary. It is an objective evaluation method used to determine the type and degree of incontinence.
Change: Week 12- baseline
baseline and week 12 (after intervention)
Primary Senior fitness test- functional performance-30-second chair stand test SPPS 29 is validated. 30-second chair stand test score were recorded at the baseline and after the intervention.
The participant was asked to sit in the middle part of a 43.18 cm (12in) high chair with his back upright, feet on the ground and arms crossed in front of his chest (right hand on the left shoulder, left hand on the right shoulder). While in this position, the participant starts the test with the start command and takes off as fully as he can during 30 seconds. The number of complete takes off during 30 seconds determines the score.A score of less than 10 in 30 seconds indicates lower extremity muscle weakness.
Change: Week 12- baseline.
baseline and week 12 (after intervention)
Primary Senior fitness test- functional performance-Eight (2.45m) Food Up and Go Test SPPS 29 is validated.For the test, which is used to evaluate functional mobility and dynamic balance in elderly participants, the participants was seated in a chair with a backrest and armrests, with his back and arms supported. After the command to "get up" was given to the patient, he was asked to walk at his normal speed to an object placed 2.45 m away from the chair, and then turn around the object and walk back. The period started when the patient was commanded to "get up" and was stopped when he/she sat on the chair.
Change: Week 12- baseline.
baseline and week 12 (after intervention)
Primary Senior fitness test- functional performance-Chair Sit and Reach Test SPSS 29 is validated.This test, is used especially to determine the flexibility of the hamstring muscle group. The participant was seated on a 43.18 cm high chair leaning against a wall or a solid place, with the junction of the thigh and hip bones in front of the chair. The participant was allowed to extend one foot forward, in full extension, with the heel on the ground and the ankle at approximately 90 degrees, leaving it to the participant's own choice (right or left). The participant was told to stretch his body forward with both hands, without bending his extended knee, and to reach towards his toe without pushing the pain limit. Participant; If the fingertips do not touch the tip of the foot, the distance between them, in centimeters (-), is the participant's; If the fingertips of the middle hand touch the tip of the foot, zero (0) is given to the participant. baseline and week 12 (after intervention)
Primary Senior fitness test- functional performance-Two Minutes Step Test SPPS 29 is validated. In order to perform the test, the participant stands in an upright position; The distance from the front protrusion of the hip bone (iliac crest) to the midpoint of the kneecap (patella) was marked and the midpoint of the distance between these two bones was determined. The participant's step height was determined by marking the height of this determined point from the ground. In order to determine whether the step height reached the target height, a strip was drawn at the determined height or the target height was marked on the wall and it was checked whether the participant's step height (knee height) reached the target height. The participant was made to step where both knees were, reaching the specified height for 2 minutes. At the end of 2 minutes, the total number of right steps taken correctly was recorded.
Change: Week 12-baseline
baseline and week 12 (after intervention)
Primary Muscle Function- Pelvic floor muscles-Superficial electromyography (EMG) SPPS 29 is validated.EMG measurement; It was used to record the bioelectrical activity generated by superficial PFM. In the research, NeuroTrac MyoPlus 4 PRO type EMG device was used. Superficial PFM EMG activities were evaluated using disposable, superficial, self-adhesive, silver-silver chloride (Ag/AgCl) electrodes. The diameter of the circular adhesive electrodes was 3.2 cm. The skin area where the superficial electrodes would be attached was cleaned with an alcohol swab to reduce skin impedance. Superficial electrodes were then placed on the muscles parallel to the muscle fibers: superficial PFM- on both sides of the perineal body. The monopolar reference electrode was placed on the right spina iliac anterior superior (SIAS) to eliminate external signals from outside. baseline and week 12 (after intervention).
Primary Fear of falling-Fall Efficacy Scale (FES) SPPS 29 is validated.The first version of the Falls Efficacy Scale (FES) was developed by Tinetti and colleagues in the form of 10 questions covering simple daily living activities to evaluate the fear of falling in the elderly population. It enables the detection and evaluation of the activities that cause fear in people. The Fall Activity Scale-International, which is frequently used today, was developed by Yardley et al.by modifying and preserving the 10 items in the original scale and adding 6 new items. According to this index, as the score increases, the fear of falling increases (scale score between 0-100).
Change: Week 12-baseline
baseline and week 12 (after intervention).
See also
  Status Clinical Trial Phase
Recruiting NCT05534412 - A Practice-Based Intervention To Improve Care for a Diverse Population Of Women With Urinary Incontinence N/A
Recruiting NCT05515198 - Improving Care for Women With Urinary Incontinence (EMPOWER) N/A
Completed NCT04071301 - Collection of Real-life Measurement Data for TENA SmartCare Change Indicator in Subjects With Urinary Incontinence N/A
Completed NCT03623880 - Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders N/A
Recruiting NCT05880862 - Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls Early Phase 1
Recruiting NCT04159467 - Effect of Pelvic Floor Muscle Training on Urinary Incontinence Reports in Obese Women Undergoing a Low Calorie Diet N/A
Completed NCT05485922 - Performance of a Single-use Intermittent Micro-hole Zone Catheter N/A
Completed NCT06268782 - The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women N/A
Not yet recruiting NCT03027986 - Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy N/A
Recruiting NCT02490917 - ACT™ Balloons Versus Artificial Urinary Sphincter (AMS800™) for the Treatment of Female Stress Urinary Incontinence N/A
Enrolling by invitation NCT02529371 - Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients N/A
Enrolling by invitation NCT02530372 - Feasibility of the UriCap-F for Urine Collection in Hospitalized Women N/A
Completed NCT02338726 - Pelvic Floor Symptoms and Quality of Life in Elderly Women - a Population-based Pilot Study N/A
Completed NCT02600676 - Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis N/A
Completed NCT02549729 - Effect of the Pelvic Floor Training in Postmenopausal Women With or Without Hormonal Therapy N/A
Completed NCT02368262 - Prevalence of Incontinence and Risk Factors in Children With Cerebral Palsy N/A
Completed NCT02239796 - Feasibility Controlled Trial of Tibial Nerve Stimulation for Stroke Related Urinary Incontinence N/A
Completed NCT01942681 - Female Patients With Signs of uRgE and Stress Urinary Incontinence Study of Propiverine Hydrochloride N/A
Recruiting NCT01804153 - Stem Cells Tratment for the Local Feminine Stress Urinary Incontinence Treatment (HULPURO) Phase 1/Phase 2
Completed NCT01520948 - Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease Phase 3