Urinary Incontinence Clinical Trial
Official title:
Investigation of the Effects of Pelvic Floor Muscle Training and Balance Exercises on Ankle Muscle Function, Joint Range of Motion and Balance in Elderly People With Incontinence
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 the effects of pelvic floor muscle training and balance exercises on ankle muscle function, joint range of motion and balance in individuals aged 65 and over with urinary incontinence.
Status | Not yet recruiting |
Enrollment | 36 |
Est. completion date | July 30, 2024 |
Est. primary completion date | April 5, 2024 |
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Melda BASER SEÇER | Mani?sa | Yunusemre |
Lead Sponsor | Collaborator |
---|---|
Celal Bayar University | Dokuz Eylul University, Saglik Bilimleri Universitesi |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ankle muscle function | SPSS 29 is validated. Using superficial electromyography for ankle muscle function, the initial and post-treatment values of the gastrocinemus and tibialis anterior muscles will be recorded. Change: Week 14-baseline |
baseline and week 14 (after intervention) | |
Primary | ankle range of motion | SPSS 29 is validated. Ankle range of motion will be measured and recorded with a digital goniometer at baseline and after the intervention. Change: Week 14-baseline. Ankle range of motion will be measured and recorded with a digital goniometer at baseline and after the intervention. Tibialis anterior and gastrocinemus muscle strength will be recorded by measuring baseline and after intervention using a manual muscle tester. Change: Week 14-baseline |
baseline and week 14 (after intervention) | |
Primary | muscle strength | SPSS 29 is validated. Tibialis anterior and gastrocinemus muscle strength will be recorded by measuring baseline and after intervention using a manual muscle tester. Change: Week 14-baseline. |
baseline and week 14 (after intervention) | |
Primary | incontinence symptoms and severity | SPSS 29 is validated. Urogenital Distress Inventory (UDI-6) instrument scores will be recorded at the baseline and after the intervention. Urogenital Distress Inventory consists of 6 questions. It includes three subscales: irritative symptoms (urgency, frequency, pain), stress symptoms, and obstructive/disturbing or urination difficulty symptoms.The scoring options for each item are 0: not at all, 1: slightly, 2: moderate, and 3: very much. Minimum 0 - maximum 18 points from UDI-6.Increasing scores from the scales indicate that the quality of life level is deteriorating. Change: Week 14- baseline |
baseline and week 14 (after intervention) | |
Primary | incontinence symptoms and severity | PSS 29 is validated. Incontinence Impact Questionnaire (IIQ-7) instrument scores will be recorded at the baseline and after the intervention. The Incontinence Impact Questionnaire consists of 7 questions. It includes four sub-dimensions: physical activity, travel, social relations and emotional health.The scoring options for each item are 0: not at all, 1: slightly, 2: moderate, and 3: very much. Minimum 0 - maximum 21 points from IIQ-7.Increasing scores from the scales indicate that the quality of life level is deteriorating. Change: Week 14- baseline |
baseline and week 14 (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 will be 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 14- baseline |
baseline and week 14 (after intervention) | |
Primary | functional performance | SPPS 29 is validated. 30-second chair stand test score will be 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 14- baseline. |
baseline and week 14 (after intervention) |
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 |
NCT02600676 -
Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis
|
N/A | |
Completed |
NCT02338726 -
Pelvic Floor Symptoms and Quality of Life in Elderly Women - a Population-based Pilot Study
|
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 |