Urinary IncontinenceNCT06331039
The Effects of Pelvic Floor Muscle Training Combined With Otago Exercises in Elderly People With Incontinence
A study testing PFMT and PFMT+Otago in people with Urinary Incontinence and Pelvic Floor Muscle Weakness, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence, Pelvic Floor Muscle Weakness, Muscle Weakness
- What is being tested?
- PFMT and PFMT+Otago
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Apr 2023to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- Having severe walking and balance problems
- Severe cognitive impairment (Mini mental state assessment test score below 23)
- Having a serious neurological problem
- Having serious heart diseases
- Having a genito-urinary infection
- Having pelvic organ prolapse
Show all 10Show fewer
- Six months ago he received medication for incontinence
- Having had incontinence and abdominal surgery
- Having metastatic cancer
- Having any vision problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effects of Pelvic Floor Muscle Training Combined With Otago Exercises on Symptoms, Balance and Functional Status in Elderly People With UI Living in Nursing Homes
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.
Read the detailed 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.
- Being tested
- PFMT, PFMT+Otago
- Keywords
- urinary incontinence, pelvic floor muscle training, elektromyography, balance exercises, Otago Exercises
- Medical subject headings
- Urinary Incontinence, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFMTOther
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+OtagoOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PFMT+Balance Group | Experimental | PFMT+Otago group was included in the program that includes Otago exercises and pelvic floor muscle training. Otago exercises combined with pelvic floor muscle training will be performed 3 days a week (with a 1-day rest gap between 2 sessions) for 45 minutes per day. Otago exercises consist of strengthening, balance exercises and walking program. Warm-up exercises were performed before each program and cooling exercises were performed at the end of the program. Exercises were performed for 45-60 minutes in each session. Receives: Other: PFMT+Otago |
| PFMT Group | Experimental | PFMT group was included in a program that includes pelvic floor muscle training, 3 days a week (with 1 day of rest between 2 sessions) and 45 minutes per day. Receives: Other: PFMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline and week 12 (after intervention)
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
Measured: baseline and week 14 (after intervention)
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
Measured: baseline and week 12 (after intervention)
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.
Measured: baseline and week 12 (after intervention)
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.
Measured: baseline and week 12 (after intervention)
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.
Measured: baseline and week 12 (after intervention)
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
Measured: baseline and week 12 (after intervention)
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.
Measured: baseline and week 12 (after intervention).
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
Measured: baseline and week 12 (after intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start5 Apr 2023
- Primary completion5 Aug 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi, Hacettepe University, Dokuz Eylul University
- Responsible party
- Sponsor
- Investigators
- Özge ÇELİKER TOSUN, Assoc. Prof., Study director, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331039
- Sponsor's protocol ID
- CelalBayarU-5
- Status last verified
- May 2024
- First submitted
- 5 Feb 2024
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data is saved on my hard disk, I can share it if desired.
Publications
Baser Secer M, Celiker Tosun O, Akbayrak T, Ilcin N, Tosun G. Does combining two evidence-based exercise programs in elderly people with incontinence have a triple effect on incontinence symptoms, balance and functional status? Int Urol Nephrol. 2025 Jan;57(1):79-91. doi: 10.1007/s11255-024-04177-4. Epub 2024 Aug 1.
PubMed 39090517
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Pelvic Floor Muscle Training Combined With Otago Exercises on Symptoms, Balance and Functional Status in Elderly People With UI Living in Nursing Homes
- ClinicalTrials.gov ID
- NCT06331039
- Acronym / sponsor ID
- CelalBayarU-5
- Keywords
- urinary incontinence, pelvic floor muscle training, elektromyography, balance exercises, Otago Exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi, Hacettepe University, Dokuz Eylul University
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 5 Aug 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PFMT+Balance Group | Experimental | Other: PFMT+OtagoPFMT+Otago group was included in the program that includes Otago exercises and pelvic floor muscle training. Otago exercises combined with pelvic floor muscle training will be performed 3 days a week (with a 1-day rest gap between 2 sessions) for 45 minutes per day. Otago exercises consist of strengthening, balance exercises and walking program. Warm-up exercises were performed before each program and cooling exercises were performed at the end of the program. Exercises were performed for 45-60 minutes in each session. |
| PFMT Group | Experimental | Other: PFMTPFMT group was included in a program that includes pelvic floor muscle training, 3 days a week (with 1 day of rest between 2 sessions) and 45 minutes per day. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- Having severe walking and balance problems
- Severe cognitive impairment (Mini mental state assessment test score below 23)
- Having a serious neurological problem
- Having serious heart diseases
- Having a genito-urinary infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PFMTPFM 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. | Other | PFMT Group |
| PFMT+OtagoIt 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. | Other | PFMT+Balance Group |
Primary outcome
incontinence symptoms and severity
Time frame: baseline and week 12 (after intervention)
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
balance
Time frame: baseline and week 14 (after intervention)
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
bladdery diary
Time frame: baseline and week 12 (after intervention)
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
Senior fitness test- functional performance-30-second chair stand test
Time frame: baseline and week 12 (after intervention)
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.
Senior fitness test- functional performance-Eight (2.45m) Food Up and Go Test
Time frame: baseline and week 12 (after intervention)
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.
Senior fitness test- functional performance-Chair Sit and Reach Test
Time frame: baseline and week 12 (after intervention)
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.
Senior fitness test- functional performance-Two Minutes Step Test
Time frame: baseline and week 12 (after intervention)
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
Muscle Function- Pelvic floor muscles-Superficial electromyography (EMG)
Time frame: baseline and week 12 (after intervention).
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.
Fear of falling-Fall Efficacy Scale (FES)
Time frame: baseline and week 12 (after intervention).
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Derived from this study: PubMed 39090517Baser Secer M, Celiker Tosun O, Akbayrak T, Ilcin N, Tosun G. Does combining two evidence-based exercise programs in elderly people with incontinence have a triple effect on incontinence symptoms, balance and functional status? Int Urol Nephrol. 2025 Jan;57(1):79-91. doi: 10.1007/s11255-024-04177-4. Epub 2024 Aug 1.
- Individual participant dataSharing planned: Yes. The data is saved on my hard disk, I can share it if desired.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Özge ÇELİKER TOSUN, Assoc. Prof. study director
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PFMT and PFMT+Otago in people with Urinary Incontinence and Pelvic Floor Muscle Weakness, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incontinence symptoms and severity (time frame: baseline and week 12 (after intervention)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06331039, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.