Urinary IncontinenceNCT05549193
The Effects of the Pelvic Floor and Abdominal Muscle Training on Urinary Incontinence
A study testing Exercises Training in people with Urinary Incontinence, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
To investigate the effects of the pelvic floor and abdominal muscle training on the severity of incontinence in women with stress and mixed urinary incontinence. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Exercises Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Nov 2018to 1 Jul 2019
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being female,
- Being 18 years of age or older
- Having been diagnosed of SUI and stress-predominant MUI after urodynamic evaluation by the urologist.
Who cannot join
- Currently taking medications for UI,
- Having urinary tract infection,
- Neurological disorders,
- Pelvic organ prolapse stage >2,
- Pregnancy,
- a mental problem and/or
- been applied prior to physiotherapy for UI.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of the Pelvic Floor and Abdominal Muscle Training in Urinary Incontinence According to the Severity
To investigate the effects of the pelvic floor and abdominal muscle training on the severity of incontinence in women with stress and mixed urinary incontinence.
Read the detailed description
The aim of this study is to investigate the effect of incontinence severity on the pelvic floor and abdominal muscle strengthening training in women with stress urinary incontinence (UI). Sixteen patients with stress and mixed UI were included in the study. According to the 24-hour pad test (24hPT), individuals were divided into two groups as group 1 (24hPT 4-20gr, mild group, n: 9) and group 2 (24hPT 21g and above in 24hPT, moderate-severe group, n: 7). Pelvic floor muscle training (PFMT) and abdominal muscle training were applied to the groups for 6 weeks.
PFMT was given as a home-based exercise program to increase pelvic floor muscle (PFM) strength and endurance. Before starting the program, PFM was taught first schematically and then by the biofeedback method. It was ensured that the patient learned the PFM. Fast and slow pelvic floor contractions were taught for both type 1 and type 2 muscle fibres. For slow contractions, it was asked to gradually contract in 5 seconds, wait at a maximum of 5 seconds and gradually relax in 5 seconds. For fast contractions, it was asked to contract at a maximum of 2 seconds and then to relax. Patients were asked to perform 10 slow contractions after every 10 rapid contractions. 10 fast + 10 slow contractions were accepted as 1 set exercise. Subjects were asked to make 10 sets every day for 6 weeks.
Strengthening exercises for transversus abdominus and internal obliques abdominus muscles were given as a home program and the details were written below:
Transversus Abdominus: Patients were in the crook lying position and were asked to contract their abdominal muscles strongly and statically. Fifteen repetitions were carried out; each one consisting of contraction for 10 s followed by relaxation for 20 s. After 15 repetitions, patients rested for 5 min. The sequence was then repeated for two sets of 15 repetitions.
Internal Obliquus Abdominus: Patients were in the crook lying position and were asked to contract their abdominal muscles strongly and statically and then try to touch the furthest point of their legs with their fingertips for 15 repetitions consisting of contraction for 10 s followed by relaxation for 20 s. After 15 repetitions, patients rested for 5 min. The sequence was then repeated on the other leg.
Urinary incontinence, pelvic floor muscle strength measurement, quality of life, symptom, and the presence of pelvic floor dysfunction were evaluated respectively using 24hPT, Electromyography (EMG) Biofeedback device, King's Health Questionnaire, Urogenital Distress Inventory, and Global Pelvic Floor Bother Questionnaire. Evaluations were performed at the beginning and at the end of the physiotherapy program, and a subjective improvement rate was determined.
- Conditions
- Urinary Incontinence
- Being tested
- Exercises Training
- Keywords
- Rectus Abdominus, Pelvic Floor Muscle Training, Stress Urinary Incontinence, Quality of Life, Biofeedback, Home Exercises
- Medical subject headings
- Urinary Incontinence, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercises TrainingOther
Pelvic Floor Muscle Training: For slow contractions, it was asked to contract in 5 seconds gradually, wait at a maximum of 5 seconds and gradually relax in 5 seconds. For fast contractions, it was asked to contract at a maximum of 2 seconds and then to relax. 10 fast + 10 slow contractions were accepted as 1 set exercise. (10 sets x Every Day x 6 weeks)
Transversus Abdominus: Patients were in the crook lying position and were asked to contract their abdominal muscles strongly and statically. 15 repetitions were carried out, each consisting of contraction for 10 s and relaxation for 20 s. 2 sets of 15 repetitions were done.
Internal Obliquus Abdominus: Patients were in the crook lying position and were asked to contract their abdominal muscles strongly and statically and then try to touch the furthest point of their legs with their fingertips for 15 repetitions consisting of contraction for 10 s followed by relaxation for 20 s. The sequence was then repeated on the other leg.
| Study group | Role | What they receive |
|---|---|---|
| Mild and Moderate-Severe Urinary Incontinence Group | Experimental | 10 sets of pelvic floor muscle training and 2 sets of abdominal muscle strengthening training were given every day for 6 weeks. All analyzes were conducted at the beginning and end of the 6-week training. The same training program was applied to both groups ( Group 1 (mild urinary incontinence) and Group 2 (moderate-severe urinary incontinence), and the effects were compared according to the severity of incontinence. Receives: Other: Exercises Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Incontinence Severity
A 24-hour pad test was used to assess and standardize the severity of UI. The patients were informed before the test. The patients were told to change their pads every 4-6 hours and put the pads in an airtight locked bag to prevent the urine from evaporating. Since the pads should be weighed immediately after the evaluation, they were asked to do the test 1 day before the evaluation. Pads that were used for 24 hours were requested in a mouth-locked bag. 1 unused pad of the same type was requested. Urinary incontinence was determined by measuring the weight of the pad with precision scales (Isolab Laborgerate GMBH, Germany) before and after 24 hours. As a result of the 24-hour pad test, 4-20 grams were defined as mild, 21-74 grams as moderate, and > 75 grams as severe UI.
Measured: 6 weeks
Secondary outcomes (6)
Pelvic Floor Muscle Activity
Muscle activity in electromyography was evaluated by the EMG Biofeedback program of MMS brand Uro Solar Model urodynamics device (Medical Measurement Systems b.v. the Netherlands). Superficial electrodes were used for the measurement. Electrodes were non-invasively measured by adhering 2 pieces to the right and left of the perineal body and 1 to the inner leg. EMG values were recorded. Evaluations were made with the patient in the lithotomy position. During the measurement, it was warned that the PFM should contract for 10 seconds and during contractions they should not contract the abdominal, hip and thigh muscles and hold their breath. For correct contraction, patients were asked to breathe normally and then to squeeze and lift the pelvic floor as if preventing the escape of urine or flatus. Muscle activation response recorded in microvolts (μV).
Measured: 6 weeks
Abdominal Muscles Strength
To assess abdominal muscle strength, Dr Robert W. Lovett's manual muscle test was used. It was started with the value 3, and patients that can make the value of 3 were examined with 3+, 4, and 5 values of the muscle. If the patients cannot make 3, 2, 1, and 0 values were examined. All tests were performed by the same physiotherapist according to a standardised protocol.
Measured: 6 weeks
Quality of life about Urinary Incontinence
King's Health Questionnaire was used to assess the quality of life specific to UI. It consists of two parts and 32 items.
Measured: 6 weeks
Urinary Incontinence Symptom severity
The Urinary Distress Inventory-short form was used to evaluate the symptom severity score. It consisted of 6 questions and each question was scored between 0-3 points. If the scoring is high, the quality of life is low.
Measured: 6 weeks
Existing pelvic floor dysfunction
Global Pelvic Floor Bother Questionnaire was used to determine how much pelvic floor dysfunction exists. The questionnaire consists of 9 questions and if the scoring is high, the complaint is high.
Measured: 6 weeks
Treatment adherence
At the beginning of the treatment, an exercise follow-up form was given, and the patients were asked to mark it regularly. In the final evaluation, follow-up forms were obtained from the patients. During the treatment, the patients were followed up every week by phone. The compliance and continuity of the patients were followed closely. Patients who missed more than 2 treatments were excluded from the study.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start28 Nov 2018
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
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.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilke Keser, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549193
- Sponsor's protocol ID
- 24074710-604.01.01-44
- Status last verified
- Sep 2022
- First submitted
- 12 Sep 2022
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Eroglu HS, Ipek Halatci E, Sen I, Keser I. A pilot study of combined pelvic floor and abdominal muscle training for urinary incontinence: Home-based program. Urologia. 2026 May 23:3915603261452344. doi: 10.1177/03915603261452344. Online ahead of print.
PubMed 42175871
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the Pelvic Floor and Abdominal Muscle Training in Urinary Incontinence According to the Severity
- ClinicalTrials.gov ID
- NCT05549193
- Acronym / sponsor ID
- 24074710-604.01.01-44
- Conditions
- Urinary Incontinence
- Keywords
- Rectus Abdominus, Pelvic Floor Muscle Training, Stress Urinary Incontinence, Quality of Life, Biofeedback, Home Exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 22 Sep 2022 (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.
To investigate the effects of the pelvic floor and abdominal muscle training on the severity of incontinence in women with stress and mixed urinary incontinence.
Detailed description
The aim of this study is to investigate the effect of incontinence severity on the pelvic floor and abdominal muscle strengthening training in women with stress urinary incontinence (UI). Sixteen patients with stress and mixed UI were included in the study. According to the 24-hour pad test (24hPT), individuals were divided into two groups as group 1 (24hPT 4-20gr, mild group, n: 9) and group 2 (24hPT 21g and above in 24hPT, moderate-severe group, n: 7). Pelvic floor muscle training (PFMT) and abdominal muscle training were applied to the groups for 6 weeks.
PFMT was given as a home-based exercise program to increase pelvic floor muscle (PFM) strength and endurance. Before starting the program, PFM was taught first schematically and then by the biofeedback method. It was ensured that the patient learned the PFM. Fast and slow pelvic floor contractions were taught for both type 1 and type 2 muscle fibres. For slow contractions, it was asked to gradually contract in 5 seconds, wait at a maximum of 5 seconds and gradually relax in 5 seconds. For fast contractions, it was asked to contract at a maximum of 2 seconds and then to relax. Patients were asked to perform 10 slow contractions after every 10 rapid contractions. 10 fast + 10 slow contractions were accepted as 1 set exercise. Subjects were asked to make 10 sets every day for 6 weeks.
Strengthening exercises for transversus abdominus and internal obliques abdominus muscles were given as a home program and the details were written below:
Transversus Abdominus: Patients were in the crook lying position and were asked to contract their abdominal muscles strongly and statically. Fifteen repetitions were carried out; each one consisting of contraction for 10 s followed by relaxation for 20 s. After 15 repetitions, patients rested for 5 min. The sequence was then repeated for two sets of 15 repetitions.
Internal Obliquus Abdominus: Patients were in the crook lying position and were asked to contract their abdominal muscles strongly and statically and then try to touch the furthest point of their legs with their fingertips for 15 repetitions consisting of contraction for 10 s followed by relaxation for 20 s. After 15 repetitions, patients rested for 5 min. The sequence was then repeated on the other leg.
Urinary incontinence, pelvic floor muscle strength measurement, quality of life, symptom, and the presence of pelvic floor dysfunction were evaluated respectively using 24hPT, Electromyography (EMG) Biofeedback device, King's Health Questionnaire, Urogenital Distress Inventory, and Global Pelvic Floor Bother Questionnaire. Evaluations were performed at the beginning and at the end of the physiotherapy program, and a subjective improvement rate was determined.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mild and Moderate-Severe Urinary Incontinence Group | Experimental | Other: Exercises Training10 sets of pelvic floor muscle training and 2 sets of abdominal muscle strengthening training were given every day for 6 weeks. All analyzes were conducted at the beginning and end of the 6-week training. The same training program was applied to both groups ( Group 1 (mild urinary incontinence) and Group 2 (moderate-severe urinary incontinence), and the effects were compared according to the severity of incontinence. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being female,
- Being 18 years of age or older
- Having been diagnosed of SUI and stress-predominant MUI after urodynamic evaluation by the urologist.
Key exclusion criteria (7 listed)
- Currently taking medications for UI,
- Having urinary tract infection,
- Neurological disorders,
- Pelvic organ prolapse stage >2,
- Pregnancy,
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 |
|---|---|---|
| Exercises TrainingPelvic Floor Muscle Training: For slow contractions, it was asked to contract in 5 seconds gradually, wait at a maximum of 5 seconds and gradually relax in 5 seconds. For fast contractions, it was asked to contract at a maximum of 2 seconds and then to relax. 10 fast + 10 slow contractions were accepted as 1 set exercise. (10 sets x Every Day x 6 weeks) Transversus Abdominus: Patients were in the crook lying position and were asked to contract their abdominal muscles strongly and statically. 15 repetitions were carried out, each consisting of contraction for 10 s and relaxation for 20 s. 2 sets of 15 repetitions were done. Internal Obliquus Abdominus: Patients were in the crook lying position and were asked to contract their abdominal muscles strongly and statically and then try to touch the furthest point of their legs with their fingertips for 15 repetitions consisting of contraction for 10 s followed by relaxation for 20 s. The sequence was then repeated on the other leg. | Other | Mild and Moderate-Severe Urinary Incontinence Group |
Primary outcome
Urinary Incontinence Severity
Time frame: 6 weeks
A 24-hour pad test was used to assess and standardize the severity of UI. The patients were informed before the test. The patients were told to change their pads every 4-6 hours and put the pads in an airtight locked bag to prevent the urine from evaporating. Since the pads should be weighed immediately after the evaluation, they were asked to do the test 1 day before the evaluation. Pads that were used for 24 hours were requested in a mouth-locked bag. 1 unused pad of the same type was requested. Urinary incontinence was determined by measuring the weight of the pad with precision scales (Isolab Laborgerate GMBH, Germany) before and after 24 hours. As a result of the 24-hour pad test, 4-20 grams were defined as mild, 21-74 grams as moderate, and > 75 grams as severe UI.
6 secondary outcomes
Pelvic Floor Muscle Activity
Time frame: 6 weeks
Abdominal Muscles Strength
Time frame: 6 weeks
Quality of life about Urinary Incontinence
Time frame: 6 weeks
Urinary Incontinence Symptom severity
Time frame: 6 weeks
Existing pelvic floor dysfunction
Time frame: 6 weeks
Treatment adherence
Time frame: 6 weeks
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 23 Sep 2022.
- Derived from this study: PubMed 42175871Eroglu HS, Ipek Halatci E, Sen I, Keser I. A pilot study of combined pelvic floor and abdominal muscle training for urinary incontinence: Home-based program. Urologia. 2026 May 23:3915603261452344. doi: 10.1177/03915603261452344. Online ahead of print.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercises Training in people with Urinary Incontinence, run by Gazi 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 3 inclusion and 7 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 23 Sep 2022. 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?
Urinary Incontinence Severity (time frame: 6 weeks). 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 NCT05549193, 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 23 Sep 2022.