Low Back PainNCT05666427
Investigation of the Effects of Stabilization Exercises and Pelvic Floor Muscle Training on Pain and Urinary Parameters in Individuals With Chronic Low Back Pain With Urinary Incontinence
A study testing Pelvic floor muscle training combined with stabilization exercises and Pelvic floor muscle training in people with Low Back Pain and Urinary Incontinence, run by Hasan Kalyoncu University.
Trial summary
The research will be done with people with urinary incontinence and low back pain. 3 groups of volunteer participants will be formed. The groups were planned as study group, classical application group and control group. Classical pelvic floor muscle training will be applied to the classical application group. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Urinary Incontinence
- What is being tested?
- Pelvic floor muscle training combined with stabilization exercises and Pelvic floor muscle training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 1 Apr 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Those with low back pain for at least 3 months (at least once a week with low back pain)
- Those with urinary incontinence
- 4 and above according to Numerical Pains Rating Scale
- At least 20% according to the Oswestry Disability Index
- Body Mass Index 30 and below
Who cannot join
- Those who have undergone lumbar or pelvic surgery in the last 6 months
- Those who received pelvic floor muscle training in the last 3 months
- Systemic, inflammatory, rheumatic, malignant, osseous pathologies etc. that may cause low back pain. those with diseases
- Those who are pregnant
- Stage 3-4 of pelvic organ prolapse
- Those who are pregnant
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Investigation of the Effect of Pelvic Floor Muscle Training Combined With Stabilization Exercises on Pain and Urinary Parameters in Individuals With Low Back Pain With Urinary Incontinence
The research will be done with people with urinary incontinence and low back pain. 3 groups of volunteer participants will be formed. The groups were planned as study group, classical application group and control group. Classical pelvic floor muscle training will be applied to the classical application group. Pelvic floor muscle training combined with stabilization exercises will be applied to the study group. In this study, the effect of pelvic floor muscle training combined with stabilization exercises on pain and urinary parameters compared to classical pelvic floor muscle training will be investigated in people with urinary incontinence and low back pain at the same time.
Read the detailed description
The rehabilitation period in the study was determined as 2 months. Participants will receive treatment with a supervisor 1 or 2 days a week. On other days, they will continue as a home program.
- Conditions
- Low Back Pain, Urinary Incontinence
- Being tested
- Pelvic floor muscle training combined with stabilization exercises, Pelvic floor muscle training
- Keywords
- low back pain, Urinary Incontinence, pelvic floor muscle training, stabilization exercises
- Medical subject headings
- Low Back Pain, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor muscle training combined with stabilization exercisesBehavioural
While people are doing stabilization exercises, they will also work the pelvic floor muscles. Practices will be combined with breathing.
Pelvic floor muscle trainingBehavioural
Exercises that activate the pelvic floor muscles to strengthen and increase endurance.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | No application will be made until the end of this group work. After the end of the study, the effective protocol will be applied. |
| Classic Application Group | Active comparator | In this group, classical pelvic floor muscle training will be applied. Receives: Behavioral: Pelvic floor muscle training |
| Study Group | Active comparator | The protocol determined for the study will be applied in this group. This protocol is planned as follows: It will perform stabilization exercises with the activation of the pelvic floor muscles. Receives: Behavioral: Pelvic floor muscle training combined with stabilization exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Rating Scale
In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'
Measured: a day before rehabilitation
Euro Quality of Life 5D-3L
The EQ-5D-3L (European Quality of Life 5 Dimensions 3 Level Version) is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease
Measured: a day before rehabilitation
Incontinence Severity Index
The incontinence severity index (ISI) consists of two questions, regarding frequency and amount of leakage. It categorizes urinary incontinence (UI) into slight, moderate, severe, and very severe.
Measured: a day before rehabilitation
Secondary outcomes (7)
Modified Oxford Scale
The Modified Oxford Scale (MOS) was used to rate pelvic floor muscle contraction on a scale of 0-511: 0 = no contraction; 1 = minor muscle 'flicker'; 2 = weak muscle contraction; 3 = moderate muscle contraction; 4 = good muscle contraction and 5 = strong muscle contraction
Measured: a day before rehabilitation
Tampa Kinesiophobia Scale
The Tampa Scale of Kinesiophobia (TSK) that was developed in 1990 is a 17 item scale originally developed to measure the fear of movement related to chronic lower back pain.
Measured: a day before rehabilitation
Oswestry Disability Index
The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain.The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel.
Measured: a day before rehabilitation
Pain Catastrophizing Scale
Pain catastrophizing is characterized by the tendency to magnify the threat value of a pain stimulus and to feel helpless in the presence of pain, as well as by a relative inability to prevent or inhibit pain-related thoughts in anticipation of, during, or following a painful event.
Measured: a day before rehabilitation
State-Trait Anxiety Inventory
The State-Trait Anxiety Inventory (STAI) is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety and trait anxiety. Higher scores are positively correlated with higher levels of anxiety. Its most current revision is Form Y and it is offered in more than 40 languages
Measured: a day before rehabilitation
Incontinence Quality of Life Instrument
The I-QOL has 22 questions with the following 3 subscales: avoid and limiting behaviors (items), psychosocial impacts (9 items), and social embarrassment (5 items). It is easily self-administered and takes about 5 minutes to complete.
Measured: a day before rehabilitation
Urinary Distress Inventory
The Urogenital Distress Inventory (UDI-6) is a validated 6-item questionnaire that assesses lower urinary tract symptoms, including incontinence, in women.
Measured: a day before rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start1 Jan 2023 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Kucukcan, Hasan Kalyoncu University
- Investigators
- Yavuz Yakut, Professor, Study director, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666427
- Sponsor's protocol ID
- Kalyoncu-kucukcan001
- Status last verified
- Dec 2022
- First submitted
- 17 Dec 2022
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kucukcan I, Yakut Y. Effects of Stabilization Exercises and Pelvic Floor Muscle Training on Urinary Parameters in Individuals with Chronic Low Back Pain and Urinary Incontinence: A Randomized Controlled Trial. J Clin Med. 2026 Mar 18;15(6):2333. doi: 10.3390/jcm15062333.
PubMed 41899257Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.
PubMed 39704322
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Pelvic Floor Muscle Training Combined With Stabilization Exercises on Pain and Urinary Parameters in Individuals With Low Back Pain With Urinary Incontinence
- ClinicalTrials.gov ID
- NCT05666427
- Acronym / sponsor ID
- Kalyoncu-kucukcan001
- Conditions
- Low Back Pain, Urinary Incontinence
- Keywords
- low back pain, Urinary Incontinence, pelvic floor muscle training, stabilization exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 27 Dec 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.
The research will be done with people with urinary incontinence and low back pain. 3 groups of volunteer participants will be formed. The groups were planned as study group, classical application group and control group. Classical pelvic floor muscle training will be applied to the classical application group. Pelvic floor muscle training combined with stabilization exercises will be applied to the study group. In this study, the effect of pelvic floor muscle training combined with stabilization exercises on pain and urinary parameters compared to classical pelvic floor muscle training will be investigated in people with urinary incontinence and low back pain at the same time.
Detailed description
The rehabilitation period in the study was determined as 2 months. Participants will receive treatment with a supervisor 1 or 2 days a week. On other days, they will continue as a home program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –No application will be made until the end of this group work. After the end of the study, the effective protocol will be applied. |
| Classic Application Group | Active comparator | Behavioral: Pelvic floor muscle trainingIn this group, classical pelvic floor muscle training will be applied. |
| Study Group | Active comparator | Behavioral: Pelvic floor muscle training combined with stabilization exercisesThe protocol determined for the study will be applied in this group. This protocol is planned as follows: It will perform stabilization exercises with the activation of the pelvic floor muscles. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Those with low back pain for at least 3 months (at least once a week with low back pain)
- Those with urinary incontinence
- 4 and above according to Numerical Pains Rating Scale
- At least 20% according to the Oswestry Disability Index
- Body Mass Index 30 and below
Key exclusion criteria (6 listed)
- Those who have undergone lumbar or pelvic surgery in the last 6 months
- Those who received pelvic floor muscle training in the last 3 months
- Systemic, inflammatory, rheumatic, malignant, osseous pathologies etc. that may cause low back pain. those with diseases
- Those who are pregnant
- Stage 3-4 of pelvic organ prolapse
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 |
|---|---|---|
| Pelvic floor muscle training combined with stabilization exercisesWhile people are doing stabilization exercises, they will also work the pelvic floor muscles. Practices will be combined with breathing. | Behavioural | Study Group |
| Pelvic floor muscle trainingExercises that activate the pelvic floor muscles to strengthen and increase endurance. | Behavioural | Classic Application Group |
Primary outcome
Numerical Pain Rating Scale
Time frame: a day before rehabilitation
In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'
Euro Quality of Life 5D-3L
Time frame: a day before rehabilitation
The EQ-5D-3L (European Quality of Life 5 Dimensions 3 Level Version) is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease
Incontinence Severity Index
Time frame: a day before rehabilitation
The incontinence severity index (ISI) consists of two questions, regarding frequency and amount of leakage. It categorizes urinary incontinence (UI) into slight, moderate, severe, and very severe.
7 secondary outcomes
Modified Oxford Scale
Time frame: a day before rehabilitation
Tampa Kinesiophobia Scale
Time frame: a day before rehabilitation
Oswestry Disability Index
Time frame: a day before rehabilitation
Pain Catastrophizing Scale
Time frame: a day before rehabilitation
State-Trait Anxiety Inventory
Time frame: a day before rehabilitation
Incontinence Quality of Life Instrument
Time frame: a day before rehabilitation
Urinary Distress Inventory
Time frame: a day before rehabilitation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Derived from this study: PubMed 41899257Kucukcan I, Yakut Y. Effects of Stabilization Exercises and Pelvic Floor Muscle Training on Urinary Parameters in Individuals with Chronic Low Back Pain and Urinary Incontinence: A Randomized Controlled Trial. J Clin Med. 2026 Mar 18;15(6):2333. doi: 10.3390/jcm15062333.
- Derived from this study: PubMed 39704322Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.
- Individual participant dataSharing planned: No
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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.
Yavuz Yakut, Professor study director
Hasan Kalyoncu University
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor muscle training combined with stabilization exercises and Pelvic floor muscle training in people with Low Back Pain and Urinary Incontinence, run by Hasan Kalyoncu University.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ibrahim Kucukcan, PHD (+905300351105, pt.kucukcan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Pain Rating Scale (time frame: a day before rehabilitation). The study lists 3 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 NCT05666427, which also lists 2 linked publications.
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 4 Jan 2023.