Urinary Incontinence , StressNCT06627452
Effectiveness of DNS on Incontinence Severity, Pelvic Floor Strength and QoL in Urinary Incontinence
A study testing Dynamic Neuromuscular Stabilization Training and Pelvic Floor Muscle Training in people with Urinary Incontinence , Stress and Urinary Incontinence (UI), run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effects of Dynamic Neuromuscular Stabilization (DNS) Training on incontinence severity, pelvic floor muscle strength, and quality of life in women with Urinary Incontinence, compared to Pelvic Floor Muscle Training (PFMT). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Urinary Incontinence , Stress, Urinary Incontinence (UI), Exercise
- What is being tested?
- Dynamic Neuromuscular Stabilization Training and Pelvic Floor Muscle Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2024to 15 Jun 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of severity stress urinary incontinence based on symptoms
- Being literate
- Aged between 18 and 65
- Not having received any conservative treatment in the last 6 months.
Who cannot join
- Presence of prolapse
- Diagnosis of overactive bladder
- Ongoing urinary tract infection
- Use of medication for urinary incontinence
- Pregnancy
- Lack of cooperation for assessment and/or treatment
- Having undergone uro-surgical procedures within the last two years
- Patients with serious systemic diseases that would prevent them from exercising (such as cardiovascular disease, COPD, stroke, and/or cancer, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Dynamic Neuromuscular Stabilization on Incontinence Severity, Pelvic Floor Muscle Strength and Quality of Life in Women With Urinary Incontinence
The aim of this study is to investigate the effects of Dynamic Neuromuscular Stabilization (DNS) Training on incontinence severity, pelvic floor muscle strength, and quality of life in women with Urinary Incontinence, compared to Pelvic Floor Muscle Training (PFMT). The hypothesis of the study is that DNS Training will be at least as effective as PFMT in terms of its impact on incontinence severity, pelvic floor muscle strength, and quality of life in women with Urinary Incontinence. A total of 56 women diagnosed with urinary incontinence will be included in the study. Participants will be divided into two groups: DNS and PFMT, and will engage in the designated exercise program 5 days a week for a total of 12 weeks. All participants will undergo an initial assessment before starting treatment, and a final assessment will be conducted by the same physiotherapist after the treatment.
Read the detailed description
Urinary incontinence (UI) is defined by the International Continence Society as involuntary leakage of urine and is a symptom that can objectively be demonstrated, leading to social and hygienic problems. UI negatively affects daily life activities, perception of health status, and mental and social well-being, thereby reducing individuals; health-related quality of life. UI is commonly observed in women, with a reported prevalence ranging from 25% to 45%. There are three main types of urinary incontinence: stress urinary incontinence, urge urinary incontinence, and mixed urinary incontinence. The most commonly seen type, stress urinary incontinence, is defined as involuntary urine leakage due to a sudden increase in intra-abdominal pressure (IAP) during activities such as coughing, sneezing, exertion, or physical activity without detrusor contraction. It generally occurs after childbirth or during pregnancy. Risk factors for stress urinary incontinence in women include a higher number of births, age, smoking, lung disease, and obesity. One of the significant causes of UI is the weakness of the pelvic floor muscles (PFM).
It is known that the PFM helps stabilize the bladder neck and contributes to continence control by increasing intraurethral pressure. The PFM also aids in stabilizing the lumbopelvic region (core). Studies show that the transverse abdominis (TrA), one of the most essential muscles providing core stabilization, works synergistically with the PFM. This co-activation has been reported to enhance pelvic stability and support urinary control, modulating IAP and load transfer. In this context, in addition to PFM training, stabilization exercises have begun to be included in treatment programs for patients with UI as a first-line treatment.
Dynamic Neuromuscular Stabilization (DNS) is a neuromuscular and functional stabilization approach based on developmental kinesiology models, utilizing the normal motor development process to assess and treat motor disorders. The primary aim is to restore the physiological movement patterns defined by developmental kinesiology. DNS provides stabilization of the spine and surrounding muscles during static and dynamic movements. Deep spinal flexors and extensors, multifidus, diaphragm, pelvic floor muscles, and abdominal muscles are part of this system. The co-contractions of these muscles increase IAP, thereby aiding. This also helps with stabilization. DNS is based on the principle that the core muscle system works synergistically with various components. When part of this system is weak or dysfunctional, it can also affect the functioning of other core muscles. DNS exercises focus on comprehensive activation and strengthening of the entire core muscle system rather than targeting individual muscles one by one. In this context, DNS training includes the development of pelvic floor muscles along with the improvement of core (lumbopelvic) stabilization.
It is known that the strength of the pelvic floor muscles (PFM) decreases in women with UI, and strengthening these muscles plays a crucial role in controlling incontinence. However, there are also studies reporting low stabilization in women with UI. Considering that stress urinary incontinence occurs due to a sudden increase in intra-abdominal pressure during physical activity, regulating IAP and improving stabilization could be more effective in controlling UI. The DNS method, which targets lumbopelvic stabilization along with PFM training and focuses on intra-abdominal pressure regulation, has been shown to have positive effects on various neuromuscular disorders and postural dysfunctions. There is only one pilot study in the literature investigating the effects of DNS training on women with UI. This study reported that DNS improved PFM strength more than Kegel exercises. Given this information, it is hypothesized that DNS training may more effectively reduce the severity of urinary incontinence in women compared to PFM training. Therefore, this research aims to compare the effects of DNS training on urinary incontinence severity in women with urinary incontinence to PFM training.
METHOD
The research will include young adult women who have been diagnosed with urinary incontinence and volunteered to participate. Participants will be divided into two parallel groups (1:1): the dynamic neuromuscular stabilization (DNS) group and the pelvic floor muscle training (PFMT) group. Our study will be conducted per the Helsinki Declaration, and all participants will be informed about the research and provide written consent.
Indıviduals will be randomly divided into the dynamic neuromuscular stabilization (DNS) and pelvic floor muscle training (PFMT) groups. The treatment program will be implemented by the same experienced physiotherapist, who holds a training certificate in both DNS and PFMT. Participants will be taught how to perform the exercises correctly and receive an exercise sheet containing exercises to perform at home as a guide.
Dynamic Neuromuscular Stabilization Training Participants in this group will undergo Dynamic Neuromuscular Stabilization exercises. The exercises will be performed with the physiotherapist twice a week, while participants will practice at home three days a week, with each session lasting approximately 30 minutes. This program will continue for 12 weeks, totaling five days of exercise per week. The DNS therapist will manually and verbally instruct the participants on how to perform exercises in various developmental positions.
Pelvic Floor Muscle Training Pelvic floor exercises will be taught to patients through vaginal palpation. The exercises will be performed with the physiotherapist twice a week, while participants will practice at home three days a week. To increase adherence to the home exercises and encourage proper execution, a PTKE schedule and a document demonstrating and explaining the pelvic floor exercises will be provided. Exercise schedules will be checked weekly.
Patients will be instructed to perform pelvic floor exercises in sets for approximately 30 minutes daily over a period of 12 weeks.
- Being tested
- Dynamic Neuromuscular Stabilization Training, Pelvic Floor Muscle Training
- Keywords
- dynamic neuromuscular stabilization, kegel exercise, urinary incontinence
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Neuromuscular Stabilization TrainingOther
Patients will be taught how to perform exercises in different developmental positions both manually and verbally by the DNS therapist. In the DNS concept, proper breathing patterns are important alongside stabilization, and elastic bands will be used to regulate intra-abdominal pressure (IAP) and teach correct breathing. The elastic band will be secured around the chest just below the ribcage, and the patient will be asked to expand the elastic band in all directions while inhaling, thereby regulating the IAP. After teaching IAP guidance, exercises will be conducted in developmental positions with IAP regulation. The exercises will be conducted twice a week under the supervision of a physiotherapist, and three days at home, with sessions lasting approximately 30 minutes, for a total of five days a week over a period of 12 weeks.
Pelvic Floor Muscle TrainingOther
Pelvic floor exercises involving both slow and fast muscle contractions will be taught to patients through vaginal palpation. During fast contractions, patients will be instructed to quickly contract and relax their pelvic floor muscles. During slow contractions, patients will be asked to gradually squeeze their pelvic floor muscles, hold for 10 seconds, and then slowly relax. Each set of pelvic floor exercises will consist of 10 fast contractions and 10 slow contractions. Patients will perform pelvic floor exercises twice a week with a physiotherapist and three days at home. The exercises will be done in sets throughout the day, lasting approximately 30 minutes, and will be conducted over a period of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Participants in Dynamic Neuromuscular Stabilization(DNS) will perform exercises with a physiotherapist twice a week and at home three days a week. The sessions will last approximately 30 minutes and will be conducted five days a week for 12 weeks. Receives: Other: Dynamic Neuromuscular Stabilization Training |
| Control Group | Active comparator | Participants in Pelvic Floor Muscle Training (PFMT) will be taught pelvic floor exercises through vaginal palpation. They will perform the exercises with a physiotherapist two days a week and at home three days a week. The sessions will last approximately 30 minutes and will be conducted five days a week for 12 weeks. Receives: Other: Pelvic Floor Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incontinence Severity Index (ISI)
Patients incontinence severity will be assessed using the Incontinence Severity Index (ISI). The index has two questions: 1) How often do you leak urine? (0=Never, 1=Less than once a month, 2=Once a month, 3=Several times a week, 4=Almost every day/night), and 2) How much urine do you leak? (0=None, 1=A few drops, 2=Small spots, 3=More). The result obtained from this index is the product of the two items that assess the frequency and amount of incontinence.
The total score ranges from 1 to 12 and is categorized into four levels of incontinence severity: Mild (1 and 2 points), Moderate (3, 4, and 6 points), severe (8 and 9 points), and very severe (12 points).
Measured: 12 WEEKS
24-Hour Pad Test
The pad test is one of the assessments that provide information about the severity of incontinence. One day before the examination, patients will be instructed to place a dry pad in their underwear after their first morning urination and continue their daily activities. They should change the pad every 4 to 6 hours to prevent evaporation and store the used pads in a sealed bag.
Patients must bring all pads used until the next morning, along with a dry pad sample, for examination. The pads will be weighed on a sensitive scale to calculate the amount of urinary leakage. In the 24-hour pad test, values above 4 grams are considered significant, with incontinence severity classified as mild (≥4-20 grams/24 hours), moderate (21-74 grams/24 hours), and severe (≥75 grams/24 hours).
Measured: 12 WEEKS
Urinary Diary
A urinary diary is an assessment tool that records the frequency of urination, types and amounts of fluids consumed, and the frequency and severity of incontinence over a specified period. The recommended duration for keeping the diary is typically 1 to 7 days. A 3-day diary has been noted as an appropriate outcome measure for clinical studies evaluating stress incontinence treatments.
Patients are advised not to change their usual urination habits or fluid intake while completing the diaries. A total of three diaries are collected from each patient and filled out on non-consecutive days. Patients are asked to record their urination times, the amount of urine produced, and their activities at the time of any leakage, including the corresponding times.
Measured: 12 WEEKS
Secondary outcomes (2)
Pelvic Floor Muscle Strength (PFMS)
Pelvic Floor Muscle Strength (PFMS) will be evaluated using the digital palpation method, which is a low-cost, easy-to-apply, and widely used reliable assessment tool in clinical practice. In this study, participants will be positioned in the supine position with their knees in flexion and abduction, and a pillow will be placed under their heads. The assessing physiotherapist will insert the index and middle fingers horizontally into the vaginal canal and will ask the participant to contract the pelvic floor muscles as if attempting to stop the flow of urine or gas. The strength of the muscle contraction felt around the fingers will be assessed using the Modified Oxford Scale, a widely used grading system in the literature ranging from 0 to 5. An increase in the score will indicate an improvement in pelvic floor muscle strength.
Measured: 12 WEEKS
Quality of Life Assessment
The King Health Questionnaire (KHQ) will evaluate the patient\'s quality of life. The KHQ is a commonly used survey comprising 32 items divided into two sections. It is designed to assess patients\' quality of life with urinary incontinence. In addition to two single-item questions regarding general health status and quality of life impact, it includes seven subheadings made up of multiple items: role limitations, physical limitations, social limitations, limitations in personal relationships, emotional problems, sleep, and energy disturbances related to urinary incontinence, and severity measurements for urinary incontinence. The second section is the 11-item Symptom Severity Scale, which evaluates the presence and severity of urinary symptoms. The score for the Symptom Severity Scale ranges from 0 (best) to 30 (worst). Scores for other KHQ areas range from 0 (best) to 100 (worst). A higher score indicates a deterioration in the patient\'s quality of life.
Measured: 12 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start30 Sep 2024
- Primary completion30 May 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence , StressStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Zengin Alpozgen, Istanbul University - Cerrahpasa
- Investigators
- Ayse Zengin Alpozgen, Assoc. Prof., Principal investigator, Istanbul University - CerrahpasaAycan Cakmak Reyhan, Asst. Prof., Study chair, Istanbul Bilgi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627452
- Sponsor's protocol ID
- _IstanbulUCdılanacar13579.....
- Status last verified
- Sep 2024
- First submitted
- 2 Oct 2024
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Dynamic Neuromuscular Stabilization on Incontinence Severity, Pelvic Floor Muscle Strength and Quality of Life in Women With Urinary Incontinence
- ClinicalTrials.gov ID
- NCT06627452
- Acronym / sponsor ID
- _IstanbulUCdılanacar13579.....
- Keywords
- dynamic neuromuscular stabilization, kegel exercise, urinary incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 4 Oct 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.
The aim of this study is to investigate the effects of Dynamic Neuromuscular Stabilization (DNS) Training on incontinence severity, pelvic floor muscle strength, and quality of life in women with Urinary Incontinence, compared to Pelvic Floor Muscle Training (PFMT). The hypothesis of the study is that DNS Training will be at least as effective as PFMT in terms of its impact on incontinence severity, pelvic floor muscle strength, and quality of life in women with Urinary Incontinence. A total of 56 women diagnosed with urinary incontinence will be included in the study. Participants will be divided into two groups: DNS and PFMT, and will engage in the designated exercise program 5 days a week for a total of 12 weeks. All participants will undergo an initial assessment before starting treatment, and a final assessment will be conducted by the same physiotherapist after the treatment.
Detailed description
Urinary incontinence (UI) is defined by the International Continence Society as involuntary leakage of urine and is a symptom that can objectively be demonstrated, leading to social and hygienic problems. UI negatively affects daily life activities, perception of health status, and mental and social well-being, thereby reducing individuals; health-related quality of life. UI is commonly observed in women, with a reported prevalence ranging from 25% to 45%. There are three main types of urinary incontinence: stress urinary incontinence, urge urinary incontinence, and mixed urinary incontinence. The most commonly seen type, stress urinary incontinence, is defined as involuntary urine leakage due to a sudden increase in intra-abdominal pressure (IAP) during activities such as coughing, sneezing, exertion, or physical activity without detrusor contraction. It generally occurs after childbirth or during pregnancy. Risk factors for stress urinary incontinence in women include a higher number of births, age, smoking, lung disease, and obesity. One of the significant causes of UI is the weakness of the pelvic floor muscles (PFM).
It is known that the PFM helps stabilize the bladder neck and contributes to continence control by increasing intraurethral pressure. The PFM also aids in stabilizing the lumbopelvic region (core). Studies show that the transverse abdominis (TrA), one of the most essential muscles providing core stabilization, works synergistically with the PFM. This co-activation has been reported to enhance pelvic stability and support urinary control, modulating IAP and load transfer. In this context, in addition to PFM training, stabilization exercises have begun to be included in treatment programs for patients with UI as a first-line treatment.
Dynamic Neuromuscular Stabilization (DNS) is a neuromuscular and functional stabilization approach based on developmental kinesiology models, utilizing the normal motor development process to assess and treat motor disorders. The primary aim is to restore the physiological movement patterns defined by developmental kinesiology. DNS provides stabilization of the spine and surrounding muscles during static and dynamic movements. Deep spinal flexors and extensors, multifidus, diaphragm, pelvic floor muscles, and abdominal muscles are part of this system. The co-contractions of these muscles increase IAP, thereby aiding. This also helps with stabilization. DNS is based on the principle that the core muscle system works synergistically with various components. When part of this system is weak or dysfunctional, it can also affect the functioning of other core muscles. DNS exercises focus on comprehensive activation and strengthening of the entire core muscle system rather than targeting individual muscles one by one. In this context, DNS training includes the development of pelvic floor muscles along with the improvement of core (lumbopelvic) stabilization.
It is known that the strength of the pelvic floor muscles (PFM) decreases in women with UI, and strengthening these muscles plays a crucial role in controlling incontinence. However, there are also studies reporting low stabilization in women with UI. Considering that stress urinary incontinence occurs due to a sudden increase in intra-abdominal pressure during physical activity, regulating IAP and improving stabilization could be more effective in controlling UI. The DNS method, which targets lumbopelvic stabilization along with PFM training and focuses on intra-abdominal pressure regulation, has been shown to have positive effects on various neuromuscular disorders and postural dysfunctions. There is only one pilot study in the literature investigating the effects of DNS training on women with UI. This study reported that DNS improved PFM strength more than Kegel exercises. Given this information, it is hypothesized that DNS training may more effectively reduce the severity of urinary incontinence in women compared to PFM training. Therefore, this research aims to compare the effects of DNS training on urinary incontinence severity in women with urinary incontinence to PFM training.
METHOD
The research will include young adult women who have been diagnosed with urinary incontinence and volunteered to participate. Participants will be divided into two parallel groups (1:1): the dynamic neuromuscular stabilization (DNS) group and the pelvic floor muscle training (PFMT) group. Our study will be conducted per the Helsinki Declaration, and all participants will be informed about the research and provide written consent.
Indıviduals will be randomly divided into the dynamic neuromuscular stabilization (DNS) and pelvic floor muscle training (PFMT) groups. The treatment program will be implemented by the same experienced physiotherapist, who holds a training certificate in both DNS and PFMT. Participants will be taught how to perform the exercises correctly and receive an exercise sheet containing exercises to perform at home as a guide.
Dynamic Neuromuscular Stabilization Training Participants in this group will undergo Dynamic Neuromuscular Stabilization exercises. The exercises will be performed with the physiotherapist twice a week, while participants will practice at home three days a week, with each session lasting approximately 30 minutes. This program will continue for 12 weeks, totaling five days of exercise per week. The DNS therapist will manually and verbally instruct the participants on how to perform exercises in various developmental positions.
Pelvic Floor Muscle Training Pelvic floor exercises will be taught to patients through vaginal palpation. The exercises will be performed with the physiotherapist twice a week, while participants will practice at home three days a week. To increase adherence to the home exercises and encourage proper execution, a PTKE schedule and a document demonstrating and explaining the pelvic floor exercises will be provided. Exercise schedules will be checked weekly.
Patients will be instructed to perform pelvic floor exercises in sets for approximately 30 minutes daily over a period of 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Dynamic Neuromuscular Stabilization TrainingParticipants in Dynamic Neuromuscular Stabilization(DNS) will perform exercises with a physiotherapist twice a week and at home three days a week. The sessions will last approximately 30 minutes and will be conducted five days a week for 12 weeks. |
| Control Group | Active comparator | Other: Pelvic Floor Muscle TrainingParticipants in Pelvic Floor Muscle Training (PFMT) will be taught pelvic floor exercises through vaginal palpation. They will perform the exercises with a physiotherapist two days a week and at home three days a week. The sessions will last approximately 30 minutes and will be conducted five days a week for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of severity stress urinary incontinence based on symptoms
- Being literate
- Aged between 18 and 65
- Not having received any conservative treatment in the last 6 months.
Key exclusion criteria (8 listed)
- Presence of prolapse
- Diagnosis of overactive bladder
- Ongoing urinary tract infection
- Use of medication for urinary incontinence
- 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 |
|---|---|---|
| Dynamic Neuromuscular Stabilization TrainingPatients will be taught how to perform exercises in different developmental positions both manually and verbally by the DNS therapist. In the DNS concept, proper breathing patterns are important alongside stabilization, and elastic bands will be used to regulate intra-abdominal pressure (IAP) and teach correct breathing. The elastic band will be secured around the chest just below the ribcage, and the patient will be asked to expand the elastic band in all directions while inhaling, thereby regulating the IAP. After teaching IAP guidance, exercises will be conducted in developmental positions with IAP regulation. The exercises will be conducted twice a week under the supervision of a physiotherapist, and three days at home, with sessions lasting approximately 30 minutes, for a total of five days a week over a period of 12 weeks. | Other | Study Group |
| Pelvic Floor Muscle TrainingPelvic floor exercises involving both slow and fast muscle contractions will be taught to patients through vaginal palpation. During fast contractions, patients will be instructed to quickly contract and relax their pelvic floor muscles. During slow contractions, patients will be asked to gradually squeeze their pelvic floor muscles, hold for 10 seconds, and then slowly relax. Each set of pelvic floor exercises will consist of 10 fast contractions and 10 slow contractions. Patients will perform pelvic floor exercises twice a week with a physiotherapist and three days at home. The exercises will be done in sets throughout the day, lasting approximately 30 minutes, and will be conducted over a period of 12 weeks. | Other | Control Group |
Primary outcome
Incontinence Severity Index (ISI)
Time frame: 12 WEEKS
Patients incontinence severity will be assessed using the Incontinence Severity Index (ISI). The index has two questions: 1) How often do you leak urine? (0=Never, 1=Less than once a month, 2=Once a month, 3=Several times a week, 4=Almost every day/night), and 2) How much urine do you leak? (0=None, 1=A few drops, 2=Small spots, 3=More). The result obtained from this index is the product of the two items that assess the frequency and amount of incontinence. The total score ranges from 1 to 12 and is categorized into four levels of incontinence severity: Mild (1 and 2 points), Moderate (3, 4, and 6 points), severe (8 and 9 points), and very severe (12 points).
24-Hour Pad Test
Time frame: 12 WEEKS
The pad test is one of the assessments that provide information about the severity of incontinence. One day before the examination, patients will be instructed to place a dry pad in their underwear after their first morning urination and continue their daily activities. They should change the pad every 4 to 6 hours to prevent evaporation and store the used pads in a sealed bag. Patients must bring all pads used until the next morning, along with a dry pad sample, for examination. The pads will be weighed on a sensitive scale to calculate the amount of urinary leakage. In the 24-hour pad test, values above 4 grams are considered significant, with incontinence severity classified as mild (≥4-20 grams/24 hours), moderate (21-74 grams/24 hours), and severe (≥75 grams/24 hours).
Urinary Diary
Time frame: 12 WEEKS
A urinary diary is an assessment tool that records the frequency of urination, types and amounts of fluids consumed, and the frequency and severity of incontinence over a specified period. The recommended duration for keeping the diary is typically 1 to 7 days. A 3-day diary has been noted as an appropriate outcome measure for clinical studies evaluating stress incontinence treatments. Patients are advised not to change their usual urination habits or fluid intake while completing the diaries. A total of three diaries are collected from each patient and filled out on non-consecutive days. Patients are asked to record their urination times, the amount of urine produced, and their activities at the time of any leakage, including the corresponding times.
2 secondary outcomes
Pelvic Floor Muscle Strength (PFMS)
Time frame: 12 WEEKS
Quality of Life Assessment
Time frame: 12 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 7 Aug 2025.
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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.
Ayse Zengin Alpozgen, Assoc. Prof. principal investigator
Istanbul University - Cerrahpasa
Aycan Cakmak Reyhan, Asst. Prof. study chair
Istanbul Bilgi 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 Dynamic Neuromuscular Stabilization Training and Pelvic Floor Muscle Training in people with Urinary Incontinence , Stress and Urinary Incontinence (UI), run by Istanbul University - Cerrahpasa 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 8 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 7 Aug 2025. 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 Severity Index (ISI) (time frame: 12 WEEKS). 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?
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 7 Aug 2025.