Urinary IncontinenceNCT05253898
Comparison of Pelvic Floor Therapy and Yoga on Stres Urinary Incontinence Incontinence
A study testing Pelvic floor Physical Therapy and Therapeutic Yoga Training in people with Urinary Incontinence and Urinary Tract Disorders, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the effectiveness of pelvic floor physical therapy (PFT) and therapeutic yoga training (TYT) for women who have postnatal stress urinary incontinence (SUI). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Urinary Incontinence, Urinary Tract Disorders
- What is being tested?
- Pelvic floor Physical Therapy and Therapeutic Yoga Training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jan 2022to 15 Aug 2022
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women ages between 18 and 50 years old,
- Women who have SUI 45 days and above after giving birth
- Patients who accept to join the group sessions and will participate regularly in the treatment program
Who cannot join
- Women who have pelvic organ prolapsus and fecal incontinence
- Women who have undergone surgery for the lower urinary system
- Those who receive medication treatment for incontinence in the last 3 months
- Those with acute infection and bladder stones or tumors will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Nergiz Sayin, PT contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Special Nova Therapy and Rehabilitation Center
Diyarbakır
Nergiz Sayin, PT
About this study
Official title: Comparison of Group-based Pelvic Floor Physical Therapy and Therapeutic Yoga for Postnatal Stress Urinary Incontinence
The aim of this study is to compare the effectiveness of pelvic floor physical therapy (PFT) and therapeutic yoga training (TYT) for women who have postnatal stress urinary incontinence (SUI).
Read the detailed description
32 subjects with postnatal stress urinary incontinence will be included in the study after a voluntary consent form will be filled out. Subjects will randomly be divided into two groups according to the order.
Pelvic floor physical therapy (PFT) (n=16) will be Group 1, and therapeutic yoga training (TYT) (n=16) will be the Group 2.
PFT group will be received sessions twice a week and a special home exercise program once a week for 8 weeks. Each session will include warm-up exercises, pelvic floor muscle contractions in different positions, and abdominal breathing techniques. Each session is planned for 45 minutes.
TYT group will be received sessions twice a week and a special home exercise program once a week for 8 weeks. Each session will include warm-up exercises, different asanas, and yogi breathing exercises. each session is planned for 45 minutes.
- Conditions
- Urinary Incontinence, Urinary Tract Disorders
- Being tested
- Pelvic floor Physical Therapy, Therapeutic Yoga Training
- Keywords
- Urinary incontinence, Postnatal, Yoga, Pelvic floor muscle, Rehabilitation, Quality of life
- Medical subject headings
- Urinary Incontinence, Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor Physical TherapyProcedure or surgery
Purpose of pelvic floor muscle education program is reduce the symptoms of stress urinary incontinence and improving quality of life.
Therapeutic Yoga TrainingProcedure or surgery
Purpose of this group show the effectiveness of yoga therapy on stress urinary incontinence and quality of life.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Floor Physical Therapy | Active comparator | Group 1 includes a training program about correctly using pelvic floor muscles. At the first session, an educational program will be given to all women about the anatomy and function of the pelvic floor muscles. Then, the pelvic floor muscles contractions will be controlled by vaginal palpation for approximately 10 minutes.
Then it will follow with 5 minutes of warm-up exercises, 30 minutes of fast and slow pelvic floor muscles contractions in different positions, and 10 minutes of abdominal breathing, general relaxation, stretching, and cool-down exercises.
It is planned to teach contractions with internal palpation for 10 minutes before the first session to ensure that the patients' pelvic floor contractions are performed correctly. PFT treatment will be given as two sessions per week, 45 minutes, and 8 weeks as group sessions. Receives: Procedure: Pelvic floor Physical Therapy |
| Therapeutic Yoga Training | Active comparator | Group 2 program includes therapeutic yoga training. It will begin with education about the positive effects of yoga on the body and pelvic floor.
Then it will follow with 5 minutes of warm-up exercises, 30 minutes of different asanas coordinated with breathing, and 10 minutes of yogi breathing and cool-down exercises.
Also, a home exercise program will be given based on yoga sessions. Participants will receive a detailed description of the home program. Receives: Procedure: Therapeutic Yoga Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
İncontinence Questionary at 8 weeks
İncontinence Questionary-3 (3IQ) is a simple questionnaire to categorize the type of urinary incontinence.
First question evaluates the existence of incontinence in the past 3 months. Second and third questions are directed to familiarity and the existence of the types of incontinence.
The 3IQ is a quick test to evaluate the types of urinary incontinence with high sensitivity especially for stress urinary incontinence.
Measured: Change from Baseline in incontinence questionary at 8 weeks
Incontinence Severity Index
Incontinence Severity Index (ISI) is a tool for assessing the severity of female urinary incontinence. ISI is consists of 2 questions to establish frequency and amount of leakage. The results categorize the severity into 4 as; slight, moderate, severe, and very severe.
Measured: Change from Baseline in Incontinence Severity Index at 8 weeks
Incontinence Quality of Life
Incontinence Quality of Life (I-QoL) is used for assessing the decrease of quality of life depending on urinary incontinence symptoms. I-QoL consists of 22 questions and results with 4 domains. I-QoL has identified the 3 factors; avoidance and limiting behavior (8 items), psychosocial impacts (9 items), and social embarrassment (5 items).
Measured: Change from Baseline in Incontinence Quality of Life at 8 weeks
Global Perception of Improvement
Global Perception of Improvement (GPI) is used for showing the individual improvement of healing depending patient's perspective. GPI is rated to the satisfaction of advancement depending on the treatment for patients. Patients rated themselves as much better, better, about the same, worse, and much worse.
Measured: Change from Baseline in Global Perception of Improvement at 8 weeks
Pelvic Floor Muscle Strength assessing with PERFECT
PERFECT is used to assess pelvic floor muscle power, endurance, maximal repetitions, and the number of fast contractions by using internal digital palpation.
(P) symbolizes the power and this value is identified with modified oxford Scale during max. volunteer contraction.
(E) symbolizes the endurance and it's identified by how much time will continue the max. volunteer contraction.
(R) symbolizes the repetitions and it's identified with the number of maximum volunteer contractions, between each contraction, must be 4 s resting time.
(F) symbolizes the fast and it's identified the number of fast contractions.
(ECT) symbolizes every contraction time which means recording all numbers and times during evaluation.
Measured: Change from Baseline in PERFECT degrees at 8 weeks
1 hour Pad Test
Pad test is an objective way to scale the amount of incontinence in a specific time and the same conditions. The test begins with drinking 500ml water and 30 minutes sitting, then equal repetitions of jumping, walking, coughing, bending down, and washing hands-on running water for each patient.
Measured: Change from Baseline in Pad Test at 8 weeks
State-Trait Anxiety Inventory
State-Trait Anxiety Inventory (STAI) form consist of 2 different tool. STAI-I examines the current anxiety level, and STAI-II examines the aspects of anxiety proneness general states of calmness and confidence. STAI-I consist of 20 questions about how person feel during the test. STAI-II consist of 20 questions about continues anxiety level.
Measured: Change from Baseline in State-Trait Anxiety Inventory at 8 weeks
Bladder Diary
Bladder diary is used to asses lower urinary tract symptoms (LUTS).
Measured: Change from Baseline in Bladder Diary at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start18 Jan 2022
- Primary completion13 Jun 2022 (estimated)
- Study completion15 Aug 2022 (estimated)
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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nergiz Sayın, Hasan Kalyoncu University
- Investigators
- Aysenur Tuncer, PT, PhD, Study director, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253898
- Sponsor's protocol ID
- 2021/005
- Status last verified
- Jan 2022
- First submitted
- 15 Feb 2022
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hay-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 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Group-based Pelvic Floor Physical Therapy and Therapeutic Yoga for Postnatal Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT05253898
- Acronym / sponsor ID
- 2021/005
- Conditions
- Urinary Incontinence, Urinary Tract Disorders
- Keywords
- Urinary incontinence, Postnatal, Yoga, Pelvic floor muscle, Rehabilitation, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 13 Jun 2022 (estimated)
- Study completion
- 15 Aug 2022 (estimated)
- First posted
- 24 Feb 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 aim of this study is to compare the effectiveness of pelvic floor physical therapy (PFT) and therapeutic yoga training (TYT) for women who have postnatal stress urinary incontinence (SUI).
Detailed description
32 subjects with postnatal stress urinary incontinence will be included in the study after a voluntary consent form will be filled out. Subjects will randomly be divided into two groups according to the order.
Pelvic floor physical therapy (PFT) (n=16) will be Group 1, and therapeutic yoga training (TYT) (n=16) will be the Group 2.
PFT group will be received sessions twice a week and a special home exercise program once a week for 8 weeks. Each session will include warm-up exercises, pelvic floor muscle contractions in different positions, and abdominal breathing techniques. Each session is planned for 45 minutes.
TYT group will be received sessions twice a week and a special home exercise program once a week for 8 weeks. Each session will include warm-up exercises, different asanas, and yogi breathing exercises. each session is planned for 45 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic Floor Physical Therapy | Active comparator | Procedure: Pelvic floor Physical TherapyGroup 1 includes a training program about correctly using pelvic floor muscles. At the first session, an educational program will be given to all women about the anatomy and function of the pelvic floor muscles. Then, the pelvic floor muscles contractions will be controlled by vaginal palpation for approximately 10 minutes. Then it will follow with 5 minutes of warm-up exercises, 30 minutes of fast and slow pelvic floor muscles contractions in different positions, and 10 minutes of abdominal breathing, general relaxation, stretching, and cool-down exercises. It is planned to teach contractions with internal palpation for 10 minutes before the first session to ensure that the patients' pelvic floor contractions are performed correctly. PFT treatment will be given as two sessions per week, 45 minutes, and 8 weeks as group sessions. |
| Therapeutic Yoga Training | Active comparator | Procedure: Therapeutic Yoga TrainingGroup 2 program includes therapeutic yoga training. It will begin with education about the positive effects of yoga on the body and pelvic floor. Then it will follow with 5 minutes of warm-up exercises, 30 minutes of different asanas coordinated with breathing, and 10 minutes of yogi breathing and cool-down exercises. Also, a home exercise program will be given based on yoga sessions. Participants will receive a detailed description of the home program. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women ages between 18 and 50 years old,
- Women who have SUI 45 days and above after giving birth
- Patients who accept to join the group sessions and will participate regularly in the treatment program
Key exclusion criteria (4 listed)
- Women who have pelvic organ prolapsus and fecal incontinence
- Women who have undergone surgery for the lower urinary system
- Those who receive medication treatment for incontinence in the last 3 months
- Those with acute infection and bladder stones or tumors will not be included in the study.
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 Physical TherapyPurpose of pelvic floor muscle education program is reduce the symptoms of stress urinary incontinence and improving quality of life. | Procedure or surgery | Pelvic Floor Physical Therapy |
| Therapeutic Yoga TrainingPurpose of this group show the effectiveness of yoga therapy on stress urinary incontinence and quality of life. | Procedure or surgery | Therapeutic Yoga Training |
Primary outcome
İncontinence Questionary at 8 weeks
Time frame: Change from Baseline in incontinence questionary at 8 weeks
İncontinence Questionary-3 (3IQ) is a simple questionnaire to categorize the type of urinary incontinence. First question evaluates the existence of incontinence in the past 3 months. Second and third questions are directed to familiarity and the existence of the types of incontinence. The 3IQ is a quick test to evaluate the types of urinary incontinence with high sensitivity especially for stress urinary incontinence.
Incontinence Severity Index
Time frame: Change from Baseline in Incontinence Severity Index at 8 weeks
Incontinence Severity Index (ISI) is a tool for assessing the severity of female urinary incontinence. ISI is consists of 2 questions to establish frequency and amount of leakage. The results categorize the severity into 4 as; slight, moderate, severe, and very severe.
Incontinence Quality of Life
Time frame: Change from Baseline in Incontinence Quality of Life at 8 weeks
Incontinence Quality of Life (I-QoL) is used for assessing the decrease of quality of life depending on urinary incontinence symptoms. I-QoL consists of 22 questions and results with 4 domains. I-QoL has identified the 3 factors; avoidance and limiting behavior (8 items), psychosocial impacts (9 items), and social embarrassment (5 items).
Global Perception of Improvement
Time frame: Change from Baseline in Global Perception of Improvement at 8 weeks
Global Perception of Improvement (GPI) is used for showing the individual improvement of healing depending patient's perspective. GPI is rated to the satisfaction of advancement depending on the treatment for patients. Patients rated themselves as much better, better, about the same, worse, and much worse.
Pelvic Floor Muscle Strength assessing with PERFECT
Time frame: Change from Baseline in PERFECT degrees at 8 weeks
PERFECT is used to assess pelvic floor muscle power, endurance, maximal repetitions, and the number of fast contractions by using internal digital palpation. (P) symbolizes the power and this value is identified with modified oxford Scale during max. volunteer contraction. (E) symbolizes the endurance and it's identified by how much time will continue the max. volunteer contraction. (R) symbolizes the repetitions and it's identified with the number of maximum volunteer contractions, between each contraction, must be 4 s resting time. (F) symbolizes the fast and it's identified the number of fast contractions. (ECT) symbolizes every contraction time which means recording all numbers and times during evaluation.
1 hour Pad Test
Time frame: Change from Baseline in Pad Test at 8 weeks
Pad test is an objective way to scale the amount of incontinence in a specific time and the same conditions. The test begins with drinking 500ml water and 30 minutes sitting, then equal repetitions of jumping, walking, coughing, bending down, and washing hands-on running water for each patient.
State-Trait Anxiety Inventory
Time frame: Change from Baseline in State-Trait Anxiety Inventory at 8 weeks
State-Trait Anxiety Inventory (STAI) form consist of 2 different tool. STAI-I examines the current anxiety level, and STAI-II examines the aspects of anxiety proneness general states of calmness and confidence. STAI-I consist of 20 questions about how person feel during the test. STAI-II consist of 20 questions about continues anxiety level.
Bladder Diary
Time frame: Change from Baseline in Bladder Diary at 8 weeks
Bladder diary is used to asses lower urinary tract symptoms (LUTS).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- 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.
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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.
Nergiz Sayin, PT contact
Aysenur Tuncer, PT, PhD study director
Hasan Kalyoncu 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 Pelvic floor Physical Therapy and Therapeutic Yoga Training in people with Urinary Incontinence and Urinary Tract Disorders, run by Hasan Kalyoncu 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 4 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 11 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aysenur Tuncer, PT, PhD (+90-342 2118080, aysenur.tuncer@hku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
İncontinence Questionary at 8 weeks (time frame: Change from Baseline in incontinence questionary at 8 weeks). The study lists 8 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 NCT05253898, 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 11 Mar 2022.