Prevention Pelvic Muscle DysfunctionNCT06204718
Preventing Pelvic Floor Dysfunction With Pelvic Floor Exercises
A study testing Standard pelvic floor exercises and Involuntary reflexive pelvic floor exercises in people with Prevention Pelvic Muscle Dysfunction, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
Trial summary
Study participants will be randomised into 2 groups. Group 1: 1st assessment + 6 weeks of Global Postural Reeducation training plus standard pelvic floor exercises + 2nd assessment + 6 weeks of Global Postural Reeducation training plus standard pelvic floor exercises + 3rd assessment 2nd Group: 1st assessment + 6… 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
- Prevention Pelvic Muscle Dysfunction
- What is being tested?
- Standard pelvic floor exercises and Involuntary reflexive pelvic floor exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 1 Sep 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteering to participate in the study
- Being a desk worker between the ages of 18-65
- No pelvic floor dysfunction
- Being a woman
Who cannot join
- Systemic diseases such as hypertension and diabetes mellitus
- Presence of respiratory disease (asthma, COPD, etc...)
- Hormone replacement therapy
- History of neurogenic bladder
- Gynaecological cancer or collagen disease
- Breastfeeding
Show all 12Show fewer
- Pregnancy
- Early postnatal period (less than one year)
- Pelvic organ prolapse (POP) or gynecological surgery
- Menopause
- Psychiatric comorbidities and/or cognitive impairment
- Impossibility of intra-vaginal physiotherapeutic examination due to untreated active or recurrent urinary infection, haematuria, or vaginal pain during physiotherapy assessment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bandırma Onyedi Eylül University
Bandırma, Balıkesir, 10200
About this study
Official title: Preventing Pelvic Floor Dysfunction With Standard and Reflexive Pelvic Floor Exercises in Addition to Global Postural Re-education
Study participants will be randomised into 2 groups. Group 1: 1st assessment + 6 weeks of Global Postural Reeducation training plus standard pelvic floor exercises + 2nd assessment + 6 weeks of Global Postural Reeducation training plus standard pelvic floor exercises + 3rd assessment 2nd Group: 1st assessment + 6 weeks of Global Postural Reeducation training plus involuntary reflexive pelvic floor exercises + 2nd assessment + 6 weeks of Global Postural Reeducation training plus involuntary reflexive pelvic floor exercises + 3rd assessment
Read the detailed description
Voluntary participants who agreed to participate in the study will be randomised into 2 groups of 36 people each (standard pelvic floor exercises and involuntary reflexive pelvic floor exercises) with the "Research Randomizer" programme (https://www.randomizer.org/). Group 1 (36 people) will receive Global Postural Reeducation training plus standard pelvic floor exercises for 12 weeks, 7 days a week (Total 84 sessions, 15 sessions face to face, 69 sessions home programme). Even numbers will be included in the 2nd group (36 people) and involuntary reflexive pelvic floor exercises will be given in addition to Global Postural Reeducation training for 12 weeks, 7 days a week (Total 84 sessions, 15 sessions face-to-face, 69 sessions home programme). In the study, detailed pelvic floor training will be given to both groups and the same assessments will be made on the pelvic floor muscles. After the initial assessments are completed, both groups will be given a total of 42 sessions of standard and involuntary reflexive pelvic floor exercises for 6 weeks (7 days a week). Participants in both groups will be evaluated at the end of 6 weeks and the remaining 6 weeks exercise programme will be given according to the arranged programme. At the end of the 12th week, the participants will be evaluated again.
Group 1: 1st assessment + 6 weeks of Global Postural Reeducation training plus standard pelvic floor exercises + 2nd assessment + 6 weeks of Global Postural Reeducation training plus standard pelvic floor exercises + 3rd assessment 2nd Group: 1st assessment + 6 weeks of Global Postural Reeducation training plus involuntary reflexive pelvic floor exercises + 2nd assessment + 6 weeks of Global Postural Reeducation training plus involuntary reflexive pelvic floor exercises + 3rd assessment
- Conditions
- Prevention Pelvic Muscle Dysfunction
- Being tested
- Standard pelvic floor exercises, Involuntary reflexive pelvic floor exercises
- Keywords
- Global postural re-education, Reflexive Pelvic Floor Exercises, Prevention pelvic floor dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard pelvic floor exercisesOther
Pelvic floor muscle exercises will be given as 2 separate exercises including fast and slow contractions. For fast contractions, participants will be asked to contract their pelvic floor muscles strongly, hold them contracted for 5 seconds, and then relax them. For slow contractions, participants will be asked to gradually contract the pelvic floor muscles, hold them at maximum contraction for 5 seconds, and relax them gradually. Participants will be asked to perform 10 slow contractions after every 10 fast contractions. The aim is to train strength, coordination, endurance, and symmetry of pelvic floor muscles, motor learning and control, dynamic lumbopelvic stability, pelvic floor, and abdominal co-contraction. Every day, 10 fast, and 10 slow contractions with a total of 20 repetitions will be applied without changing the number by modifying the exercises every week. It will be applied for a total of 12 weeks.
Involuntary reflexive pelvic floor exercisesOther
Reflexive exercises (jump, squat jump, etc.) with 20 repetitions per day will be applied to the participants for 12 weeks with modifications every week.
| Study group | Role | What they receive |
|---|---|---|
| Standard pelvic floor exercises | Experimental | Standard pelvic floor exercises in addition to Global Postural Reeducation training Receives: Other: Standard pelvic floor exercises |
| Involuntary reflexive pelvic floor exercises | Experimental | Involuntary reflexive pelvic floor exercises in addition to Global Postural re-education training Receives: Other: Involuntary reflexive pelvic floor exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Floor Distress Inventory-PFDI-20
The inventory consists of 3 sub-dimensions and contains 20 questions in total. The number of questions of each sub-dimension is indicated next to the name of that sub-dimension (For example; KRADE-8 contains 8 questions in total. The answer option of each question is divided into two as no and yes. Yes option is graded from Unimportant to Very. No=0, and the level of the answer of Yes corresponds to Insignificant=1, Less=1, Less=2, Moderate=3, Very=4 points. The score calculation system of the inventory is as follows; the average score of each sub-dimension is multiplied by 25. The number of points of 3 sub-dimensions is summed and a number between 0-300 points is obtained. The higher the score, the more serious the individual's problems are.
Measured: Baseline
Pelvic Floor Distress Inventory-PFDI-20
The inventory consists of 3 sub-dimensions and contains 20 questions in total. The number of questions of each sub-dimension is indicated next to the name of that sub-dimension (For example; KRADE-8 contains 8 questions in total. The answer option of each question is divided into two as no and yes. Yes option is graded from Unimportant to Very. No=0, and the level of the answer of Yes corresponds to Insignificant=1, Less=1, Less=2, Moderate=3, Very=4 points. The score calculation system of the inventory is as follows; the average score of each sub-dimension is multiplied by 25. The number of points of 3 sub-dimensions is summed and a number between 0-300 points is obtained. The higher the score, the more serious the individual's problems are.
Measured: 6 Weeks Later
Pelvic Floor Distress Inventory-PFDI-20
The inventory consists of 3 sub-dimensions and contains 20 questions in total. The number of questions of each sub-dimension is indicated next to the name of that sub-dimension (For example; KRADE-8 contains 8 questions in total. The answer option of each question is divided into two as no and yes. Yes option is graded from Unimportant to Very. No=0, and the level of the answer of Yes corresponds to Insignificant=1, Less=1, Less=2, Moderate=3, Very=4 points. The score calculation system of the inventory is as follows; the average score of each sub-dimension is multiplied by 25. The number of points of 3 sub-dimensions is summed and a number between 0-300 points is obtained. The higher the score, the more serious the individual's problems are.
Measured: 12 Weeks Later
The female sexual function index (FSFI)
This scale assesses six dimensions of sexual function: sexual desire (first 2 questions), sexual arousal (questions 3-6), lubrication (questions 7-10), orgasm (questions 11-13), satisfaction (questions 14-16) and pain or discomfort (e.g. pain associated with vaginal penetration, questions 17-19). The highest total raw score that can be obtained in this scale is 95.0 and the lowest raw score is 4.0. Factor loadings used for scoring the whole scale were determined as 0.6 for sexual desire, 0.3 for sexual arousal and lubrication, 0.4 for orgasm, satisfaction and pain/discomfort. After multiplication by factor loadings, the highest score is 36.0 and the lowest score is 2.0. Total score >22.7 indicates normal sexual function and ≤ 22.7 indicates sexual dysfunction.
Measured: Baseline
The female sexual function index (FSFI)
This scale assesses six dimensions of sexual function: sexual desire (first 2 questions), sexual arousal (questions 3-6), lubrication (questions 7-10), orgasm (questions 11-13), satisfaction (questions 14-16) and pain or discomfort (e.g. pain associated with vaginal penetration, questions 17-19). The highest total raw score that can be obtained in this scale is 95.0 and the lowest raw score is 4.0. Factor loadings used for scoring the whole scale were determined as 0.6 for sexual desire, 0.3 for sexual arousal and lubrication, 0.4 for orgasm, satisfaction and pain/discomfort. After multiplication by factor loadings, the highest score is 36.0 and the lowest score is 2.0. Total score >22.7 indicates normal sexual function and ≤ 22.7 indicates sexual dysfunction.
Measured: 6 Weeks Later
The female sexual function index (FSFI)
This scale assesses six dimensions of sexual function: sexual desire (first 2 questions), sexual arousal (questions 3-6), lubrication (questions 7-10), orgasm (questions 11-13), satisfaction (questions 14-16) and pain or discomfort (e.g. pain associated with vaginal penetration, questions 17-19). The highest total raw score that can be obtained in this scale is 95.0 and the lowest raw score is 4.0. Factor loadings used for scoring the whole scale were determined as 0.6 for sexual desire, 0.3 for sexual arousal and lubrication, 0.4 for orgasm, satisfaction and pain/discomfort. After multiplication by factor loadings, the highest score is 36.0 and the lowest score is 2.0. Total score >22.7 indicates normal sexual function and ≤ 22.7 indicates sexual dysfunction.
Measured: 12 Weeks Later
Global Pelvic Floor Bother Questionnaire
The scale consists of 9 questions in total. The questions were graded as "yes" or "no" (0) according to whether they had the complaint or not, and if they answered yes, how much the complaint bothered them was graded as "not at all" (1), "very little" (2), "a little" (3), "quite" (4), "very much" (5). Each question was given a score between 1 and 5. The scoring system gives the same weight to each question. The total score is between 0 and 45. For a score between 0 and 100, the total score is averaged and multiplied by 20. A high score indicates a high number of complaints.
Measured: Baseline
Global Pelvic Floor Bother Questionnaire
The scale consists of 9 questions in total. The questions were graded as "yes" or "no" (0) according to whether they had the complaint or not, and if they answered yes, how much the complaint bothered them was graded as "not at all" (1), "very little" (2), "a little" (3), "quite" (4), "very much" (5). Each question was given a score between 1 and 5. The scoring system gives the same weight to each question. The total score is between 0 and 45. For a score between 0 and 100, the total score is averaged and multiplied by 20. A high score indicates a high number of complaints.
Measured: 6 Weeks Later
Global Pelvic Floor Bother Questionnaire
The scale consists of 9 questions in total. The questions were graded as "yes" or "no" (0) according to whether they had the complaint or not, and if they answered yes, how much the complaint bothered them was graded as "not at all" (1), "very little" (2), "a little" (3), "quite" (4), "very much" (5). Each question was given a score between 1 and 5. The scoring system gives the same weight to each question. The total score is between 0 and 45. For a score between 0 and 100, the total score is averaged and multiplied by 20. A high score indicates a high number of complaints.
Measured: 12 Weeks Later
Overactive Bladder Questionnaire (OAB-V8)
The OAB-V8 consists of the first 8 questions of the OAB-q and has been proposed as an overactive bladder screening and awareness test.
Measured: Baseline
Overactive Bladder Questionnaire (OAB-V8)
The OAB-V8 consists of the first 8 questions of the OAB-q and has been proposed as an overactive bladder screening and awareness test.
Measured: 6 Weeks Later
Overactive Bladder Questionnaire (OAB-V8)
The OAB-V8 consists of the first 8 questions of the OAB-q and has been proposed as an overactive bladder screening and awareness test.
Measured: 12 Weeks Later
Pelvic Muscle Assessment
The PERFECT Scale can be used to assess voluntary contraction strength (P), endurance (E), slow-twitch muscle fibre performance (R), fast-twitch muscle fibre performance (F), pelvic floor muscle contraction pattern (E), transversus abdominus muscle cocontraction (C) and involuntary contraction in response to increased intra-abdominal pressure (T).
Measured: Baseline
Pelvic Muscle Assessment
The PERFECT Scale can be used to assess voluntary contraction strength (P), endurance (E), slow-twitch muscle fibre performance (R), fast-twitch muscle fibre performance (F), pelvic floor muscle contraction pattern (E), transversus abdominus muscle cocontraction (C) and involuntary contraction in response to increased intra-abdominal pressure (T).
Measured: 6 Weeks Later
Pelvic Muscle Assessment
The PERFECT Scale can be used to assess voluntary contraction strength (P), endurance (E), slow-twitch muscle fibre performance (R), fast-twitch muscle fibre performance (F), pelvic floor muscle contraction pattern (E), transversus abdominus muscle cocontraction (C) and involuntary contraction in response to increased intra-abdominal pressure (T).
Measured: 12 Weeks Later
Secondary outcomes (9)
Waist/ Hip Ratio
Waist-to-hip ratio (WHR) is the waist circumference divided by the hip circumference
Measured: Baseline
Waist/ Hip Ratio
Waist-to-hip ratio (WHR) is the waist circumference divided by the hip circumference
Measured: 6 Weeks Later
Waist/ Hip Ratio
Waist-to-hip ratio (WHR) is the waist circumference divided by the hip circumference
Measured: 12 Weeks Later
Estimating body fat
This technique is based on the compression of the skin fold to measure the skin and the subcutaneous fat layer beneath it. To improve accuracy, multiple readings are taken in each body region and these readings are averaged and evaluated. The most common application is to measure skinfold thickness from three or four areas of the body and estimate the percentage of BF using prognostic equations.
Measured: Baseline
Estimating body fat
This technique is based on the compression of the skin fold to measure the skin and the subcutaneous fat layer beneath it. To improve accuracy, multiple readings are taken in each body region and these readings are averaged and evaluated. The most common application is to measure skinfold thickness from three or four areas of the body and estimate the percentage of BF using prognostic equations.
Measured: 6 Weeks Later
Estimating body fat
This technique is based on the compression of the skin fold to measure the skin and the subcutaneous fat layer beneath it. To improve accuracy, multiple readings are taken in each body region and these readings are averaged and evaluated. The most common application is to measure skinfold thickness from three or four areas of the body and estimate the percentage of BF using prognostic equations.
Measured: 12 Weeks Later
ICIQ-SF: International Consultation on Incontinence Questionnaire-Short Form
The International Consultation on Incontinence Questionaire Short Form (ICIQ-SF), which has Turkish validity and reliability, will be used to question the type, frequency, amount and effects of urinary incontinence on daily life.
Measured: Baseline
ICIQ-SF: International Consultation on Incontinence Questionnaire-Short Form
The International Consultation on Incontinence Questionaire Short Form (ICIQ-SF), which has Turkish validity and reliability, will be used to question the type, frequency, amount and effects of urinary incontinence on daily life.
Measured: 6 Weeks Later
ICIQ-SF: International Consultation on Incontinence Questionnaire-Short Form
The International Consultation on Incontinence Questionaire Short Form (ICIQ-SF), which has Turkish validity and reliability, will be used to question the type, frequency, amount and effects of urinary incontinence on daily life.
Measured: 12 Weeks Later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 Dec 2023
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention Pelvic Muscle DysfunctionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bandırma Onyedi Eylül University
- Sponsor type
- University, hospital or other
- Collaborators
- Ebru Kaya Mutlu
- Responsible party
- Principal investigator, Gizem Türkmen, Bandırma Onyedi Eylül University
- Investigators
- Ebru Kaya Mutlu, Professor, PhD, Study director, Bandırma Onyedi Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204718
- Sponsor's protocol ID
- 2023-30
- Status last verified
- Jan 2024
- First submitted
- 19 Dec 2023
- Last updated
- 12 Jan 2024
- 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 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Pelvic Floor Dysfunction With Standard and Reflexive Pelvic Floor Exercises in Addition to Global Postural Re-education
- ClinicalTrials.gov ID
- NCT06204718
- Acronym / sponsor ID
- 2023-30
- Conditions
- Prevention Pelvic Muscle Dysfunction
- Keywords
- Global postural re-education, Reflexive Pelvic Floor Exercises, Prevention pelvic floor dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Bandırma Onyedi Eylül UniversityUniversity, hospital or other
- Collaborators
- Ebru Kaya Mutlu
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 12 Jan 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.
Study participants will be randomised into 2 groups. Group 1: 1st assessment + 6 weeks of Global Postural Reeducation training plus standard pelvic floor exercises + 2nd assessment + 6 weeks of Global Postural Reeducation training plus standard pelvic floor exercises + 3rd assessment 2nd Group: 1st assessment + 6 weeks of Global Postural Reeducation training plus involuntary reflexive pelvic floor exercises + 2nd assessment + 6 weeks of Global Postural Reeducation training plus involuntary reflexive pelvic floor exercises + 3rd assessment
Detailed description
Voluntary participants who agreed to participate in the study will be randomised into 2 groups of 36 people each (standard pelvic floor exercises and involuntary reflexive pelvic floor exercises) with the "Research Randomizer" programme (https://www.randomizer.org/). Group 1 (36 people) will receive Global Postural Reeducation training plus standard pelvic floor exercises for 12 weeks, 7 days a week (Total 84 sessions, 15 sessions face to face, 69 sessions home programme). Even numbers will be included in the 2nd group (36 people) and involuntary reflexive pelvic floor exercises will be given in addition to Global Postural Reeducation training for 12 weeks, 7 days a week (Total 84 sessions, 15 sessions face-to-face, 69 sessions home programme). In the study, detailed pelvic floor training will be given to both groups and the same assessments will be made on the pelvic floor muscles. After the initial assessments are completed, both groups will be given a total of 42 sessions of standard and involuntary reflexive pelvic floor exercises for 6 weeks (7 days a week). Participants in both groups will be evaluated at the end of 6 weeks and the remaining 6 weeks exercise programme will be given according to the arranged programme. At the end of the 12th week, the participants will be evaluated again.
Group 1: 1st assessment + 6 weeks of Global Postural Reeducation training plus standard pelvic floor exercises + 2nd assessment + 6 weeks of Global Postural Reeducation training plus standard pelvic floor exercises + 3rd assessment 2nd Group: 1st assessment + 6 weeks of Global Postural Reeducation training plus involuntary reflexive pelvic floor exercises + 2nd assessment + 6 weeks of Global Postural Reeducation training plus involuntary reflexive pelvic floor exercises + 3rd assessment
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard pelvic floor exercises | Experimental | Other: Standard pelvic floor exercisesStandard pelvic floor exercises in addition to Global Postural Reeducation training |
| Involuntary reflexive pelvic floor exercises | Experimental | Other: Involuntary reflexive pelvic floor exercisesInvoluntary reflexive pelvic floor exercises in addition to Global Postural re-education training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Volunteering to participate in the study
- Being a desk worker between the ages of 18-65
- No pelvic floor dysfunction
- Being a woman
Key exclusion criteria (12 listed)
- Systemic diseases such as hypertension and diabetes mellitus
- Presence of respiratory disease (asthma, COPD, etc...)
- Hormone replacement therapy
- History of neurogenic bladder
- Gynaecological cancer or collagen disease
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 |
|---|---|---|
| Standard pelvic floor exercisesPelvic floor muscle exercises will be given as 2 separate exercises including fast and slow contractions. For fast contractions, participants will be asked to contract their pelvic floor muscles strongly, hold them contracted for 5 seconds, and then relax them. For slow contractions, participants will be asked to gradually contract the pelvic floor muscles, hold them at maximum contraction for 5 seconds, and relax them gradually. Participants will be asked to perform 10 slow contractions after every 10 fast contractions. The aim is to train strength, coordination, endurance, and symmetry of pelvic floor muscles, motor learning and control, dynamic lumbopelvic stability, pelvic floor, and abdominal co-contraction. Every day, 10 fast, and 10 slow contractions with a total of 20 repetitions will be applied without changing the number by modifying the exercises every week. It will be applied for a total of 12 weeks. | Other | Standard pelvic floor exercises |
| Involuntary reflexive pelvic floor exercisesReflexive exercises (jump, squat jump, etc.) with 20 repetitions per day will be applied to the participants for 12 weeks with modifications every week. | Other | Involuntary reflexive pelvic floor exercises |
Primary outcome
Pelvic Floor Distress Inventory-PFDI-20
Time frame: Baseline
The inventory consists of 3 sub-dimensions and contains 20 questions in total. The number of questions of each sub-dimension is indicated next to the name of that sub-dimension (For example; KRADE-8 contains 8 questions in total. The answer option of each question is divided into two as no and yes. Yes option is graded from Unimportant to Very. No=0, and the level of the answer of Yes corresponds to Insignificant=1, Less=1, Less=2, Moderate=3, Very=4 points. The score calculation system of the inventory is as follows; the average score of each sub-dimension is multiplied by 25. The number of points of 3 sub-dimensions is summed and a number between 0-300 points is obtained. The higher the score, the more serious the individual's problems are.
Pelvic Floor Distress Inventory-PFDI-20
Time frame: 6 Weeks Later
The inventory consists of 3 sub-dimensions and contains 20 questions in total. The number of questions of each sub-dimension is indicated next to the name of that sub-dimension (For example; KRADE-8 contains 8 questions in total. The answer option of each question is divided into two as no and yes. Yes option is graded from Unimportant to Very. No=0, and the level of the answer of Yes corresponds to Insignificant=1, Less=1, Less=2, Moderate=3, Very=4 points. The score calculation system of the inventory is as follows; the average score of each sub-dimension is multiplied by 25. The number of points of 3 sub-dimensions is summed and a number between 0-300 points is obtained. The higher the score, the more serious the individual's problems are.
Pelvic Floor Distress Inventory-PFDI-20
Time frame: 12 Weeks Later
The inventory consists of 3 sub-dimensions and contains 20 questions in total. The number of questions of each sub-dimension is indicated next to the name of that sub-dimension (For example; KRADE-8 contains 8 questions in total. The answer option of each question is divided into two as no and yes. Yes option is graded from Unimportant to Very. No=0, and the level of the answer of Yes corresponds to Insignificant=1, Less=1, Less=2, Moderate=3, Very=4 points. The score calculation system of the inventory is as follows; the average score of each sub-dimension is multiplied by 25. The number of points of 3 sub-dimensions is summed and a number between 0-300 points is obtained. The higher the score, the more serious the individual's problems are.
The female sexual function index (FSFI)
Time frame: Baseline
This scale assesses six dimensions of sexual function: sexual desire (first 2 questions), sexual arousal (questions 3-6), lubrication (questions 7-10), orgasm (questions 11-13), satisfaction (questions 14-16) and pain or discomfort (e.g. pain associated with vaginal penetration, questions 17-19). The highest total raw score that can be obtained in this scale is 95.0 and the lowest raw score is 4.0. Factor loadings used for scoring the whole scale were determined as 0.6 for sexual desire, 0.3 for sexual arousal and lubrication, 0.4 for orgasm, satisfaction and pain/discomfort. After multiplication by factor loadings, the highest score is 36.0 and the lowest score is 2.0. Total score >22.7 indicates normal sexual function and ≤ 22.7 indicates sexual dysfunction.
The female sexual function index (FSFI)
Time frame: 6 Weeks Later
This scale assesses six dimensions of sexual function: sexual desire (first 2 questions), sexual arousal (questions 3-6), lubrication (questions 7-10), orgasm (questions 11-13), satisfaction (questions 14-16) and pain or discomfort (e.g. pain associated with vaginal penetration, questions 17-19). The highest total raw score that can be obtained in this scale is 95.0 and the lowest raw score is 4.0. Factor loadings used for scoring the whole scale were determined as 0.6 for sexual desire, 0.3 for sexual arousal and lubrication, 0.4 for orgasm, satisfaction and pain/discomfort. After multiplication by factor loadings, the highest score is 36.0 and the lowest score is 2.0. Total score >22.7 indicates normal sexual function and ≤ 22.7 indicates sexual dysfunction.
The female sexual function index (FSFI)
Time frame: 12 Weeks Later
This scale assesses six dimensions of sexual function: sexual desire (first 2 questions), sexual arousal (questions 3-6), lubrication (questions 7-10), orgasm (questions 11-13), satisfaction (questions 14-16) and pain or discomfort (e.g. pain associated with vaginal penetration, questions 17-19). The highest total raw score that can be obtained in this scale is 95.0 and the lowest raw score is 4.0. Factor loadings used for scoring the whole scale were determined as 0.6 for sexual desire, 0.3 for sexual arousal and lubrication, 0.4 for orgasm, satisfaction and pain/discomfort. After multiplication by factor loadings, the highest score is 36.0 and the lowest score is 2.0. Total score >22.7 indicates normal sexual function and ≤ 22.7 indicates sexual dysfunction.
Global Pelvic Floor Bother Questionnaire
Time frame: Baseline
The scale consists of 9 questions in total. The questions were graded as "yes" or "no" (0) according to whether they had the complaint or not, and if they answered yes, how much the complaint bothered them was graded as "not at all" (1), "very little" (2), "a little" (3), "quite" (4), "very much" (5). Each question was given a score between 1 and 5. The scoring system gives the same weight to each question. The total score is between 0 and 45. For a score between 0 and 100, the total score is averaged and multiplied by 20. A high score indicates a high number of complaints.
Global Pelvic Floor Bother Questionnaire
Time frame: 6 Weeks Later
The scale consists of 9 questions in total. The questions were graded as "yes" or "no" (0) according to whether they had the complaint or not, and if they answered yes, how much the complaint bothered them was graded as "not at all" (1), "very little" (2), "a little" (3), "quite" (4), "very much" (5). Each question was given a score between 1 and 5. The scoring system gives the same weight to each question. The total score is between 0 and 45. For a score between 0 and 100, the total score is averaged and multiplied by 20. A high score indicates a high number of complaints.
Global Pelvic Floor Bother Questionnaire
Time frame: 12 Weeks Later
The scale consists of 9 questions in total. The questions were graded as "yes" or "no" (0) according to whether they had the complaint or not, and if they answered yes, how much the complaint bothered them was graded as "not at all" (1), "very little" (2), "a little" (3), "quite" (4), "very much" (5). Each question was given a score between 1 and 5. The scoring system gives the same weight to each question. The total score is between 0 and 45. For a score between 0 and 100, the total score is averaged and multiplied by 20. A high score indicates a high number of complaints.
Overactive Bladder Questionnaire (OAB-V8)
Time frame: Baseline
The OAB-V8 consists of the first 8 questions of the OAB-q and has been proposed as an overactive bladder screening and awareness test.
Overactive Bladder Questionnaire (OAB-V8)
Time frame: 6 Weeks Later
The OAB-V8 consists of the first 8 questions of the OAB-q and has been proposed as an overactive bladder screening and awareness test.
Overactive Bladder Questionnaire (OAB-V8)
Time frame: 12 Weeks Later
The OAB-V8 consists of the first 8 questions of the OAB-q and has been proposed as an overactive bladder screening and awareness test.
Pelvic Muscle Assessment
Time frame: Baseline
The PERFECT Scale can be used to assess voluntary contraction strength (P), endurance (E), slow-twitch muscle fibre performance (R), fast-twitch muscle fibre performance (F), pelvic floor muscle contraction pattern (E), transversus abdominus muscle cocontraction (C) and involuntary contraction in response to increased intra-abdominal pressure (T).
Pelvic Muscle Assessment
Time frame: 6 Weeks Later
The PERFECT Scale can be used to assess voluntary contraction strength (P), endurance (E), slow-twitch muscle fibre performance (R), fast-twitch muscle fibre performance (F), pelvic floor muscle contraction pattern (E), transversus abdominus muscle cocontraction (C) and involuntary contraction in response to increased intra-abdominal pressure (T).
Pelvic Muscle Assessment
Time frame: 12 Weeks Later
The PERFECT Scale can be used to assess voluntary contraction strength (P), endurance (E), slow-twitch muscle fibre performance (R), fast-twitch muscle fibre performance (F), pelvic floor muscle contraction pattern (E), transversus abdominus muscle cocontraction (C) and involuntary contraction in response to increased intra-abdominal pressure (T).
9 secondary outcomes
Waist/ Hip Ratio
Time frame: Baseline
Waist/ Hip Ratio
Time frame: 6 Weeks Later
Waist/ Hip Ratio
Time frame: 12 Weeks Later
Estimating body fat
Time frame: Baseline
Estimating body fat
Time frame: 6 Weeks Later
Estimating body fat
Time frame: 12 Weeks Later
ICIQ-SF: International Consultation on Incontinence Questionnaire-Short Form
Time frame: Baseline
ICIQ-SF: International Consultation on Incontinence Questionnaire-Short Form
Time frame: 6 Weeks Later
ICIQ-SF: International Consultation on Incontinence Questionnaire-Short Form
Time frame: 12 Weeks Later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
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.
Ebru Kaya Mutlu, Professor, PhD study director
Bandırma Onyedi Eylül 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 Standard pelvic floor exercises and Involuntary reflexive pelvic floor exercises in people with Prevention Pelvic Muscle Dysfunction, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 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 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
Pelvic Floor Distress Inventory-PFDI-20 (time frame: Baseline). The study lists 15 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 12 Jan 2024.