Stress Urinary IncontinenceNCT05390008
The Effects of PFMT and MPE in Elderly Women With SUI.
A study testing Pelvic Floor Muscle Training and Modified Pilates Exercise in people with Stress Urinary Incontinence and Pelvic Floor Disorders, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to compare the effects of PFMT and MPE on SUI frequency and explosure from symptoms, PFM activation response and strength of lumbar stabilizing muscle in elderly women with SUI. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence, Pelvic Floor Disorders, Aging
- What is being tested?
- Pelvic Floor Muscle Training and Modified Pilates Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2020to 20 Jan 2021
- 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 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- being volunteer to participate in a study;
- being a woman over the age of 65;
- having the diagnosis of SUI;
- participants who scored at least 24 on the Mini Mental State Exam (MMSE).
Who cannot join
- having a neurological disease;
- having PFM which cannot contract;
- having a urinary tract infection;
- having the stage two or higher pelvic organ prolapse; and
- participants who received a SUI treatment in the recent year.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Darulaceze Directorate of Istanbul
Istanbul, Kayisdagi, 34755
About this study
Official title: The Effects of Pelvic Floor Muscle Training and Modified Pilates Exercises in Elderly Women With Stress Urinary Incontinence
The aim of the study was to compare the effects of PFMT and MPE on SUI frequency and explosure from symptoms, PFM activation response and strength of lumbar stabilizing muscle in elderly women with SUI.
Read the detailed description
Stress Urinary Incontinence (SUI) is associated with situations which bladder pressure exceeds the pressure at which the urethra has the capacity to remain closed, such as physical exertion, coughing, and sneezing. SUI is more predominant in women worldwide, with a prevalence ranging from 10% in young women to 45% in the elderly. Physiotherapy interventions in SUI include patient education including recommendations for bladder and/or bowel training, fluid management, and diet modification; modalities for decrease pain; pelvic floor muscle training (PFMT) with or without biofeedback and/or electrical stimulation to improve strength and coordination of the pelvic floor muscle (PFM) and stabilization exercises to improve strength of abdominal and/or lumbar stabilizer muscles.
PFMT includes repetitive contraction of the PFM, which increases perineal support and improves the muscle tone of the PFM. Modified pilates exercises (MPE) is a mind-body approach that includes slow, controlled movements that focus on posture and breathing.
The aim of the study was to compare the effects of PFMT and MPE on SUI frequency and explosure from symptoms, PFM activation response and strength of lumbar stabilizing muscle in elderly women with SUI. In this study, thirty-four elderly women who were diagnosed with SUI were randomized into Group 1: PFMT (n=17) or Group 2: MPE (n=17). Both groups performed their exercises twice a week for 12 weeks and accompanied by a physiotherapist. Incontinence Severity Index (ISI), Urogenital Distress Inventory-Short Form (UDI-6) and Incontinence Impact Questionnaire-Short Form (IIQ-7) were used to assess SUI frequency and explosure from symptoms, electromyography (EMG) device was used to assess PFM activation response and a stabilizer was used to assess strength of lumbar stabilizing muscle. The assessments were performed at baseline and after 12 week treatment. The effect size was calculated for the assessments used in the study.
- Conditions
- Stress Urinary Incontinence, Pelvic Floor Disorders, Aging
- Being tested
- Pelvic Floor Muscle Training, Modified Pilates Exercise
- Keywords
- aging, exercise, pelvic floor, urinary incontinence, women
- Medical subject headings
- Urinary Incontinence, Stress, Pelvic Floor Disorders, Motor Activity, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor Muscle TrainingOther
In order to increase participants' PFM strength and endurance , PFMT was taught two days a week for 12 weeks. This training included two type of exercises that consisted of fast and slow PFM contractions.
Fast Contractions: This exercise was done in sitting position, While participants' arms were on thighs with their feet resting on the floor and sitting unsupported on the back of their seat. They were taught how to quickly contract and relax their PFM.
Slow Contractions: The practice position of this exercise was in sitting position as it happened in fast contraction. This training lasted for 12 weeks and it was divided into periods as 1-3 week, 4-6 week, 7-9 week, 10-12 week. In the forth coming weeks of this period, the number of exercise repetitions and the number of sets were increased.
Modified Pilates ExerciseOther
Before starting the 12-week practice protocol, the concept of stabilization was explained to the participants. Participants were taught how to control the core region by using the stabilizer device and the basic principles of pilates. The exercise program was planned that would last 50 minutes. This program was carried out as three-stage and these stages were warm-up phase, main exercise program and cool down phase. The allocated times for the warm-up phase was 10 minutes. The allocated time for the main exercise program was 30 minutes and active resting was done by performing breathing exercises in the 15th minute of the main exercise program. The allocated time for the cool down phase was 10 minutes. Each exercise was done as 10 repetitions then the next exercise was started.
The exercises of the second 6 weeks were performed by adding a red elastic exercise band at the beginner-intermediate level, which released 1.7 kg force with 100% stretching.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Pelvic Floor Muscle Training | Experimental | volunteer elderly women with SUI Receives: Other: Pelvic Floor Muscle Training |
| Group 2: Modified Pilates Exercises | Experimental | volunteer elderly women with SUI Receives: Other: Modified Pilates Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUI frequency change - Incontinence Severity Index (ISI)
Incontinence Severity Index (ISI) was used to determine the UI frequency of the participants. This test consisted of two questions, regarding frequency and amount of leakage. Incontinence severity was determined by multiplying assigned values of two questions' responses. By taking into account the results, urine leakage was identified according to the following scale; 1-2 as 'slight', 3-4 as 'moderate', 8-9 as 'severe', 12 as 'very severe'.
Measured: SUI frequency was assessed by Incontinence Severity Index (ISI) at before and after 12 weeks of treatment
SUI frequency and explosure from symptoms change - Urogenital Distress Inventory-Short Form (UDI-6)
Urogenital Distress Inventory-Short Form (UDI-6) questionnaire was used to measure the participants' exposure to incontinence symptoms. In this form consisting of 6 questions, each question takes values in the range of 0-4. Then, the total value is converted to values ranging from 0-100. A score of 0 indicates that the patient is not bothered at all, while a score of 100 indicates that the patient is extremely disturbed by this symptom.
Measured: SUI frequency and explosure from symptoms was assessed by Urogenital Distress Inventory-Short Form (UDI-6) at before and after 12 weeks of treatment
SUI frequency and explosure from symptoms change - Incontinence Impact Questionnaire-Short Form (IIQ-7)
Incontinence Impact Questionnaire-Short Form (IIQ-7) was used to determine the extent to which urinary symptoms affect the participants' activities of daily living, social relationships and psychological states. This form included 7 questions and each question was assigned a value from 0 to 3. Then, the total value is converted to values ranging from 0-100. A score of 0 indicates that the patient is not bothered at all, while a score of 100 indicates that the patient is extremely disturbed by this symptom.
Measured: SUI frequency and explosure from symptoms was assessed by Incontinence Impact Questionnaire-Short Form (IIQ-7) at before and after 12 weeks of treatment
PFM activation change - MyoPlus4Puro-EMG device
MyoPlus4Puro-EMG device was used to determined the participants' PFM activation. The measurement was performed while subjects' knees were positioned at 140° of flexion with soles in the bed and there was a 30 cm gap between the feet. Active electrodes were placed on the right and left side of the perineal body. Passive electrode was located in front of the femoral. The length of contraction lasted five seconds and resting lasted five seconds, too. Five repeated contractions with a five second pause between each contraction were performed in total and the measurement lasted 50 seconds. However, in order for the contraction to be only in the pelvic floor muscles, before the measurement, the subjects were told how to perform the correct pelvic floor contraction without contracting the abdominal, hip and thigh muscles and without holding the breath.
Measured: PFM activation was assessed by MyoPlus4Puro-EMG device at before and after 12 weeks of treatment
Strength of lumbar stabilizing muscle change - Stabilizer Pressure Biofeedback
Stabilizer Pressure Biofeedback device was used to determine the strength of lumbar stabilizing muscle. Subjects were asked to be in the face-down position and the pillow was located in the abdominal region. The bottom edge of the pillow was placed in paralel with crista iliaca. Meanwhile, subjects' knees were in flat position, arms were by their side and their head was in a relaxed position. After the manometric pressure was adjusted to 70 mmHg, participant was asked to slowly contract his/her transversus abdominis (TrA) muscle. That's why, subject was instructed by saying 'suck your belly in'. The decrease of pressure value increases in direct proportion to the to the magnitude of the stabilization force. Three tests were completed in total and the average value was calculated.
Measured: Strength of lumbar stabilizing muscle was assessed by stabilizer at before and after 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start20 Jul 2020
- Primary completion20 Oct 2020
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Kaya Mutlu, PT, Istanbul University - Cerrahpasa
- Investigators
- Ebru Kaya Mutlu, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390008
- Sponsor's protocol ID
- 06/05/2022
- Status last verified
- May 2022
- First submitted
- 18 May 2022
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Falah-Hassani K, Reeves J, Shiri R, Hickling D, McLean L. The pathophysiology of stress urinary incontinence: a systematic review and meta-analysis. Int Urogynecol J. 2021 Mar;32(3):501-552. doi: 10.1007/s00192-020-04622-9. Epub 2021 Jan 8.
PubMed 33416968Oliveira M, Ferreira M, Azevedo MJ, Firmino-Machado J, Santos PC. Pelvic floor muscle training protocol for stress urinary incontinence in women: A systematic review. Rev Assoc Med Bras (1992). 2017 Jul;63(7):642-650. doi: 10.1590/1806-9282.63.07.642.
PubMed 28977091Celiker Tosun O, Kaya Mutlu E, Ergenoglu AM, Yeniel AO, Tosun G, Malkoc M, Askar N, Itil IM. Does pelvic floor muscle training abolish symptoms of urinary incontinence? A randomized controlled trial. Clin Rehabil. 2015 Jun;29(6):525-37. doi: 10.1177/0269215514546768. Epub 2014 Aug 20.
PubMed 25142280Lausen A, Marsland L, Head S, Jackson J, Lausen B. Modified Pilates as an adjunct to standard physiotherapy care for urinary incontinence: a mixed methods pilot for a randomised controlled trial. BMC Womens Health. 2018 Jan 12;18(1):16. doi: 10.1186/s12905-017-0503-y.
PubMed 29329567Hay-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 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Pelvic Floor Muscle Training and Modified Pilates Exercises in Elderly Women With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT05390008
- Acronym / sponsor ID
- 06/05/2022
- Conditions
- Stress Urinary Incontinence, Pelvic Floor Disorders, Aging
- Keywords
- aging, exercise, pelvic floor, urinary incontinence, women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 25 May 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 the study was to compare the effects of PFMT and MPE on SUI frequency and explosure from symptoms, PFM activation response and strength of lumbar stabilizing muscle in elderly women with SUI.
Detailed description
Stress Urinary Incontinence (SUI) is associated with situations which bladder pressure exceeds the pressure at which the urethra has the capacity to remain closed, such as physical exertion, coughing, and sneezing. SUI is more predominant in women worldwide, with a prevalence ranging from 10% in young women to 45% in the elderly. Physiotherapy interventions in SUI include patient education including recommendations for bladder and/or bowel training, fluid management, and diet modification; modalities for decrease pain; pelvic floor muscle training (PFMT) with or without biofeedback and/or electrical stimulation to improve strength and coordination of the pelvic floor muscle (PFM) and stabilization exercises to improve strength of abdominal and/or lumbar stabilizer muscles.
PFMT includes repetitive contraction of the PFM, which increases perineal support and improves the muscle tone of the PFM. Modified pilates exercises (MPE) is a mind-body approach that includes slow, controlled movements that focus on posture and breathing.
The aim of the study was to compare the effects of PFMT and MPE on SUI frequency and explosure from symptoms, PFM activation response and strength of lumbar stabilizing muscle in elderly women with SUI. In this study, thirty-four elderly women who were diagnosed with SUI were randomized into Group 1: PFMT (n=17) or Group 2: MPE (n=17). Both groups performed their exercises twice a week for 12 weeks and accompanied by a physiotherapist. Incontinence Severity Index (ISI), Urogenital Distress Inventory-Short Form (UDI-6) and Incontinence Impact Questionnaire-Short Form (IIQ-7) were used to assess SUI frequency and explosure from symptoms, electromyography (EMG) device was used to assess PFM activation response and a stabilizer was used to assess strength of lumbar stabilizing muscle. The assessments were performed at baseline and after 12 week treatment. The effect size was calculated for the assessments used in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Pelvic Floor Muscle Training | Experimental | Other: Pelvic Floor Muscle Trainingvolunteer elderly women with SUI |
| Group 2: Modified Pilates Exercises | Experimental | Other: Modified Pilates Exercisevolunteer elderly women with SUI |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- being volunteer to participate in a study;
- being a woman over the age of 65;
- having the diagnosis of SUI;
- participants who scored at least 24 on the Mini Mental State Exam (MMSE).
Key exclusion criteria (5 listed)
- having a neurological disease;
- having PFM which cannot contract;
- having a urinary tract infection;
- having the stage two or higher pelvic organ prolapse; and
- participants who received a SUI treatment in the recent year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic Floor Muscle TrainingIn order to increase participants' PFM strength and endurance , PFMT was taught two days a week for 12 weeks. This training included two type of exercises that consisted of fast and slow PFM contractions. Fast Contractions: This exercise was done in sitting position, While participants' arms were on thighs with their feet resting on the floor and sitting unsupported on the back of their seat. They were taught how to quickly contract and relax their PFM. Slow Contractions: The practice position of this exercise was in sitting position as it happened in fast contraction. This training lasted for 12 weeks and it was divided into periods as 1-3 week, 4-6 week, 7-9 week, 10-12 week. In the forth coming weeks of this period, the number of exercise repetitions and the number of sets were increased. | Other | Group 1: Pelvic Floor Muscle Training |
| Modified Pilates ExerciseBefore starting the 12-week practice protocol, the concept of stabilization was explained to the participants. Participants were taught how to control the core region by using the stabilizer device and the basic principles of pilates. The exercise program was planned that would last 50 minutes. This program was carried out as three-stage and these stages were warm-up phase, main exercise program and cool down phase. The allocated times for the warm-up phase was 10 minutes. The allocated time for the main exercise program was 30 minutes and active resting was done by performing breathing exercises in the 15th minute of the main exercise program. The allocated time for the cool down phase was 10 minutes. Each exercise was done as 10 repetitions then the next exercise was started. The exercises of the second 6 weeks were performed by adding a red elastic exercise band at the beginner-intermediate level, which released 1.7 kg force with 100% stretching. | Other | Group 2: Modified Pilates Exercises |
Primary outcome
SUI frequency change - Incontinence Severity Index (ISI)
Time frame: SUI frequency was assessed by Incontinence Severity Index (ISI) at before and after 12 weeks of treatment
Incontinence Severity Index (ISI) was used to determine the UI frequency of the participants. This test consisted of two questions, regarding frequency and amount of leakage. Incontinence severity was determined by multiplying assigned values of two questions' responses. By taking into account the results, urine leakage was identified according to the following scale; 1-2 as 'slight', 3-4 as 'moderate', 8-9 as 'severe', 12 as 'very severe'.
SUI frequency and explosure from symptoms change - Urogenital Distress Inventory-Short Form (UDI-6)
Time frame: SUI frequency and explosure from symptoms was assessed by Urogenital Distress Inventory-Short Form (UDI-6) at before and after 12 weeks of treatment
Urogenital Distress Inventory-Short Form (UDI-6) questionnaire was used to measure the participants' exposure to incontinence symptoms. In this form consisting of 6 questions, each question takes values in the range of 0-4. Then, the total value is converted to values ranging from 0-100. A score of 0 indicates that the patient is not bothered at all, while a score of 100 indicates that the patient is extremely disturbed by this symptom.
SUI frequency and explosure from symptoms change - Incontinence Impact Questionnaire-Short Form (IIQ-7)
Time frame: SUI frequency and explosure from symptoms was assessed by Incontinence Impact Questionnaire-Short Form (IIQ-7) at before and after 12 weeks of treatment
Incontinence Impact Questionnaire-Short Form (IIQ-7) was used to determine the extent to which urinary symptoms affect the participants' activities of daily living, social relationships and psychological states. This form included 7 questions and each question was assigned a value from 0 to 3. Then, the total value is converted to values ranging from 0-100. A score of 0 indicates that the patient is not bothered at all, while a score of 100 indicates that the patient is extremely disturbed by this symptom.
PFM activation change - MyoPlus4Puro-EMG device
Time frame: PFM activation was assessed by MyoPlus4Puro-EMG device at before and after 12 weeks of treatment
MyoPlus4Puro-EMG device was used to determined the participants' PFM activation. The measurement was performed while subjects' knees were positioned at 140° of flexion with soles in the bed and there was a 30 cm gap between the feet. Active electrodes were placed on the right and left side of the perineal body. Passive electrode was located in front of the femoral. The length of contraction lasted five seconds and resting lasted five seconds, too. Five repeated contractions with a five second pause between each contraction were performed in total and the measurement lasted 50 seconds. However, in order for the contraction to be only in the pelvic floor muscles, before the measurement, the subjects were told how to perform the correct pelvic floor contraction without contracting the abdominal, hip and thigh muscles and without holding the breath.
Strength of lumbar stabilizing muscle change - Stabilizer Pressure Biofeedback
Time frame: Strength of lumbar stabilizing muscle was assessed by stabilizer at before and after 12 weeks of treatment
Stabilizer Pressure Biofeedback device was used to determine the strength of lumbar stabilizing muscle. Subjects were asked to be in the face-down position and the pillow was located in the abdominal region. The bottom edge of the pillow was placed in paralel with crista iliaca. Meanwhile, subjects' knees were in flat position, arms were by their side and their head was in a relaxed position. After the manometric pressure was adjusted to 70 mmHg, participant was asked to slowly contract his/her transversus abdominis (TrA) muscle. That's why, subject was instructed by saying 'suck your belly in'. The decrease of pressure value increases in direct proportion to the to the magnitude of the stabilization force. Three tests were completed in total and the average value was calculated.
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 25 May 2022.
- Background: PubMed 33416968Falah-Hassani K, Reeves J, Shiri R, Hickling D, McLean L. The pathophysiology of stress urinary incontinence: a systematic review and meta-analysis. Int Urogynecol J. 2021 Mar;32(3):501-552. doi: 10.1007/s00192-020-04622-9. Epub 2021 Jan 8.
- Background: PubMed 28977091Oliveira M, Ferreira M, Azevedo MJ, Firmino-Machado J, Santos PC. Pelvic floor muscle training protocol for stress urinary incontinence in women: A systematic review. Rev Assoc Med Bras (1992). 2017 Jul;63(7):642-650. doi: 10.1590/1806-9282.63.07.642.
- Background: PubMed 25142280Celiker Tosun O, Kaya Mutlu E, Ergenoglu AM, Yeniel AO, Tosun G, Malkoc M, Askar N, Itil IM. Does pelvic floor muscle training abolish symptoms of urinary incontinence? A randomized controlled trial. Clin Rehabil. 2015 Jun;29(6):525-37. doi: 10.1177/0269215514546768. Epub 2014 Aug 20.
- Background: PubMed 29329567Lausen A, Marsland L, Head S, Jackson J, Lausen B. Modified Pilates as an adjunct to standard physiotherapy care for urinary incontinence: a mixed methods pilot for a randomised controlled trial. BMC Womens Health. 2018 Jan 12;18(1):16. doi: 10.1186/s12905-017-0503-y.
- Derived from this study: PubMed 39704322Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ebru Kaya Mutlu principal investigator
Istanbul University - Cerrahpasa
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 Muscle Training and Modified Pilates Exercise in people with Stress Urinary Incontinence and Pelvic Floor Disorders, 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 5 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 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUI frequency change - Incontinence Severity Index (ISI) (time frame: SUI frequency was assessed by Incontinence Severity Index (ISI) at before and after 12 weeks of treatment). The study lists 5 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 NCT05390008, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.