Stress Urinary IncontinencePELSTABNCT04340323
The Effect of Pelvic Floor Muscle Training With Stabilization Exercises With Various Intensity in Women With Stress Urinary Incontinence
A study testing Pelvic Floor Muscle Training (PFMT) in people with Stress Urinary Incontinence, run by Pavol Jozef Safarik University at 1 site in Slovakia.
Trial summary
This study will evaluate the safety, tolerability and efficacy of high- and low-intensity PFMT with stabilization exercises in women with SUI Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Pelvic Floor Muscle Training (PFMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSlovakia
- Study dates
- 2 May 2020to 26 Jan 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to provide written informed consent
- Over 18 years old and experiencing uncomplicated SUI
- Score on the International Consultation on Urinary Incontinence Questionnaire of ≥ 6 points
- Symptoms of urinary incontinence for at least three consecutive months
- Degree of pelvic organ prolapse, stage ≤ 2
- Willingness to accept the randomization process and fully participate in tests
Who cannot join
- History of anti-incontinence surgery in the past 12 months
- History of pelvic prolapse repair or urethral surgery in the past 12 months
- History of PFMT in the past 12 months
- History of interstitial cystitis or bladder-related pain
- Chronic severe constipation
- Clinically significant renal or hepatic impairment
Show all 13Show fewer
- Clinically significant heart impairment
- Pregnant, lactating or actively trying to become pregnant
- Positive urinary tract infection
- Use of rehabilitation aids (pessaries, urethral plugs, vaginal beads, etc.)
- Insufficient understanding of pelvic floor exercises and/or omitting exercises
- Incomplete questionnaire
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
Slovakia1 site
Pavol Jozef Safarik University, Faculty of Medicine
Košice, 04001
About this study
Official title: A Randomized Interventional Parallel Study to Evaluate the Effect of Pelvic Floor Muscle Training With Stabilization Exercises of High and Low Intensity in Women With Stress Urinary Incontinence - the PELSTAB Study
This study will evaluate the safety, tolerability and efficacy of high- and low-intensity PFMT with stabilization exercises in women with SUI
Read the detailed description
This is a randomized interventional parallel study to evaluate the effect of PFMT with stabilization exercises of high and low intensity in women with SUI
- Conditions
- Stress Urinary Incontinence
- Being tested
- Pelvic Floor Muscle Training (PFMT)
- Keywords
- Stress urinary incontinence;, 2D/3D ultrasound, Pelvic floor muscle training
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor Muscle Training (PFMT)Other
The method of first choice in SUI treatment according to the International Continence Society (ICS) is training of the pelvic floor muscles. Pelvic floor muscle training (PFMT) is a method based on scientific evidence, defined by the ICS as repeated selective voluntary contraction and relaxation of specific pelvic floor muscles. It is important to train the strength and endurance of the pelvic floor muscles but also their relaxation (Abrams, 2018; Arnold, 2014; Bo, 2013).
| Study group | Role | What they receive |
|---|---|---|
| Group A-intensive exercise group | Experimental | Dosage of intensive exercise group - 12 weeks, five times a week for 30 minutes per day; five times with education by a physiotherapist, followed by continuation at home.
PFMT with lumbopelvic stabilization. Exercise up to five times a week for up to 30 minutes per day, after initial training with a physiotherapist.
1. Educating probands about anatomy, physiology and pelvic floor muscle function.
2. Training of pelvic floor muscles in different positions.
3. Training of pelvic floor muscles with six stabilization exercises - activation of deep trunk muscles. Receives: Other: Pelvic Floor Muscle Training (PFMT) |
| Group B-low-intensity exercise group | Active comparator | Dosage of low-intensity exercise group - 12 weeks, twice a week for 15 minutes per day; five times with physiotherapist education, followed by continuation at home.
PFMT with lumbopelvic stabilization. Exercise up to five times a week for up to 30 minutes per day, after initial training with a physiotherapist.
1. Educating probands about anatomy, physiology and pelvic floor muscle function.
2. Training of pelvic floor muscles in different positions.
3. Training of pelvic floor muscles with six stabilization exercises - activation of deep trunk muscles. Receives: Other: Pelvic Floor Muscle Training (PFMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in incontinence episode frequency (IEF) over one week.
Change in the number of urinary leakages during the day, measured by the voiding diary.
Measured: change in incontinence episode frequency over 12 weeks of treatment
Secondary outcomes (4)
Change in performance and endurance of pelvic floor muscles
Performance on five-degree scale of 0-5 is used (no contraction, weak contraction, normal contraction, strong contraction, very strong contraction).
Endurance - the patient is requested to perform a maximum voluntary contraction of the pelvic floor and the contraction weakening time is measured. Time is given in seconds, for a maximum of 10 seconds.
Measured: Change in performance and endurance of pelvic floor muscles over 12 weeks of treatment
Change in hiatal area (HA, in cm2) during the Valsalva manoeuvre, assessed by 3D ultrasound
Examination will be carried out using a ultrasound console, volume contrast imaging software and a 3D/4D 4-8 MHz probe in the midsagittal plane. Examination will take place with an empty bladder in the lithotomy position. The probe will be placed longitudinally on the perineum. A 3D image will be taken at rest, at maximum contraction and at the Valsalva manoeuvre. The amount of hiatial space at the Valsalva manoeuvre will be measured in cm2.
Measured: Change in hiatal area (HA, in cm2) during the Valsalva manoeuvre, assessed by 3D ultrasound over 12 weeks of treatment
Change in incontinence quality of life
Urinary Incontinence Quality of Life Scale (I-QoL)
The I-QoL is composed of three subscales (avoidance and limiting behaviour; psychosocial impact; social embarrassment) and comprises 22 questions with a total score in the range from 0 (worst quality of life) to 100 (best quality of life).
Measured: Change in incontinence quality of life over 12 weeks of treatment
Change in patient global impression
Patient Global Impression of Improvement Scale (PGI-I)
The PGI-I evaluates the status of urination problems compared to the patient's condition before treatment in the study. Patient impressions are evaluated according to the following scores: 1, much better; 2, quite better; 3, a little better; 4, no change; 5, a little worse; 6, a lot worse; 7, definitely worse.
Measured: Change in patient global impression over 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 posted9 Apr 2020
- Study start2 May 2020
- Primary completion1 Dec 2021
- Study completion26 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress 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
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pavol Jozef Safarik University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Urdzik, Pavol Jozef Safarik University
- Investigators
- Peter Urdzik, prof.MD,PhD, Principal investigator, Pavol Jozef Safarik University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340323
- Sponsor's protocol ID
- 3545/2020/ODDZ-06621
- Acronym
- PELSTAB
- Status last verified
- Mar 2022
- First submitted
- 3 Apr 2020
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 39704322Hagovska M, Urdzik P, Svihra J. A randomized interventional parallel study to evaluate the effect of pelvic floor muscle training with stabilization exercises of high and low intensity in women with stress urinary incontinence: The PELSTAB study. Medicine (Baltimore). 2020 Jul 17;99(29):e21264. doi: 10.1097/MD.0000000000021264.
PubMed 32702912
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Interventional Parallel Study to Evaluate the Effect of Pelvic Floor Muscle Training With Stabilization Exercises of High and Low Intensity in Women With Stress Urinary Incontinence - the PELSTAB Study
- ClinicalTrials.gov ID
- NCT04340323
- Acronym / sponsor ID
- PELSTAB / 3545/2020/ODDZ-06621
- Conditions
- Stress Urinary Incontinence
- Keywords
- Stress urinary incontinence;, 2D/3D ultrasound, Pelvic floor muscle training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Pavol Jozef Safarik UniversityUniversity, hospital or other
- Study start
- 2 May 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 26 Jan 2022 (actual)
- First posted
- 9 Apr 2020 (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.
This study will evaluate the safety, tolerability and efficacy of high- and low-intensity PFMT with stabilization exercises in women with SUI
Detailed description
This is a randomized interventional parallel study to evaluate the effect of PFMT with stabilization exercises of high and low intensity in women with SUI
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A-intensive exercise group | Experimental | Other: Pelvic Floor Muscle Training (PFMT)Dosage of intensive exercise group - 12 weeks, five times a week for 30 minutes per day; five times with education by a physiotherapist, followed by continuation at home. PFMT with lumbopelvic stabilization. Exercise up to five times a week for up to 30 minutes per day, after initial training with a physiotherapist. 1. Educating probands about anatomy, physiology and pelvic floor muscle function. 2. Training of pelvic floor muscles in different positions. 3. Training of pelvic floor muscles with six stabilization exercises - activation of deep trunk muscles. |
| Group B-low-intensity exercise group | Active comparator | Other: Pelvic Floor Muscle Training (PFMT)Dosage of low-intensity exercise group - 12 weeks, twice a week for 15 minutes per day; five times with physiotherapist education, followed by continuation at home. PFMT with lumbopelvic stabilization. Exercise up to five times a week for up to 30 minutes per day, after initial training with a physiotherapist. 1. Educating probands about anatomy, physiology and pelvic floor muscle function. 2. Training of pelvic floor muscles in different positions. 3. Training of pelvic floor muscles with six stabilization exercises - activation of deep trunk muscles. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Willing to provide written informed consent
- Over 18 years old and experiencing uncomplicated SUI
- Score on the International Consultation on Urinary Incontinence Questionnaire of ≥ 6 points
- Symptoms of urinary incontinence for at least three consecutive months
- Degree of pelvic organ prolapse, stage ≤ 2
Key exclusion criteria (13 listed)
- History of anti-incontinence surgery in the past 12 months
- History of pelvic prolapse repair or urethral surgery in the past 12 months
- History of PFMT in the past 12 months
- History of interstitial cystitis or bladder-related pain
- Chronic severe constipation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic Floor Muscle Training (PFMT)The method of first choice in SUI treatment according to the International Continence Society (ICS) is training of the pelvic floor muscles. Pelvic floor muscle training (PFMT) is a method based on scientific evidence, defined by the ICS as repeated selective voluntary contraction and relaxation of specific pelvic floor muscles. It is important to train the strength and endurance of the pelvic floor muscles but also their relaxation (Abrams, 2018; Arnold, 2014; Bo, 2013). | Other | Group A-intensive exercise group, Group B-low-intensity exercise group |
Primary outcome
Change in incontinence episode frequency (IEF) over one week.
Time frame: change in incontinence episode frequency over 12 weeks of treatment
Change in the number of urinary leakages during the day, measured by the voiding diary.
4 secondary outcomes
Change in performance and endurance of pelvic floor muscles
Time frame: Change in performance and endurance of pelvic floor muscles over 12 weeks of treatment
Change in hiatal area (HA, in cm2) during the Valsalva manoeuvre, assessed by 3D ultrasound
Time frame: Change in hiatal area (HA, in cm2) during the Valsalva manoeuvre, assessed by 3D ultrasound over 12 weeks of treatment
Change in incontinence quality of life
Time frame: Change in incontinence quality of life over 12 weeks of treatment
Change in patient global impression
Time frame: Change in patient global impression over 12 weeks of treatment
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 2 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.
- Derived from this study: PubMed 32702912Hagovska M, Urdzik P, Svihra J. A randomized interventional parallel study to evaluate the effect of pelvic floor muscle training with stabilization exercises of high and low intensity in women with stress urinary incontinence: The PELSTAB study. Medicine (Baltimore). 2020 Jul 17;99(29):e21264. doi: 10.1097/MD.0000000000021264.
- 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.
Peter Urdzik, prof.MD,PhD principal investigator
Pavol Jozef Safarik University, Faculty of Medicine
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 (PFMT) in people with Stress Urinary Incontinence, run by Pavol Jozef Safarik University at 1 site in Slovakia.
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 6 inclusion and 13 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 2 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 Slovakia. 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?
Change in incontinence episode frequency (IEF) over one week. (time frame: change in incontinence episode frequency over 12 weeks of treatment). 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 NCT04340323, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.