Urinary Incontinence,StressNCT06848517
Synchronous and Asynchronous Telerehabilitation for Women With Urinary Incontinence
A study testing BSATP Group and FtFS Group in people with Urinary Incontinence,Stress, run by University of Patras at 1 site in Greece.
Trial summary
In the adult female Greek population,approximately 27% suffer from urinary incontinence (UI). Nowadays, the conservative, evidence-based and 'gold standard' therapy of UI involves pelvic floor muscles (PFM) training programs, which are effective when performed intensively (daily) and for at least three months'… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Urinary Incontinence,Stress
- What is being tested?
- BSATP Group and FtFS Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 15 Feb 2025to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Greek women,
- 18-75 years old,
- Diagnosis of Stress Urinary Incontinence (SUI) or Mixed UI (via Urodynamic examination).
- Writing and reading of the Greek language
- Having ease in using synchronous communication platforms (e.g., Zoom) and asynchronous educational videos via smart phones, tablets, computers etc
- Able to voluntarily contract the PFM, during the initial clinical examination.
Who cannot join
- 6 months after postpartum,
- Systemic diseases
- Malignancy,
- Major gynecological surgery (i.e. total hysterectomy) over the last 10 years,
- Neurological dysfunction,
- Mental impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
University of Patras, School of Health Rehabilitation Science, Department of Physiotherapy
Pátrai, Rion, Achaia, GR26504
Evdokia Billis, Professor, +302610962406 ext. +30, billis@upatras.gr
Professor
About this study
Official title: The Effectiveness of a Blended Synchronous and Asynchronous Telerehabilitation Program for Greek Adult Women With Urinary Incontinence. A Randomized Controlled Trial
In the adult female Greek population,approximately 27% suffer from urinary incontinence (UI). Nowadays, the conservative, evidence-based and 'gold standard' therapy of UI involves pelvic floor muscles (PFM) training programs, which are effective when performed intensively (daily) and for at least three months' duration. Unfortunately, patients' adherence to PFM exercises programs is often compromised for various reasons (lack of patient interest, inability to exercise daily etc.). Therefore, the development of synchronous and asynchronous telerehabilitation programs has revolutionized UI treatment, because they offer an interactive environment which might increase patient motivation and improve patient's adherence to this demanding PFM exercise regime. Synchronous Telerehabilitation Programs (STP) have developed via communication platforms that allow users to connect with video, audio, phone, and chat applications (e.g. Zoom), where users can interact in real time with their therapist and follow their treatment through the PFM exercise program. Furthermore, Asynchronous Telerehabilitation Programs (ATP) have emerged via mobile applications, educational videos etc., where users can follow their treatment using the PFM exercise program at a more convenient time that fits into their personal schedule. Although some studies have examined either STP or ATP with or without face-to-face sessions, no study has investigated a blended approach of STP and ATP for the management of UI.
Given the above, the primary aim of this study is to evaluate the effectiveness of a blended STP and ATP, in comparison to face-to-face therapy sessions. A secondary objective is to investigate the level of patients' adherence, and the amount of supervision required, in a blended STP and ATP. Furthermore, the necessity of telerehabilitation programs (whether provided in a synchronous or asynchronous manner) in the field of pelvic floor dysfunctions specifically in UI, will be explored. Finally, the study will assess the usability of a telerehabilitation program (whether provided in a synchronous or asynchronous manner) in women with UI.
Read the detailed description
The study is designed to be conducted with three groups.
- st. In the Blended STP and ATP (BSATP) group, participants will use communication platforms and educational videos to follow their PFM exercise treatment. No face-to face meetings will take place between participants and the therapist while supervision will occur remotely.
- nd.In the Face-to-face Sessions (FtFS) group, participants will follow their PFM exercise treatment in a healthcare setting under the continuous supervision of their therapist.
- rd. In the Control Group (CG), participants will follow their PFM exercise treatment without any supervision or face-to-face sessions with their therapist.
Three assessments sessions will take place at baseline (0 week), half-way at 6 weeks and at the end of the treatment (after 12 weeks). A follow-up assessment will be conducted at 6 and 9 months after the baseline.
Participants will be selected voluntarily through the University Urology clinic, social networks (e.g. facebook), etc. This study has been approved by the Research Ethics Committee (R.E.C.). All participants' data will be archived anonymously in a secure cloud platform accessible only to members of the research team.
To guarantee complete allocation concealment of the groups, a randomization process will be employed by a 'blind' researcher with no knowledge of the assessment or treatment procedures. The distribution of the participants to the three groups will be undertaken through a pre-defined computer-generated list, in blocks of six people. Each participant will receive a randomly assigned number from the list (through sealed envelopes), after which participants will be randomly assigned to one of the three groups using sealed envelopes.To accomplish a homogeneous sample distribution between the groups, each block will encompass three envelopes for every group. Given the nature of the treatment, the intervention is not blinded between participants and therapists. However, the data analysis will be carried through a 'blind' assessor.
An intention-to-treat analysis will performed, based on the initial allocation of participants into groups. The data will be gathered in excel tables and through Statistical Package for the Social Sciences (SPSS) version 24.0 for Windows. An analysis within the groups before and after the intervention, will be conducted using repeated measurements ANOVA. An analysis between the groups after the intervention will be carried out by the Student t-test (independent measurements). Furthermore, the effect size with 95% confidence intervals will be measured for each outcome measure with continuous variables. Results will be deemed statistically significant if p<.05. Finally, the results will be provided by means (M) values and their standard deviations (SD).
- Conditions
- Urinary Incontinence,Stress
- Being tested
- BSATP Group, FtFS Group, Control Group (CG)
- 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.
BSATP GroupOther
Also called Blended Synchronous and Asynchronous Telerehabilitation Programs
Participants and the therapist will communicate once weekly synchronously (e.g. through video calls with a 30 minute duration), regarding the proper execution of the PFM exercises, providing motivation etc. Additionally, participants will be advised to watch the educational videos (10 mins duration) asynchronously twice a week. In total, participants will follow a BSATP three times a week (for 12 weeks). The PFM exercise program will include endurance training (slow velocity contractions), speed training (quick contractions) and "Knack maneuver" training (pre-contraction before the increment of the intra-abdominal pressure).The PFM exercise program will be based on three assessments conducted by the therapist throughout the study (baseline, 6 weeks and 12 weeks). As a result, the PFM exercise program will be individualized to meet their needs and progressively increases in difficulty, with the exercise position being modified every two weeks (e.g. supine, side, prone ect)
FtFS GroupOther
Also called Face-to face Sessions
Participants will attend one weekly face-to-face session with their therapist, to discuss the progress of their treatment and ensure its seamless continuation (intra-vaginal assessment, adjustments, motivation etc.). Each session will last approximately 30 minutes. Participants will also be advised to perform the PFM program twice a week on their own e.g. at home. In total, participants will follow a PFM program three times a week (for 12 weeks), once with their therapist and twice independently. The participants in the FtFS group will follow the same PFM exercise treatment program as the BSATP group, which will be an individualized program where the position will change every two weeks and include endurance training, speed training and 'Knack maneuver' training.
Control Group (CG)Other
Also called PFM exercises without supervision
The participants will be advised to follow a PFM exercise treatment program at home, based on an educational home leaflet (with instructions and images about PFM exercises) that they received during their first assessment session (baseline). The participants of this group will follow a PFM exercise therapy program (through the leaflet) which will last 12 weeks and they will be advised to attend it three times a week. No face-to-face meetings or supervision will occur by the therapist during the treatment period. Similarly to the other two intervention groups, the provided PFM exercise treatment program will be individualized, will include endurance training, speed training, and 'Knack maneuver' training, and the participants will be encouraged to change their exercise position on their own every two weeks.
| Study group | Role | What they receive |
|---|---|---|
| BSATP (Blended Synchronous and Asynchronous Telerehabilitation Programs) Group | Experimental | In the BSATP Group, participants will use synchronous telerehabilitation methods such as communications platforms (e.g. Zoom etc.) and asynchronous methods like educational videos (created by the researchers to meet the needs of this study). Through these, they will follow a PFM exercise treatment program at a convenient location of their choice such as their home. No face-to face meetings will take place between participants and the therapist while supervision (regarding the execution, frequency of the PFM exercises etc.) will occur remotely. Receives: Other: BSATP Group |
| FtFS (Face-to face Sessions) Group | Active comparator | Participants will undertake their PFM exercise treatment in a healthcare setting under the continuous supervision of their therapist, drawing on the"realistic" treatment of UI, presently used in rehabilitation clinics etc. Receives: Other: FtFS Group |
| CG (Control Group) | Other | In the CG, participants will follow their PFM exercise treatment program without any supervision or face-to-face sessions with their therapist. Receives: Other: Control Group (CG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI-SF)
The ICIQ-UI-SF is a patient-centered questionnaire. It includes questions that evaluate the frequency, severity, and impact of incontinence. The ICIQ-UI SF (range 0-21) is assessed using four scoring categories: (a) slight symptoms (1-5), (b) moderate symptoms (6-12), (c) severe symptoms (13-18) and (d) very severe symptoms (19-21).
Measured: At baseline (0 weeks), in the middle (6 weeks), at the end of the intervention (12 weeks), and at 6 and 9 months after baseline during the follow-up period
1-hour Pad test
The 1-hour Pad test is a clinician-administered test. The pad is weighed, the participant wear the pad and executes a set of standardized exercises (squats, running on the spot etc.). After one hour the pad re-weighed and estimated the difference in the amount of urine leakage before and after the exercises in the pad.Τhe 1-hour Pad test is assessed using three scoring categories:(a) mild incontinence (<10 ml), (b) moderate incontinence (11-50ml) and (c) severe incontinence (>50 ml)
Measured: At baseline (0 week) and at the end of the intervention (12 weeks)
Secondary outcomes (8)
PERFECT assessment scheme
The PERFECT assessment scheme is a clinician-administered test. PERFECT assessment scheme will be used for digital intravaginal evaluation of PFM contraction. It assesses a) the PFMs' Power (via Modified Oxford scale) b) the PFMs' Endurance, c) the number of Repetitions the Maximum Voluntary Contraction (MVC) is performed d) the number of fast PFM contractions the participant is able to complete) the elevation of the PFMs, f) the co-contraction with other muscles (like lower abdominals) and g) the involuntary contraction of the PFM on coughing
Measured: At baseline (0 week), in the middle (6 weeks), and at the end of the intervention (12 weeks)
Electromyographic (EMG) PFM's activity
The EMG is a clinician-administered test. The intravaginal probe is inserted into the vagina to measure the PFMs electromyographic (EMG) activity of the PFM contraction, displaying the results on the computer as feedback (NeuroTrac® Software). Similarly to the PERFECT assessment scheme above, it evaluates the following PFM parameters: endurance, repetitions, fast contractions and involuntary PFM contraction during coughing.
Measured: At baseline (0 week), in the middle (6 weeks), and at the end of the intervention (12 weeks)
Australian Pelvic Floor Questionnaire (APFQ)
The APFQ is a patient-centered questionnaire. Australian Pelvic Floor Questionnaire (APFQ), which is standardized in the Greek language, evaluates 42 questions in four categories: bladder (1-15 question), bowel ( 16-27 question), pelvic organ prolapsed (28-32 question) and sexual function (33-42 question).The scores for each category are calculated by dividing the total score by the number of relevant questions and multiplying by 10. As a result, the scores for each area range from 0 to 10 with a total score ranging from 0 to 40 (2 questions are not included in the total score). A higher score reflects more severe symptoms
Measured: At baseline (0 weeks), at the end of the intervention (12 weeks), and at 6 and 9 months after baseline during the follow-up period
Patient Global Impression of Improvement (PGI-I Scale)
The PGI-I Scale is a patient-centered questionnaire. The participants evaluate their perceived improvement on a scale from 1 ('much better') to 7 ('much worse').
Measured: At the end of the intervention (12 weeks)
Adherence Questionnaire (AQ)
The AQ is a patient-centered questionnaire. It includes 28 questions in total and most of them are closed type (yes/no). It is categorized into the following sections: a) social and demographic factors (1 to 4 questions), b) therapy-related factors (5 to 9 questions) c) healthcare team and system-related factors (physical therapists) (10 to 12 questions), d) patient-related factors (13 to 23 questions) and e) condition-related factors (24 to 26 questions). Question 27 pertains to a 10-point scale of adherence while question 28 pertains to an open-ended answer where the patient explains the reason of low or moderate adherence.
Measured: At the middle (6 weeks), and at the end of the intervention (12 weeks)
Adherence Exercise Diary (AED)
A PFM AED, designed to meet the needs of the current research. Participants record the daily and weekly frequency of performing the PFM exercises, along with the sets, repetitions and the rest periods they follow throughout their treatment.
Measured: At baseline (0 week) the PFM AED is supplied to the participants, who will then re-submit it at the end of the intervention(12 weeks)
Telehealth Usability Questionnaire (TUQ)
The Telehealth Usability Questionnaire (TUQ) is a patient-centered questionnaire, standardized in the Greek language, and consists of 21 questions. The patients rate their opinion on a scale from 1 ('strongly disagree') to 7 ('strongly agree'). The total score is calculated and then the average of the responses to all statements, is determined. The higher the total average, the higher the usability of the telehealth system.
Measured: At the end of the intervention(12 weeks)
"The Necessity of Creating Tele-rehabilitation Services for Pelvic Floor Dysfunctions (PFD)" through a Questionnaire
It is a patient-centered questionnaire, which was developed in the Greek language and underwent pilot testing as part of a Master's dissertation. It was created through a multi-stage process. The questionnaire consists of 23 items which are divided into the following 5 sections: a) Socio-demographic questions, b) questions regarding technology, c) questions regarding participants' intention to use telerehabilitation programs for PFD d) questions related to compliance with telerehabilitation programs and e) questions regarding the cost of telerehabilitation programs for PFD. Participants respond using closed-ended multiple choice answers. Finally, the purpose of this questionnaire is to gather information regarding the extent to which women are aware of the existence of telerehabilitation services for PFD, and whether they would be willing to participate in such a program.
Measured: At baseline (0 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start15 Feb 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion30 May 2026 (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 Incontinence,StressStudies 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Papanikolaou Dimitra-Tania, University of Patras
- Investigators
- Dimitra-Tania Papanikolaou, Principal investigator, University of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848517
- Sponsor's protocol ID
- Incontinence&Telerehab Methods
- Status last verified
- Feb 2025
- First submitted
- 21 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Papanikolaou DT, Lampropoulou S, Giannitsas K, Skoura A, Fousekis K, Billis E. Pelvic floor muscle training: Novel versus traditional remote rehabilitation methods. A systematic review and meta-analysis on their effectiveness for women with urinary incontinence. Neurourol Urodyn. 2023 Apr;42(4):856-874. doi: 10.1002/nau.25150. Epub 2023 Feb 18.
PubMed 36808744
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Blended Synchronous and Asynchronous Telerehabilitation Program for Greek Adult Women With Urinary Incontinence. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06848517
- Acronym / sponsor ID
- Incontinence&Telerehab Methods
- Conditions
- Urinary Incontinence,Stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 27 Feb 2025 (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.
In the adult female Greek population,approximately 27% suffer from urinary incontinence (UI). Nowadays, the conservative, evidence-based and 'gold standard' therapy of UI involves pelvic floor muscles (PFM) training programs, which are effective when performed intensively (daily) and for at least three months' duration. Unfortunately, patients' adherence to PFM exercises programs is often compromised for various reasons (lack of patient interest, inability to exercise daily etc.). Therefore, the development of synchronous and asynchronous telerehabilitation programs has revolutionized UI treatment, because they offer an interactive environment which might increase patient motivation and improve patient's adherence to this demanding PFM exercise regime. Synchronous Telerehabilitation Programs (STP) have developed via communication platforms that allow users to connect with video, audio, phone, and chat applications (e.g. Zoom), where users can interact in real time with their therapist and follow their treatment through the PFM exercise program. Furthermore, Asynchronous Telerehabilitation Programs (ATP) have emerged via mobile applications, educational videos etc., where users can follow their treatment using the PFM exercise program at a more convenient time that fits into their personal schedule. Although some studies have examined either STP or ATP with or without face-to-face sessions, no study has investigated a blended approach of STP and ATP for the management of UI.
Given the above, the primary aim of this study is to evaluate the effectiveness of a blended STP and ATP, in comparison to face-to-face therapy sessions. A secondary objective is to investigate the level of patients' adherence, and the amount of supervision required, in a blended STP and ATP. Furthermore, the necessity of telerehabilitation programs (whether provided in a synchronous or asynchronous manner) in the field of pelvic floor dysfunctions specifically in UI, will be explored. Finally, the study will assess the usability of a telerehabilitation program (whether provided in a synchronous or asynchronous manner) in women with UI.
Detailed description
The study is designed to be conducted with three groups.
- st. In the Blended STP and ATP (BSATP) group, participants will use communication platforms and educational videos to follow their PFM exercise treatment. No face-to face meetings will take place between participants and the therapist while supervision will occur remotely.
- nd.In the Face-to-face Sessions (FtFS) group, participants will follow their PFM exercise treatment in a healthcare setting under the continuous supervision of their therapist.
- rd. In the Control Group (CG), participants will follow their PFM exercise treatment without any supervision or face-to-face sessions with their therapist.
Three assessments sessions will take place at baseline (0 week), half-way at 6 weeks and at the end of the treatment (after 12 weeks). A follow-up assessment will be conducted at 6 and 9 months after the baseline.
Participants will be selected voluntarily through the University Urology clinic, social networks (e.g. facebook), etc. This study has been approved by the Research Ethics Committee (R.E.C.). All participants' data will be archived anonymously in a secure cloud platform accessible only to members of the research team.
To guarantee complete allocation concealment of the groups, a randomization process will be employed by a 'blind' researcher with no knowledge of the assessment or treatment procedures. The distribution of the participants to the three groups will be undertaken through a pre-defined computer-generated list, in blocks of six people. Each participant will receive a randomly assigned number from the list (through sealed envelopes), after which participants will be randomly assigned to one of the three groups using sealed envelopes.To accomplish a homogeneous sample distribution between the groups, each block will encompass three envelopes for every group. Given the nature of the treatment, the intervention is not blinded between participants and therapists. However, the data analysis will be carried through a 'blind' assessor.
An intention-to-treat analysis will performed, based on the initial allocation of participants into groups. The data will be gathered in excel tables and through Statistical Package for the Social Sciences (SPSS) version 24.0 for Windows. An analysis within the groups before and after the intervention, will be conducted using repeated measurements ANOVA. An analysis between the groups after the intervention will be carried out by the Student t-test (independent measurements). Furthermore, the effect size with 95% confidence intervals will be measured for each outcome measure with continuous variables. Results will be deemed statistically significant if p<.05. Finally, the results will be provided by means (M) values and their standard deviations (SD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BSATP (Blended Synchronous and Asynchronous Telerehabilitation Programs) Group | Experimental | Other: BSATP GroupIn the BSATP Group, participants will use synchronous telerehabilitation methods such as communications platforms (e.g. Zoom etc.) and asynchronous methods like educational videos (created by the researchers to meet the needs of this study). Through these, they will follow a PFM exercise treatment program at a convenient location of their choice such as their home. No face-to face meetings will take place between participants and the therapist while supervision (regarding the execution, frequency of the PFM exercises etc.) will occur remotely. |
| FtFS (Face-to face Sessions) Group | Active comparator | Other: FtFS GroupParticipants will undertake their PFM exercise treatment in a healthcare setting under the continuous supervision of their therapist, drawing on the"realistic" treatment of UI, presently used in rehabilitation clinics etc. |
| CG (Control Group) | Other | Other: Control Group (CG)In the CG, participants will follow their PFM exercise treatment program without any supervision or face-to-face sessions with their therapist. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Greek women,
- 18-75 years old,
- Diagnosis of Stress Urinary Incontinence (SUI) or Mixed UI (via Urodynamic examination).
- Writing and reading of the Greek language
- Having ease in using synchronous communication platforms (e.g., Zoom) and asynchronous educational videos via smart phones, tablets, computers etc
Key exclusion criteria (6 listed)
- 6 months after postpartum,
- Systemic diseases
- Malignancy,
- Major gynecological surgery (i.e. total hysterectomy) over the last 10 years,
- Neurological dysfunction,
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 |
|---|---|---|
| BSATP GroupAlso: Blended Synchronous and Asynchronous Telerehabilitation ProgramsParticipants and the therapist will communicate once weekly synchronously (e.g. through video calls with a 30 minute duration), regarding the proper execution of the PFM exercises, providing motivation etc. Additionally, participants will be advised to watch the educational videos (10 mins duration) asynchronously twice a week. In total, participants will follow a BSATP three times a week (for 12 weeks). The PFM exercise program will include endurance training (slow velocity contractions), speed training (quick contractions) and "Knack maneuver" training (pre-contraction before the increment of the intra-abdominal pressure).The PFM exercise program will be based on three assessments conducted by the therapist throughout the study (baseline, 6 weeks and 12 weeks). As a result, the PFM exercise program will be individualized to meet their needs and progressively increases in difficulty, with the exercise position being modified every two weeks (e.g. supine, side, prone ect) | Other | BSATP (Blended Synchronous and Asynchronous Telerehabilitation Programs) Group |
| FtFS GroupAlso: Face-to face SessionsParticipants will attend one weekly face-to-face session with their therapist, to discuss the progress of their treatment and ensure its seamless continuation (intra-vaginal assessment, adjustments, motivation etc.). Each session will last approximately 30 minutes. Participants will also be advised to perform the PFM program twice a week on their own e.g. at home. In total, participants will follow a PFM program three times a week (for 12 weeks), once with their therapist and twice independently. The participants in the FtFS group will follow the same PFM exercise treatment program as the BSATP group, which will be an individualized program where the position will change every two weeks and include endurance training, speed training and 'Knack maneuver' training. | Other | FtFS (Face-to face Sessions) Group |
| Control Group (CG)Also: PFM exercises without supervisionThe participants will be advised to follow a PFM exercise treatment program at home, based on an educational home leaflet (with instructions and images about PFM exercises) that they received during their first assessment session (baseline). The participants of this group will follow a PFM exercise therapy program (through the leaflet) which will last 12 weeks and they will be advised to attend it three times a week. No face-to-face meetings or supervision will occur by the therapist during the treatment period. Similarly to the other two intervention groups, the provided PFM exercise treatment program will be individualized, will include endurance training, speed training, and 'Knack maneuver' training, and the participants will be encouraged to change their exercise position on their own every two weeks. | Other | CG (Control Group) |
Primary outcome
International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI-SF)
Time frame: At baseline (0 weeks), in the middle (6 weeks), at the end of the intervention (12 weeks), and at 6 and 9 months after baseline during the follow-up period
The ICIQ-UI-SF is a patient-centered questionnaire. It includes questions that evaluate the frequency, severity, and impact of incontinence. The ICIQ-UI SF (range 0-21) is assessed using four scoring categories: (a) slight symptoms (1-5), (b) moderate symptoms (6-12), (c) severe symptoms (13-18) and (d) very severe symptoms (19-21).
1-hour Pad test
Time frame: At baseline (0 week) and at the end of the intervention (12 weeks)
The 1-hour Pad test is a clinician-administered test. The pad is weighed, the participant wear the pad and executes a set of standardized exercises (squats, running on the spot etc.). After one hour the pad re-weighed and estimated the difference in the amount of urine leakage before and after the exercises in the pad.Τhe 1-hour Pad test is assessed using three scoring categories:(a) mild incontinence (<10 ml), (b) moderate incontinence (11-50ml) and (c) severe incontinence (>50 ml)
8 secondary outcomes
PERFECT assessment scheme
Time frame: At baseline (0 week), in the middle (6 weeks), and at the end of the intervention (12 weeks)
Electromyographic (EMG) PFM's activity
Time frame: At baseline (0 week), in the middle (6 weeks), and at the end of the intervention (12 weeks)
Australian Pelvic Floor Questionnaire (APFQ)
Time frame: At baseline (0 weeks), at the end of the intervention (12 weeks), and at 6 and 9 months after baseline during the follow-up period
Patient Global Impression of Improvement (PGI-I Scale)
Time frame: At the end of the intervention (12 weeks)
Adherence Questionnaire (AQ)
Time frame: At the middle (6 weeks), and at the end of the intervention (12 weeks)
Adherence Exercise Diary (AED)
Time frame: At baseline (0 week) the PFM AED is supplied to the participants, who will then re-submit it at the end of the intervention(12 weeks)
Telehealth Usability Questionnaire (TUQ)
Time frame: At the end of the intervention(12 weeks)
"The Necessity of Creating Tele-rehabilitation Services for Pelvic Floor Dysfunctions (PFD)" through a Questionnaire
Time frame: At baseline (0 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Background: PubMed 36808744Papanikolaou DT, Lampropoulou S, Giannitsas K, Skoura A, Fousekis K, Billis E. Pelvic floor muscle training: Novel versus traditional remote rehabilitation methods. A systematic review and meta-analysis on their effectiveness for women with urinary incontinence. Neurourol Urodyn. 2023 Apr;42(4):856-874. doi: 10.1002/nau.25150. Epub 2023 Feb 18.
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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.
Dimitra-Tania Papanikolaou principal investigator
University of Patras
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BSATP Group and FtFS Group in people with Urinary Incontinence,Stress, run by University of Patras at 1 site in Greece.
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 6 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: looking for participants now, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evdokia Billis, Professor (6973047170, billis@upatras.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI-SF) (time frame: At baseline (0 weeks), in the middle (6 weeks), at the end of the intervention (12 weeks), and at 6 and 9 months after baseline during the follow-up period). The study lists 2 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 NCT06848517, 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 27 Feb 2025.