Stress Urinary IncontinenceNCT05114395
Comparison Between a Telerehabilitation Program for Urinary Incontinence Versus a Conventional Face-to-face Program
A study testing Pelvic Floor Telerehabilitation Program and Pelvic Floor Face-to-Face Program in people with Stress Urinary Incontinence and Incontinence, Urinary, run by Centro Hospitalar De São João, E.P.E. at 2 sites in Portugal.
Trial summary
Urinary incontinence (UI) is defined as any involuntary loss of urine. It affects a significant percentage of the population, mainly female, with a prevalence of 21.4% in Portuguese women, having a negative impact on quality of life and sexual function. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Stress Urinary Incontinence, Incontinence, Urinary, Covid19
- What is being tested?
- Pelvic Floor Telerehabilitation Program and Pelvic Floor Face-to-Face Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesPortugal
- Study dates
- 8 Mar 2021to 9 Aug 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged between 18 and 65 years with SUI or MUI with a predominance of SUI with at least 1 urinary incontinence episode per week in the last month
- Pelvic floor muscle strength greater than or equal to 2 (modified Oxford scale)
- Capable of understanding and executing the therapeutic program and expressing agreement to participate in the study after free and informed consent
Who cannot join
- Patients with urgency urinary incontinence or MUI with a predominance of urgency
- Pregnant women
- Submitted to conservative or surgical treatment of UI in the last 12 months
- Active urinary tract infection
- Macroscopic hematuria
- Neurogenic dysfunction of the lower urinary tract
Show all 12Show fewer
- Cognitive deficit
- Osteoarticular, neurological or psychiatric pathologies that prevent the realization of the therapeutic program
- Active pelvic neoplasia
- Pelvic organ prolapse grade greater than or equal to 2
- Impossibility of access or illiteracy to technological means (phone or computer)
- Unavailable to attend the face-to-face program due to accessibility, schedule, economic reasons or fear of the pandemic context
Trial locations and contacts
2 sites in 1 country.
Portugal2 sites
Physical and Rehabilitation Medicine Department - Centro Hospitalar Universitário de São João
Porto, 4200-319
Susana Cristina Alves Moreira
Porto, 4200-319
About this study
Official title: Comparison Between a Telerehabilitation Program for Urinary Incontinence Versus a Conventional Face-to-face Program: a Longitudinal Study in Pandemic Times
Urinary incontinence (UI) is defined as any involuntary loss of urine. It affects a significant percentage of the population, mainly female, with a prevalence of 21.4% in Portuguese women, having a negative impact on quality of life and sexual function.
About half presents with stress UI (SUI), followed by mixed UI (MUI), with isolated urgency UI being less common.
Read more
Pelvic floor rehabilitiation is a first line treatment for SUI and MUI, however, it is not yet defined which is the best treatment program or the ideal strategies to improve adherence to it.
Telerehabilitation assumed a leading role in the covid pandemic phase, although there are few studies on pelvic floor rehabilitation for UI, none in Portugal to date.
The authors aim to evaluate the effectiveness of a hybrid program of pelvic floor rehabilitation in female patients with SUI and MUI with a predominance of SUI, including consultation and face-to-face sessions complemented with telerehabilitation.
Read the detailed description
Randomized longitudinal study including consecutively admitted patients on pelvic floor rehabilitation consultation of the Physical Medicine and Rehabilitation Department of Centro Hospitalar São João for conservative treatment of UI.
Patients who meet the inclusion criteria and do not meet any of the exclusion criteria will be randomized one to one between the intervention group and the control group.
The intervention group includes a hybrid program of face-to-face sessions followed by sessions of video, while the control group develops the entire program in face-to-face sessions.
The effectiveness of the program will be assessed by the results in the UI-related quality of life (primary outcome); UI severity, patient's overall perception of improvement, sexual function, depression/anxiety symptoms and satisfaction and adherence to treatment (secondary outcomes).
- Being tested
- Pelvic Floor Telerehabilitation Program, Pelvic Floor Face-to-Face Program
- Keywords
- Pelvic floor, Physical therapy, Urinary incontinence, Quality of life, Telerehabilitation, Training, Pelvic floor musculature, Female, Pelvic Floor Muscle Training
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor Telerehabilitation ProgramOther
See experimental and active comparator arms.
Pelvic Floor Face-to-Face ProgramOther
See experimental and active comparator arms.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation Group | Experimental | The intervention group includes a hybrid program of face-to-face sessions and video sessions. In the first consultation, a face-to-face one, patients will be instructed with behavioral and lifestyle measures and it will be prescribed a 12-week exercise program, including exercises to be performed three times a day and two weekly exercise sessions - three face-to-face sessions (2 initial and one at 8 weeks) and video sessions of 30 minutes, divided into 3 phases with gradual addition of exercises of increasing difficulty in terms of duration, number of repetitions and positions.
In the middle of the treatment (at 6 weeks) a medical teleconsultation is performed for reassessment. In the end of the 12-week program there will also be a face-to-face consultation. Receives: Other: Pelvic Floor Telerehabilitation Program |
| Face-to-Face Group | Active comparator | The control group develops the entire program in face-to-face consultations and exercise sessions. Receives: Other: Pelvic Floor Face-to-Face Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of urinary incontinence related quality of life using the Portuguese Version of the King's Health Questionnaire (KHQ).
The primary outcome is the assessment of urinary incontinence related quality of life using the Portuguese Version of KHQ.
Measured: From admission to discharge of the program, up to 13 weeks.
Secondary outcomes (7)
Assessment of UI severity.
Assessment of UI severity using the International Continence Society (ICS) pad test.
Measured: From admission to discharge of the program, up to 13 weeks.
Evaluation of the global perception of improvement of the patient.
Evaluation of the global perception of improvement of the patient using the Portuguese version of the Patient Global Impression of Improvement (PGI-I) Scale.
The minimum value is 0 and the maximum is 10. A higher score means a better outcome.
Measured: From admission to discharge of the program, up to 13 weeks.
Evaluation of sexual function.
Evaluation of sexual function using the Portuguese version of the Female Sexual Functioning Index (FSFI)
Measured: From admission to discharge of the program, up to 13 weeks.
Assessment of the presence of symptoms of depression/anxiety.
Assessment of the presence of symptoms of depression/anxiety using the Portuguese version of the Hospital Anxiety \& Depression Scale (HADS) questionnaire.
The minimum value is 0 and the maximum is 21. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.
Measured: From admission to discharge of the program, up to 13 weeks.
Assessment of satisfaction with the treatment.
Assessment of satisfaction with the treatment using the 9-point Likert scale. The minimum value is 1 and the maximum is 9. A higher score means a better outcome.
Measured: From admission to discharge of the program, up to 13 weeks.
Assessment of adherence to the treatment.
Assessment of adherence to the treatment including compliance to the exercise program (number of performed sessions) and to the behavioral measures.
Measured: From admission to discharge of the program, up to 13 weeks.
Assessment of UI severity.
Assessment of UI severity using the Portuguese version of the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF).
Measured: From admission to discharge of the program, up to 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start8 Mar 2021
- Primary completion12 Jul 2021
- Study completion9 Aug 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.
- 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar De São João, E.P.E.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susana Moreira, Centro Hospitalar De São João, E.P.E.
- Investigators
- Susana Moreira, Principal investigator, Centro Hospitalar De São João, E.P.E.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114395
- Sponsor's protocol ID
- CE 114-21
- Status last verified
- Nov 2021
- First submitted
- 26 May 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
D'Ancona C, Haylen B, Oelke M, Abranches-Monteiro L, Arnold E, Goldman H, Hamid R, Homma Y, Marcelissen T, Rademakers K, Schizas A, Singla A, Soto I, Tse V, de Wachter S, Herschorn S; Standardisation Steering Committee ICS and the ICS Working Group on Terminology for Male Lower Urinary Tract & Pelvic Floor Symptoms and Dysfunction. The International Continence Society (ICS) report on the terminology for adult male lower urinary tract and pelvic floor symptoms and dysfunction. Neurourol Urodyn. 2019 Feb;38(2):433-477. doi: 10.1002/nau.23897. Epub 2019 Jan 25.
PubMed 30681183Correia S, Dinis P, Rolo F, Lunet N. Prevalence, treatment and known risk factors of urinary incontinence and overactive bladder in the non-institutionalized Portuguese population. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Dec;20(12):1481-9. doi: 10.1007/s00192-009-0975-x. Epub 2009 Aug 14.
PubMed 19684999Hay-Smith EJ, Bo Berghmans LC, Hendriks HJ, de Bie RA, van Waalwijk van Doorn ES. Pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2001;(1):CD001407. doi: 10.1002/14651858.CD001407.
PubMed 11279716Carrion Perez F, Rodriguez Moreno MS, Carnerero Cordoba L, Romero Garrido MC, Quintana Tirado L, Garcia Montes I. [Telerehabilitation to treat stress urinary incontinence. Pilot study]. Med Clin (Barc). 2015 May 21;144(10):445-8. doi: 10.1016/j.medcli.2014.05.036. Epub 2014 Jul 30. Spanish.
PubMed 25087210Santiago M, Cardoso-Teixeira P, Pereira S, Firmino-Machado J, Moreira S. A Hybrid-Telerehabilitation Versus a Conventional Program for Urinary Incontinence: a Randomized Trial during COVID-19 Pandemic. Int Urogynecol J. 2023 Mar;34(3):717-727. doi: 10.1007/s00192-022-05108-6. Epub 2022 May 21.
PubMed 35596802
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between a Telerehabilitation Program for Urinary Incontinence Versus a Conventional Face-to-face Program: a Longitudinal Study in Pandemic Times
- ClinicalTrials.gov ID
- NCT05114395
- Acronym / sponsor ID
- CE 114-21
- Keywords
- Pelvic floor, Physical therapy, Urinary incontinence, Quality of life, Telerehabilitation, Training, Pelvic floor musculature, Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Centro Hospitalar De São João, E.P.E.University, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 12 Jul 2021 (actual)
- Study completion
- 9 Aug 2021 (actual)
- First posted
- 10 Nov 2021 (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.
Urinary incontinence (UI) is defined as any involuntary loss of urine. It affects a significant percentage of the population, mainly female, with a prevalence of 21.4% in Portuguese women, having a negative impact on quality of life and sexual function.
About half presents with stress UI (SUI), followed by mixed UI (MUI), with isolated urgency UI being less common.
Pelvic floor rehabilitiation is a first line treatment for SUI and MUI, however, it is not yet defined which is the best treatment program or the ideal strategies to improve adherence to it.
Telerehabilitation assumed a leading role in the covid pandemic phase, although there are few studies on pelvic floor rehabilitation for UI, none in Portugal to date.
The authors aim to evaluate the effectiveness of a hybrid program of pelvic floor rehabilitation in female patients with SUI and MUI with a predominance of SUI, including consultation and face-to-face sessions complemented with telerehabilitation.
Detailed description
Randomized longitudinal study including consecutively admitted patients on pelvic floor rehabilitation consultation of the Physical Medicine and Rehabilitation Department of Centro Hospitalar São João for conservative treatment of UI.
Patients who meet the inclusion criteria and do not meet any of the exclusion criteria will be randomized one to one between the intervention group and the control group.
The intervention group includes a hybrid program of face-to-face sessions followed by sessions of video, while the control group develops the entire program in face-to-face sessions.
The effectiveness of the program will be assessed by the results in the UI-related quality of life (primary outcome); UI severity, patient's overall perception of improvement, sexual function, depression/anxiety symptoms and satisfaction and adherence to treatment (secondary outcomes).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation Group | Experimental | Other: Pelvic Floor Telerehabilitation ProgramThe intervention group includes a hybrid program of face-to-face sessions and video sessions. In the first consultation, a face-to-face one, patients will be instructed with behavioral and lifestyle measures and it will be prescribed a 12-week exercise program, including exercises to be performed three times a day and two weekly exercise sessions - three face-to-face sessions (2 initial and one at 8 weeks) and video sessions of 30 minutes, divided into 3 phases with gradual addition of exercises of increasing difficulty in terms of duration, number of repetitions and positions. In the middle of the treatment (at 6 weeks) a medical teleconsultation is performed for reassessment. In the end of the 12-week program there will also be a face-to-face consultation. |
| Face-to-Face Group | Active comparator | Other: Pelvic Floor Face-to-Face ProgramThe control group develops the entire program in face-to-face consultations and exercise sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients aged between 18 and 65 years with SUI or MUI with a predominance of SUI with at least 1 urinary incontinence episode per week in the last month
- Pelvic floor muscle strength greater than or equal to 2 (modified Oxford scale)
- Capable of understanding and executing the therapeutic program and expressing agreement to participate in the study after free and informed consent
Key exclusion criteria (12 listed)
- Patients with urgency urinary incontinence or MUI with a predominance of urgency
- Pregnant women
- Submitted to conservative or surgical treatment of UI in the last 12 months
- Active urinary tract infection
- Macroscopic hematuria
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 Telerehabilitation ProgramSee experimental and active comparator arms. | Other | Telerehabilitation Group |
| Pelvic Floor Face-to-Face ProgramSee experimental and active comparator arms. | Other | Face-to-Face Group |
Primary outcome
Assessment of urinary incontinence related quality of life using the Portuguese Version of the King's Health Questionnaire (KHQ).
Time frame: From admission to discharge of the program, up to 13 weeks.
The primary outcome is the assessment of urinary incontinence related quality of life using the Portuguese Version of KHQ.
7 secondary outcomes
Assessment of UI severity.
Time frame: From admission to discharge of the program, up to 13 weeks.
Evaluation of the global perception of improvement of the patient.
Time frame: From admission to discharge of the program, up to 13 weeks.
Evaluation of sexual function.
Time frame: From admission to discharge of the program, up to 13 weeks.
Assessment of the presence of symptoms of depression/anxiety.
Time frame: From admission to discharge of the program, up to 13 weeks.
Assessment of satisfaction with the treatment.
Time frame: From admission to discharge of the program, up to 13 weeks.
Assessment of adherence to the treatment.
Time frame: From admission to discharge of the program, up to 13 weeks.
Assessment of UI severity.
Time frame: From admission to discharge of the program, up to 16 weeks.
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 10 Nov 2021.
- Background: PubMed 30681183D'Ancona C, Haylen B, Oelke M, Abranches-Monteiro L, Arnold E, Goldman H, Hamid R, Homma Y, Marcelissen T, Rademakers K, Schizas A, Singla A, Soto I, Tse V, de Wachter S, Herschorn S; Standardisation Steering Committee ICS and the ICS Working Group on Terminology for Male Lower Urinary Tract & Pelvic Floor Symptoms and Dysfunction. The International Continence Society (ICS) report on the terminology for adult male lower urinary tract and pelvic floor symptoms and dysfunction. Neurourol Urodyn. 2019 Feb;38(2):433-477. doi: 10.1002/nau.23897. Epub 2019 Jan 25.
- Background: PubMed 19684999Correia S, Dinis P, Rolo F, Lunet N. Prevalence, treatment and known risk factors of urinary incontinence and overactive bladder in the non-institutionalized Portuguese population. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Dec;20(12):1481-9. doi: 10.1007/s00192-009-0975-x. Epub 2009 Aug 14.
- Background: PubMed 11279716Hay-Smith EJ, Bo Berghmans LC, Hendriks HJ, de Bie RA, van Waalwijk van Doorn ES. Pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2001;(1):CD001407. doi: 10.1002/14651858.CD001407.
- Background: PubMed 25087210Carrion Perez F, Rodriguez Moreno MS, Carnerero Cordoba L, Romero Garrido MC, Quintana Tirado L, Garcia Montes I. [Telerehabilitation to treat stress urinary incontinence. Pilot study]. Med Clin (Barc). 2015 May 21;144(10):445-8. doi: 10.1016/j.medcli.2014.05.036. Epub 2014 Jul 30. Spanish.
- Derived from this study: PubMed 35596802Santiago M, Cardoso-Teixeira P, Pereira S, Firmino-Machado J, Moreira S. A Hybrid-Telerehabilitation Versus a Conventional Program for Urinary Incontinence: a Randomized Trial during COVID-19 Pandemic. Int Urogynecol J. 2023 Mar;34(3):717-727. doi: 10.1007/s00192-022-05108-6. Epub 2022 May 21.
- 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.
Susana Moreira principal investigator
Centro Hospitalar De São João, E.P.E.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic Floor Telerehabilitation Program and Pelvic Floor Face-to-Face Program in people with Stress Urinary Incontinence and Incontinence, Urinary, run by Centro Hospitalar De São João, E.P.E. at 2 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 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: finished, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. 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?
Assessment of urinary incontinence related quality of life using the Portuguese Version of the King's Health Questionnaire (KHQ). (time frame: From admission to discharge of the program, up to 13 weeks.). 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 NCT05114395, 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 10 Nov 2021; AzTrials last refreshed its copy on 30 Oct 2026.