Pelvic Floor DisordersACTITUD2NCT06014021

Tele-rehabilitation for Female Athletes With Pelvic Floor Dysfunctions

A study testing Pelvic floor muscle training with biofeedback device, Pelvic floor muscle training and Information about pelvic floor and communication with health professionals in people with Pelvic Floor Disorders, run by University of the Balearic Islands at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Pelvic floor dysfunctions (PFD) are especially prevalent among females. As conservative management, strengthening pelvic floor (PF) musculature under health supervision, regard an important research line. However, embarrassment of female athletes limits healthcare demands. Read more about this study

Who is it for?: Ages 18 to 45 years, women only
Conditions the study is for: Pelvic Floor Disorders
What is being tested?: Pelvic floor muscle training with biofeedback device, Pelvic floor muscle training and Information about pelvic floor and communication with health professionals
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 1 siteSpain
Study dates: 15 Sep 2023to 20 Nov 2023
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 45 years
Women only
No healthy volunteers
Adult

Who may be able to join

To train and compete in any of the Track and Field modalities
To have sports license from regional or national Track and Field Federation in the season when study starts.
To have a self-reported pelvic floor disorder (urinary incontinence, fecal incontinence, sexual dysfunction or pelvic organ prolapse).

Who cannot join

To have pelvic pain during the last three months.
To have recurrent infections of urinary tract during the last three months.
To be receiving physiotherapy treatment due to any pelvic floor disorder at the moment of the start of the study.
To have been pregnant during the year prior to the start of the study.

Trial locations and contacts

1 site in 1 country.

Spain1 site

University of the Balearic Islands
Palma de Mallorca, Balearic Islands, 07122

Other trials in Spain

About this study

Official title: Treatment of Urinary Incontinence and Other Pelvic Floor Dysfunctions in Female Athletes

This study will evaluate the effects of a 6-weeks strengthening PF program by using tele-rehabilitation, with or without intracavitary biofeedback, in the PF anatomo-functional characteristics, quality of life and sports performance of female athletes with PFD.

To this end, 45 female athletes with self-reported PFD who train and compete in athletic in Spain will be recruited and randomly distributed in three groups of the experimental study. During 6 weeks, all participants will use an specifically developed Smartphone application (named ACTITUD): the control group (CG) will have access to information about PF and direct communication with healthcare team; experimental group 1 (EG1) will have access to the same information and communication, and will perform a strengthening program for PF, which will be instructed by 3D avatars, while using an intracavitary biofeedback device that will inform about vaginal pressure; the experimental group 2 (EG2) will be similar to EG1, but they will not use the intracavitary biofeedback device.

Before and after these 6 weeks, anatomo-functional PF characteristics, quality of life, PFD symptoms and sports performance of all participants will be evaluated. As an additional outcome, the level of engagement of the athletes from experimental groups to complete the training program will be registered.

Read the detailed description

Female athletes from EG1 and EG2 will complete the strengthening program for PF three times per week, during six weeks. Each session will last about 20 minutes and exercises will be modified every two weeks to meet the principle of training progression and avoid athletes become bored.

Conditions: Pelvic Floor Disorders
Being tested: Pelvic floor muscle training with biofeedback device, Pelvic floor muscle training, Information about pelvic floor and communication with health professionals
Keywords: Female, Athletes, Track and Field, Tele-rehabilitation, Strengthening
Medical subject headings: Pelvic Floor Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pelvic floor muscle training with biofeedback deviceBehavioural
Use of the Smartphone application to perform a strengthening program for pelvic floor musculature, while using an intracavitary biofeedback device that will inform about vaginal pressure.
Pelvic floor muscle trainingBehavioural
Use of the Smartphone application to perform a strengthening program for pelvic floor musculature.
Information about pelvic floor and communication with health professionalsBehavioural
Use of the Smartphone application with access to information about pelvic floor and direct communication with healthcare team.

Study groups in NCT06014021
Study group	Role	What they receive
Experimental group 1	Experimental	All participants will use an Smartphone application with access to information about pelvic floor and communication with healthcare team, and a strengthening program for PF, while using an intracavitary biofeedback device. Receives: Behavioral: Pelvic floor muscle training with biofeedback device; Behavioral: Information about pelvic floor and communication with health professionals
Experimental group 2	Active comparator	All participants will use an Smartphone application with access to information about pelvic floor and communication with healthcare team, and a strengthening program for PF. Receives: Behavioral: Pelvic floor muscle training; Behavioral: Information about pelvic floor and communication with health professionals
Control group	Active comparator	All participants will use an Smartphone application with access to information about pelvic floor and communication with healthcare team. Receives: Behavioral: Information about pelvic floor and communication with health professionals

What is being measured

The primary outcome is the main question the study is designed to answer.

Functional characteristics of pelvic floor musculature with perineometer
Change in the maximal voluntary contraction (MVC) according to the values of pressure collected by a perineometer (in mmHg) after the intervention period and compared to the athletes from the rest of groups. To assess it, participants will perform a maximal contraction of pelvic floor musculature during 3 seconds (three trials with 60 seconds apart). The best trial (the highest pressure) will be collected, as well as the rest vaginal pressure before the first trial of MVC.
Measured: 6 weeks
Anatomical characteristics of pelvic floor structures with ultrasound I
Change in the levator hiatus length (in mm) after the intervention period and compared to the athletes from the rest of groups. This variable will be assessed by using transperineal approach with transducer in longitudinal orientation, at three different functional situations: at rest, while participants perform a maximal voluntary contraction (MVC) of the pelvic floor musculature, and also at straining.
Measured: 6 weeks
Anatomical characteristics of pelvic floor structures with ultrasound II
Change in the anorectal angle (in degrees) and pubourethral angle (in degrees) after the intervention period and compared to the athletes from the rest of groups. These variables will be assessed by using transperineal approach with transducer in longitudinal orientation, at three different functional situations: at rest, while participants perform a maximal voluntary contraction (MVC) of the pelvic floor musculature, and also at straining.
Measured: 6 weeks
Anatomical characteristics of pelvic floor structures with ultrasound III
Change in the symmetry of the bladder base (in mm) at rest and bladder base displacement (in mm) while participants perform a MVC of the pelvic floor musculature (PFM) and also during straining, after the intervention period and compared to the athletes from the rest of groups. These variables will be assessed by using a transabdominal approach with transducer, in transverse orientation.
Measured: 6 weeks
Sports performance through maximal vertical jump
Change in the maximal height that athletes reach with a vertical jump (in meters) after the intervention period and compared to the athletes from the rest of groups. To assess it, participants will perform a maximal countermovement jump (three trials with 30 seconds apart). It will be collected the average of the three trials.
Measured: 6 weeks
Presence of pelvic floor disorders symptomatology
Change in self-reported PFD symptoms through the PFD-SENTINEL questionnaire, after the intervention period and compared to the athletes from the rest of groups. To this end, athletes will reply the proposed PFD-SENTINEL tool consisting of 5 symptoms (urinary incontinence, anal incontinence, pelvic pain, pelvic organ prolapse, and overactive bladder syndrome) and 28 items. The responses to each item are categorized in yes or no. One point will be assigned for the affirmative response to each item. It will be considered the symptom score (presence or not of PFD symptoms),and total score (from 0 to 28 points).
Measured: 6 weeks
Frequency of pelvic floor disorders symptomatology
In case of affirmative response to the presence of one or more PFD symptoms, it will be explore the frequency of the existing symptom. The responses will be graded on a 4-point scale indicating how often women have each symptom (1 = rarely, 2 = sometimes, 3 = often, and 4 = always). It will be explored the change after the intervention period and compared to the athletes from the rest of groups.
Measured: 6 weeks
Sexual dysfunction symptomatology
Change in self-reported sexual dysfunction symptoms through The Female Sexual Function Index (FSFI), after the intervention period and compared to the athletes from the rest of groups. This scale consists of 19 items that assess sexual function over the past 4 weeks and yield domain scores in six areas: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. The responses to each item are graded as follows: 1 = never or very low, 2 = rarely or low, 3 = sometimes or moderate, 4 = often or high, 5 = always or very high. It will be consider individual score for each area (max 6 points) and total score (max 36 points).
Measured: 6 weeks
Level of quality of life
It will be explore the change in quality of life due to the pelvic floor disorders symptoms (according to a scale from 0, no affection, to 10, maximal affection) after the intervention period and compared to the athletes from the rest of groups.
Measured: 6 weeks

Secondary outcomes (1)

Engagement to training program
Percentage of training program sessions that athletes from experimental groups completed during the six weeks of intervention, according to the number of proposed sessions (three times per week).
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Sep 202320 Nov 2023

First posted28 Aug 2023
Study start15 Sep 2023
Primary completion5 Oct 2023
Study completion20 Nov 2023

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 Pelvic Floor DisordersStudies 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: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06014021
Sponsor's protocol ID: 124CER19_
Acronym: ACTITUD2
Status last verified: Mar 2024
First submitted: 22 Aug 2023
Last updated: 2 Apr 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Rodriguez-Lopez ES, Acevedo-Gomez MB, Romero-Franco N, Basas-Garcia A, Ramirez-Parenteau C, Calvo-Moreno SO, Fernandez-Dominguez JC. Urinary Incontinence Among Elite Track and Field Athletes According to Their Event Specialization: A Cross-Sectional Study. Sports Med Open. 2022 Jun 15;8(1):78. doi: 10.1186/s40798-022-00468-1.
PubMed 35704136
Romero-Franco N, Molina-Mula J, Bosch-Donate E, Casado A. Therapeutic exercise to improve pelvic floor muscle function in a female sporting population: a systematic review and meta-analysis. Physiotherapy. 2021 Dec;113:44-52. doi: 10.1016/j.physio.2021.04.006. Epub 2021 Apr 29.
PubMed 34555673

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
Effects of Pelvic Floor Muscle Training and a Modified Lumbopelvic Belt on Pain, Kinesiophobia, and Functional Status in Pregnant Women With Symphysis Pubis Pain
Symphysis Pubis Dysfunction, Pregnancy
Not yet recruitingObservational study
Clinical, Functional, and Therapeutic Characterization of Women With Urinary Incontinence and Analysis of Factors Associated With Treatment Response
Urinary Incontinence (UI)
Not yet recruiting
Integrated Care Pathway for Hormonally Mediated Vestibulodynia: a Feasibility and Acceptability Pilot
Vestibulodynia, Vulvodynia
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)

All Pelvic Floor Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of Urinary Incontinence and Other Pelvic Floor Dysfunctions in Female Athletes
ClinicalTrials.gov ID: NCT06014021
Acronym / sponsor ID: ACTITUD2 / 124CER19_
Conditions: Pelvic Floor Disorders
Keywords: Female, Athletes, Track and Field, Tele-rehabilitation, Strengthening
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: University of the Balearic IslandsUniversity, hospital or other
Collaborators: Fundació d'investigació Sanitària de les Illes Balears, Consejo Superior de Deportes, Spain
Study start: 15 Sep 2023 (actual)
Primary completion: 5 Oct 2023 (actual)
Study completion: 20 Nov 2023 (actual)
First posted: 28 Aug 2023 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Experimental group 1	Experimental	Behavioral: Pelvic floor muscle training with biofeedback device, Behavioral: Information about pelvic floor and communication with health professionalsAll participants will use an Smartphone application with access to information about pelvic floor and communication with healthcare team, and a strengthening program for PF, while using an intracavitary biofeedback device.
Experimental group 2	Active comparator	Behavioral: Pelvic floor muscle training, Behavioral: Information about pelvic floor and communication with health professionalsAll participants will use an Smartphone application with access to information about pelvic floor and communication with healthcare team, and a strengthening program for PF.
Control group	Active comparator	Behavioral: Information about pelvic floor and communication with health professionalsAll participants will use an Smartphone application with access to information about pelvic floor and communication with healthcare team.

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

To train and compete in any of the Track and Field modalities
To have sports license from regional or national Track and Field Federation in the season when study starts.
To have a self-reported pelvic floor disorder (urinary incontinence, fecal incontinence, sexual dysfunction or pelvic organ prolapse).

Key exclusion criteria (4 listed)

To have pelvic pain during the last three months.
To have recurrent infections of urinary tract during the last three months.
To be receiving physiotherapy treatment due to any pelvic floor disorder at the moment of the start of the study.
To have been pregnant during the year prior to the start of the study.

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 with biofeedback deviceUse of the Smartphone application to perform a strengthening program for pelvic floor musculature, while using an intracavitary biofeedback device that will inform about vaginal pressure.	Behavioural	Experimental group 1
Pelvic floor muscle trainingUse of the Smartphone application to perform a strengthening program for pelvic floor musculature.	Behavioural	Experimental group 2
Information about pelvic floor and communication with health professionalsUse of the Smartphone application with access to information about pelvic floor and direct communication with healthcare team.	Behavioural	Control group, Experimental group 1, Experimental group 2

Primary outcome

Functional characteristics of pelvic floor musculature with perineometer
Time frame: 6 weeks
Change in the maximal voluntary contraction (MVC) according to the values of pressure collected by a perineometer (in mmHg) after the intervention period and compared to the athletes from the rest of groups. To assess it, participants will perform a maximal contraction of pelvic floor musculature during 3 seconds (three trials with 60 seconds apart). The best trial (the highest pressure) will be collected, as well as the rest vaginal pressure before the first trial of MVC.
Anatomical characteristics of pelvic floor structures with ultrasound I
Time frame: 6 weeks
Change in the levator hiatus length (in mm) after the intervention period and compared to the athletes from the rest of groups. This variable will be assessed by using transperineal approach with transducer in longitudinal orientation, at three different functional situations: at rest, while participants perform a maximal voluntary contraction (MVC) of the pelvic floor musculature, and also at straining.
Anatomical characteristics of pelvic floor structures with ultrasound II
Time frame: 6 weeks
Change in the anorectal angle (in degrees) and pubourethral angle (in degrees) after the intervention period and compared to the athletes from the rest of groups. These variables will be assessed by using transperineal approach with transducer in longitudinal orientation, at three different functional situations: at rest, while participants perform a maximal voluntary contraction (MVC) of the pelvic floor musculature, and also at straining.
Anatomical characteristics of pelvic floor structures with ultrasound III
Time frame: 6 weeks
Change in the symmetry of the bladder base (in mm) at rest and bladder base displacement (in mm) while participants perform a MVC of the pelvic floor musculature (PFM) and also during straining, after the intervention period and compared to the athletes from the rest of groups. These variables will be assessed by using a transabdominal approach with transducer, in transverse orientation.
Sports performance through maximal vertical jump
Time frame: 6 weeks
Change in the maximal height that athletes reach with a vertical jump (in meters) after the intervention period and compared to the athletes from the rest of groups. To assess it, participants will perform a maximal countermovement jump (three trials with 30 seconds apart). It will be collected the average of the three trials.
Presence of pelvic floor disorders symptomatology
Time frame: 6 weeks
Change in self-reported PFD symptoms through the PFD-SENTINEL questionnaire, after the intervention period and compared to the athletes from the rest of groups. To this end, athletes will reply the proposed PFD-SENTINEL tool consisting of 5 symptoms (urinary incontinence, anal incontinence, pelvic pain, pelvic organ prolapse, and overactive bladder syndrome) and 28 items. The responses to each item are categorized in yes or no. One point will be assigned for the affirmative response to each item. It will be considered the symptom score (presence or not of PFD symptoms),and total score (from 0 to 28 points).
Frequency of pelvic floor disorders symptomatology
Time frame: 6 weeks
In case of affirmative response to the presence of one or more PFD symptoms, it will be explore the frequency of the existing symptom. The responses will be graded on a 4-point scale indicating how often women have each symptom (1 = rarely, 2 = sometimes, 3 = often, and 4 = always). It will be explored the change after the intervention period and compared to the athletes from the rest of groups.
Sexual dysfunction symptomatology
Time frame: 6 weeks
Change in self-reported sexual dysfunction symptoms through The Female Sexual Function Index (FSFI), after the intervention period and compared to the athletes from the rest of groups. This scale consists of 19 items that assess sexual function over the past 4 weeks and yield domain scores in six areas: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. The responses to each item are graded as follows: 1 = never or very low, 2 = rarely or low, 3 = sometimes or moderate, 4 = often or high, 5 = always or very high. It will be consider individual score for each area (max 6 points) and total score (max 36 points).
Level of quality of life
Time frame: 6 weeks
It will be explore the change in quality of life due to the pelvic floor disorders symptoms (according to a scale from 0, no affection, to 10, maximal affection) after the intervention period and compared to the athletes from the rest of groups.

1 secondary outcome

Engagement to training program
Time frame: 6 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 2 Apr 2024.
Results publication: PubMed 35704136Rodriguez-Lopez ES, Acevedo-Gomez MB, Romero-Franco N, Basas-Garcia A, Ramirez-Parenteau C, Calvo-Moreno SO, Fernandez-Dominguez JC. Urinary Incontinence Among Elite Track and Field Athletes According to Their Event Specialization: A Cross-Sectional Study. Sports Med Open. 2022 Jun 15;8(1):78. doi: 10.1186/s40798-022-00468-1.
Results publication: PubMed 34555673Romero-Franco N, Molina-Mula J, Bosch-Donate E, Casado A. Therapeutic exercise to improve pelvic floor muscle function in a female sporting population: a systematic review and meta-analysis. Physiotherapy. 2021 Dec;113:44-52. doi: 10.1016/j.physio.2021.04.006. Epub 2021 Apr 29.
Individual participant dataSharing planned: No

Related trials for Pelvic Floor Disorders

Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
Effects of Pelvic Floor Muscle Training and a Modified Lumbopelvic Belt on Pain, Kinesiophobia, and Functional Status in Pregnant Women With Symphysis Pubis Pain
Symphysis Pubis Dysfunction, Pregnancy
Not yet recruitingObservational study
Clinical, Functional, and Therapeutic Characterization of Women With Urinary Incontinence and Analysis of Factors Associated With Treatment Response
Urinary Incontinence (UI)
Not yet recruiting
Integrated Care Pathway for Hormonally Mediated Vestibulodynia: a Feasibility and Acceptability Pilot
Vestibulodynia, Vulvodynia
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)

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.

Natalia Romero-Franco principal investigator

University of the Balearic Islands

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 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 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. 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?

Functional characteristics of pelvic floor musculature with perineometer (time frame: 6 weeks). The study lists 9 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 NCT06014021, 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 Apr 2024.