Pelvic Floor DisordersNCT06814743
A Mobile Application for Female Athletes With Pelvic Floor Dysfunctions (ACTITUD2.0)
A study testing Pelvic floor exercises program guided with an intravaginal biofeedback device, Pelvic floor exercises program 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.
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 exercises program guided with an intravaginal biofeedback device, Pelvic floor exercises program 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
- 107 participants
- Where
- 1 siteSpain
- Study dates
- 10 Feb 2025to 30 Sep 2025
- 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 sport.
- To have a self-reported pelvic floor disorder (urinary incontinence, anorectal incontinence, sexual dysfunction or chronic pelvic pain).
Who cannot join
- 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.
About this study
Official title: Analysis, Awareness and Tele-rehabilitation of Urinary Incontinence and Other Pelvic Floor Dysfunctions in Female Athletes
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. New technologies could facilitate an autonomous but supervised tele-rehabilitation programs.
This study will evaluate the effects of a 12-weeks program with exercises focused on PF awareness and strengthening by using a mobile application supervised by physiotherapists, with or without intracavitary biofeedback, on the PF anatomical and functional characteristics, symptomatology and sports performance of female athletes with PFD.
Read more
To this end, 105 female athletes with self-reported PFD who train and compete in sport in Spain will be recruited and randomly distributed in three groups of the experimental study. During 12 weeks, all participants will use the mobile 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 the exercise program for PF; the experimental group 2 (EG2) will be similar to EG1, but they will use an intravaginal biofeedback device during exercises to receive information about their intra-vaginal pressure.
Before and after these 12 weeks, anatomical and functional PF characteristics, PF symptoms and sports performance of all participants will be evaluated. As additional outcome, the compliance of the athletes from experimental groups to complete the training program will be registered (in %).
Read the detailed description
Female athletes from EG1 and EG2 will complete the exercise program for PF three times per week, during 12 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 exercises program guided with an intravaginal biofeedback device, Pelvic floor exercises program, Information about pelvic floor and communication with health professionals
- Keywords
- Female, Athletes, e-Health, Exercises
- Medical subject headings
- Pelvic Floor Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor exercises program guided with an intravaginal biofeedback deviceBehavioural
Also called Information about pelvic floor and communication with health professionals
Use of the mobile application to perform a exercise program for pelvic floor musculature, while using an intracavitary biofeedback device that will inform about vaginal pressure. Behavioral: mobile application with access to information about pelvic floor and direct communication with healthcare team.
Pelvic floor exercises programBehavioural
Also called Information about pelvic floor and communication with health professionals
Use of the mobile application to perform a exercise program for pelvic floor musculature.
Behavioral: Information about pelvic floor and communication with health professionals Use of the mobile application with access to information about pelvic floor and direct communication with healthcare team.
Information about pelvic floor and communication with health professionalsBehavioural
Use of the mobile application with access to information about pelvic floor and direct communication with healthcare team.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group 2: Exercises with biofeedback guidance | Experimental | All participants will use a mobile application with access to information about pelvic floor and communication with healthcare team, and a exercise program for pelvic floor, while using an intravaginal biofeedback device. Receives: Behavioral: Pelvic floor exercises program guided with an intravaginal biofeedback device; Behavioral: Pelvic floor exercises program; Behavioral: Information about pelvic floor and communication with health professionals |
| Experimental group 1: Exercises | Active comparator | All participants will use a mobile application with access to information about pelvic floor and communication with healthcare team, and a exercise program for pelvic floor. Receives: Behavioral: Pelvic floor exercises program; Behavioral: Information about pelvic floor and communication with health professionals |
| Control group: No exercises | Active comparator | All participants will use a mobile 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
Change in the pelvic floor strength according to the modified grading Oxford Scale (graded from 0 - minimal strength- to 5 points - maximal strength) after the intervention period and compared to the athletes from the rest of groups. To assess it, the evaluator will insert the first two phalanges of the second and third fingers smeared in lubricant gel with a gloved hand into the anterior third of the vaginal opening and will request a maximal voluntary contraction (MVC) by giving the command "contract the anus, do as if you wanted to hold a strong desire to void".
Measured: 12 weeks
Functional characteristics of pelvic floor musculature with manometry I
Change in the maximal voluntary contraction (MVC) according to the values of pressure collected by a manometer (in cmH20) 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 (two trials with 30 seconds apart). The best trial (the highest pressure) will be collected.
Measured: 12 weeks
Functional characteristics of pelvic floor musculature with manometry II
Change in the vaginal pressure at rest (in cmH20) after the intervention period and compared to the athletes from the rest of groups. To assess it, the probe of the manometer will be covered with a lubricated condom and placed about 3.5 cm proximal to the vaginal introitus, without pain or discomfort. The air in the probe will be emptied before being inserted into the vagina introitus and vaginal pressure at rest will be registered.
Measured: 12 weeks
Functional characteristics of pelvic floor musculature with manometry III
Change in the proprioceptive error during a force sense test (Proprioception) according to the values of pressure collected by a manometer (in cmH20) after the intervention period and compared to the athletes from the rest of groups. To assess it, participants will perform a contraction of pelvic floor musculature at 50% of maximal voluntary contraction (MVC) (TARGET) during 3 seconds (two trials with 10 seconds apart). The difference between the average of the two trials and the target value will be the proprioceptive error (in %).
Measured: 12 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: 12 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: 12 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 maximal voluntary contraction (MVC) of the pelvic floor musculature 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: 12 weeks
Sports performance through maximal vertical jump I
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 60 seconds apart). It will be collected the best of the three trials.
Measured: 12 weeks
Sports performance through maximal vertical jump II
Change in the maximal ground reaction forces during a vertical jump (in Newton) 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 60 seconds apart). It will be collected the best of the three trials.
Measured: 12 weeks
Occurrence of urinary incontinence symptomatology
Change in self-reported pelvic floor symptoms regarding urinary incontinence, assessed through the International Consultation on Incontinence Questionnaire - Short form (ICIQ-SF) after the intervention period and compared to the athletes from the rest of groups. To this end, athletes will reply the proposed tool consisting of 3 questions, with a total score of 21 points. Scoring 0 points will mean that athletes do not have urinary incontinence; score between 1 and 21 will mean a progressively more severe urinary incontinence.
Measured: 12 weeks
Sexual dysfunction symptomatology
Change in self-reported sexual dysfunction symptoms (orgasm and pain domains of the Female Sexual Function Index - FSFI), after the intervention period and compared to the athletes from the rest of groups. The score of each domain is rated from 1 (the worst sexual function) to 15 points (the best sexual function)
Measured: 12 weeks
Occurrence of ano-rectal incontinence
Change in self-reported pelvic floor symptoms regarding ano-rectal incontinence, assessed through the Wexner Scale, after the intervention period and compared to the athletes from the rest of groups. To this end, athletes will reply the proposed tool consisting of 5 questions ranging from 0 (never incontinent) to 4 (always incontinent). A score of 0 points will mean that athletes do not have ano-rectal incontinence. Results in the score from 1 to 20 will mean ano-rectal incontinence progressively more severe.
Measured: 12 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: 12 weeks
Secondary outcomes (1)
Compliance to the proposed pelvic floor exercise program
Percentage of exercises program sessions that athletes from experimental groups 1 and 2 completed during the 12 weeks of intervention, according to the number of proposed sessions (three times per week).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start10 Feb 2025
- Primary completion30 Jun 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Balearic Islands
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Ciencia e Innovación, Spain
- Responsible party
- Sponsor
- Investigators
- Natalia Romero-Franco, Principal investigator, University of the Balearic IslandsNatalia Romero-Franco, PhD, Principal investigator, University of the Balearic Islands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814743
- Sponsor's protocol ID
- 124CER19_2.0
- Status last verified
- Sep 2025
- First submitted
- 21 Jan 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis, Awareness and Tele-rehabilitation of Urinary Incontinence and Other Pelvic Floor Dysfunctions in Female Athletes
- ClinicalTrials.gov ID
- NCT06814743
- Acronym / sponsor ID
- 124CER19_2.0
- Conditions
- Pelvic Floor Disorders
- Keywords
- Female, Athletes, e-Health, Exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- University of the Balearic IslandsUniversity, hospital or other
- Collaborators
- Ministerio de Ciencia e Innovación, Spain
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 7 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.
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. New technologies could facilitate an autonomous but supervised tele-rehabilitation programs.
This study will evaluate the effects of a 12-weeks program with exercises focused on PF awareness and strengthening by using a mobile application supervised by physiotherapists, with or without intracavitary biofeedback, on the PF anatomical and functional characteristics, symptomatology and sports performance of female athletes with PFD.
To this end, 105 female athletes with self-reported PFD who train and compete in sport in Spain will be recruited and randomly distributed in three groups of the experimental study. During 12 weeks, all participants will use the mobile 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 the exercise program for PF; the experimental group 2 (EG2) will be similar to EG1, but they will use an intravaginal biofeedback device during exercises to receive information about their intra-vaginal pressure.
Before and after these 12 weeks, anatomical and functional PF characteristics, PF symptoms and sports performance of all participants will be evaluated. As additional outcome, the compliance of the athletes from experimental groups to complete the training program will be registered (in %).
Detailed description
Female athletes from EG1 and EG2 will complete the exercise program for PF three times per week, during 12 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.
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 2: Exercises with biofeedback guidance | Experimental | Behavioral: Pelvic floor exercises program guided with an intravaginal biofeedback device, Behavioral: Pelvic floor exercises program, Behavioral: Information about pelvic floor and communication with health professionalsAll participants will use a mobile application with access to information about pelvic floor and communication with healthcare team, and a exercise program for pelvic floor, while using an intravaginal biofeedback device. |
| Experimental group 1: Exercises | Active comparator | Behavioral: Pelvic floor exercises program, Behavioral: Information about pelvic floor and communication with health professionalsAll participants will use a mobile application with access to information about pelvic floor and communication with healthcare team, and a exercise program for pelvic floor. |
| Control group: No exercises | Active comparator | Behavioral: Information about pelvic floor and communication with health professionalsAll participants will use a mobile 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 (2 listed)
- To train and compete in any sport.
- To have a self-reported pelvic floor disorder (urinary incontinence, anorectal incontinence, sexual dysfunction or chronic pelvic pain).
Key exclusion criteria (3 listed)
- 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 exercises program guided with an intravaginal biofeedback deviceAlso: Information about pelvic floor and communication with health professionalsUse of the mobile application to perform a exercise program for pelvic floor musculature, while using an intracavitary biofeedback device that will inform about vaginal pressure. Behavioral: mobile application with access to information about pelvic floor and direct communication with healthcare team. | Behavioural | Experimental group 2: Exercises with biofeedback guidance |
| Pelvic floor exercises programAlso: Information about pelvic floor and communication with health professionalsUse of the mobile application to perform a exercise program for pelvic floor musculature. Behavioral: Information about pelvic floor and communication with health professionals Use of the mobile application with access to information about pelvic floor and direct communication with healthcare team. | Behavioural | Experimental group 1: Exercises, Experimental group 2: Exercises with biofeedback guidance |
| Information about pelvic floor and communication with health professionalsUse of the mobile application with access to information about pelvic floor and direct communication with healthcare team. | Behavioural | Control group: No exercises, Experimental group 1: Exercises, Experimental group 2: Exercises with biofeedback guidance |
Primary outcome
Functional characteristics of pelvic floor musculature
Time frame: 12 weeks
Change in the pelvic floor strength according to the modified grading Oxford Scale (graded from 0 - minimal strength- to 5 points - maximal strength) after the intervention period and compared to the athletes from the rest of groups. To assess it, the evaluator will insert the first two phalanges of the second and third fingers smeared in lubricant gel with a gloved hand into the anterior third of the vaginal opening and will request a maximal voluntary contraction (MVC) by giving the command "contract the anus, do as if you wanted to hold a strong desire to void".
Functional characteristics of pelvic floor musculature with manometry I
Time frame: 12 weeks
Change in the maximal voluntary contraction (MVC) according to the values of pressure collected by a manometer (in cmH20) 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 (two trials with 30 seconds apart). The best trial (the highest pressure) will be collected.
Functional characteristics of pelvic floor musculature with manometry II
Time frame: 12 weeks
Change in the vaginal pressure at rest (in cmH20) after the intervention period and compared to the athletes from the rest of groups. To assess it, the probe of the manometer will be covered with a lubricated condom and placed about 3.5 cm proximal to the vaginal introitus, without pain or discomfort. The air in the probe will be emptied before being inserted into the vagina introitus and vaginal pressure at rest will be registered.
Functional characteristics of pelvic floor musculature with manometry III
Time frame: 12 weeks
Change in the proprioceptive error during a force sense test (Proprioception) according to the values of pressure collected by a manometer (in cmH20) after the intervention period and compared to the athletes from the rest of groups. To assess it, participants will perform a contraction of pelvic floor musculature at 50% of maximal voluntary contraction (MVC) (TARGET) during 3 seconds (two trials with 10 seconds apart). The difference between the average of the two trials and the target value will be the proprioceptive error (in %).
Anatomical characteristics of pelvic floor structures with ultrasound I
Time frame: 12 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: 12 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: 12 weeks
Change in the symmetry of the bladder base (in mm) at rest and bladder base displacement (in mm) while participants perform a maximal voluntary contraction (MVC) of the pelvic floor musculature 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 I
Time frame: 12 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 60 seconds apart). It will be collected the best of the three trials.
Sports performance through maximal vertical jump II
Time frame: 12 weeks
Change in the maximal ground reaction forces during a vertical jump (in Newton) 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 60 seconds apart). It will be collected the best of the three trials.
Occurrence of urinary incontinence symptomatology
Time frame: 12 weeks
Change in self-reported pelvic floor symptoms regarding urinary incontinence, assessed through the International Consultation on Incontinence Questionnaire - Short form (ICIQ-SF) after the intervention period and compared to the athletes from the rest of groups. To this end, athletes will reply the proposed tool consisting of 3 questions, with a total score of 21 points. Scoring 0 points will mean that athletes do not have urinary incontinence; score between 1 and 21 will mean a progressively more severe urinary incontinence.
Sexual dysfunction symptomatology
Time frame: 12 weeks
Change in self-reported sexual dysfunction symptoms (orgasm and pain domains of the Female Sexual Function Index - FSFI), after the intervention period and compared to the athletes from the rest of groups. The score of each domain is rated from 1 (the worst sexual function) to 15 points (the best sexual function)
Occurrence of ano-rectal incontinence
Time frame: 12 weeks
Change in self-reported pelvic floor symptoms regarding ano-rectal incontinence, assessed through the Wexner Scale, after the intervention period and compared to the athletes from the rest of groups. To this end, athletes will reply the proposed tool consisting of 5 questions ranging from 0 (never incontinent) to 4 (always incontinent). A score of 0 points will mean that athletes do not have ano-rectal incontinence. Results in the score from 1 to 20 will mean ano-rectal incontinence progressively more severe.
Level of quality of life
Time frame: 12 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
Compliance to the proposed pelvic floor exercise program
Time frame: 12 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 24 Dec 2025.
- 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
Natalia Romero-Franco, PhD 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?
A study testing Pelvic floor exercises program guided with an intravaginal biofeedback device, Pelvic floor exercises program 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.
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 2 inclusion and 3 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 24 Dec 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 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 (time frame: 12 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Dec 2025.