Urinary IncontinenceNCT05732844
Efficacy of the Use of Vaginal Balls for the Improvement of Urinary Incontinence and Sexual Function in Women.
A study testing Intervention group with Enna pelvic ball in people with Urinary Incontinence and Stress Urinary Incontinence, run by RAPbarcelona at 1 site in Spain.
Trial summary
Asess if adding vaginal spheres treatment to the conventional Pelvic Floor Muscle Trainning (PFMT) produces a greater decrease in the severity of the stress urinary incontinence or a greater perceived quality of life related to incontinence. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Stress Urinary Incontinence, Sexual Dysfunction
- What is being tested?
- Intervention group with Enna pelvic ball
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSpain
- Study dates
- 5 Oct 2022to 27 Jan 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18 or over
- Suffer from stress urinary incontinence or mixed urinary incontinence.
- Understand Spanish to be able to self-complete the questionnaires (validated in Spanish).
Who cannot join
- Not giving informed consent.
- Women with faecal incontinence.
- Women with grade III-IV prolapse.
- Women with pathology that can affect the neuro-muscular response.
- Women with incontinence that is not of functional origin.
- Women who have perineal pain that makes it impossible to apply the spheres.
Show all 10Show fewer
- Women with an open vagina of more than 2.5 cm opening
- Being pregnant.
- Not being committed to complying with a minimum of 80% of the treatment.
- Having previously started other pelvic physiotherapy treatments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of the Use of Vaginal Balls for the Improvement of Urinary Incontinence and Sexual Function in Women. Randomized Control Trial.
Asess if adding vaginal spheres treatment to the conventional Pelvic Floor Muscle Trainning (PFMT) produces a greater decrease in the severity of the stress urinary incontinence or a greater perceived quality of life related to incontinence.
Read the detailed description
The intervention group will perform the pelvic floor muscle trainning (PFMT) plus the use of vaginal spheres, while the control group will perform the PFMT treatment only, daily at home. The study will be conducted on women with stress urinary incontinence. The intervention will last four months and will consist of a monthly session with the physiotherapist, doing a total of 4 sessions and the final assessment.
- Being tested
- Intervention group with Enna pelvic ball, Control group
- Keywords
- vaginal spheres, physiotherapy, pelvic floor muscle trainning
- Medical subject headings
- Urinary Incontinence, Urinary Incontinence, Stress, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group with Enna pelvic ballDevice
The home guideline for placement of the vaginal spheres will be as described in next:
st-2nd week 15 minutes, 1 time a day nd-4th week 30 minutes, 1 time a day 4th-8th week 1 hour, 1 time a day 8th-12th week 2 hours, 1 time a day 12th-16th week 3 hours, 1 time a day
Control groupOther
According to the PERFECT score, a daily home guideline for the performance of PFMT will be requested three times a day, two types of exercises (endurance and strength), and eight repetitions of each.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group with Enna pelvic ball | Experimental | This group will receive instructions on how to carry out PFMT daily at home, and indications for the placement of Enna pelvic ball vaginal spheres daily. Receives: Device: Intervention group with Enna pelvic ball |
| Control group | Active comparator | This group will receive instructions on how to carry out PFMT daily at home. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of urinary incontinence using the ICIQ-SF questionnaire (International Consultation on Incontinence Questionnaire Short form) at Week 16.
The ICIQ-SF is a validated self-reported instrument assessing the urinary incontinence severity and It's quality of life. Possible scores range from 0 (no incontinence) to 21 (severe incontinence). Change=(Week 16 score - baseline score).
Measured: Time Frame: Baseline and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start5 Oct 2022
- Primary completion27 Jan 2023
- Study completion27 Jan 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 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
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAPbarcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inés Ramírez-García, RAPbarcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732844
- Sponsor's protocol ID
- LAIA_bolas
- Status last verified
- Feb 2023
- First submitted
- 29 Jan 2023
- Last updated
- 17 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oblasser C, Christie J, McCourt C. Vaginal cones or balls to improve pelvic floor muscle performance and urinary continence in women post partum: A quantitative systematic review. Midwifery. 2015 Nov;31(11):1017-25. doi: 10.1016/j.midw.2015.08.011. Epub 2015 Sep 9.
PubMed 26428191Blanco-Ratto L, Ramirez-Garcia I, Kauffmann S, Ortiz CN, Farres MG. Effect of Vaginal Spheres and Pelvic Floor Exercises on Female Sexual Function in Women with Urinary Incontinence: A Randomized Controlled Trial (Secondary Analysis). Int Urogynecol J. 2026 Apr;37(4):945-955. doi: 10.1007/s00192-025-06404-7. Epub 2025 Nov 4.
PubMed 41186701
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Use of Vaginal Balls for the Improvement of Urinary Incontinence and Sexual Function in Women. Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT05732844
- Acronym / sponsor ID
- LAIA_bolas
- Keywords
- vaginal spheres, physiotherapy, pelvic floor muscle trainning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- RAPbarcelonaUniversity, hospital or other
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 27 Jan 2023 (actual)
- Study completion
- 27 Jan 2023 (actual)
- First posted
- 17 Feb 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.
Asess if adding vaginal spheres treatment to the conventional Pelvic Floor Muscle Trainning (PFMT) produces a greater decrease in the severity of the stress urinary incontinence or a greater perceived quality of life related to incontinence.
Detailed description
The intervention group will perform the pelvic floor muscle trainning (PFMT) plus the use of vaginal spheres, while the control group will perform the PFMT treatment only, daily at home. The study will be conducted on women with stress urinary incontinence. The intervention will last four months and will consist of a monthly session with the physiotherapist, doing a total of 4 sessions and the final assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group with Enna pelvic ball | Experimental | Device: Intervention group with Enna pelvic ballThis group will receive instructions on how to carry out PFMT daily at home, and indications for the placement of Enna pelvic ball vaginal spheres daily. |
| Control group | Active comparator | Other: Control groupThis group will receive instructions on how to carry out PFMT daily at home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women aged 18 or over
- Suffer from stress urinary incontinence or mixed urinary incontinence.
- Understand Spanish to be able to self-complete the questionnaires (validated in Spanish).
Key exclusion criteria (10 listed)
- Not giving informed consent.
- Women with faecal incontinence.
- Women with grade III-IV prolapse.
- Women with pathology that can affect the neuro-muscular response.
- Women with incontinence that is not of functional origin.
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 |
|---|---|---|
| Intervention group with Enna pelvic ballThe home guideline for placement of the vaginal spheres will be as described in next: st-2nd week 15 minutes, 1 time a day nd-4th week 30 minutes, 1 time a day 4th-8th week 1 hour, 1 time a day 8th-12th week 2 hours, 1 time a day 12th-16th week 3 hours, 1 time a day | Device | Intervention group with Enna pelvic ball |
| Control groupAccording to the PERFECT score, a daily home guideline for the performance of PFMT will be requested three times a day, two types of exercises (endurance and strength), and eight repetitions of each. | Other | Control group |
Primary outcome
Severity of urinary incontinence using the ICIQ-SF questionnaire (International Consultation on Incontinence Questionnaire Short form) at Week 16.
Time frame: Time Frame: Baseline and Week 16
The ICIQ-SF is a validated self-reported instrument assessing the urinary incontinence severity and It's quality of life. Possible scores range from 0 (no incontinence) to 21 (severe incontinence). Change=(Week 16 score - baseline score).
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 17 Feb 2023.
- Results publication: PubMed 26428191Oblasser C, Christie J, McCourt C. Vaginal cones or balls to improve pelvic floor muscle performance and urinary continence in women post partum: A quantitative systematic review. Midwifery. 2015 Nov;31(11):1017-25. doi: 10.1016/j.midw.2015.08.011. Epub 2015 Sep 9.
- Derived from this study: PubMed 41186701Blanco-Ratto L, Ramirez-Garcia I, Kauffmann S, Ortiz CN, Farres MG. Effect of Vaginal Spheres and Pelvic Floor Exercises on Female Sexual Function in Women with Urinary Incontinence: A Randomized Controlled Trial (Secondary Analysis). Int Urogynecol J. 2026 Apr;37(4):945-955. doi: 10.1007/s00192-025-06404-7. Epub 2025 Nov 4.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group with Enna pelvic ball in people with Urinary Incontinence and Stress Urinary Incontinence, run by RAPbarcelona 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 3 inclusion and 10 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 17 Feb 2023. 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?
Severity of urinary incontinence using the ICIQ-SF questionnaire (International Consultation on Incontinence Questionnaire Short form) at Week 16. (time frame: Time Frame: Baseline and Week 16). 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 NCT05732844, 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 17 Feb 2023.