Efficacy of the Use of Vaginal Balls for the Improvement of Urinary Incontinence and Sexual Function in Women.
NCT ID: NCT05732844
Last Updated: 2023-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
64 participants
INTERVENTIONAL
2022-10-05
2023-01-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention group with Enna pelvic ball
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.
Intervention group with Enna pelvic ball
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 group
This group will receive instructions on how to carry out PFMT daily at home.
Control group
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.
Interventions
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Intervention group with Enna pelvic ball
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 group
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.
Eligibility Criteria
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Inclusion Criteria
* Suffer from stress urinary incontinence or mixed urinary incontinence.
* Understand Spanish to be able to self-complete the questionnaires (validated in Spanish).
Exclusion Criteria
* 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.
* 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
18 Years
FEMALE
No
Sponsors
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RAPbarcelona
OTHER
Responsible Party
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Inés Ramírez-García
Director
Locations
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RAPbarcelona SL
Barcelona, , Spain
Countries
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References
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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.
Other Identifiers
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LAIA_bolas
Identifier Type: -
Identifier Source: org_study_id
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