Efficacy of the Use of Vaginal Balls for the Improvement of Urinary Incontinence and Sexual Function in Women.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of the Use of Vaginal Balls for the Improvement of Urinary Incontinence and Sexual Function in Women. Randomized Control Trial.

Conditions
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Urinary Incontinence, Stress Urinary Incontinence, Sexual Dysfunction

Intervention / Treatment
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* Device: Intervention group with Enna pelvic ball
* Other: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group with Enna pelvic ball<br>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. | Device: Intervention group with Enna pelvic ball<br>* 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<br>|
| Active Comparator: Control group<br>This group will receive instructions on how to carry out PFMT daily at home. | Other: Control group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Time Frame: Baseline and Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaginal spheres, physiotherapy, pelvic floor muscle trainning