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

RAPbarcelona

Status: Completed

Conditions: Stress Urinary Incontinence; Sexual Dysfunction; Urinary Incontinence

Treatments: Other: Control group; Device: Intervention group with Enna pelvic ball

Study type: Interventional

Funder types: Other

Identifiers

NCT05732844

LAIA_bolas

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Intervention group with Enna pelvic ball

Experimental group

Description:

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.

Treatment:

Device: Intervention group with Enna pelvic ball

Control group

Active Comparator group

Description:

This group will receive instructions on how to carry out PFMT daily at home.

Treatment:

Other: Control group