Sexual Dysfunction, Stress Urinary Incontinence, Urinary Incontinence
Conditions
Keywords
vaginal spheres, physiotherapy, pelvic floor muscle trainning
Brief 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.
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.
Interventions
DEVICEIntervention 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
OTHERControl 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.
Sponsors
RAPbarcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of urinary incontinence using the ICIQ-SF questionnaire (International Consultation on Incontinence Questionnaire Short form) at Week 16. | 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). |
Countries
Spain
Outcome results
None listed