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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control group | Active Comparator | This group will receive instructions on how to carry out PFMT daily at home. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention group with Enna pelvic ball | Device | 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RAPbarcelona SL | Barcelona | 08037 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26428191 | Result | 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. | |
| 41186701 | Derived | Blanco-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. |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014550 | Urinary Incontinence, Stress |
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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|
| Control group | Other | 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. |
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000091662 | Genital Diseases |
| D008722 | Methods |