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| Name | Class |
|---|---|
| Hospital Universitario Principe de Asturias | OTHER |
| Instituto de Salud Carlos III | OTHER_GOV |
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To find out the effectiveness of physical therapy associated with the surgical treatment over the simptoms and quality of life in III and IV grades of pelvic organ prolapse, patients will be randomly assigned to one of these groups: experimental group: pre-surgical and post-surgical physical therapy + behavioral education + surgical therapy. Control group: surgical treatment + behavioral education.
In both groups several physical therapy assessments will be undertaken: 1st before surgery; 2nd immediately after surgery; and after 6 weeks, 3th, 6th, 12th and 24th months post-surgery.
Intervention in the experimental group, patients assigned to this group will receive:
Pre-surgical physical therapy: 9 sessions of physical therapy aimed at correcting posture, to the awareness and the strengthening of the pelvic floor muscles. They will be also informed and instructed on hygienic and behavioral education to prevent pelvic organ prolapse and urinary incontinence. Each session will be about 45 minutes and 3 sessions will be held a week for 3 weeks.
Post-surgical Physical Therapy:
2. Hospital discharge patients will receive the same fact sheet on sanitary and behavioral measures recommended for the prevention of pelvic organ prolapse and urinary incontinence.
3. 6th weeks after surgery: 8 physical therapy sessions (2 per week for 4 weeks) about 30 minutes to review hypopressive exercises and contractions of the pelvic floor.
Intervention in the control group, patients assigned to this group will receive:
After surgical correction of pelvic organ prolapse, at hospital discharge, patients will receive a fact sheet on the sanitary and behavioral measures recommended for the prevention of pelvic organ prolapse and urinary incontinence (proper weight, prevent constipation, avoid weight bearing and cough and high impact exercise). No physical therapy intervention will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| surgical treatment+behavior therapy+physical therapy | Experimental | Including POP surgical treatment, and pre- post physical therapy to aim the posture, PFM awareness and the strengthening. They will be also informed and instructed on hygienic and behavioral education to prevent POP and urinary incontinence (behavior therapy). |
|
| surgical treatment+behavior therapy | Experimental | Including POP surgical treatment, and information and instruction about hygienic and behavioral education to prevent POP and urinary incontinence (behavior therapy). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| physical therapy | Other | Pre-surgical Physical Therapy: physical therapy aimed to correct the posture, to the awareness and the strengthening of the pelvic floor muscles. Post-surgical Physical Therapy: checking the correct contraction of the pelvic floor muscles and hypopressive exercises. |
| Measure | Description | Time Frame |
|---|---|---|
| The SF-12 Health Survey (SF-12) Spanish version | up to 24th months post-surgery. | |
| Assessment of pelvic floor muscles strength with Modified Oxford Scale and vaginal perineometry, vaginal dynamometry | up to 24th months post-surgery. | |
| International Consultation on Incontinences Short Form (ICIQ-SF) Spanish version. | up to 24th months post-surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary symptoms (urinary frequency, nocturia, urgency, incontinence, coital incontinence, nocturnal enuresis, frequency of urinary tract infections, dysuria and urinary difficulty). | up to 24th months post-surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria José Yuste, PHD | Alcalá University | Study Director |
| MarÃa Torres, PHD | Alcalá University | Study Chair |
| Beatriz Navarro, PHD | Alcalá University | Study Chair |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D013514 | Surgical Procedures, Operative |
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| surgical treatment | Other | Surgical correction of POP. |
|
| behavior therapy | Other | At hospital discharge, patients will receive a fact sheet on the sanitary and behavioral measures recommended for the prevention of POP and urinary incontinence (proper weight, prevent constipation, avoid weight bearing and cough and high impact exercise). |
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