Benefits of Peri-surgical Physical Therapy in the Management of III and IV Grades of Pelvic Organ Prolapse

NCT ID: NCT02846480

Last Updated: 2018-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2017-06-30

Brief Summary

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.

Detailed Description

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.

Conditions

Pelvic Organ Prolapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

surgical treatment+behavior therapy+physical therapy

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).

Group Type: EXPERIMENTAL

physical therapy

Intervention Type: 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.

surgical treatment

Intervention Type: OTHER

Surgical correction of POP.

behavior therapy

Intervention Type: 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).

surgical treatment+behavior therapy

Including POP surgical treatment, and information and instruction about hygienic and behavioral education to prevent POP and urinary incontinence (behavior therapy).

Group Type: EXPERIMENTAL

surgical treatment

Intervention Type: OTHER

Surgical correction of POP.

behavior therapy

Intervention Type: 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).

Interventions

physical therapy

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.

Intervention Type: OTHER

surgical treatment

Surgical correction of POP.

Intervention Type: OTHER

behavior therapy

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Consecutive women diagnosed with grade III and IV pelvic organ prolapse, which would be operated for this reason at the Asturias Prince Hospital (Madrid-Spain).

Exclusion Criteria

• Women diagnosed with different III / IV grade of POP or a history of conservative treatment not from the subproject "Physiotherapy in the POP grades I and II", or a history of POP surgery, or concurrent conditions that would be affect the treatment (neurological, gynecological or urological), or recurrent urinary infection or hematuria, or those III / IV grades in POP which is contraindicated or not possible to perform surgery.
• Pregnant women or women with a vaginal birth in the last six months.
• Women with cognitive limitations to understand the information, answer questionnaires, consent and / or participate in the study.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Principe de Asturias

OTHER

Sponsor Role: collaborator

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

BEATRIZ SANCHEZ SANCHEZ

OTHER

Sponsor Role: lead

Responsible Party

BEATRIZ SANCHEZ SANCHEZ

PHD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Maria José Yuste, PHD

Role: STUDY_DIRECTOR

Alcalá University

María Torres, PHD

Role: STUDY_CHAIR

Alcalá University

Beatriz Navarro, PHD

Role: STUDY_CHAIR

Alcalá University

Other Identifiers

UAlcala_POP

Identifier Type: -

Identifier Source: org_study_id