Benefits of Peri-surgical Physical Therapy in the Management of III and IV Grades of Pelvic Organ Prolapse
Primary Purpose
Pelvic Organ Prolapse
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
physical therapy
surgical treatment
behavior therapy
Sponsored by
About this trial
This is an interventional prevention trial for Pelvic Organ Prolapse
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
surgical treatment+behavior therapy+physical therapy
surgical treatment+behavior therapy
Arm Description
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).
Including POP surgical treatment, and information and instruction about hygienic and behavioral education to prevent POP and urinary incontinence (behavior therapy).
Outcomes
Primary Outcome Measures
The SF-12 Health Survey (SF-12) Spanish version
Assessment of pelvic floor muscles strength with Modified Oxford Scale and vaginal perineometry, vaginal dynamometry
International Consultation on Incontinences Short Form (ICIQ-SF) Spanish version.
Secondary Outcome Measures
Urinary symptoms (urinary frequency, nocturia, urgency, incontinence, coital incontinence, nocturnal enuresis, frequency of urinary tract infections, dysuria and urinary difficulty).
Full Information
NCT ID
NCT02846480
First Posted
July 15, 2016
Last Updated
May 12, 2018
Sponsor
BEATRIZ SANCHEZ SANCHEZ
Collaborators
Hospital Universitario Principe de Asturias, Instituto de Salud Carlos III
1. Study Identification
Unique Protocol Identification Number
NCT02846480
Brief Title
Benefits of Peri-surgical Physical Therapy in the Management of III and IV Grades of Pelvic Organ Prolapse
Official Title
Benefits of Peri-surgical Physical Therapy in the Management of III and IV Grades of Pelvic Organ Prolapse
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
June 2010 (Actual)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
BEATRIZ SANCHEZ SANCHEZ
Collaborators
Hospital Universitario Principe de Asturias, Instituto de Salud Carlos III
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
surgical treatment+behavior therapy+physical therapy
Arm Type
Experimental
Arm Description
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).
Arm Title
surgical treatment+behavior therapy
Arm Type
Experimental
Arm Description
Including POP surgical treatment, and information and instruction about hygienic and behavioral education to prevent POP and urinary incontinence (behavior therapy).
Intervention Type
Other
Intervention Name(s)
physical therapy
Intervention Description
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
Intervention Name(s)
surgical treatment
Intervention Description
Surgical correction of POP.
Intervention Type
Other
Intervention Name(s)
behavior therapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
The SF-12 Health Survey (SF-12) Spanish version
Time Frame
up to 24th months post-surgery.
Title
Assessment of pelvic floor muscles strength with Modified Oxford Scale and vaginal perineometry, vaginal dynamometry
Time Frame
up to 24th months post-surgery.
Title
International Consultation on Incontinences Short Form (ICIQ-SF) Spanish version.
Time Frame
up to 24th months post-surgery.
Secondary Outcome Measure Information:
Title
Urinary symptoms (urinary frequency, nocturia, urgency, incontinence, coital incontinence, nocturnal enuresis, frequency of urinary tract infections, dysuria and urinary difficulty).
Time Frame
up to 24th months post-surgery.
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria José Yuste, PHD
Organizational Affiliation
Alcalá University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
María Torres, PHD
Organizational Affiliation
Alcalá University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Beatriz Navarro, PHD
Organizational Affiliation
Alcalá University
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Benefits of Peri-surgical Physical Therapy in the Management of III and IV Grades of Pelvic Organ Prolapse
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