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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
BEATRIZ SANCHEZ SANCHEZ
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pelvic Organ Prolapse

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    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
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    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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