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

NCT02846480 | Completed

• 1 other identifier: UAlcala_POP
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (3)

• 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.

Secondary Outcomes (1)

• 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.

Study Arms (2)

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).

Other: physical therapy; Other: surgical treatment; Other: 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).

Other: surgical treatment; Other: behavior therapy

Interventions

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.

surgical treatment+behavior therapy+physical therapy

surgical treatment OTHER

Surgical correction of POP.

surgical treatment+behavior therapy; surgical treatment+behavior therapy+physical therapy

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).

surgical treatment+behavior therapy; surgical treatment+behavior therapy+physical therapy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• BEATRIZ SANCHEZ SANCHEZ: lead
• Hospital Universitario Principe de Asturias: collaborator
• Instituto de Salud Carlos III: collaborator

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Physical Therapy Modalities; Surgical Procedures, Operative; Behavior Therapy

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Maria José Yuste, PHD

  Alcalá University

  STUDY DIRECTOR

• María Torres, PHD

  Alcalá University

  STUDY CHAIR

• Beatriz Navarro, PHD

  Alcalá University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PHD

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: July 27, 2016
• Study Start: June 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2017
• Last Updated: May 15, 2018

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share