Clinical trial NCT02846480: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Lead sponsor: University of Alcala
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Principe de Asturias
name: Instituto de Salud Carlos III
First posted: 2016-07-27
Enrollment: 65
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: The SF-12 Health Survey (SF-12) Spanish version
timeFrame: up to 24th months post-surgery.
measure: Assessment of pelvic floor muscles strength with Modified Oxford Scale and vaginal perineometry, vaginal dynamometry
timeFrame: up to 24th months post-surgery.
measure: International Consultation on Incontinences Short Form (ICIQ-SF) Spanish version.
timeFrame: up to 24th months post-surgery.
Secondary outcomes:
measure: Urinary symptoms (urinary frequency, nocturia, urgency, incontinence, coital incontinence, nocturnal enuresis, frequency of urinary tract infections, dysuria and urinary difficulty).
timeFrame: up to 24th months post-surgery.
Other outcomes:
Locations:
Study officials:
affiliation: Alcalá University
name: Maria José Yuste, PHD
role: STUDY_DIRECTOR
affiliation: Alcalá University
name: María Torres, PHD
role: STUDY_CHAIR
affiliation: Alcalá University
name: Beatriz Navarro, PHD
role: STUDY_CHAIR
References: