Pelvic Organ ProlapseNCT02846480
Benefits of Peri-surgical Physical Therapy in the Management of III and IV Grades of Pelvic Organ Prolapse
A study testing physical therapy, surgical treatment and behavior therapy in people with Pelvic Organ Prolapse, run by BEATRIZ SANCHEZ SANCHEZ.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- physical therapy, surgical treatment and behavior therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
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.
Read the 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:
- 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.
- 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
- Being tested
- physical therapy, surgical treatment, behavior therapy
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical therapyOther
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 treatmentOther
Surgical correction of POP.
behavior therapyOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: surgical treatment; Other: behavior therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The SF-12 Health Survey (SF-12) Spanish version
Measured: up to 24th months post-surgery.
Assessment of pelvic floor muscles strength with Modified Oxford Scale and vaginal perineometry, vaginal dynamometry
Measured: up to 24th months post-surgery.
International Consultation on Incontinences Short Form (ICIQ-SF) Spanish version.
Measured: 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).
Measured: up to 24th months post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startJun 2010
- Primary completionDec 2013
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- BEATRIZ SANCHEZ SANCHEZ
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Principe de Asturias, Instituto de Salud Carlos III
- Responsible party
- Sponsor-investigator, BEATRIZ SANCHEZ SANCHEZ, University of Alcala
- Investigators
- Maria José Yuste, PHD, Study director, Alcalá UniversityMaría Torres, PHD, Study chair, Alcalá UniversityBeatriz Navarro, PHD, Study chair, Alcalá University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846480
- Sponsor's protocol ID
- UAlcala_POP
- Status last verified
- Feb 2016
- First submitted
- 15 Jul 2016
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Peri-surgical Physical Therapy in the Management of III and IV Grades of Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT02846480
- Acronym / sponsor ID
- UAlcala_POP
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- BEATRIZ SANCHEZ SANCHEZUniversity, hospital or other
- Collaborators
- Hospital Universitario Principe de Asturias, Instituto de Salud Carlos III
- Study start
- Jun 2010 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgical treatment+behavior therapy+physical therapy | Experimental | Other: physical therapy, Other: surgical treatment, Other: behavior therapyIncluding 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). |
| surgical treatment+behavior therapy | Experimental | Other: surgical treatment, Other: behavior therapyIncluding POP surgical treatment, and information and instruction about hygienic and behavioral education to prevent POP and urinary incontinence (behavior therapy). |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical therapyPre-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. | Other | surgical treatment+behavior therapy+physical therapy |
| surgical treatmentSurgical correction of POP. | Other | surgical treatment+behavior therapy, surgical treatment+behavior therapy+physical therapy |
| behavior therapyAt 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). | Other | surgical treatment+behavior therapy, surgical treatment+behavior therapy+physical therapy |
Primary outcome
The SF-12 Health Survey (SF-12) Spanish version
Time frame: up to 24th months post-surgery.
Assessment of pelvic floor muscles strength with Modified Oxford Scale and vaginal perineometry, vaginal dynamometry
Time frame: up to 24th months post-surgery.
International Consultation on Incontinences Short Form (ICIQ-SF) Spanish version.
Time frame: up to 24th months post-surgery.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria José Yuste, PHD study director
Alcalá University
María Torres, PHD study chair
Alcalá University
Beatriz Navarro, PHD study chair
Alcalá University
Questions about this trial
What is this clinical trial studying?
A study testing physical therapy, surgical treatment and behavior therapy in people with Pelvic Organ Prolapse, run by BEATRIZ SANCHEZ SANCHEZ.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The SF-12 Health Survey (SF-12) Spanish version (time frame: up to 24th months post-surgery.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018.