Pelvic Organ ProlapseCONTRAPOPNCT03064750
Pelvic Floor Exercise Before Surgery in Women With Pelvic Organ Prolapse
A study testing pelvic floor exercises and Waiting list in people with Pelvic Organ Prolapse and Pelvic Floor Disorders, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
The lifetime risk for a woman to undergo surgery for either vaginal prolapse or urinary incontinence is high. There are many different surgical techniques for treatment of prolapse, but there is a lack of knowledge about factors that contribute to objective result and patient satisfaction after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Pelvic Floor Disorders
- What is being tested?
- pelvic floor exercises and Waiting list
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2017to 26 Jun 2019
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- referred to surgery for urogenital prolapse
- informed consent
Who cannot join
- not able to communicate in Norwegian or English
- not able or willing to sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The lifetime risk for a woman to undergo surgery for either vaginal prolapse or urinary incontinence is high. There are many different surgical techniques for treatment of prolapse, but there is a lack of knowledge about factors that contribute to objective result and patient satisfaction after surgery.
The aim of the study is to investigate factors that could be related to patient satisfaction and objective result such as pelvic floor muscle contractility/strength and muscle injury, objective measures of prolapse and women's symptoms. This study will investigate whether systematic pelvic floor exercise and life style advise before surgery can improve outcomes after surgery for either vaginal prolapse. Another aim is to determine an ultrasound scale for measure of pelvic floor muscle contraction.
- Conditions
- Pelvic Organ Prolapse, Pelvic Floor Disorders
- Being tested
- pelvic floor exercises, Waiting list
- Keywords
- Exercise Therapy, Pelvic Floor, Preoperative Care
- Medical subject headings
- Pelvic Organ Prolapse, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvic floor exercisesBehavioural
In preparation for surgery, patients receive individual information by a physiotherapist on pelvic floor anatomy and correct pelvic floor contraction. Patients are told to do the following pelvic floor exercises 3 times a day: 8-12 maximal contractions, hold contractions during 10 seconds, and 3 fast contractions after each long contraction. In addition exercise in groups with skilled physical therapists once a week during 12 weeks.
Waiting listOther
patients wait as usual until surgery without special treatment.
| Study group | Role | What they receive |
|---|---|---|
| Pre-surgery exercise | Experimental | pelvic floor exercises individually and in groups Receives: Behavioral: pelvic floor exercises |
| Waiting list | Other | wait as usual until surgery Receives: Other: Waiting list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic floor muscle strength assessed by palpation
Muscle strength is evaluated using 6 point modified Oxford Scale (MOS) range 0-5.
Measured: 9 months
Pelvic floor muscle strength assessed by ultrasound
Changes in pelvic floor muscle at rest and during pelvic floor contraction, measured in mm and calculated proportional change
Measured: 9 months
Symptoms of pelvic floor disorders
Symptoms of pelvic floor disorders assessed by validated questionnaire (PDFI-20)
Measured: 9 months
Secondary outcomes (9)
Pelvic floor muscle strength assessed by perineometry
measuring the pressure with vaginal manometry in cm H2O during pelvic floor contraction
Measured: 9 months
Pelvic floor muscle strength assessed by electromyography
Assessed by vaginal surface electrode during pelvic floor contraction, measured in mV
Measured: 9 months
Proportion of anatomical pelvic organ prolapse
Assessment with the Pelvic Organ Prolapse Quantification (POP-Q) System
Measured: 9 months
Proportion of anatomical sphincter ani defect
Anatomical sphincter ani defect assessed by transperineal ultrasound
Measured: 9 months
Proportion of levator ani muscle trauma
Assessed by transperineal ultrasound on contraction and Valsalva
Measured: 9 months
Assessment of pelvic organ mobility as a measure of pelvic organ function/dysfunction
Movement of the pelvic organs during Valsalva and contraction
Measured: 9 months
Imaging of synthetic implants assessed by ultrasound
Registration of implants after pelvic floor surgery and their relations to anatomical structures in mm.
Measured: 9 months
Symptoms of pelvic floor disorders
Symptoms of pelvic floor disorders assessed by validated questionnaire (PFIQ-7)
Measured: 9 months
Symptoms of pelvic floor disorders
Symptoms of pelvic floor disorders assessed by visual analogue scale (VAS 1-10)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start1 Jan 2017
- Primary completion26 Jun 2019
- Study completion26 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Kjell Å Salvesen, md prof, Study director, St Olavs Hospital University Hospital Trondheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064750
- Sponsor's protocol ID
- 2015/1751
- Acronym
- CONTRAPOP
- Status last verified
- Dec 2021
- First submitted
- 22 Feb 2017
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nyhus MO, Oversand SH, Salvesen O, Salvesen KA, Mathew S, Volloyhaug I. Ultrasound assessment of pelvic floor muscle contraction: reliability and development of an ultrasound-based contraction scale. Ultrasound Obstet Gynecol. 2020 Jan;55(1):125-131. doi: 10.1002/uog.20382. Epub 2019 Dec 13.
PubMed 31237722Nyhus MO, Mathew S, Salvesen O, Salvesen KA, Stafne S, Volloyhaug I. Effect of preoperative pelvic floor muscle training on pelvic floor muscle contraction and symptomatic and anatomical pelvic organ prolapse after surgery: randomized controlled trial. Ultrasound Obstet Gynecol. 2020 Jul;56(1):28-36. doi: 10.1002/uog.22007. Epub 2020 Jun 9.
PubMed 32144829Mathew S, Nyhus MO, Salvesen O, Salvesen KA, Stafne SN, Volloyhaug I. The effect of preoperative pelvic floor muscle training on urinary and colorectal-anal distress in women undergoing pelvic organ prolapse surgery-a randomized controlled trial. Int Urogynecol J. 2021 Oct;32(10):2787-2794. doi: 10.1007/s00192-021-04684-3. Epub 2021 Feb 13.
PubMed 33580809
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Floor Exercise Before Surgery in Women With Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT03064750
- Acronym / sponsor ID
- CONTRAPOP / 2015/1751
- Conditions
- Pelvic Organ Prolapse, Pelvic Floor Disorders
- Keywords
- Exercise Therapy, Pelvic Floor, Preoperative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 26 Jun 2019 (actual)
- Study completion
- 26 Jun 2019 (actual)
- First posted
- 27 Feb 2017 (actual)
- 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.
The lifetime risk for a woman to undergo surgery for either vaginal prolapse or urinary incontinence is high. There are many different surgical techniques for treatment of prolapse, but there is a lack of knowledge about factors that contribute to objective result and patient satisfaction after surgery.
The aim of the study is to investigate factors that could be related to patient satisfaction and objective result such as pelvic floor muscle contractility/strength and muscle injury, objective measures of prolapse and women's symptoms. This study will investigate whether systematic pelvic floor exercise and life style advise before surgery can improve outcomes after surgery for either vaginal prolapse. Another aim is to determine an ultrasound scale for measure of pelvic floor muscle contraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-surgery exercise | Experimental | Behavioral: pelvic floor exercisespelvic floor exercises individually and in groups |
| Waiting list | Other | Other: Waiting listwait as usual until surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- referred to surgery for urogenital prolapse
- informed consent
Key exclusion criteria (2 listed)
- not able to communicate in Norwegian or English
- not able or willing to sign informed consent
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 |
|---|---|---|
| pelvic floor exercisesIn preparation for surgery, patients receive individual information by a physiotherapist on pelvic floor anatomy and correct pelvic floor contraction. Patients are told to do the following pelvic floor exercises 3 times a day: 8-12 maximal contractions, hold contractions during 10 seconds, and 3 fast contractions after each long contraction. In addition exercise in groups with skilled physical therapists once a week during 12 weeks. | Behavioural | Pre-surgery exercise |
| Waiting listpatients wait as usual until surgery without special treatment. | Other | Waiting list |
Primary outcome
Pelvic floor muscle strength assessed by palpation
Time frame: 9 months
Muscle strength is evaluated using 6 point modified Oxford Scale (MOS) range 0-5.
Pelvic floor muscle strength assessed by ultrasound
Time frame: 9 months
Changes in pelvic floor muscle at rest and during pelvic floor contraction, measured in mm and calculated proportional change
Symptoms of pelvic floor disorders
Time frame: 9 months
Symptoms of pelvic floor disorders assessed by validated questionnaire (PDFI-20)
9 secondary outcomes
Pelvic floor muscle strength assessed by perineometry
Time frame: 9 months
Pelvic floor muscle strength assessed by electromyography
Time frame: 9 months
Proportion of anatomical pelvic organ prolapse
Time frame: 9 months
Proportion of anatomical sphincter ani defect
Time frame: 9 months
Proportion of levator ani muscle trauma
Time frame: 9 months
Assessment of pelvic organ mobility as a measure of pelvic organ function/dysfunction
Time frame: 9 months
Imaging of synthetic implants assessed by ultrasound
Time frame: 9 months
Symptoms of pelvic floor disorders
Time frame: 9 months
Symptoms of pelvic floor disorders
Time frame: 9 months
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 17 Dec 2021.
- Background: PubMed 31237722Nyhus MO, Oversand SH, Salvesen O, Salvesen KA, Mathew S, Volloyhaug I. Ultrasound assessment of pelvic floor muscle contraction: reliability and development of an ultrasound-based contraction scale. Ultrasound Obstet Gynecol. 2020 Jan;55(1):125-131. doi: 10.1002/uog.20382. Epub 2019 Dec 13.
- Results publication: PubMed 32144829Nyhus MO, Mathew S, Salvesen O, Salvesen KA, Stafne S, Volloyhaug I. Effect of preoperative pelvic floor muscle training on pelvic floor muscle contraction and symptomatic and anatomical pelvic organ prolapse after surgery: randomized controlled trial. Ultrasound Obstet Gynecol. 2020 Jul;56(1):28-36. doi: 10.1002/uog.22007. Epub 2020 Jun 9.
- Results publication: PubMed 33580809Mathew S, Nyhus MO, Salvesen O, Salvesen KA, Stafne SN, Volloyhaug I. The effect of preoperative pelvic floor muscle training on urinary and colorectal-anal distress in women undergoing pelvic organ prolapse surgery-a randomized controlled trial. Int Urogynecol J. 2021 Oct;32(10):2787-2794. doi: 10.1007/s00192-021-04684-3. Epub 2021 Feb 13.
- 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.
Kjell Å Salvesen, md prof study director
St Olavs Hospital University Hospital Trondheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pelvic floor exercises and Waiting list in people with Pelvic Organ Prolapse and Pelvic Floor Disorders, run by St. Olavs Hospital at 1 site in Norway.
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 2 inclusion and 2 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 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Pelvic floor muscle strength assessed by palpation (time frame: 9 months). 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?
On the ClinicalTrials.gov record for NCT03064750, which also lists 3 linked publications.
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 17 Dec 2021.