Pelvic Organ ProlapseNCT04539782
A Feasibility Study on the Value of Pelvic Floor Training After Pelvic Organ Prolapse Surgery
A study testing Physiotherapy intervention in people with Pelvic Organ Prolapse, run by Landspitali University Hospital at 1 site in Iceland.
Trial summary
The main objective is to assess the feasibility of a randomized controlled trial that investigates the effects of pelvic floor training on recurrence in pelvic organ prolapse surgeries. This will be achieved by measuring POP-Q stage and by a validated questionnaire before surgery and one year after. Read more about this study
- Who is it for?
- Ages Up to 80 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Physiotherapy intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIceland
- Study dates
- 10 Jun 2020to 15 Jun 2021
- 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 Up to 80 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women having their first POP surgery at LSH
- <80 years old
- Icelandic speaking
Who cannot join
- Women that previously have had incontinence surgery, hysterectomy or previous POP surgery.
- Dementia, physical disabilities that could affect the research, previous radiotherapy and neurological diseases.
- Women participating in the research that need to have recurrent POP surgery or incontinence surgery within the year of the surgery.
Trial locations and contacts
1 site in 1 country.
About this study
The main objective is to assess the feasibility of a randomized controlled trial that investigates the effects of pelvic floor training on recurrence in pelvic organ prolapse surgeries. This will be achieved by measuring POP-Q stage and by a validated questionnaire before surgery and one year after. Women having POP surgery at Landspitali will be offered to participate if they meet the criteria of the research. Participants will be randomized into two groups, interventions and control group that gets standard care at the hospital. The intervention group will meet a physiotherapist 6 weeks post-op for targeted physiotherapy with pelvic floor training, conventional advice and support. Over 16 weeks period participants in intervention group will get physiotherapy four times and get two follow up phone calls. Pelvic floor activity will be measured with EMG and symptoms collected with questionnaire before surgery and year post-op.
Recurrent surgeries are common problem shortly after the first one. POP symtoms can be bothersome for women and reduce their quality of life. More knowledge is needed to figure out if targeted physiotherapy with pelvic floor training can help reduce recurrency and bothersome symptoms.
Read the detailed description
A feasibility study to assess the practicality of physiotherapy treatment after pelvic organ prolapse (POP) surgery and the effect on recurrent POP symptoms, pelvic floor activity and general physical fitness.
Pelvic organ prolapse is a common problem among women and many do need surgery. Little is known about recurrence of POP surgeries. Pelvic floor muscle training (PFMT) has positive effects on POP symptoms and quality of life. Research shows PFMT can reduce stage of the prolapse.
Before surgery POP-Q stage will be measured by urogynocologist. Pelvic floor muscle activity will be measured with EMG vaginal probes. General physical fitness will be tested with 30s chair-stand and core strenght with prone bride test. An Icelandic version of The Australian Female PelvicFloor questionnaire will be used to assess symptoms and affect on quality of life.
Participants will be randomized into two groups, intervention and control group. The control group gets standard care at the hospital. The interventional group gets physiotherapy with PFMT, conventional advise and support. During 16 weeks intervention participants get four sessions with specialized physiotherapist and two follow up phone calls. Follow up measures will be made at 12 months.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Physiotherapy intervention
- Keywords
- pelvic floor, physiotherapy, pelvic organ prolapse, post op, recurrence
- Medical subject headings
- Pelvic Organ Prolapse, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy interventionOther
Compare the effect of structured pelvic floor muscle training supported by physiotherapist post operation on POP on recurrence of symptoms or symptoms in a new compartment, quality of life and pelvic floor muscle function.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy intervention | Experimental | Pelvic floor muscle training given by a physiotherapist in four sessions and follow up phone calls twice in 14 weeks Receives: Other: Physiotherapy intervention |
| No intervention | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
POP-Q
POP-Q stages are measured by urogynocologists who are blinded outcome assessors.
Measured: One year
Secondary outcomes (1)
The Australian Female Pelvic Floor Questionnaire
Pelvic floor symptoms
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start10 Jun 2020
- Primary completion15 Jun 2021 (estimated)
- Study completion15 Jun 2021 (estimated)
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Landspitali University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iceland
- Responsible party
- Sponsor
- Investigators
- Þorgerður Sigurðardóttir, MSc, Principal investigator, Landspítali University Hospital/University of Iceland, Reykjavík, Iceland.Helga Medek, MD, MSc, Study chair, Landspítali University Hospital/University of Iceland, Reykjavík, Iceland.Þórarinn Sveinsson, PhD, Study chair, University of Iceland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539782
- Sponsor's protocol ID
- LSH-20-001
- Status last verified
- Aug 2020
- First submitted
- 31 Aug 2020
- Last updated
- 7 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study on the Value of Pelvic Floor Training After Pelvic Organ Prolapse Surgery
- ClinicalTrials.gov ID
- NCT04539782
- Acronym / sponsor ID
- LSH-20-001
- Conditions
- Pelvic Organ Prolapse
- Keywords
- pelvic floor, physiotherapy, pelvic organ prolapse, post op, recurrence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Landspitali University HospitalUniversity, hospital or other
- Collaborators
- University of Iceland
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 15 Jun 2021 (estimated)
- Study completion
- 15 Jun 2021 (estimated)
- First posted
- 7 Sep 2020 (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 main objective is to assess the feasibility of a randomized controlled trial that investigates the effects of pelvic floor training on recurrence in pelvic organ prolapse surgeries. This will be achieved by measuring POP-Q stage and by a validated questionnaire before surgery and one year after. Women having POP surgery at Landspitali will be offered to participate if they meet the criteria of the research. Participants will be randomized into two groups, interventions and control group that gets standard care at the hospital. The intervention group will meet a physiotherapist 6 weeks post-op for targeted physiotherapy with pelvic floor training, conventional advice and support. Over 16 weeks period participants in intervention group will get physiotherapy four times and get two follow up phone calls. Pelvic floor activity will be measured with EMG and symptoms collected with questionnaire before surgery and year post-op.
Recurrent surgeries are common problem shortly after the first one. POP symtoms can be bothersome for women and reduce their quality of life. More knowledge is needed to figure out if targeted physiotherapy with pelvic floor training can help reduce recurrency and bothersome symptoms.
Detailed description
A feasibility study to assess the practicality of physiotherapy treatment after pelvic organ prolapse (POP) surgery and the effect on recurrent POP symptoms, pelvic floor activity and general physical fitness.
Pelvic organ prolapse is a common problem among women and many do need surgery. Little is known about recurrence of POP surgeries. Pelvic floor muscle training (PFMT) has positive effects on POP symptoms and quality of life. Research shows PFMT can reduce stage of the prolapse.
Before surgery POP-Q stage will be measured by urogynocologist. Pelvic floor muscle activity will be measured with EMG vaginal probes. General physical fitness will be tested with 30s chair-stand and core strenght with prone bride test. An Icelandic version of The Australian Female PelvicFloor questionnaire will be used to assess symptoms and affect on quality of life.
Participants will be randomized into two groups, intervention and control group. The control group gets standard care at the hospital. The interventional group gets physiotherapy with PFMT, conventional advise and support. During 16 weeks intervention participants get four sessions with specialized physiotherapist and two follow up phone calls. Follow up measures will be made at 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy intervention | Experimental | Other: Physiotherapy interventionPelvic floor muscle training given by a physiotherapist in four sessions and follow up phone calls twice in 14 weeks |
| No intervention | No intervention | –Standard care |
Who may qualify
- Ages
- Up to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Women having their first POP surgery at LSH
- <80 years old
- Icelandic speaking
Key exclusion criteria (3 listed)
- Women that previously have had incontinence surgery, hysterectomy or previous POP surgery.
- Dementia, physical disabilities that could affect the research, previous radiotherapy and neurological diseases.
- Women participating in the research that need to have recurrent POP surgery or incontinence surgery within the year of the surgery.
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 |
|---|---|---|
| Physiotherapy interventionCompare the effect of structured pelvic floor muscle training supported by physiotherapist post operation on POP on recurrence of symptoms or symptoms in a new compartment, quality of life and pelvic floor muscle function. | Other | Physiotherapy intervention |
Primary outcome
POP-Q
Time frame: One year
POP-Q stages are measured by urogynocologists who are blinded outcome assessors.
1 secondary outcome
The Australian Female Pelvic Floor Questionnaire
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
- 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.
Þorgerður Sigurðardóttir, MSc principal investigator
Landspítali University Hospital/University of Iceland, Reykjavík, Iceland.
Helga Medek, MD, MSc study chair
Landspítali University Hospital/University of Iceland, Reykjavík, Iceland.
Þórarinn Sveinsson, PhD study chair
University of Iceland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy intervention in people with Pelvic Organ Prolapse, run by Landspitali University Hospital at 1 site in Iceland.
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 3 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: status not confirmed, as of the sponsor's last update on 7 Sep 2020. 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 Iceland. 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?
Results are not available in the source record.
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?
POP-Q (time frame: One year). 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 7 Sep 2020.