Pelvic Organ ProlapsePEPPYNCT01136889
PEssary Plus Physiotherapy for Pelvic Organ Prolapse (PEPPY)
A study testing PFMT in people with Pelvic Organ Prolapse, run by Glasgow Caledonian University at 4 sites in United Kingdom.
Trial summary
1. To determine the feasibility of conducting a randomised controlled trial (RCT) of the effectiveness of a PFMT intervention in conjunction with vaginal pessary management versus vaginal pessary management alone for women with pelvic organ prolapse. 2. To develop and test the methods for a main trial. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- PFMT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Apr 2008to Dec 2010
- 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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women:
- who are new attendees at outpatient gynaecology clinics with a primary complaint of prolapse;
- who have a prolapse of stage I to IV confirmed by their gynaecologist using the POP-Q grading system;
- who have a prolapse of one or more of the following types:
- anterior vaginal wall prolapse (urethrocele, cystocele,paravaginal defect);
- uterine/cervical prolapse;
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- vaginal vault (after hysterectomy)prolapse;
- posterior vaginal wall prolapse (enterocele, rectocele, perineal deficiency);
- who require a vaginal pessary for treatment of their prolapse (the process of fitting the pessary will be according to standard practice at the centre thus the protocol for choice of pessary, insertion and follow-up will be determined locally);
- who successfully retain the vaginal pessary for two weeks after fitting;
- who are willing to participate in the study and to comply with their group allocation.
Who cannot join
- Women:
- who wish surgical treatment for prolapse and wish to be immediately added to the surgical waiting list;
- who have had previous surgical treatment for prolapse;
- who have had a pessary fitted for treatment of prolapse within the last 12 months;
- who have had previous formal instruction in PFMT;
- who present with contraindications to either pessary or PFMT treatment;
Show all 11Show fewer
- who are unable to comply with PFMT treatment;
- who have local atrophy (this must be treated first);
- who are less than 6-months postnatal;
- who are pregnant;
- who are unable to give informed consent.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Aberdeen Royal Infirmary
Aberdeen
Falkirk and District Royal Infirmary
Falkirk
Southern General Hospital
Glasgow
Victoria Infirmary
Glasgow
About this study
Official title: A Feasibility Study for a Randomised Controlled Trial of Pelvic Floor Muscle Training Combined With Vaginal Pessary for Women With Pelvic Organ Prolapse.
- To determine the feasibility of conducting a randomised controlled trial (RCT) of the effectiveness of a PFMT intervention in conjunction with vaginal pessary management versus vaginal pessary management alone for women with pelvic organ prolapse.
- To develop and test the methods for a main trial.
The ultimate aim of a large multi-centre RCT would be to answer the question:
Is conservative management of pelvic organ prolapse with an individualised PFMT intervention in conjunction with vaginal pessary more effective than vaginal pessary alone in reducing prolapse-specific symptoms, prolapse severity and the need for further prolapse treatment?
Read the detailed description
It is hypothesised that undertaking PFMT with a pessary in place may increase the level of existing muscle support in the pelvic area: by reducing the descent of the pelvic organs and the consequent stretching of soft tissue the pessary may allow the pelvic floor muscles to be exercised and strengthened more effectively. Potentially this could lead to additional improvements in the pessary retention rate and associated prolapse symptoms beyond that expected from the pessary alone. Urine, bowel and sexual function, which can be affected by prolapse, may also improve independently in response to a PFMT intervention. If a more permanent reduction in prolapse symptoms results from concurrent use of PFMT, this may delay or prevent the need for long term pessary use or surgical intervention. In summary, a PFMT intervention in combination with pessary management for vaginal prolapse may be more effective in reducing symptoms and increasing quality of life than management of the prolapse with a pessary alone. This study will start to provide the evidence to address this question.
This is a feasibility study to develop the methods for a multi-centre RCT. It will run alongside The POPPY Trial (a 17 centre trial of PFMT already underway in the UK; ClinicalTrials Number NCT00476892). Three of The POPPY Trial centres will be involved in this feasibility study. Over a 12 month period, we plan to enrol 50 women with diagnosed prolapse of stage I to IV, who are not eligible for The POPPY Trial because they require a pessary. These women will be randomised into one of two groups: PFMT (delivered by a physiotherapist at 5 appointments over 16 weeks) in conjunction with pessary management of their prolapse or pessary management alone. All women will have a nurse appointment six months after randomisation at which time their pessary will be removed. A replacement pessary will not be immediately re-fitted. At seven months after randomisation all women will have a review appointment with their gynaecologist to have their prolapse assessed, the pessary re-fitted if necessary, and other treatment needs discussed. Women will complete postal questionnaires, at baseline (prior to randomisation), at six months post-randomisation (prior to seeing the nurse to have the pessary removed), and seven months post-randomisation (prior to the 7 month gynaecologist review appointment), and record symptoms in a diary for one month after removal of the pessary. Key outcomes are: prolapse symptoms, prolapse-related quality of life, prolapse severity, and additional prolapse treatment received up to seven months after study entry.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- PFMT
- Keywords
- PFMT, Vaginal pessary, Pelvic Organ Prolapse
- 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.
PFMTOther
Also called Pelvic Floor Muscle Training
Women who have been successfully fitted with a vaginal pessary will be asked to attend five outpatient appointments over a 16 week period with a trained specialist women's health physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| PFMT plus routine pessary management | Active comparator | Women allocated to the intervention group will be invited to attend 5 out-patient appointments over a 16 week period with a trained specialist women's health physiotherapist at the study centre. Women will be taught how to contract the muscles, and also how to contract and hold prior to an event that increases intra-abdominal pressure ("the Knack"). Tailored advice will be given on ways of reducing intra-abdominal pressure, e.g. advice on weight loss, chronic cough, heavy lifting and general exercise. A prolapse specific Lifestyle Advice sheet will also be given to the women by the physiotherapist. Receives: Other: PFMT |
| Lifestyle | Active comparator | Women allocated to the control group will be sent a Lifestyle Advice Leaflet only. They will have no planned intervention after their pessary is fitted, other than routine pessary management according to local protocols. The Lifestyle Advice Leaflet gives instructions on seeking advice, where appropriate, about weight loss, constipation, and avoidance of heavy lifting, coughing and high impact exercise, with a view to minimising increases in intra-abdominal pressure which may cause the prolapse to worsen. Receives: Other: PFMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolapse symptom score (POP-SS)
Measured: 7 months
Secondary outcomes (8)
Prolapse-related quality of life(single item scored 0 to 10)
Measured: 7 months
Prolapse severity (POP-Q)
Measured: 7 months
Urinary, bowel and sexual symptoms
Measured: 7 months
Lifestyle changes
Measured: 7 months
General Health Status
Measured: 7 months
Recurrence of prolapse symptoms over the one month period between removal of the pessary (month 6) and gynaecology clinic review (month 7)
Measured: 7 months
Time without pessary (i.e. time from removal of pessary to pessary being re-fitted)
Measured: 7 months
Need for further prolapse treatment including continuing use of pessary, PFMT or surgery.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2010 (estimated)
- Study startApr 2008
- Primary completionOct 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glasgow Caledonian University
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde
- Investigators
- Professor Suzanne Hagen, Principal investigator, NMAHP Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136889
- Sponsor's protocol ID
- RG957
- Other IDs
- Wellbeing of Women, MREC, NHS GG&C
- Acronym
- PEPPY
- Status last verified
- Jan 2011
- First submitted
- 2 Jun 2010
- Last updated
- 19 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Bugge C, Adams EJ, Gopinath D, Stewart F, Dembinsky M, Sobiesuo P, Kearney R. Pessaries (mechanical devices) for managing pelvic organ prolapse in women. Cochrane Database Syst Rev. 2020 Nov 18;11(11):CD004010. doi: 10.1002/14651858.CD004010.pub4.
PubMed 33207004Bugge C, Williams B, Hagen S, Logan J, Glazener C, Pringle S, Sinclair L. A process for Decision-making after Pilot and feasibility Trials (ADePT): development following a feasibility study of a complex intervention for pelvic organ prolapse. Trials. 2013 Oct 25;14:353. doi: 10.1186/1745-6215-14-353.
PubMed 24160371
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study for a Randomised Controlled Trial of Pelvic Floor Muscle Training Combined With Vaginal Pessary for Women With Pelvic Organ Prolapse.
- ClinicalTrials.gov ID
- NCT01136889
- Acronym / sponsor ID
- PEPPY / RG957
- Conditions
- Pelvic Organ Prolapse
- Keywords
- PFMT, Vaginal pessary, Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Glasgow Caledonian UniversityUniversity, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde
- Study start
- Apr 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 4 Jun 2010 (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 determine the feasibility of conducting a randomised controlled trial (RCT) of the effectiveness of a PFMT intervention in conjunction with vaginal pessary management versus vaginal pessary management alone for women with pelvic organ prolapse.
- To develop and test the methods for a main trial.
The ultimate aim of a large multi-centre RCT would be to answer the question:
Is conservative management of pelvic organ prolapse with an individualised PFMT intervention in conjunction with vaginal pessary more effective than vaginal pessary alone in reducing prolapse-specific symptoms, prolapse severity and the need for further prolapse treatment?
Detailed description
It is hypothesised that undertaking PFMT with a pessary in place may increase the level of existing muscle support in the pelvic area: by reducing the descent of the pelvic organs and the consequent stretching of soft tissue the pessary may allow the pelvic floor muscles to be exercised and strengthened more effectively. Potentially this could lead to additional improvements in the pessary retention rate and associated prolapse symptoms beyond that expected from the pessary alone. Urine, bowel and sexual function, which can be affected by prolapse, may also improve independently in response to a PFMT intervention. If a more permanent reduction in prolapse symptoms results from concurrent use of PFMT, this may delay or prevent the need for long term pessary use or surgical intervention. In summary, a PFMT intervention in combination with pessary management for vaginal prolapse may be more effective in reducing symptoms and increasing quality of life than management of the prolapse with a pessary alone. This study will start to provide the evidence to address this question.
This is a feasibility study to develop the methods for a multi-centre RCT. It will run alongside The POPPY Trial (a 17 centre trial of PFMT already underway in the UK; ClinicalTrials Number NCT00476892). Three of The POPPY Trial centres will be involved in this feasibility study. Over a 12 month period, we plan to enrol 50 women with diagnosed prolapse of stage I to IV, who are not eligible for The POPPY Trial because they require a pessary. These women will be randomised into one of two groups: PFMT (delivered by a physiotherapist at 5 appointments over 16 weeks) in conjunction with pessary management of their prolapse or pessary management alone. All women will have a nurse appointment six months after randomisation at which time their pessary will be removed. A replacement pessary will not be immediately re-fitted. At seven months after randomisation all women will have a review appointment with their gynaecologist to have their prolapse assessed, the pessary re-fitted if necessary, and other treatment needs discussed. Women will complete postal questionnaires, at baseline (prior to randomisation), at six months post-randomisation (prior to seeing the nurse to have the pessary removed), and seven months post-randomisation (prior to the 7 month gynaecologist review appointment), and record symptoms in a diary for one month after removal of the pessary. Key outcomes are: prolapse symptoms, prolapse-related quality of life, prolapse severity, and additional prolapse treatment received up to seven months after study entry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PFMT plus routine pessary management | Active comparator | Other: PFMTWomen allocated to the intervention group will be invited to attend 5 out-patient appointments over a 16 week period with a trained specialist women's health physiotherapist at the study centre. Women will be taught how to contract the muscles, and also how to contract and hold prior to an event that increases intra-abdominal pressure ("the Knack"). Tailored advice will be given on ways of reducing intra-abdominal pressure, e.g. advice on weight loss, chronic cough, heavy lifting and general exercise. A prolapse specific Lifestyle Advice sheet will also be given to the women by the physiotherapist. |
| Lifestyle | Active comparator | Other: PFMTWomen allocated to the control group will be sent a Lifestyle Advice Leaflet only. They will have no planned intervention after their pessary is fitted, other than routine pessary management according to local protocols. The Lifestyle Advice Leaflet gives instructions on seeking advice, where appropriate, about weight loss, constipation, and avoidance of heavy lifting, coughing and high impact exercise, with a view to minimising increases in intra-abdominal pressure which may cause the prolapse to worsen. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- who are new attendees at outpatient gynaecology clinics with a primary complaint of prolapse;
- who have a prolapse of stage I to IV confirmed by their gynaecologist using the POP-Q grading system;
- who have a prolapse of one or more of the following types:
- anterior vaginal wall prolapse (urethrocele, cystocele,paravaginal defect);
- uterine/cervical prolapse;
Key exclusion criteria (11 listed)
- who wish surgical treatment for prolapse and wish to be immediately added to the surgical waiting list;
- who have had previous surgical treatment for prolapse;
- who have had a pessary fitted for treatment of prolapse within the last 12 months;
- who have had previous formal instruction in PFMT;
- who present with contraindications to either pessary or PFMT treatment;
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 |
|---|---|---|
| PFMTAlso: Pelvic Floor Muscle TrainingWomen who have been successfully fitted with a vaginal pessary will be asked to attend five outpatient appointments over a 16 week period with a trained specialist women's health physiotherapist. | Other | Lifestyle, PFMT plus routine pessary management |
Primary outcome
Prolapse symptom score (POP-SS)
Time frame: 7 months
8 secondary outcomes
Prolapse-related quality of life(single item scored 0 to 10)
Time frame: 7 months
Prolapse severity (POP-Q)
Time frame: 7 months
Urinary, bowel and sexual symptoms
Time frame: 7 months
Lifestyle changes
Time frame: 7 months
General Health Status
Time frame: 7 months
Recurrence of prolapse symptoms over the one month period between removal of the pessary (month 6) and gynaecology clinic review (month 7)
Time frame: 7 months
Time without pessary (i.e. time from removal of pessary to pessary being re-fitted)
Time frame: 7 months
Need for further prolapse treatment including continuing use of pessary, PFMT or surgery.
Time frame: 7 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 19 Jan 2011.
- Derived from this study: PubMed 33207004Bugge C, Adams EJ, Gopinath D, Stewart F, Dembinsky M, Sobiesuo P, Kearney R. Pessaries (mechanical devices) for managing pelvic organ prolapse in women. Cochrane Database Syst Rev. 2020 Nov 18;11(11):CD004010. doi: 10.1002/14651858.CD004010.pub4.
- Derived from this study: PubMed 24160371Bugge C, Williams B, Hagen S, Logan J, Glazener C, Pringle S, Sinclair L. A process for Decision-making after Pilot and feasibility Trials (ADePT): development following a feasibility study of a complex intervention for pelvic organ prolapse. Trials. 2013 Oct 25;14:353. doi: 10.1186/1745-6215-14-353.
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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.
Professor Suzanne Hagen principal investigator
NMAHP Research Unit
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PFMT in people with Pelvic Organ Prolapse, run by Glasgow Caledonian University at 4 sites in United Kingdom.
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 11 inclusion and 11 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 19 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. 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?
Prolapse symptom score (POP-SS) (time frame: 7 months). 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 NCT01136889, which also lists 2 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 19 Jan 2011.