Pelvic Organ ProlapseNTRSPOPNCT02808377
Native Tissue Repair With Surgical Pelvic Organ Pessary - an RCT
A study testing Surgical Pelvic Organ Pessary in people with Pelvic Organ Prolapse, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This is an RCT looking at the primary outcome of composite success following anterior repair with native tissue at 6, 12, 24 months in two arms. One arm will be randomised to have a soft silicone pessary inserted into the vagina post operatively for three weeks and the other will not. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Surgical Pelvic Organ Pessary
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2016to Jun 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women with symptomatic pelvic organ prolapse requiring an anterior vaginal repair at the study centre.
- Currently on the hospital waiting list for vaginal native tissue repair
- Willingness to participate
- Medically fit for surgery
- 18 years or over
- Reasonable level of English to complete questionnaires
- Patients have not been recommended surgery that involves colpocliesis, mesh, or laparoscopic approach
Who cannot join
- Asymptomatic pelvic organ prolapse
- Refusal to participate
- Medically unfit for surgery
- Under 18
- Unable to complete questionnaires due to poor level of english
- Patients has been recommended surgery that involves colpocliesis, mesh, or laparoscopic approach
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Urogynaecology
Cambridge, Cambridgeshire
Miss Pandeva, 07971397396, ivilina.pandeva@addenbrookes.nhs.uk
Mark C Slack, mark.slack@addenbrookes.nhs.uk
About this study
Official title: VAGINAL NATIVE TISSUE REPAIR AUGMENTATION WITH POST OPERATIVE PLACEMENT OF SURGICAL PELVIC ORGAN PESSARY (SPOP). A MULTICENTRE SINGLE BLINDED RANDOMISED CONTROLLED STUDY
This is an RCT looking at the primary outcome of composite success following anterior repair with native tissue at 6, 12, 24 months in two arms. One arm will be randomised to have a soft silicone pessary inserted into the vagina post operatively for three weeks and the other will not.
Read the detailed description
Prolapse of the vagina is a common problem for women and varies from mildly bothersome to very problematic. About one in ten women in the developed world will require surgery for prolapse in their lifetime. The results of surgery are not perfect and some of women will develop prolapse again or not be satisfied with the result.
In this study a soft silicone support (SPOP) is inserted into the vagina straight after prolapse surgery. Women who have agreed to the study will be randomly chosen to have the SPOP at the time of surgery. There will be 120 patients in the study; so 60 women will have the SPOP inserted.
The investigators think that SPOP will support the vagina as it heals, improving the results of surgery. There are already some studies of the SPOP with other surgeries that show improved results. The SPOP is inserted while the patient is sleeping and is removed four weeks after surgery. It is attached with two dissolving stiches to the vagina. After four weeks is will be removed in the out patient clinic without any discomfort. It is not usually painful or uncomfortable at any time.
The actual surgery the women have will not be any different had they not been in the study. All the women in the study will have the normal assessment prior to their operation, and will fill out some questionnaires about their symptoms too. All women involved in the study will come back the clinic to be seen after six months, one year and two years from the date of the surgery. This is regardless of whether they had the SPOP or not. When the women return they will be examined and complete the questionnaires again each visit.
The results of the study will be reported and published.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Surgical Pelvic Organ Pessary
- 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.
Surgical Pelvic Organ PessaryOther
In participants randomized to intervention, the SPOP will be placed at the completion of surgery, following routine placement of IDC and prior to placement of vaginal pack. The SPOP is available in 4 sizes and the surgeon will select the appropriate size so that the SPOP rests snugly without undue tension inside the hymeneal remnant. The SPOP is sutured in place with 2/0 Vicryl to prevent dislodgement at the level of the hymen.
| Study group | Role | What they receive |
|---|---|---|
| SPOP | Active comparator | This arm will have the soft silicone pessary inserted post operatively and it will remain in-situ for 3 weeks. Receives: Other: Surgical Pelvic Organ Pessary |
| Non Intervention | No intervention | Routine post operative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success in anterior compartment.
Success defined as composite of success based on objective findings and subjective patient report.
Objective anatomic success as Anterior Prolapse no greater than Stage 1 (reference point Ba <-1cm) on validated POPQ examination. Subjective success as defined as absence of 'bulge' symptom on PDFI-20 validated questionnaire.
Failure will be defined as leading edge of anterior vaginal wall a Stage 2 or more (reference point Ba =>-1cm), or presence of 'vaginal bulge' symptom on validated questionnaire.
Measured: 6 months post operative
Success in Anterior Compartment
Success defined as composite of success based on objective findings and subjective patient report.
Objective anatomic success as Anterior Prolapse no greater than Stage 1 (reference point Ba <-1cm) on validated POPQ examination. Subjective success as defined as absence of 'bulge' symptom on PDFI-20 validated questionnaire.
Failure will be defined as leading edge of anterior vaginal wall a Stage 2 or more (reference point Ba =>-1cm), or presence of 'vaginal bulge' symptom on validated questionnaire.
Measured: 12 months post operative
Success in Anterior Compartment
Success defined as composite of success based on objective findings and subjective patient report.
Objective anatomic success as Anterior Prolapse no greater than Stage 1 (reference point Ba <-1cm) on validated POPQ examination. Subjective success as defined as absence of 'bulge' symptom on PDFI-20 validated questionnaire.
Failure will be defined as leading edge of anterior vaginal wall a Stage 2 or more (reference point Ba =>-1cm), or presence of 'vaginal bulge' symptom on validated questionnaire.
Measured: 24months post operative
Secondary outcomes (18)
Change in POP-Q quantitative measurements from baseline
Measured: 6 months
Change in POP-Q quantitative measurements from baseline
Measured: 12 months
Change in POP-Q quantitative measurements from baseline
Measured: 24 months
Division of vaginal band
Any patient requiring repeat procedure for division vaginal band with in 6 months post operative.
Measured: 6months
Anatomic success of any associated posterior repair procedure
Objective anatomic success as Posterior Prolapse no greater than Stage 1 (reference point Bp <-1cm) on validated POPQ examination.
Measured: 24 months post operative
Anatomic success of any associated posterior repair procedure
Objective anatomic success as Posterior Prolapse no greater than Stage 1 (reference point Bp <-1cm) on validated POPQ examination.
Measured: 6 months
Anatomic success of any associated posterior repair procedure
Objective anatomic success as Posterior Prolapse no greater than Stage 1 (reference point Bp <-1cm) on validated POPQ examination.
Measured: 12 months
Anatomic success of any associated apical repair procedure
Objective anatomic success as apical prolapse no greater than Stage 1 (reference point C <-1cm) on validated POPQ examination.
Measured: 6 months
Anatomic success of any associated apical repair procedure
Objective anatomic success as apical prolapse no greater than Stage 1 (reference point C <-1cm) on validated POPQ examination.
Measured: 12 months
Anatomic success of any associated apical repair procedure
Objective anatomic success as apical prolapse no greater than Stage 1 (reference point C <-1cm) on validated POPQ examination.
Measured: 24 months
Five point Patient Global Assessment of Change (PGA-C) visual analogue scale 6 months following surgery
Measured: 6 months
Five point Patient Global Assessment of Change (PGA-C) visual analogue scale 6 months following surgery
Measured: 12 months
Five point Patient Global Assessment of Change (PGA-C) visual analogue scale 6 months following surgery
Measured: 24months
Change in PISQ-IR
Validated patient reported outcome - pelvic organ prolapse incontinence questionnaire IUGA revised
Measured: 6 months
Change in PISQ-IR
Validated patient reported outcome - pelvic organ prolapse incontinence questionnaire IUGA revised
Measured: 12 months
Change in PISQ-IR
Validated patient reported outcome - pelvic organ prolapse incontinence questionnaire IUGA revised
Measured: 24 months
Change in PFDI - 20
Validated patient reported outcome (pelvic floor distress inventory) -
Measured: 24 months
Change in PFDI-20
Validated patient reported outcome (pelvic floor distress inventory) -
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Ivilina Pandeva, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808377
- Sponsor's protocol ID
- A094029
- Acronym
- NTRSPOP
- Status last verified
- Jun 2016
- First submitted
- 7 Jun 2016
- Last updated
- 21 Jun 2016
- 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 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VAGINAL NATIVE TISSUE REPAIR AUGMENTATION WITH POST OPERATIVE PLACEMENT OF SURGICAL PELVIC ORGAN PESSARY (SPOP). A MULTICENTRE SINGLE BLINDED RANDOMISED CONTROLLED STUDY
- ClinicalTrials.gov ID
- NCT02808377
- Acronym / sponsor ID
- NTRSPOP / A094029
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 21 Jun 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.
This is an RCT looking at the primary outcome of composite success following anterior repair with native tissue at 6, 12, 24 months in two arms. One arm will be randomised to have a soft silicone pessary inserted into the vagina post operatively for three weeks and the other will not.
Detailed description
Prolapse of the vagina is a common problem for women and varies from mildly bothersome to very problematic. About one in ten women in the developed world will require surgery for prolapse in their lifetime. The results of surgery are not perfect and some of women will develop prolapse again or not be satisfied with the result.
In this study a soft silicone support (SPOP) is inserted into the vagina straight after prolapse surgery. Women who have agreed to the study will be randomly chosen to have the SPOP at the time of surgery. There will be 120 patients in the study; so 60 women will have the SPOP inserted.
The investigators think that SPOP will support the vagina as it heals, improving the results of surgery. There are already some studies of the SPOP with other surgeries that show improved results. The SPOP is inserted while the patient is sleeping and is removed four weeks after surgery. It is attached with two dissolving stiches to the vagina. After four weeks is will be removed in the out patient clinic without any discomfort. It is not usually painful or uncomfortable at any time.
The actual surgery the women have will not be any different had they not been in the study. All the women in the study will have the normal assessment prior to their operation, and will fill out some questionnaires about their symptoms too. All women involved in the study will come back the clinic to be seen after six months, one year and two years from the date of the surgery. This is regardless of whether they had the SPOP or not. When the women return they will be examined and complete the questionnaires again each visit.
The results of the study will be reported and published.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPOP | Active comparator | Other: Surgical Pelvic Organ PessaryThis arm will have the soft silicone pessary inserted post operatively and it will remain in-situ for 3 weeks. |
| Non Intervention | No intervention | –Routine post operative care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women with symptomatic pelvic organ prolapse requiring an anterior vaginal repair at the study centre.
- Currently on the hospital waiting list for vaginal native tissue repair
- Willingness to participate
- Medically fit for surgery
- 18 years or over
Key exclusion criteria (6 listed)
- Asymptomatic pelvic organ prolapse
- Refusal to participate
- Medically unfit for surgery
- Under 18
- Unable to complete questionnaires due to poor level of english
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 |
|---|---|---|
| Surgical Pelvic Organ PessaryIn participants randomized to intervention, the SPOP will be placed at the completion of surgery, following routine placement of IDC and prior to placement of vaginal pack. The SPOP is available in 4 sizes and the surgeon will select the appropriate size so that the SPOP rests snugly without undue tension inside the hymeneal remnant. The SPOP is sutured in place with 2/0 Vicryl to prevent dislodgement at the level of the hymen. | Other | SPOP |
Primary outcome
Success in anterior compartment.
Time frame: 6 months post operative
Success defined as composite of success based on objective findings and subjective patient report. Objective anatomic success as Anterior Prolapse no greater than Stage 1 (reference point Ba <-1cm) on validated POPQ examination. Subjective success as defined as absence of 'bulge' symptom on PDFI-20 validated questionnaire. Failure will be defined as leading edge of anterior vaginal wall a Stage 2 or more (reference point Ba =>-1cm), or presence of 'vaginal bulge' symptom on validated questionnaire.
Success in Anterior Compartment
Time frame: 12 months post operative
Success defined as composite of success based on objective findings and subjective patient report. Objective anatomic success as Anterior Prolapse no greater than Stage 1 (reference point Ba <-1cm) on validated POPQ examination. Subjective success as defined as absence of 'bulge' symptom on PDFI-20 validated questionnaire. Failure will be defined as leading edge of anterior vaginal wall a Stage 2 or more (reference point Ba =>-1cm), or presence of 'vaginal bulge' symptom on validated questionnaire.
Success in Anterior Compartment
Time frame: 24months post operative
Success defined as composite of success based on objective findings and subjective patient report. Objective anatomic success as Anterior Prolapse no greater than Stage 1 (reference point Ba <-1cm) on validated POPQ examination. Subjective success as defined as absence of 'bulge' symptom on PDFI-20 validated questionnaire. Failure will be defined as leading edge of anterior vaginal wall a Stage 2 or more (reference point Ba =>-1cm), or presence of 'vaginal bulge' symptom on validated questionnaire.
18 secondary outcomes
Change in POP-Q quantitative measurements from baseline
Time frame: 6 months
Change in POP-Q quantitative measurements from baseline
Time frame: 12 months
Change in POP-Q quantitative measurements from baseline
Time frame: 24 months
Division of vaginal band
Time frame: 6months
Anatomic success of any associated posterior repair procedure
Time frame: 24 months post operative
Anatomic success of any associated posterior repair procedure
Time frame: 6 months
Anatomic success of any associated posterior repair procedure
Time frame: 12 months
Anatomic success of any associated apical repair procedure
Time frame: 6 months
Anatomic success of any associated apical repair procedure
Time frame: 12 months
Anatomic success of any associated apical repair procedure
Time frame: 24 months
Five point Patient Global Assessment of Change (PGA-C) visual analogue scale 6 months following surgery
Time frame: 6 months
Five point Patient Global Assessment of Change (PGA-C) visual analogue scale 6 months following surgery
Time frame: 12 months
Five point Patient Global Assessment of Change (PGA-C) visual analogue scale 6 months following surgery
Time frame: 24months
Change in PISQ-IR
Time frame: 6 months
Change in PISQ-IR
Time frame: 12 months
Change in PISQ-IR
Time frame: 24 months
Change in PFDI - 20
Time frame: 24 months
Change in PFDI-20
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Pelvic Organ Pessary in people with Pelvic Organ Prolapse, run by Cambridge University Hospitals NHS Foundation Trust at 1 site 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 7 inclusion and 6 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 21 Jun 2016. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success in anterior compartment. (time frame: 6 months post operative). 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 21 Jun 2016.