Pelvic Organ ProlapsePhase 4NCT00697489
Treatment of Urinary Stress Incontinence During or Following Correction of Pelvic Organ Prolapse
A Phase 4 study testing correction of POP plus preventive continence procedure and POP surgery followed by eventual incontinence procedure in people with Pelvic Organ Prolapse, run by University Magna Graecia at 1 site in Italy.
Trial summary
The incidence of pelvic organ prolapse (POP) in parous women is estimated over 50%. A variety of urinary, bowel and sexual symptoms may be associated with POP. Moreover, a proportion of women who underwent a surgical correction of POP may occur post-surgical urinary incontinence and, thus, if this last presents as… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- correction of POP plus preventive continence procedure and POP surgery followed by eventual incontinence procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2008to Aug 2010
- Phase
- Phase 4
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pelvic organ prolapse stage 2-3
- Absence of subjective urinary stress incontinence
Who cannot join
- pregnancy
- <12 months postpartum
- systemic disease known to affect bladder function
- current chemotherapy or radiation therapy
- urethral diverticulum, augmentation cytoplasty, or artificial sphincter
- recent pelvic surgery
- patient age under 18 and over 80
- any previous pelvic surgery, diabetes mellitus and collagen disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pelvic Organ Prolapse Correction Plus Preventive Treatment of Urinary Stress Incontinence vs. Correction of Pelvic Organ Prolapse Followed by Treatment of Urinary Stress Incontinence
The incidence of pelvic organ prolapse (POP) in parous women is estimated over 50%. A variety of urinary, bowel and sexual symptoms may be associated with POP. Moreover, a proportion of women who underwent a surgical correction of POP may occur post-surgical urinary incontinence and, thus, if this last presents as genuine stress-type or mixed-type, a second surgical intervention may be required. At this proposal, with the aim to reduce the incidence of postoperative urinary incontinence, the addition of a preventive continence procedure to a POP repair intervention has been widely proposed, but the potential benefits needs to be balanced against potential disadvantages.
Based on these considerations, the aim of this trial will be to compare two different surgical strategies for women with POP without urinary stress incontinence. Specifically, the efficacy to associate and to follow a preventive continence procedure to the correction of POP will be compared.
Read the detailed description
Women with POP not associated to urinary stress incontinence will be enrolled and randomized in two arms(groups A and B). Patients of group A will be treated with unique surgery (correction of POP plus preventive continence procedure), whereas in patients of group B POP will be surgically corrected and, in case of stress or mixed postoperative incontinence, a further intervention for urinary stress incontinence will be tailored.
All patients eligible will undergo baseline assessment consisting of anthropometric, clinical, hormonal, ultrasonographic and urodynamic evaluations. During the study, the clinical outcomes, and the adverse experience will be evaluated in each patient.
Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- correction of POP plus preventive continence procedure, POP surgery followed by eventual incontinence procedure
- Keywords
- Pelvic organ prolapse, Urinary incontinence, Mesh
- Medical subject headings
- Pelvic Organ Prolapse, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
correction of POP plus preventive continence procedureProcedure or surgery
POP surgery followed by eventual incontinence procedureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | unique surgery Receives: Procedure: correction of POP plus preventive continence procedure |
| 2 | Active comparator | Double surgery Receives: Procedure: POP surgery followed by eventual incontinence procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy (cure rate)
Measured: 12 months
Secondary outcomes (6)
intra-operative complication rate
Measured: one day
postoperative complications rate
Measured: 12 months
sexual function
Measured: 12 months
quality of life
Measured: 12 months
Failure rate
Measured: 12 months
Recurrence rate
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 posted16 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionAug 2010
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Palomba, University Magna Graecia
- Investigators
- Stefano Palomba, MD, Principal investigator, Chair of Obstetrics and Gynecology, University "Magna Graecia" of CatanzaroFulvio Zullo, MD, Study chair, Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00697489
- Sponsor's protocol ID
- 01/2008
- Status last verified
- Apr 2013
- First submitted
- 12 Jun 2008
- Last updated
- 8 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Organ Prolapse Correction Plus Preventive Treatment of Urinary Stress Incontinence vs. Correction of Pelvic Organ Prolapse Followed by Treatment of Urinary Stress Incontinence
- ClinicalTrials.gov ID
- NCT00697489
- Acronym / sponsor ID
- 01/2008
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Pelvic organ prolapse, Urinary incontinence, Mesh
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Aug 2010 (actual)
- First posted
- 16 Jun 2008 (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.
The incidence of pelvic organ prolapse (POP) in parous women is estimated over 50%. A variety of urinary, bowel and sexual symptoms may be associated with POP. Moreover, a proportion of women who underwent a surgical correction of POP may occur post-surgical urinary incontinence and, thus, if this last presents as genuine stress-type or mixed-type, a second surgical intervention may be required. At this proposal, with the aim to reduce the incidence of postoperative urinary incontinence, the addition of a preventive continence procedure to a POP repair intervention has been widely proposed, but the potential benefits needs to be balanced against potential disadvantages.
Based on these considerations, the aim of this trial will be to compare two different surgical strategies for women with POP without urinary stress incontinence. Specifically, the efficacy to associate and to follow a preventive continence procedure to the correction of POP will be compared.
Detailed description
Women with POP not associated to urinary stress incontinence will be enrolled and randomized in two arms(groups A and B). Patients of group A will be treated with unique surgery (correction of POP plus preventive continence procedure), whereas in patients of group B POP will be surgically corrected and, in case of stress or mixed postoperative incontinence, a further intervention for urinary stress incontinence will be tailored.
All patients eligible will undergo baseline assessment consisting of anthropometric, clinical, hormonal, ultrasonographic and urodynamic evaluations. During the study, the clinical outcomes, and the adverse experience will be evaluated in each patient.
Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: correction of POP plus preventive continence procedureunique surgery |
| 2 | Active comparator | Procedure: POP surgery followed by eventual incontinence procedureDouble surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pelvic organ prolapse stage 2-3
- Absence of subjective urinary stress incontinence
Key exclusion criteria (8 listed)
- pregnancy
- <12 months postpartum
- systemic disease known to affect bladder function
- current chemotherapy or radiation therapy
- urethral diverticulum, augmentation cytoplasty, or artificial sphincter
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 |
|---|---|---|
| correction of POP plus preventive continence procedure | Procedure or surgery | 1 |
| POP surgery followed by eventual incontinence procedure | Procedure or surgery | 2 |
Primary outcome
efficacy (cure rate)
Time frame: 12 months
6 secondary outcomes
intra-operative complication rate
Time frame: one day
postoperative complications rate
Time frame: 12 months
sexual function
Time frame: 12 months
quality of life
Time frame: 12 months
Failure rate
Time frame: 12 months
Recurrence rate
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2013.
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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.
Stefano Palomba, MD principal investigator
Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Fulvio Zullo, MD study chair
Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing correction of POP plus preventive continence procedure and POP surgery followed by eventual incontinence procedure in people with Pelvic Organ Prolapse, run by University Magna Graecia at 1 site in Italy.
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 8 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: withdrawn, as of the sponsor's last update on 8 Apr 2013. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
efficacy (cure rate) (time frame: 12 months). 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 8 Apr 2013.