Pelvic Organ ProlapseNCT00576004
Pelvic Organ Prolapse Repair With or Without Concomitant Burch Colposuspension in Patients With Urinary Incontinence
A study testing Pelvic organ prolapse repair and Burch colposuspension in people with Pelvic Organ Prolapse and Urinary Incontinence, run by University Of Perugia at 1 site in Italy.
Trial summary
To evaluate the impact of Burch colposuspension (BC), as an anti-incontinence measure, in patients with urinary incontinence (UI) undergoing abdominal surgery for pelvic organ prolapse (POP) repair Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Urinary Incontinence
- What is being tested?
- Pelvic organ prolapse repair and Burch colposuspension
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2002to Dec 2006
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Study inclusion criteria were POP > 2, UI as was defined by ICS [2], age ≥ 18 and ≤ 75 yrs.
Who cannot join
- Benign or malignant uterus lesion (leiomyoma, fibromyoma, cervical or endometrial carcinoma)
- Active pelvic inflammatory disease,
- Known hypersensitivity to synthetic materials (polypropylene, polythetrafloroethilene, polyethileneterephtalate, polyglactil acid or polyglycolic acid)
- Pregnancy or lactation
- Evidence of clinically significant cardiovascular, renal, hepatic or respiratory diseases; and
- Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pelvic Organ Prolapse Repair With or Without Concomitant Burch Colposuspension in Patients With Urinary Incontinence: A Randomised Surgical Trial
To evaluate the impact of Burch colposuspension (BC), as an anti-incontinence measure, in patients with urinary incontinence (UI) undergoing abdominal surgery for pelvic organ prolapse (POP) repair
Read the detailed description
Forty-seven women suffering from POP and UI were randomly assigned to abdominal POP repair and concomitant BC ( 24 patients; group A) or POP repair alone without any anti-incontinence procedure ( 23 patients.; group B). They were followed-up at 3, 6, and 9 months after surgery and then annually. The primary outcome measures were anatomical outcome and changes in incontinence status as indicated by a bladder diary, the number of daily pads and the stress test. Secondary endpoints were changes in subjective symptoms and Quality of Life (QoL) as measured by the Urogenital Distress Inventory (UDI-6) and the Impact Incontinence Quality of Life (IIQ-7) questionnaires.
- Conditions
- Pelvic Organ Prolapse, Urinary Incontinence
- Being tested
- Pelvic organ prolapse repair and Burch colposuspension
- Keywords
- Pelvic organ prolapse, Urinary incontinence, Burch colposuspension, surgery
- 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.
Pelvic organ prolapse repair and Burch colposuspensionProcedure or surgery
Abdominal pelvic organ prolapse repair and retropubic Burch colposuspension
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | Pelvic organ prolapse repair plus concomitant Burch Colposuspension Receives: Procedure: Pelvic organ prolapse repair and Burch colposuspension |
| group B | Active comparator | Pelvic organ prolapse without Burch colposuspension Receives: Procedure: Pelvic organ prolapse repair and Burch colposuspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in the incontinence rate as shown by a bladder diary, number of daily pads and the stress test.
Measured: 2002-2006
Secondary outcomes (1)
changes in subjective symptoms and Quality of Life (QoL) as measured by questionnaires
Measured: 2002-2206
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startJan 2002
- Study completionDec 2006
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
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Of Perugia
- Sponsor type
- University, hospital or other
- Investigators
- Elisabetta Costantini, MD, Principal investigator, University Of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576004
- Sponsor's protocol ID
- EC_ML_001
- Other IDs
- EC_ML_001s
- Status last verified
- Dec 2007
- First submitted
- 17 Dec 2007
- Last updated
- 18 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Organ Prolapse Repair With or Without Concomitant Burch Colposuspension in Patients With Urinary Incontinence: A Randomised Surgical Trial
- ClinicalTrials.gov ID
- NCT00576004
- Acronym / sponsor ID
- EC_ML_001
- Conditions
- Pelvic Organ Prolapse, Urinary Incontinence
- Keywords
- Pelvic organ prolapse, Urinary incontinence, Burch colposuspension, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University Of PerugiaUniversity, hospital or other
- Study start
- Jan 2002
- Study completion
- Dec 2006 (actual)
- First posted
- 18 Dec 2007 (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 evaluate the impact of Burch colposuspension (BC), as an anti-incontinence measure, in patients with urinary incontinence (UI) undergoing abdominal surgery for pelvic organ prolapse (POP) repair
Detailed description
Forty-seven women suffering from POP and UI were randomly assigned to abdominal POP repair and concomitant BC ( 24 patients; group A) or POP repair alone without any anti-incontinence procedure ( 23 patients.; group B). They were followed-up at 3, 6, and 9 months after surgery and then annually. The primary outcome measures were anatomical outcome and changes in incontinence status as indicated by a bladder diary, the number of daily pads and the stress test. Secondary endpoints were changes in subjective symptoms and Quality of Life (QoL) as measured by the Urogenital Distress Inventory (UDI-6) and the Impact Incontinence Quality of Life (IIQ-7) questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Procedure: Pelvic organ prolapse repair and Burch colposuspensionPelvic organ prolapse repair plus concomitant Burch Colposuspension |
| group B | Active comparator | Procedure: Pelvic organ prolapse repair and Burch colposuspensionPelvic organ prolapse without Burch colposuspension |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Study inclusion criteria were POP > 2, UI as was defined by ICS [2], age ≥ 18 and ≤ 75 yrs.
Key exclusion criteria (6 listed)
- Benign or malignant uterus lesion (leiomyoma, fibromyoma, cervical or endometrial carcinoma)
- Active pelvic inflammatory disease,
- Known hypersensitivity to synthetic materials (polypropylene, polythetrafloroethilene, polyethileneterephtalate, polyglactil acid or polyglycolic acid)
- Pregnancy or lactation
- Evidence of clinically significant cardiovascular, renal, hepatic or respiratory diseases; and
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 organ prolapse repair and Burch colposuspensionAbdominal pelvic organ prolapse repair and retropubic Burch colposuspension | Procedure or surgery | group A, group B |
Primary outcome
changes in the incontinence rate as shown by a bladder diary, number of daily pads and the stress test.
Time frame: 2002-2006
1 secondary outcome
changes in subjective symptoms and Quality of Life (QoL) as measured by questionnaires
Time frame: 2002-2206
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 18 Dec 2007.
- Related InfoLink provided by the sponsor.
Related trials for Pelvic Organ Prolapse
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
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.
Elisabetta Costantini, MD principal investigator
University Of Perugia
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 organ prolapse repair and Burch colposuspension in people with Pelvic Organ Prolapse and Urinary Incontinence, run by University Of Perugia 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 1 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: finished, as of the sponsor's last update on 18 Dec 2007. 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.
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?
changes in the incontinence rate as shown by a bladder diary, number of daily pads and the stress test. (time frame: 2002-2006). 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 18 Dec 2007.