Pelvic Organ ProlapseNCT00308009
Comparison of the Result of TVT Performed at the Time of Prolapse Surgery or 3 Months After
A study testing Vaginal Repair for prolapse, TVT procedure and TVT and Prolapse surgery in people with Pelvic Organ Prolapse and Urinary Stress Incontinence, run by Ullevaal University Hospital.
Trial summary
It is unknown whether it is best to do the TVT( procedure for urinary stress incontinence in women) at the time of prolapse surgery or at a later date. Women with both conditions were randomized to both procedures together or the TVT 3 months after the prolapse surgery. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Urinary Stress Incontinence
- What is being tested?
- Vaginal Repair for prolapse, TVT procedure and TVT and Prolapse surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- No sites listed yet
- Study dates
- Feb 2002to Sep 2007
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Inclusion Criteria: Pelvic Organ Prolapse that needs surgical repair and objectively proven urinary stress incontinence -
Exclusion Criteria: Not agreed to participate in randomization
-
About this study
Official title: Multicenter Prospective Randomized Trial Comparing to Strategies When Incontinence Surgery is Needed in Addition to Prolapse Surgery
It is unknown whether it is best to do the TVT( procedure for urinary stress incontinence in women) at the time of prolapse surgery or at a later date. Women with both conditions were randomized to both procedures together or the TVT 3 months after the prolapse surgery. Any or no leakage when couching was the main end-point, evaluated 1 year after the last surgery
Read the detailed description
All women were evaluated by the POP-Q (pelvic Organ Prolapse Quantification) prior to surgery and 1 year after.
Examination for urinary leakage was done prior to surgery and 1 year after. Group 2 was also examined after prolapse surgery to see if TVT was still needed.
- Conditions
- Pelvic Organ Prolapse, Urinary Stress Incontinence
- Being tested
- Vaginal Repair for prolapse, TVT procedure, TVT and Prolapse surgery
- Keywords
- Pelvic Organ Prolapse, Urinary stress incontinence, Surgery
- Medical subject headings
- Pelvic Organ Prolapse, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal Repair for prolapse, TVT procedureProcedure or surgery
Also called Incontinence surgery, Mid-urethra sling, Prolapse surgery., Prolapse repair
- TVT at the time of Vaginal Repair
- TVT 3 months after Vaginal Repair
TVT and Prolapse surgeryProcedure or surgery
- TVT at the time of Prolapse surgery
- TVT 3 months after Prolapse Surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Group I, Prolapse repair and TVT concomitantly Receives: Procedure: Vaginal Repair for prolapse, TVT procedure; Procedure: TVT and Prolapse surgery |
| 2 | Active comparator | Group II, Prolapse repair and TVT 3 months afterwards if necessary Receives: Procedure: Vaginal Repair for prolapse, TVT procedure; Procedure: TVT and Prolapse surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any or no leakage of urine when coughing
Measured: 1 year
Secondary outcomes (2)
The cure of urinary stress incontinence (USI) by only prolapse surgery
Measured: 1 year
Result of prolapse surgery in two intervention strategies in women suffering from both genital prolapse and USI
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2006 (estimated)
- Study startFeb 2002
- Primary completionSep 2007
- Study completionSep 2007
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
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ellen Borstad, MD, Principal investigator, Michael Abdelnoor Phd, Department of epidemiology (same hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308009
- Sponsor's protocol ID
- TVT Prolapse study
- Status last verified
- Nov 2007
- First submitted
- 27 Mar 2006
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Randomized Trial Comparing to Strategies When Incontinence Surgery is Needed in Addition to Prolapse Surgery
- ClinicalTrials.gov ID
- NCT00308009
- Acronym / sponsor ID
- TVT Prolapse study
- Conditions
- Pelvic Organ Prolapse, Urinary Stress Incontinence
- Keywords
- Pelvic Organ Prolapse, Urinary stress incontinence, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Study start
- Feb 2002
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 28 Mar 2006 (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.
It is unknown whether it is best to do the TVT( procedure for urinary stress incontinence in women) at the time of prolapse surgery or at a later date. Women with both conditions were randomized to both procedures together or the TVT 3 months after the prolapse surgery. Any or no leakage when couching was the main end-point, evaluated 1 year after the last surgery
Detailed description
All women were evaluated by the POP-Q (pelvic Organ Prolapse Quantification) prior to surgery and 1 year after.
Examination for urinary leakage was done prior to surgery and 1 year after. Group 2 was also examined after prolapse surgery to see if TVT was still needed.
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: Vaginal Repair for prolapse, TVT procedure, Procedure: TVT and Prolapse surgeryGroup I, Prolapse repair and TVT concomitantly |
| 2 | Active comparator | Procedure: Vaginal Repair for prolapse, TVT procedure, Procedure: TVT and Prolapse surgeryGroup II, Prolapse repair and TVT 3 months afterwards if necessary |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Vaginal Repair for prolapse, TVT procedureAlso: Incontinence surgery, Mid-urethra sling, Prolapse surgery., Prolapse repair1. TVT at the time of Vaginal Repair 2. TVT 3 months after Vaginal Repair | Procedure or surgery | 1, 2 |
| TVT and Prolapse surgery1. TVT at the time of Prolapse surgery 2. TVT 3 months after Prolapse Surgery | Procedure or surgery | 1, 2 |
Primary outcome
Any or no leakage of urine when coughing
Time frame: 1 year
2 secondary outcomes
The cure of urinary stress incontinence (USI) by only prolapse surgery
Time frame: 1 year
Result of prolapse surgery in two intervention strategies in women suffering from both genital prolapse and USI
Time frame: 1 year
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 28 Apr 2015.
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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.
Ellen Borstad, MD principal investigator
Michael Abdelnoor Phd, Department of epidemiology (same hospital)
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal Repair for prolapse, TVT procedure and TVT and Prolapse surgery in people with Pelvic Organ Prolapse and Urinary Stress Incontinence, run by Ullevaal University Hospital.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Any or no leakage of urine when coughing (time frame: 1 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 28 Apr 2015.