Pelvic Organ ProlapseNCT03221725
The Development of De-novo Stress Urinary Incontinence After Stage II-III Pelvic Organ Prolapse Surgery
A study testing sacrospinous ligament fixation in people with Pelvic Organ Prolapse, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Surgery for Stage II-III Pelvic organ prolapse Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- sacrospinous ligament fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2017to 1 Feb 2018
- 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
Who may be able to join
- Pelvic organ prolapse stage II-III
- has no incontinence before surgery
Who cannot join
- had surgery before
- Pelvic organ prolapse stage I or IV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Sacrospinous Ligament Fixation After Vaginal Hysterectomy to Development of De-novo Stress Urinary Incontinence and Postoperative Vaginal Length in Treating Stage II-III Pelvic Organ Prolapse Patients
Surgery for Stage II-III Pelvic organ prolapse
- Conditions
- Pelvic Organ Prolapse
- Being tested
- sacrospinous ligament fixation
- Keywords
- sacrospinous ligament fixation, stress urinary incontinence
- 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.
sacrospinous ligament fixationProcedure or surgery
sacrospinous ligament fixation will be applied to prevent vaginal vault prolapse
| Study group | Role | What they receive |
|---|---|---|
| sacrospinosus fixation group | Experimental | The group which sacrospinous fixation was performed Receives: Procedure: sacrospinous ligament fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
development of stress urinary incontinence
Measured: in one year
Secondary outcomes (1)
postoperative vaginal length
Measured: in one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start1 Feb 2017
- Primary completion1 Aug 2017
- Study completion1 Feb 2018
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerem Doga Seckin, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221725
- Sponsor's protocol ID
- 2016/02
- Status last verified
- Jan 2019
- First submitted
- 14 Jul 2017
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sacrospinous Ligament Fixation After Vaginal Hysterectomy to Development of De-novo Stress Urinary Incontinence and Postoperative Vaginal Length in Treating Stage II-III Pelvic Organ Prolapse Patients
- ClinicalTrials.gov ID
- NCT03221725
- Acronym / sponsor ID
- 2016/02
- Conditions
- Pelvic Organ Prolapse
- Keywords
- sacrospinous ligament fixation, stress urinary incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 19 Jul 2017 (actual)
- 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.
Surgery for Stage II-III Pelvic organ prolapse
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sacrospinosus fixation group | Experimental | Procedure: sacrospinous ligament fixationThe group which sacrospinous fixation was performed |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Pelvic organ prolapse stage II-III
- has no incontinence before surgery
Key exclusion criteria (2 listed)
- had surgery before
- Pelvic organ prolapse stage I or IV
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 |
|---|---|---|
| sacrospinous ligament fixationsacrospinous ligament fixation will be applied to prevent vaginal vault prolapse | Procedure or surgery | sacrospinosus fixation group |
Primary outcome
development of stress urinary incontinence
Time frame: in one year
1 secondary outcome
postoperative vaginal length
Time frame: in one 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 30 Jan 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Pelvic Organ Prolapse
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
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Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sacrospinous ligament fixation in people with Pelvic Organ Prolapse, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 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 30 Jan 2019. 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 Turkey (Türkiye). 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?
development of stress urinary incontinence (time frame: in one 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 30 Jan 2019.