Pelvic Organ ProlapseNCT02667002
Comparison of Anatomic Results Between Bilateral and Conventional Abdominal Sacral Hysteropexy
A study testing Bilateral Abdominal Sacral Hysteropexy, Conventional abdominal Sacral Hysteropexy and Nulliparous women with no uterovaginal prolapsed in people with Pelvic Organ Prolapse, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital.
Trial summary
Investigators separated 20 patients with uterovaginal prolapse into 2 groups according to random numbers table. In one group, conventional abdominal sacral hysteropexy will be perform and another group bilateral abdominal sacral hysteropexy will be perform with polypropylene mesh. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Bilateral Abdominal Sacral Hysteropexy, Conventional abdominal Sacral Hysteropexy and Nulliparous women with no uterovaginal prolapsed
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Jun 2017
- 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 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women with stage 3 or more pelvic organ prolapse
Who cannot join
- Women with abnormal uterine bleeding, abnormal cervical screening test, myoma uteri and want to hysterectomy
About this study
Official title: Randomized Single Blind Controlled Trial of Comparison of Anatomic and Sexual Outcomes Between Conventional and Bilateral Sacral Hysteropexy
Investigators separated 20 patients with uterovaginal prolapse into 2 groups according to random numbers table. In one group, conventional abdominal sacral hysteropexy will be perform and another group bilateral abdominal sacral hysteropexy will be perform with polypropylene mesh. After 1 mont operation vaginal configuration will be evaluate with MRI on three plane (axial, sagittal, coronal). Then the results of thus two groups will be compare to results of nullipara patients. Investigators will investigate which technique keep the vaginal axis is closer to the original anatomic position.
Read the detailed description
Since vaginal hysterectomy and mc call culdoplasty, many techniques have been described. Before, correcting only prolapsed part, now, we can measure anatomical and functional results more objectively by using different tool such us MRI, perineal ultrasonography, PISQ-12, IIQ-7 (Incontinence impact questionnaire). Hence pelvic organ prolapse surgery is important in terms of anatomic and functional results. Unilateral abdominal sacral hysteropexy can put vaginal axis to right side slightly. Therefore investigators hypothesized that bilateral sacral hysteropexy which mimic sacrouterine ligament can be more suitable in terms of anatomic results.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Bilateral Abdominal Sacral Hysteropexy, Conventional abdominal Sacral Hysteropexy, Nulliparous women with no uterovaginal prolapsed
- 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.
Bilateral Abdominal Sacral HysteropexyProcedure or surgery
The mesh will be fixed right and left side of sacrum.
Conventional abdominal Sacral HysteropexyProcedure or surgery
The mesh will be fixed only right side of sacrum
Nulliparous women with no uterovaginal prolapsedOther
This will be control group which consistent patients with no uterovaginal prolapse.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral Abdominal Sacral Hysteropexy | Experimental | Bilateral abdominal sacral hysteropexy will be perform in 10 patients. One month after patients will be evaluate by MRI and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) form. Receives: Procedure: Bilateral Abdominal Sacral Hysteropexy |
| Classic Abdominal Sacral Hysteropexy | Experimental | Conventional abdominal sacral hysteropexy will be perform in 10 patients. One month after patients will be evaluate by MRI and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) form. Receives: Procedure: Conventional abdominal Sacral Hysteropexy |
| Women with no uterovaginal prolapsed | Active comparator | Ten nulliparous participants with no uterovaginal prolapsed will be evaluate by MRI and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) form. Receives: Other: Nulliparous women with no uterovaginal prolapsed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomic Success
anatomic success will be evaluated by using magnetic resonance imaging. Vaginal axis (distance to spin ischiadic a and sacrum) will be measure on three plane
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startNov 2015
- Primary completionMay 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Baki Senturk, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Investigators
- Mehmet Baki Şentürk, MD, Study director, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667002
- Sponsor's protocol ID
- 162
- Status last verified
- Mar 2022
- First submitted
- 21 Jan 2016
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data will be available within 1 week of study completion.
Publications
Jager W, Mirenska O, Brugge S. Surgical treatment of mixed and urge urinary incontinence in women. Gynecol Obstet Invest. 2012;74(2):157-64. doi: 10.1159/000339972. Epub 2012 Aug 9.
PubMed 22890409Sze EH, Meranus J, Kohli N, Miklos JR, Karram MM. Vaginal configuration on MRI after abdominal sacrocolpopexy and sacrospinous ligament suspension. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(6):375-9; discussion 379-80. doi: 10.1007/s001920170016.
PubMed 11795640Joukhadar R, Meyberg-Solomayer G, Hamza A, Radosa J, Bader W, Barski D, Ismaeel F, Schneider G, Solomayer E, Baum S. A Novel Operative Procedure for Pelvic Organ Prolapse Utilizing a MRI-Visible Mesh Implant: Safety and Outcome of Modified Laparoscopic Bilateral Sacropexy. Biomed Res Int. 2015;2015:860784. doi: 10.1155/2015/860784. Epub 2015 Apr 19.
PubMed 25961042
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Single Blind Controlled Trial of Comparison of Anatomic and Sexual Outcomes Between Conventional and Bilateral Sacral Hysteropexy
- ClinicalTrials.gov ID
- NCT02667002
- Acronym / sponsor ID
- 162
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- May 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 28 Jan 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.
Investigators separated 20 patients with uterovaginal prolapse into 2 groups according to random numbers table. In one group, conventional abdominal sacral hysteropexy will be perform and another group bilateral abdominal sacral hysteropexy will be perform with polypropylene mesh. After 1 mont operation vaginal configuration will be evaluate with MRI on three plane (axial, sagittal, coronal). Then the results of thus two groups will be compare to results of nullipara patients. Investigators will investigate which technique keep the vaginal axis is closer to the original anatomic position.
Detailed description
Since vaginal hysterectomy and mc call culdoplasty, many techniques have been described. Before, correcting only prolapsed part, now, we can measure anatomical and functional results more objectively by using different tool such us MRI, perineal ultrasonography, PISQ-12, IIQ-7 (Incontinence impact questionnaire). Hence pelvic organ prolapse surgery is important in terms of anatomic and functional results. Unilateral abdominal sacral hysteropexy can put vaginal axis to right side slightly. Therefore investigators hypothesized that bilateral sacral hysteropexy which mimic sacrouterine ligament can be more suitable in terms of anatomic results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bilateral Abdominal Sacral Hysteropexy | Experimental | Procedure: Bilateral Abdominal Sacral HysteropexyBilateral abdominal sacral hysteropexy will be perform in 10 patients. One month after patients will be evaluate by MRI and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) form. |
| Classic Abdominal Sacral Hysteropexy | Experimental | Procedure: Conventional abdominal Sacral HysteropexyConventional abdominal sacral hysteropexy will be perform in 10 patients. One month after patients will be evaluate by MRI and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) form. |
| Women with no uterovaginal prolapsed | Active comparator | Other: Nulliparous women with no uterovaginal prolapsedTen nulliparous participants with no uterovaginal prolapsed will be evaluate by MRI and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) form. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women with stage 3 or more pelvic organ prolapse
Key exclusion criteria (1 listed)
- Women with abnormal uterine bleeding, abnormal cervical screening test, myoma uteri and want to hysterectomy
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 |
|---|---|---|
| Bilateral Abdominal Sacral HysteropexyThe mesh will be fixed right and left side of sacrum. | Procedure or surgery | Bilateral Abdominal Sacral Hysteropexy |
| Conventional abdominal Sacral HysteropexyThe mesh will be fixed only right side of sacrum | Procedure or surgery | Classic Abdominal Sacral Hysteropexy |
| Nulliparous women with no uterovaginal prolapsedThis will be control group which consistent patients with no uterovaginal prolapse. | Other | Women with no uterovaginal prolapsed |
Primary outcome
Anatomic Success
Time frame: One month
anatomic success will be evaluated by using magnetic resonance imaging. Vaginal axis (distance to spin ischiadic a and sacrum) will be measure on three plane
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 Mar 2022.
- Results publication: PubMed 22890409Jager W, Mirenska O, Brugge S. Surgical treatment of mixed and urge urinary incontinence in women. Gynecol Obstet Invest. 2012;74(2):157-64. doi: 10.1159/000339972. Epub 2012 Aug 9.
- Results publication: PubMed 11795640Sze EH, Meranus J, Kohli N, Miklos JR, Karram MM. Vaginal configuration on MRI after abdominal sacrocolpopexy and sacrospinous ligament suspension. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(6):375-9; discussion 379-80. doi: 10.1007/s001920170016.
- Results publication: PubMed 25961042Joukhadar R, Meyberg-Solomayer G, Hamza A, Radosa J, Bader W, Barski D, Ismaeel F, Schneider G, Solomayer E, Baum S. A Novel Operative Procedure for Pelvic Organ Prolapse Utilizing a MRI-Visible Mesh Implant: Safety and Outcome of Modified Laparoscopic Bilateral Sacropexy. Biomed Res Int. 2015;2015:860784. doi: 10.1155/2015/860784. Epub 2015 Apr 19.
- pubmedLink provided by the sponsor.
- pubmedLink provided by the sponsor.
- pubmedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be available within 1 week of study completion.
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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.
Mehmet Baki Şentürk, MD study director
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral Abdominal Sacral Hysteropexy, Conventional abdominal Sacral Hysteropexy and Nulliparous women with no uterovaginal prolapsed in people with Pelvic Organ Prolapse, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital.
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 1 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 28 Mar 2022. 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?
Anatomic Success (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02667002, which also lists 3 linked publications.
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 Mar 2022.