Pelvic Organ ProlapseNCT03113513
Comparison of Two Apical Repair Methods in Women Undergoing Repairs for Prolapse
A study testing fixation of the vaginal apex in people with Pelvic Organ Prolapse and Surgery, run by Medical University of Graz at 1 site in Austria.
Trial summary
To date no study has determined prospectively which technique is superior to prevent recurrent Pelvic Organ Prolapse (POP) after vaginal hysterectomy- a major unmet clinical need. The aim of the study is to determine objective anatomical recurrent prolapse after Sacrospinous Ligament Fixation (SLF) vs McCall. Read more about this study
- Who is it for?
- Ages 35 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse, Surgery, Quality of Life
- What is being tested?
- fixation of the vaginal apex
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteAustria
- Study dates
- 1 May 2016to 30 Apr 2025
- 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 35 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- declined/ failed conservative treatment for POP
- planned vaginal hysterectomy with anterior/posterior colporrhaphy as indicated
- any symptomatic POP or stage II prolapse in any compartment
- at least stage I prolapse in the apical department
- women between 35 and 80 years of age
- good German language skills
- any concomitant prolapse surgery (anterior, posterior vaginal repair, suburethral tapes) as indicated
- concomitant salpingo-oophorectomy if indicated
Who cannot join
- Unwillingness to participate
- Neurological disorders
- Previous hysterectomy
- Desire to have children
- Connective tissue disorders (i.e. Ehlers-Danlos syndrome, Marfan syndrome)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial of Sacrospinous Ligament Fixation Versus McCall Culdoplasty in Women Undergoing Vaginal Hysterectomy and Repairs for Prolapse
To date no study has determined prospectively which technique is superior to prevent recurrent Pelvic Organ Prolapse (POP) after vaginal hysterectomy- a major unmet clinical need. The aim of the study is to determine objective anatomical recurrent prolapse after Sacrospinous Ligament Fixation (SLF) vs McCall.
Read the detailed description
The aim of the study is to determine objective anatomical recurrent prolapse after SLF vs McCall. The study is designed as a Randomized Controlled Trial (RCT). Primary study endpoint will be at 12 months, secondary study endpoint at 24 months. The following parameters will be evaluated after one year: anatomical outcome, Quality of Life (QoL), sexual health, reoperations, and complications.
- Conditions
- Pelvic Organ Prolapse, Surgery, Quality of Life, Complication
- Being tested
- fixation of the vaginal apex
- 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.
fixation of the vaginal apexProcedure or surgery
In the course of vaginal hysterectomy the vaginal cuff is either fixed to the sacrospinous ligament or to the uterosacral ligament.
| Study group | Role | What they receive |
|---|---|---|
| McCall culdoplasty | Active comparator | The McCall culdoplasty will be performed in a modified version as described by McCall in 1957. Specifically, two long acting bioresorbable sutures are put through the specific anatomic landmarks. Receives: Procedure: fixation of the vaginal apex |
| Sacrospinous ligament fixation | Active comparator | The SLF technique will be performed as described by Richter et al (Amreich, 1951). Two long acting bioresorbable sutures are passed through the right sacrospinous ligament and then fixed to the vaginal cuff. Receives: Procedure: fixation of the vaginal apex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with stage 2 or higher on the Pelvic Organ Prolapse Quantification System (POP-Q).
POP-Q stage 2 or higher means any point of the POP-Q system being -1 related to the hymen or below
Measured: 12 months after surgery
Secondary outcomes (4)
Subjective cure
determined by the Patient Global Impression of Improvement (PGII) index
Measured: 12 months after surgery
Quality of life as determined by a questionnaire
The Kings Health Questionnaire was validated in women with stress urinary incontinence and assesses the impact of incontinence on quality of life. The eight subscales ("domains") scored between 0 (best) and 100 (worst). The Symptom Severity scale is scored from 0 (best) to 30 (worst); lower scores indicate better QoL. Success in terms of the study is defined as 10 points improvement on the total Kings Health Questionnaire score.
Measured: 12 months after surgery
Sexual health
The Pelvic Organ Prolapse Incontinence Sexual Questionnaire is a 20 item questionnaire and is the primary measure used to assess sexual function in women with urinary incontinence and prolapse. Mean subscale scores are calculated by summing the valid responses to items in the subscale and then divided by the number of items with valid responses. The higher the subscores, the worse the outcome.
Measured: 12 months after surgery
Reoperation rate
Number of patients with any reoperations for POP
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start1 May 2016
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- Model description
- The study is designed as a RCT.
- Masking
- None (open label)
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113513
- Sponsor's protocol ID
- V4 31.01.2016
- Status last verified
- Jan 2024
- First submitted
- 10 Apr 2017
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The sponsor has access to all study relevant data. In the specific centers only authorized study personnel has access to the data.
Publications
Colombo M, Milani R. Sacrospinous ligament fixation and modified McCall culdoplasty during vaginal hysterectomy for advanced uterovaginal prolapse. Am J Obstet Gynecol. 1998 Jul;179(1):13-20. doi: 10.1016/s0002-9378(98)70245-5.
PubMed 9704759
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Sacrospinous Ligament Fixation Versus McCall Culdoplasty in Women Undergoing Vaginal Hysterectomy and Repairs for Prolapse
- ClinicalTrials.gov ID
- NCT03113513
- Acronym / sponsor ID
- V4 31.01.2016
- Conditions
- Pelvic Organ Prolapse, Surgery, Quality of Life, Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 13 Apr 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.
To date no study has determined prospectively which technique is superior to prevent recurrent Pelvic Organ Prolapse (POP) after vaginal hysterectomy- a major unmet clinical need. The aim of the study is to determine objective anatomical recurrent prolapse after Sacrospinous Ligament Fixation (SLF) vs McCall.
Detailed description
The aim of the study is to determine objective anatomical recurrent prolapse after SLF vs McCall. The study is designed as a Randomized Controlled Trial (RCT). Primary study endpoint will be at 12 months, secondary study endpoint at 24 months. The following parameters will be evaluated after one year: anatomical outcome, Quality of Life (QoL), sexual health, reoperations, and complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is designed as a RCT.
| Arm | Type | Receives |
|---|---|---|
| McCall culdoplasty | Active comparator | Procedure: fixation of the vaginal apexThe McCall culdoplasty will be performed in a modified version as described by McCall in 1957. Specifically, two long acting bioresorbable sutures are put through the specific anatomic landmarks. |
| Sacrospinous ligament fixation | Active comparator | Procedure: fixation of the vaginal apexThe SLF technique will be performed as described by Richter et al (Amreich, 1951). Two long acting bioresorbable sutures are passed through the right sacrospinous ligament and then fixed to the vaginal cuff. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- declined/ failed conservative treatment for POP
- planned vaginal hysterectomy with anterior/posterior colporrhaphy as indicated
- any symptomatic POP or stage II prolapse in any compartment
- at least stage I prolapse in the apical department
- women between 35 and 80 years of age
Key exclusion criteria (5 listed)
- Unwillingness to participate
- Neurological disorders
- Previous hysterectomy
- Desire to have children
- Connective tissue disorders (i.e. Ehlers-Danlos syndrome, Marfan syndrome)
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 |
|---|---|---|
| fixation of the vaginal apexIn the course of vaginal hysterectomy the vaginal cuff is either fixed to the sacrospinous ligament or to the uterosacral ligament. | Procedure or surgery | McCall culdoplasty, Sacrospinous ligament fixation |
Primary outcome
Number of patients with stage 2 or higher on the Pelvic Organ Prolapse Quantification System (POP-Q).
Time frame: 12 months after surgery
POP-Q stage 2 or higher means any point of the POP-Q system being -1 related to the hymen or below
4 secondary outcomes
Subjective cure
Time frame: 12 months after surgery
Quality of life as determined by a questionnaire
Time frame: 12 months after surgery
Sexual health
Time frame: 12 months after surgery
Reoperation rate
Time frame: 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Background: PubMed 9704759Colombo M, Milani R. Sacrospinous ligament fixation and modified McCall culdoplasty during vaginal hysterectomy for advanced uterovaginal prolapse. Am J Obstet Gynecol. 1998 Jul;179(1):13-20. doi: 10.1016/s0002-9378(98)70245-5.
- Individual participant dataSharing planned: No. The sponsor has access to all study relevant data. In the specific centers only authorized study personnel has access to the data.
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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 fixation of the vaginal apex in people with Pelvic Organ Prolapse and Surgery, run by Medical University of Graz at 1 site in Austria.
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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 23 Jan 2024. 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 Austria. 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?
Results are not available in the source record.
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?
Number of patients with stage 2 or higher on the Pelvic Organ Prolapse Quantification System (POP-Q). (time frame: 12 months after surgery). 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 NCT03113513, which also lists 1 linked publication.
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 23 Jan 2024.