Anterior Vaginal Wall ProlapseTLSACNCT07144397
Transobturator Lateral Suspension in Anterior Colporrhaphy
A study testing TOLS in people with Anterior Vaginal Wall Prolapse and Pelvic Organ Prolapse, run by University Medical Centre Maribor at 1 site in Slovenia.
Trial summary
Anterior colporrhaphy (AC) is commonly used for anterior vaginal wall prolapse, but suffers high recurrence rates. This randomized trial assessed whether adding transobturator lateral suspension (TOLS) to AC decreases objective recurrence without compromising patient outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anterior Vaginal Wall Prolapse, Pelvic Organ Prolapse
- What is being tested?
- TOLS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSlovenia
- Study dates
- 9 Oct 2020to 23 Nov 2024
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult women with symptomatic anterior vaginal wall prolapse (POP-Q stage ≥ 2)
- Eligible for native tissue repair
- Provided written informed consent
Who cannot join
- Previous anterior vaginal wall prolapse repair
- Predominant apical or posterior compartment defect
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Concomitant Transobturator Lateral Suspension Improve Anterior Colporrhaphy Outcomes? A Randomized Controlled Trial
Anterior colporrhaphy (AC) is commonly used for anterior vaginal wall prolapse, but suffers high recurrence rates. This randomized trial assessed whether adding transobturator lateral suspension (TOLS) to AC decreases objective recurrence without compromising patient outcomes. In a cohort of 44 women (POP-Q ≥ 2), AC alone was compared to AC+TOLS over a 1-year follow-up. Results showed significantly lower objective recurrence with the added suspension.
Read the detailed description
Conducted prospectively at University Medical Centre Maribor (Slovenia), this single-surgeon RCT randomized women with symptomatic anterior vaginal prolapse (POP-Q stage ≥ 2) to receive either standard AC or AC plus bilateral TOLS via non-absorbable suture across the obturator foramen. Primary outcome was objective anatomical recurrence (POP-Q ≥ 2) at 1 year. Secondary outcomes included subjective recurrence, satisfaction (Likert), operative time, postoperative and pelvic sidewall pain, and validated QOL instruments (UIQ-7, CRAIQ-7, POPIQ-7, PFIQ, POPDI-6, UDI-6, PFDI, PISQ).
- Being tested
- TOLS
- Keywords
- anterior colporrhaphy, transobturator lateral suspension, native tissue repair, randomized controlled trial, pelvic organ prolapse
- 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.
TOLSProcedure or surgery
"Standard AC plus bilateral lateral suspension using non-absorbable sutures passed through the obturator foramen to support lateral vaginal wall."
| Study group | Role | What they receive |
|---|---|---|
| Anterior Colporrhaphy (AC) | No intervention | Standard midline plication of pubocervical fascia using absorbable sutures under local anesthesia |
| AC + Transobturator Lateral Suspension (TOLS) | Experimental | In addition to AC, bilateral non-absorbable sutures placed at the lateral edge of the pubocervical fascia, passed through obturator foramen, to provide lateral support Receives: Procedure: TOLS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Recurrence Rate
Anatomical recurrence defined as POP-Q stage ≥ 2 in anterior compartment
Measured: 1 year postoperative
Secondary outcomes (5)
Subjective Recurrence Rate
Subjective recurrence was determined by a positive response to the validated question: "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?"
Measured: 1 year postoperative
Patient Satisfaction
5-point Likert scale at 1 year
Measured: 1 year postoperative
Operative time
Measured in minutes during surgery.
Measured: 1 year postoperative
Postoperative Pain
Assessed via VAS at discharge and immediate postoperative period
Measured: 1 year postoperative.
Pelvic Sidewall Pain
Assessed at 1 year postoperative clinical examination, by pressing on obutrator membrane. Assesed as present or absent.
Measured: 1 year postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start9 Oct 2020
- Primary completion23 Oct 2024
- Study completion23 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Vaginal Wall 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Maribor
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rok Sumak, University Medical Centre Maribor
- Investigators
- Rok Sumak, Principal investigator, University Medical Centre Maribor, Department of General Gynaecology and Urogynaecology, Maribor, Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144397
- Sponsor's protocol ID
- UKC-MB-KME-10/22
- Acronym
- TLSAC
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in this article, including baseline characteristics, intraoperative details, and outcome measures (objective recurrence, subjective recurrence, patient satisfaction, operative time, postoperative pain scores, and quality-of-life questionnaire scores), will be available to researchers upon reasonable request. Data will be shared beginning 6 months after publication of the main results and ending 5 years after article publication.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Concomitant Transobturator Lateral Suspension Improve Anterior Colporrhaphy Outcomes? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07144397
- Acronym / sponsor ID
- TLSAC / UKC-MB-KME-10/22
- Keywords
- anterior colporrhaphy, transobturator lateral suspension, native tissue repair, randomized controlled trial, pelvic organ prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University Medical Centre MariborUniversity, hospital or other
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- 23 Oct 2024 (actual)
- Study completion
- 23 Nov 2024 (actual)
- First posted
- 27 Aug 2025 (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.
Anterior colporrhaphy (AC) is commonly used for anterior vaginal wall prolapse, but suffers high recurrence rates. This randomized trial assessed whether adding transobturator lateral suspension (TOLS) to AC decreases objective recurrence without compromising patient outcomes. In a cohort of 44 women (POP-Q ≥ 2), AC alone was compared to AC+TOLS over a 1-year follow-up. Results showed significantly lower objective recurrence with the added suspension.
Detailed description
Conducted prospectively at University Medical Centre Maribor (Slovenia), this single-surgeon RCT randomized women with symptomatic anterior vaginal prolapse (POP-Q stage ≥ 2) to receive either standard AC or AC plus bilateral TOLS via non-absorbable suture across the obturator foramen. Primary outcome was objective anatomical recurrence (POP-Q ≥ 2) at 1 year. Secondary outcomes included subjective recurrence, satisfaction (Likert), operative time, postoperative and pelvic sidewall pain, and validated QOL instruments (UIQ-7, CRAIQ-7, POPIQ-7, PFIQ, POPDI-6, UDI-6, PFDI, PISQ).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior Colporrhaphy (AC) | No intervention | –Standard midline plication of pubocervical fascia using absorbable sutures under local anesthesia |
| AC + Transobturator Lateral Suspension (TOLS) | Experimental | Procedure: TOLSIn addition to AC, bilateral non-absorbable sutures placed at the lateral edge of the pubocervical fascia, passed through obturator foramen, to provide lateral support |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult women with symptomatic anterior vaginal wall prolapse (POP-Q stage ≥ 2)
- Eligible for native tissue repair
- Provided written informed consent
Key exclusion criteria (2 listed)
- Previous anterior vaginal wall prolapse repair
- Predominant apical or posterior compartment defect
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 |
|---|---|---|
| TOLS"Standard AC plus bilateral lateral suspension using non-absorbable sutures passed through the obturator foramen to support lateral vaginal wall." | Procedure or surgery | AC + Transobturator Lateral Suspension (TOLS) |
Primary outcome
Objective Recurrence Rate
Time frame: 1 year postoperative
Anatomical recurrence defined as POP-Q stage ≥ 2 in anterior compartment
5 secondary outcomes
Subjective Recurrence Rate
Time frame: 1 year postoperative
Patient Satisfaction
Time frame: 1 year postoperative
Operative time
Time frame: 1 year postoperative
Postoperative Pain
Time frame: 1 year postoperative.
Pelvic Sidewall Pain
Time frame: 1 year postoperative.
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 27 Aug 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in this article, including baseline characteristics, intraoperative details, and outcome measures (objective recurrence, subjective recurrence, patient satisfaction, operative time, postoperative pain scores, and quality-of-life questionnaire scores), will be available to researchers upon reasonable request. Data will be shared beginning 6 months after publication of the main results and ending 5 years after article publication.
Related trials for Anterior Vaginal Wall Prolapse
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Active, not recruitingObservational study
To Explore the Surgical Outcomes and Safety of an Innovative Laparoscopic Uterine Pectopexy Technique Using Inverted T-meshes for Simultaneous Apical and Anterior Vaginal Repair.
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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.
Rok Sumak principal investigator
University Medical Centre Maribor, Department of General Gynaecology and Urogynaecology, Maribor, Slovenia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TOLS in people with Anterior Vaginal Wall Prolapse and Pelvic Organ Prolapse, run by University Medical Centre Maribor at 1 site in Slovenia.
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 3 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 27 Aug 2025. 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 Slovenia. 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?
Objective Recurrence Rate (time frame: 1 year postoperative). 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 27 Aug 2025.