Vaginal Vault ProlapseNCT06902909
Laparoscopic Pectopexy and Laparoscopic Colporrhaphies in Pelvic Organ Prolapse Treatment
An observational study of Vaginal Vault Prolapse and Uterine Prolapse, run by Tampere University Hospital at 1 site in Finland.
Trial summary
This prospective cohort study investigates the surgical outcomes of laparoscopic pectopexy and laparoscopic colporraphy performed at the Wellbeing Services County of South Ostrobothnia. The primary outcome measure is to assess changes in sensation of bulge and pressure. Read more about this study
- Who is it for?
- Ages 18 to 79 years, women only
- Conditions the study is for
- Vaginal Vault Prolapse, Uterine Prolapse, Cystocele, Midline
- How many people
- 50 participants
- Where
- 1 siteFinland
- Study dates
- 1 Feb 2024to 28 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 79 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with symptomatic vaginal or uterine prolapse at least to the hymenal level and who have an indication for vaginal apex (DeLancey level I) prolapse repair using mesh are being recruited for the surgery.
Who may be able to join
- Symptomatic pelvic organ prolapse
- Uterine or vaginal vault prolapse reaching the hymenal ring (POP-Q classification: ≥0 cm)
- If uterus in situ, consent for supracervical hysterectomy
- Suitable for laparoscopic mesh surgery
- Age: 18-79 years
- Non-pregnant, no pregnancy desire.
- Sufficient Finnish language skills
- Concurrent anterior and/or posterior prolapse repair if POP-Q criteria met: tvl >8 cm and Aa, Ba, Ap, Bp ≥0
Who cannot join
- Unwillingness to undergo surgery or mesh implantation
- High anesthetic or surgical risk due to comorbidities
- Indication for laparoscopic sacrocolporectopexy due to rectal intussusception
- Desire to preserve the uterus
- Pregnancy or planning future pregnancy
- Inability to understand Finnish or study-related forms due to cognitive impairments
- Need for concomitant urinary incontinence surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site
The Wellbeing Services County of South Ostrobothnia
Seinäjoki, 60200
About this study
This prospective cohort study investigates the surgical outcomes of laparoscopic pectopexy and laparoscopic colporraphy performed at the Wellbeing Services County of South Ostrobothnia. The primary outcome measure is to assess changes in sensation of bulge and pressure. Secondary outcome measures include evaluating other prolapse symptoms and pain, quality of life, anatomical correction of prolapse, surgical safety parameters, and postoperative complications. Approximately 40-50 laparoscopic pectopexies will be performed over two years by a single experienced surgeon. The study requires preoperative and postoperative assessments, including standardized patient questionnaires and anatomical measurements.
Read the detailed description
The study aims to evaluate the effects of laparoscopic pectopexy and colporraphy on pelvic organ prolapse (POP) symptoms, anatomical prolapse repair, and surgical outcomes. The primary outcome measure is the presence of a bulging sensation 12 months after surgery. Secondary outcome measure includes additional prolapse-related symptoms, residual urine volume, pelvic pain, urinary incontinence, and safety parameters such as intraoperative blood loss and complications. Anatomical correction will be assessed using the Pelvic Organ Prolapse Quantification (POP-Q) system.
All surgical procedures will be performed by a single experienced surgeon with over five years of experience and more than 100 laparoscopic pectopexies performed. Patients will undergo laparoscopic pectopexy, with or without concomitant anterior and posterior vaginal wall repair using sutures. The pectopexy procedure utilizes a 3x15 cm Dynamesh PRP PVDF mesh, secured with absorbable monofilament thread to the vaginal cuff or with non-absorbable multifilament sutures to the uterine cervical stump.
- Keywords
- laparoscopic pectopexy, laparoscopic colporraphy
- Medical subject headings
- Pelvic Organ Prolapse, Uterine Prolapse, Cystocele, Rectocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic pectopexy with or without concomitant laparoscopic colporraphy | Patients undergoing laparoscopic pectopexy for pelvic organ prolapse, with or without concomitant laparoscopic anterior and posterior vaginal wall repair using sutures. The procedure involves the placement of a 3x15 cm Dynamesh PRP PVDF mesh to the vaginal apex or uterine cervical stump with monofilament and multifilament sutures and anchored to the pectineal ligaments bilaterally. Follow-up assessments will be conducted 12 months postoperatively to evaluate symptom relief, anatomical correction, and surgical safety. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported postoperative sensation of bulging at 12 months postoperatively
During the history-taking process, symptoms such as a sensation of bulging or pressure are actively inquired about and documented accordingly. Results variables are presented as counts and percentages.
Measured: From the enrollment til follow-up visit at 12 months postoperatively
Secondary outcomes (12)
Change in Pelvic Floor Organ function (PFDI-20 score)
Patients are asked preoperatively and postoperatively to complete the Pelvic Floor Distress Inventory (PFDI-20) that contains 4 different scores: POPDI-6, CRADI-8, UDI-6 and PFDI-20 Sum score. For statistical analysis about measurement score changes, paired t-test will be used. The differences are considered to be statistically significant at p-value of <0.05.
Measured: From enrollment til the follow-up visit 12 months postoperatively
Change in sexual function and urinary incontinence (PISQ-12 score).
Patients are asked preoperatively and postoperatively to complete the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). For statistical analysis about measurement score change, paired t-test will be used. The differences are considered to be statistically significant at p-value of <0.05.
Measured: From the enrollment til follow-up visit at 12 months postoperatively
Change in quality of life. (15D questionnaire score)
Patients are asked preoperatively and postoperatively to complete the Quality of Life 15D questionnaire. For statistical analysis about measurement score changes, paired t-test will be used. The differences are considered to be statistically significant at p-value of <0.05.
Measured: From the enrollment til follow-up visit at 12 months postoperatively
Change in pelvic pain (VAS score)
Patients are asked to self-complete the Visual Analogue Scale (VAS) for pelvic pain both preoperatively and postoperatively. They are instructed to mark a cross or vertical line on a horizontal line labeled only with the endpoints: 0 (no pain) and 10 (worst possible pain), with no other numbers visible. A special ruler is used to determine the exact score based on the position of the mark, with results recorded to the nearest 0.5 points. For statistical analysis of changes in VAS scores, a paired t-test will be used. Differences will be considered statistically significant at a p-value of <0.05.
Measured: From the enrollment til follow-up visit at 12 months postoperatively
Post voiding residual in ml.
Postvoid residual (PVR) is measured by ultrasound during a transvaginal gynecological examination. Two dimensions are measured in centimeters in the sagittal plane, while the third dimension is consistently set at 10 cm. The PVR volume (in cubic centimeters) is calculated using the ellipsoid formula: a(cm)× b(cm) × c(10cm) × 0.52. One cubic centimeter is considered equivalent to one milliliter. For statistical analysis of changes in PVR measurements, a paired t-test will be used. Differences will be considered statistically significant at a p-value of <0.05.
Measured: From enrollment til the follow-up visit 12 months postoperatively
Duration of surgery in minutes
During surgery, the following time measurements are recorded: total operative time (in minutes), defined as the duration from skin incision to completion of skin closure; and procedure-specific time (in minutes), which includes the time required for dissection of the pectopexy area, mesh application, and colporrhaphies. The results will be presented as the mean duration ± standard deviation (in minutes) and illustrated in a figure, with the X-axis representing individual cases and the Y-axis representing time in minutes for both types of measurements.
Measured: From the beginning of surgery til the end of surgery
Estimated blood loss in ml
Estimated blood loss during surgery will be recorded in milliliters (ml). The results will be presented as the mean ± standard deviation in ml.
Measured: From the beginning of surgery til the end of surgery.
Surgical Complications according to Clavien-Dindo classification.
Surgical complications are recorded according to the Clavien-Dindo classification, from the beginning of surgery until 30 days postoperatively. Each adverse event is classified based on the Clavien-Dindo grading system. The results will be presented as counts and percentages of the study population in a table, where each complication is listed in a separate row and each grade of the Clavien-Dindo classification is represented in a separate column.
Measured: From the beginning of surgery til 30 days postoperatively
Hospitalisation duration in days
The duration of hospitalization is recorded in days, calculated from the hospitalisation for surgery until the day of discharge. The results will be presented as the mean ± standard deviation (in days).
Measured: From the hospitalisation for surgery til discharge home.
Anatomical correction of prolapse according POP-Q classification
Anatomical correction is assessed during gynecological examination using the POP-Q system, both preoperatively and at the 12-month follow-up. The following points are measured: GH, PB, TVL, Aa, Ba, C, D, Ap, and Bp. For statistical analysis of changes in these measurements, a paired t-test will be used. Differences will be considered statistically significant at a p-value of <0.05.
Measured: Right before the operaton til follow-up visit at 12 months postoperatively
Global impression of improvement. (PGI-I questionnaire)
Patient global impression of improvement (PGI-I) questionnaire is asked to fulfill by follow-up visit. It contains one question and seven answers. The results will be presented as counts and percentage for each possible answer.
Measured: At follow-up visit 12 months postoperatively
Re-operation rate due to recurrence of vaginal apical prolapse, cystocele or rectocele.
The re-operation rate due to recurrence of vaginal apical prolapse, cystocele, rectocele will be recorded. Results will be presented as the number and percentage of patients requiring re-operation during the follow-up period.
Measured: From the end of surgery til follow-up visit at 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start1 Feb 2024
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal Vault ProlapseStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seinajoki Central Hospital
- Responsible party
- Sponsor
- Investigators
- Kirsi Kuismanen, MD, PhD, Study chair, Tampere UniversityKari Nieminen, MD, PhD, Study chair, Tampere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902909
- Sponsor's protocol ID
- R23076
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In this study, it is not possible to share IPD, because of several issues: 1. Regulatory and Ethical Constraints: IPD will not be shared due to ethical considerations and data privacy regulations, including compliance with GDPR and other applicable laws protecting patient confidentiality. 2. Lack of Consent for Data Sharing: participants did not provide explicit consent for data sharing beyond the primary study objectives. 3. Institutional or Sponsor Policy: The study sponsor and institutional policies do not allow the sharing of individual participant data. 4. Confidentiality and Privacy Risks: Due to the sensitive nature of the collected data and the risk of re-identification, IPD will not be made publicly available. 5. No Plan for Secondary Use of Data: There are no current plans for sharing IPD as the study was not designed for secondary data use.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Pectopexy and Laparoscopic Colporrhaphies in Pelvic Organ Prolapse Treatment
- ClinicalTrials.gov ID
- NCT06902909
- Acronym / sponsor ID
- R23076
- Keywords
- laparoscopic pectopexy, laparoscopic colporraphy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Seinajoki Central Hospital
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 30 Mar 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.
This prospective cohort study investigates the surgical outcomes of laparoscopic pectopexy and laparoscopic colporraphy performed at the Wellbeing Services County of South Ostrobothnia. The primary outcome measure is to assess changes in sensation of bulge and pressure. Secondary outcome measures include evaluating other prolapse symptoms and pain, quality of life, anatomical correction of prolapse, surgical safety parameters, and postoperative complications. Approximately 40-50 laparoscopic pectopexies will be performed over two years by a single experienced surgeon. The study requires preoperative and postoperative assessments, including standardized patient questionnaires and anatomical measurements.
Detailed description
The study aims to evaluate the effects of laparoscopic pectopexy and colporraphy on pelvic organ prolapse (POP) symptoms, anatomical prolapse repair, and surgical outcomes. The primary outcome measure is the presence of a bulging sensation 12 months after surgery. Secondary outcome measure includes additional prolapse-related symptoms, residual urine volume, pelvic pain, urinary incontinence, and safety parameters such as intraoperative blood loss and complications. Anatomical correction will be assessed using the Pelvic Organ Prolapse Quantification (POP-Q) system.
All surgical procedures will be performed by a single experienced surgeon with over five years of experience and more than 100 laparoscopic pectopexies performed. Patients will undergo laparoscopic pectopexy, with or without concomitant anterior and posterior vaginal wall repair using sutures. The pectopexy procedure utilizes a 3x15 cm Dynamesh PRP PVDF mesh, secured with absorbable monofilament thread to the vaginal cuff or with non-absorbable multifilament sutures to the uterine cervical stump.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic pectopexy with or without concomitant laparoscopic colporraphy | – | –Patients undergoing laparoscopic pectopexy for pelvic organ prolapse, with or without concomitant laparoscopic anterior and posterior vaginal wall repair using sutures. The procedure involves the placement of a 3x15 cm Dynamesh PRP PVDF mesh to the vaginal apex or uterine cervical stump with monofilament and multifilament sutures and anchored to the pectineal ligaments bilaterally. Follow-up assessments will be conducted 12 months postoperatively to evaluate symptom relief, anatomical correction, and surgical safety. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic vaginal or uterine prolapse at least to the hymenal level and who have an indication for vaginal apex (DeLancey level I) prolapse repair using mesh are being recruited for the surgery.
Key inclusion criteria (8 listed)
- Symptomatic pelvic organ prolapse
- Uterine or vaginal vault prolapse reaching the hymenal ring (POP-Q classification: ≥0 cm)
- If uterus in situ, consent for supracervical hysterectomy
- Suitable for laparoscopic mesh surgery
- Age: 18-79 years
Key exclusion criteria (7 listed)
- Unwillingness to undergo surgery or mesh implantation
- High anesthetic or surgical risk due to comorbidities
- Indication for laparoscopic sacrocolporectopexy due to rectal intussusception
- Desire to preserve the uterus
- Pregnancy or planning future pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient-reported postoperative sensation of bulging at 12 months postoperatively
Time frame: From the enrollment til follow-up visit at 12 months postoperatively
During the history-taking process, symptoms such as a sensation of bulging or pressure are actively inquired about and documented accordingly. Results variables are presented as counts and percentages.
12 secondary outcomes
Change in Pelvic Floor Organ function (PFDI-20 score)
Time frame: From enrollment til the follow-up visit 12 months postoperatively
Change in sexual function and urinary incontinence (PISQ-12 score).
Time frame: From the enrollment til follow-up visit at 12 months postoperatively
Change in quality of life. (15D questionnaire score)
Time frame: From the enrollment til follow-up visit at 12 months postoperatively
Change in pelvic pain (VAS score)
Time frame: From the enrollment til follow-up visit at 12 months postoperatively
Post voiding residual in ml.
Time frame: From enrollment til the follow-up visit 12 months postoperatively
Duration of surgery in minutes
Time frame: From the beginning of surgery til the end of surgery
Estimated blood loss in ml
Time frame: From the beginning of surgery til the end of surgery.
Surgical Complications according to Clavien-Dindo classification.
Time frame: From the beginning of surgery til 30 days postoperatively
Hospitalisation duration in days
Time frame: From the hospitalisation for surgery til discharge home.
Anatomical correction of prolapse according POP-Q classification
Time frame: Right before the operaton til follow-up visit at 12 months postoperatively
Global impression of improvement. (PGI-I questionnaire)
Time frame: At follow-up visit 12 months postoperatively
Re-operation rate due to recurrence of vaginal apical prolapse, cystocele or rectocele.
Time frame: From the end of surgery til follow-up visit at 12 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: No. In this study, it is not possible to share IPD, because of several issues: 1. Regulatory and Ethical Constraints: IPD will not be shared due to ethical considerations and data privacy regulations, including compliance with GDPR and other applicable laws protecting patient confidentiality. 2. Lack of Consent for Data Sharing: participants did not provide explicit consent for data sharing beyond the primary study objectives. 3. Institutional or Sponsor Policy: The study sponsor and institutional policies do not allow the sharing of individual participant data. 4. Confidentiality and Privacy Risks: Due to the sensitive nature of the collected data and the risk of re-identification, IPD will not be made publicly available. 5. No Plan for Secondary Use of Data: There are no current plans for sharing IPD as the study was not designed for secondary data use.
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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.
Kirsi Kuismanen, MD, PhD study chair
Tampere University
Kari Nieminen, MD, PhD study chair
Tampere University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginal Vault Prolapse and Uterine Prolapse, run by Tampere University Hospital at 1 site in Finland.
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 7 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: enrolling by invitation, as of the sponsor's last update on 30 Mar 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 Finland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Patient-reported postoperative sensation of bulging at 12 months postoperatively (time frame: From the enrollment til follow-up visit at 12 months postoperatively). 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 Mar 2025.