Pelvic Organ Prolapse Vaginal SurgeryPINPOPSNCT07006129
Effectiveness of Perineorrhaphy in Pelvic Organ Prolapse Surgery
An observational study of Pelvic Organ Prolapse Vaginal Surgery and Pelvic Organ Prolapse (POP), run by Lund University at 1 site in Sweden.
Trial summary
This is an observational registry-based study of long-term outcome after vaginal native tissue repair for pelvic organ prolapse designed to emulate a pragmatic open-label two-arm trial for which patients, in whom perineorrhaphy is not strictly indicated but clinically tenable, perioperatively are randomized to… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse Vaginal Surgery, Pelvic Organ Prolapse (POP)
- What is being tested?
- Perineorrhaphy and No perineorrhaphy
- Type of treatment
- Surgery or procedure
- How many people
- 40,646 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2007to 31 Dec 2022
- Phase
- Observational
- 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
Study population: Patients with their primary vaginal pelvic organ prolapse surgery registered in the Swedish National Quality Register of Gynaecological Surgery (GynOp).
Who may be able to join
- Pelvic organ prolapse surgery with vaginal native tissue repair without concomitant hysterectomy.
Who cannot join
- Primary surgery with colpocleisis, use of mesh, laparoscopic or abdominal surgery, concomitant incontinence surgery (eg transvaginal tape).
- Previous hysterectomy
- Previous pelvic organ prolapse surgery
Trial locations and contacts
1 site in 1 country.
About this study
This is an observational registry-based study of long-term outcome after vaginal native tissue repair for pelvic organ prolapse designed to emulate a pragmatic open-label two-arm trial for which patients, in whom perineorrhaphy is not strictly indicated but clinically tenable, perioperatively are randomized to concomitant perineorrhaphy or not.
Read the detailed description
This is an emulated pragmatic open-label two-arm trial in patients undergoing native tissue repair surgery for pelvic organ prolapse, in which patients are randomized perioperatively to either concomitant perineorrhaphy or not. The target population is the large group of patients for whom, at the discretion of the surgeon, this intervention is currently an option while not being strictly indicated. The investigators assumed that women were randomly assigned perioperatively to either strategy within levels of baseline co-variables: age, BMI, parity, lung disease, ASA-classification, constipation, hypermobility, prolapse in which vaginal compartment and if surgery is performed on it, year of primary surgery and region. Data was obtained from The Swedish National Quality Register of Gynaecological Surgery (GynOp), the Swedish National Patient Register, the Swedish Medical Birth Register, and the Swedish Cause of Death Register. In order to emulate a target trial, multiple imputation of missing data is followed by controlling for confounding through inverse probability weighting (IPW) in order to estimate the average treatment effect (ATE) in the primary analysis. In the secondary analysis, the primary analysis will be repeated but with overlap weights. Additional analyses: The sample will be re-weighted using IPW to estimate the average treatment effect on the treated (ATT). Restricted mean survival time (RMST) will be calculated at five years of follow-up for the primary outcome. Bias analysis: Mortality during follow up for the primary outcome will be used as a negative control.
- Being tested
- Perineorrhaphy, No perineorrhaphy
- Keywords
- Target Trial Emulation, Pelvic organ prolapse, Perineorrhaphy, Vaginal surgery, Cystocele, Rectocele, Apical prolapse
- Medical subject headings
- Pelvic Organ Prolapse, Cystocele, Rectocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerineorrhaphyProcedure or surgery
Concomitant perineorrhaphy
No perineorrhaphyProcedure or surgery
No concomitant perineorrhaphy
| Study group | Role | What they receive |
|---|---|---|
| Perineorrhaphy | Primary pelvic organ prolapse surgery (no concomitant hysterectomy) with native tissue repair including perineorrhaphy Receives: Procedure: Perineorrhaphy | |
| No perineorrhaphy | Primary pelvic organ prolapse surgery (no concomitant hysterectomy) with native tissue repair excluding perineorrhaphy Receives: Procedure: No perineorrhaphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reoperation
Reported as absolute risk difference, with cumulative risks during five years of follow-up estimated using the Kaplan-Meier estimator.
Data obtained from the The Swedish National Quality Register of Gynaecological Surgery (GynOp) and the Swedish National Patient Register.
Measured: 5 years
Secondary outcomes (2)
Symptoms of a vaginal bulge (patient reported outcome)
Absolute risk difference for the outcome at 1 year follow-up with the non-inferiority margin set to 10% of the absolute risk in the comparison group. Data obtained from the The Swedish National Quality Register of Gynaecological Surgery (GynOp).
Measured: At 1 year
Unsatisfied (patient reported outcome)
Absolute risk difference for the outcome at 1 year follow-up with the non-inferiority margin set to 10% of the absolute risk in the comparison group. Data obtained from the The Swedish National Quality Register of Gynaecological Surgery (GynOp).
Measured: At 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start1 Jan 2007
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ Prolapse Vaginal SurgeryStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe 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
- 40,646 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006129
- Sponsor's protocol ID
- EPMDnr 2023-00177-01 (Study 1)
- Acronym
- PINPOPS
- Status last verified
- May 2025
- First submitted
- 27 May 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are available from the registry source.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Perineorrhaphy in Pelvic Organ Prolapse Surgery
- ClinicalTrials.gov ID
- NCT07006129
- Acronym / sponsor ID
- PINPOPS / EPMDnr 2023-00177-01 (Study 1)
- Keywords
- Target Trial Emulation, Pelvic organ prolapse, Perineorrhaphy, Vaginal surgery, Cystocele, Rectocele, Apical prolapse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40,646 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 5 Jun 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 is an observational registry-based study of long-term outcome after vaginal native tissue repair for pelvic organ prolapse designed to emulate a pragmatic open-label two-arm trial for which patients, in whom perineorrhaphy is not strictly indicated but clinically tenable, perioperatively are randomized to concomitant perineorrhaphy or not.
Detailed description
This is an emulated pragmatic open-label two-arm trial in patients undergoing native tissue repair surgery for pelvic organ prolapse, in which patients are randomized perioperatively to either concomitant perineorrhaphy or not. The target population is the large group of patients for whom, at the discretion of the surgeon, this intervention is currently an option while not being strictly indicated. The investigators assumed that women were randomly assigned perioperatively to either strategy within levels of baseline co-variables: age, BMI, parity, lung disease, ASA-classification, constipation, hypermobility, prolapse in which vaginal compartment and if surgery is performed on it, year of primary surgery and region. Data was obtained from The Swedish National Quality Register of Gynaecological Surgery (GynOp), the Swedish National Patient Register, the Swedish Medical Birth Register, and the Swedish Cause of Death Register. In order to emulate a target trial, multiple imputation of missing data is followed by controlling for confounding through inverse probability weighting (IPW) in order to estimate the average treatment effect (ATE) in the primary analysis. In the secondary analysis, the primary analysis will be repeated but with overlap weights. Additional analyses: The sample will be re-weighted using IPW to estimate the average treatment effect on the treated (ATT). Restricted mean survival time (RMST) will be calculated at five years of follow-up for the primary outcome. Bias analysis: Mortality during follow up for the primary outcome will be used as a negative control.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perineorrhaphy | – | Procedure: PerineorrhaphyPrimary pelvic organ prolapse surgery (no concomitant hysterectomy) with native tissue repair including perineorrhaphy |
| No perineorrhaphy | – | Procedure: No perineorrhaphyPrimary pelvic organ prolapse surgery (no concomitant hysterectomy) with native tissue repair excluding perineorrhaphy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with their primary vaginal pelvic organ prolapse surgery registered in the Swedish National Quality Register of Gynaecological Surgery (GynOp).
Key inclusion criteria (1 listed)
- Pelvic organ prolapse surgery with vaginal native tissue repair without concomitant hysterectomy.
Key exclusion criteria (3 listed)
- Primary surgery with colpocleisis, use of mesh, laparoscopic or abdominal surgery, concomitant incontinence surgery (eg transvaginal tape).
- Previous hysterectomy
- Previous pelvic organ prolapse surgery
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 |
|---|---|---|
| PerineorrhaphyConcomitant perineorrhaphy | Procedure or surgery | Perineorrhaphy |
| No perineorrhaphyNo concomitant perineorrhaphy | Procedure or surgery | No perineorrhaphy |
Primary outcome
Reoperation
Time frame: 5 years
Reported as absolute risk difference, with cumulative risks during five years of follow-up estimated using the Kaplan-Meier estimator. Data obtained from the The Swedish National Quality Register of Gynaecological Surgery (GynOp) and the Swedish National Patient Register.
2 secondary outcomes
Symptoms of a vaginal bulge (patient reported outcome)
Time frame: At 1 year
Unsatisfied (patient reported outcome)
Time frame: At 1 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 27 Aug 2026.
- Individual participant dataSharing planned: No. Data are available from the registry source.
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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?
An observational study of Pelvic Organ Prolapse Vaginal Surgery and Pelvic Organ Prolapse (POP), run by Lund University at 1 site in Sweden.
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 3 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 2026. 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 Sweden. 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?
Reoperation (time frame: 5 years). 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 2026.