Genital ProlapsePROLAMBUNCT02585544
Ambulatory Prolapse Surgery
A study testing day-care surgery in people with Genital Prolapse and Vaginal Floor Prolapse, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Day surgery is performed in the same way as in full hospital admission, allowing same-day discharge without increased risk. It provides many grounds for patient satisfaction. Progress in surgical and anesthesia techniques now allows this form of management to be developed and prioritized. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Genital Prolapse, Vaginal Floor Prolapse
- What is being tested?
- day-care surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2015to 3 Sep 2019
- 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
- Stage III or IV anterior genital prolapse (cystocele) on the Pelvic Organ Prolapse Quantification (POP-Q) classification and/or vaginal floor prolapse
- Vaginal approach with prosthetic reinforcement planned
- Patient eligible for day-surgery
- Patient consenting to participate
- Informed and signed consent
Who cannot join
- Interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, progressive disease, etc.
- Patient with ≥1 ineligibility criterion for day-surgery
- Impaired lower-limb range of motion preventing positioning for surgery
- Pregnancy, ongoing or planned during the study period
- Progressive or latent infection or signs of tissue necrosis on clinical examination
- Non-controlled diabetes (glycated hemoglobin >8%)
Show all 13Show fewer
- Treatment impacting immune response (immunomodulators), ongoing or within previous month
- History of pelvic region radiation therapy, at any time
- History of pelvic cancer
- Non-controlled progressive spinal pathology
- Known hypersensitivity to one of the implant components (polypropylene)
- Inability to understand information provided
- Not covered by a national health insurance scheme, prisoner or under administrative supervision.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ambulatory Prolapse Surgery: Feasibility Study
Day surgery is performed in the same way as in full hospital admission, allowing same-day discharge without increased risk. It provides many grounds for patient satisfaction. Progress in surgical and anesthesia techniques now allows this form of management to be developed and prioritized.
Day-care surgery for prolapse has been little studied. The present study is intended to help extend its future implementation, the primary objective being to assess the feasibility of the day-care approach in prolapse surgery. The secondary objectives are to study criteria of non-eligibility for day-care prolapse surgery, reasons for patients' refusal, causes of failure, predictive factors for failure, patient satisfaction, postoperative complications, 2-year anatomic and functional results, pain, quality of life and sexuality, and postoperative onset of dyspareunia and urinary incontinence.
The design is for a prospective non-randomized study conducted in 3 gynecologic surgery sites managed by the Lyon hospitals board (Hospices Civils de Lyon).
- Conditions
- Genital Prolapse, Vaginal Floor Prolapse
- Being tested
- day-care surgery
- Keywords
- genital prolapse, day-care management, vaginal route, prosthetic reinforcement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
day-care surgeryProcedure or surgery
day-care surgery
| Study group | Role | What they receive |
|---|---|---|
| Genital prolapse | Other | Single arm: i.e., all patients Receives: Procedure: day-care surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient with success for ambulatory surgery
Number of prolapse surgery patients actually managed on a day-care basis
Measured: Day 1 (postoperative)
Secondary outcomes (15)
causes of non-eligibility for day-care management analysis
list and percentage
Measured: Day 1 (before surgery)
reasons for patients' refusal analysis
list and percentage
Measured: Day 1 (before surgery)
causes of failure of day-surgery analysis
list and percentage
Measured: Day 1 (postoperative)
Number of patients satisfied with day-surgery
Measured: Day 1 (postoperative)
Post-surgery complications
number and percentage of cases of infection, hematoma, urinary retention, healing defect (exposure or erosion), retraction, death
Measured: Day 1 (postoperative), month 1, year 1 and year 2
Number of prolapse correction failure
Measured: month 1, year 1 and year 2
pain score analysis
0 to 10 scale
Measured: month 1, year 1 and year 2
quality of life scores analysis
SF- 12 Short Form (12) Health Survey PFDI-20 : Pelvic Floor Distress Inventory PFIQ-7 : Pelvic Floor Impact Questionnaire PGI-I : Patient Global Impression of Improvement
Measured: month 1, year 1 and year 2
quality of life scores analysis
SF- 12 Short Form (12) Health Survey
Measured: month 1, year 1 and year 2
quality of life scores analysis
PFDI-20 : Pelvic Floor Distress Inventory
Measured: month 1, year 1 and year 2
quality of life scores analysis
PGI-I : Patient Global Impression of Improvement
Measured: month 1, year 1 and year 2
quality of life scores analysis
PFIQ-7 : Pelvic Floor Impact Questionnaire
Measured: month 1, year 1 and year 2
sexuality score analysis
PISQ-12 questionnaire
Measured: month 1, year 1 and year 2
percentage dyspareunia
Measured: month 1, year 1 and year 2
number of onset of urinary incontinence
Measured: month 1, year 1 and year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study start15 Oct 2015
- Primary completion3 Sep 2019
- Study completion3 Sep 2019
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 Genital ProlapseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585544
- Sponsor's protocol ID
- 69HCL15_0215
- Other IDs
- 2015-A00599-40
- Acronym
- PROLAMBU
- Status last verified
- Aug 2025
- First submitted
- 19 Oct 2015
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Lamblin G, Courtieu C, Bensouda-Miguet C, Panel L, Moret S, Chabert P, Chene G, Nohuz E. Outpatient vaginal surgery for pelvic organ prolapse: a prospective feasibility study. Minerva Ginecol. 2020 Feb;72(1):19-24. doi: 10.23736/S0026-4784.20.04510-4.
PubMed 32153159
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Prolapse Surgery: Feasibility Study
- ClinicalTrials.gov ID
- NCT02585544
- Acronym / sponsor ID
- PROLAMBU / 69HCL15_0215
- Conditions
- Genital Prolapse, Vaginal Floor Prolapse
- Keywords
- genital prolapse, day-care management, vaginal route, prosthetic reinforcement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Oct 2015 (actual)
- Primary completion
- 3 Sep 2019 (actual)
- Study completion
- 3 Sep 2019 (actual)
- First posted
- 23 Oct 2015 (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.
Day surgery is performed in the same way as in full hospital admission, allowing same-day discharge without increased risk. It provides many grounds for patient satisfaction. Progress in surgical and anesthesia techniques now allows this form of management to be developed and prioritized.
Day-care surgery for prolapse has been little studied. The present study is intended to help extend its future implementation, the primary objective being to assess the feasibility of the day-care approach in prolapse surgery. The secondary objectives are to study criteria of non-eligibility for day-care prolapse surgery, reasons for patients' refusal, causes of failure, predictive factors for failure, patient satisfaction, postoperative complications, 2-year anatomic and functional results, pain, quality of life and sexuality, and postoperative onset of dyspareunia and urinary incontinence.
The design is for a prospective non-randomized study conducted in 3 gynecologic surgery sites managed by the Lyon hospitals board (Hospices Civils de Lyon).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genital prolapse | Other | Procedure: day-care surgerySingle arm: i.e., all patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Stage III or IV anterior genital prolapse (cystocele) on the Pelvic Organ Prolapse Quantification (POP-Q) classification and/or vaginal floor prolapse
- Vaginal approach with prosthetic reinforcement planned
- Patient eligible for day-surgery
- Patient consenting to participate
- Informed and signed consent
Key exclusion criteria (13 listed)
- Interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, progressive disease, etc.
- Patient with ≥1 ineligibility criterion for day-surgery
- Impaired lower-limb range of motion preventing positioning for surgery
- Pregnancy, ongoing or planned during the study period
- Progressive or latent infection or signs of tissue necrosis on clinical examination
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 |
|---|---|---|
| day-care surgeryday-care surgery | Procedure or surgery | Genital prolapse |
Primary outcome
Number of patient with success for ambulatory surgery
Time frame: Day 1 (postoperative)
Number of prolapse surgery patients actually managed on a day-care basis
15 secondary outcomes
causes of non-eligibility for day-care management analysis
Time frame: Day 1 (before surgery)
reasons for patients' refusal analysis
Time frame: Day 1 (before surgery)
causes of failure of day-surgery analysis
Time frame: Day 1 (postoperative)
Number of patients satisfied with day-surgery
Time frame: Day 1 (postoperative)
Post-surgery complications
Time frame: Day 1 (postoperative), month 1, year 1 and year 2
Number of prolapse correction failure
Time frame: month 1, year 1 and year 2
pain score analysis
Time frame: month 1, year 1 and year 2
quality of life scores analysis
Time frame: month 1, year 1 and year 2
quality of life scores analysis
Time frame: month 1, year 1 and year 2
quality of life scores analysis
Time frame: month 1, year 1 and year 2
quality of life scores analysis
Time frame: month 1, year 1 and year 2
quality of life scores analysis
Time frame: month 1, year 1 and year 2
sexuality score analysis
Time frame: month 1, year 1 and year 2
percentage dyspareunia
Time frame: month 1, year 1 and year 2
number of onset of urinary incontinence
Time frame: month 1, year 1 and year 2
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 4 Sep 2025.
- Results publication: PubMed 32153159Lamblin G, Courtieu C, Bensouda-Miguet C, Panel L, Moret S, Chabert P, Chene G, Nohuz E. Outpatient vaginal surgery for pelvic organ prolapse: a prospective feasibility study. Minerva Ginecol. 2020 Feb;72(1):19-24. doi: 10.23736/S0026-4784.20.04510-4.
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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 day-care surgery in people with Genital Prolapse and Vaginal Floor Prolapse, run by Hospices Civils de Lyon at 1 site in France.
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 5 inclusion and 13 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 4 Sep 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 France. 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?
Number of patient with success for ambulatory surgery (time frame: Day 1 (postoperative)). 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 NCT02585544, 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 4 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.