CystocelePROSPERENCT01637441
Prosthetic Pelvic Organ Prolapse Repair
A study testing laparoscopic sacropexy and vaginal mesh in people with Cystocele, run by University Hospital, Lille at 12 sites in France.
Trial summary
The cystocele is the most frequent clinical shape of the genital prolapse. It is a frequent pathology in woman which can impair quality of life and generates pelvic, urinary or sexual functional disorders. It's considered that 8 % of women will be undergo surgery in this indication before the age of 80 years. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- Cystocele
- What is being tested?
- laparoscopic sacropexy and vaginal mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 12 sitesFrance
- Study dates
- Sep 2012to Nov 2015
- 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 45 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cystocele superior or equal to stage II of the international classification POP-Q, isolated or associated with other elements of prolapse.
- Patient must have provided written informed consent form prior to enrolment
- Patient must be insured
Who cannot join
- Previous of surgery for prolapse
- Unfavourable conditions to one or other of the 2 evaluated procedure
- Pelvic malignancy in the course of evolution
- Contraindication to the use of mesh
- Women not reading French
- Patients haven't have a social insurance
Show all 9Show fewer
- Pregnancy or desire for future pregnancy
- To be under guardianship or deprived of liberty
- Simultaneous participation in another biomedical research
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Sébatien BLANC
Annecy, 74374
Hôpital Antoine Béclère
Clamart, 92140
CHU Estaing
Clermont-Ferrand, 63003
GCS Flandre Maritime
Grande-Synthe, 59760
CH La Rochelle Service de Gynécologie Obstétrique
La Rochelle, 17019
Hôpital BICETRE / Service de Gynécologie Obstétrique
Le Kremlin-Bicêtre, 94275
CHRU de Lille - Service de Gynécologie médico chirurgicale
Lille, 59037
CHU de Nîmes
Nîmes, 30029
Groupe Hospitalier Diaconesses Croix St-Simon
Paris, 75571
CHI Poissy-St-Germain / Service de gynécologie
Poissy, 78303
CHU de Poitiers
Poitiers, 86000
Hôpital de Hautepierre
Strasbourg, 67000
About this study
Official title: Randomized Study Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery in Cystocele Repair
The cystocele is the most frequent clinical shape of the genital prolapse. It is a frequent pathology in woman which can impair quality of life and generates pelvic, urinary or sexual functional disorders.
It's considered that 8 % of women will be undergo surgery in this indication before the age of 80 years. Numerous surgical techniques have been described and we distinguish the interventions according to the route (vaginal or abdominal), and according to the use or not of synthetic mesh (non-absorbable) to increase the anatomical results.
Read the detailed description
This is a multicenter, randomized, comparative, 2-parallel-arm study in patients with pelvic organ prolapse (cystocele) Approximately 260 patients aged from 45 to 75 years will be allocated to have laparoscopic sacropexy or vaginal mesh surgery.
- Conditions
- Cystocele
- Being tested
- laparoscopic sacropexy, vaginal mesh
- Keywords
- bladder prolapse (cystocele), Pelvic organ prolapse repair, coelioscopic, prosthetic surgery, vaginal approach, Randomized study, laparoscopic sacropexy, vaginal mesh surgery, Stage II, Clavien Dindo
- Medical subject headings
- Cystocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic sacropexyProcedure or surgery
Also called laparoscopic surgery
under laparoscopic vision, the vesico-vaginal space is dissected until the level of the bladder neck. a synthetic non absorbable mesh is placed between the bladder and the vagina. the mesh is sutured to the vagina and the apex (vaginal apex or uterus) and anchored to the prevertebral ligament in front of the promontorium.
vaginal meshProcedure or surgery
Also called medical vaginal device
after anterior sagittal colpotomy, the bladder is dissected under the fascia layer, and the paravesical fossa are entered. a synthetic non absorbable mesh is placed with 4 arms suspension (trans obturator or not). treatment of the apex is mandatory.
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic sacropexy | Experimental | under laparoscopic vision, the vesico-vaginal space is dissected until the level of the bladder neck. a synthetic non absorbable mesh is placed between the bladder and the vagina. the mesh is sutured to the vagina and the apex (vaginal apex or uterus) and anchored to the prevertebral ligament in front of the promontorium. Receives: Procedure: laparoscopic sacropexy |
| vaginal mesh | Experimental | after anterior sagittal colpotomy, the bladder is dissected under the fascia layer, and the paravesical fossa are entered. a synthetic non absorbable mesh is placed with 4 arms suspension (trans obturator or not). treatment of the apex is mandatory. Receives: Procedure: vaginal mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity (Dindo Classification)
Compare the morbidity of the sub-vesical synthetic mesh according to the route between laparoscopic sacropexy or vaginal in the symptomatic superior stage II cystoceles at 1 year follow-up.
Measured: 12 months
Secondary outcomes (3)
Specific complications
Comparison for the specific complications of sub-vesical mesh according to the route :
- Symptomatic erosions, shrinkages, infections,
- Serious Adverse event
Measured: 12 months
Medium-term tolerance
Comparison of both techniques for the medium-term tolerance:
- Sexual: sexual quality of life, de novo dyspareunia;
- Urinary: urinary quality of life, urinary functional signs, urgenturia, leakage
- Post-operative chronic pelvic pains
Measured: 12 months
Clinical Efficiency
Comparison of both techniques for the medium-term (1 year follow-up)clinical efficiency:
- rate of anatomical recurrences at one year,
- functional Symptoms of prolapse, general quality of life
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionJul 2015
- Study completionNov 2015
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 CystoceleStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe LUCOT, MD, Principal investigator, CHRU de LILLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637441
- Sponsor's protocol ID
- 2011_24
- Other IDs
- 2011-A01282-39
- Acronym
- PROSPERE
- Status last verified
- Nov 2015
- First submitted
- 6 Jul 2012
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lucot JP, Cosson M, Bader G, Debodinance P, Akladios C, Salet-Lizee D, Delporte P, Savary D, Ferry P, Deffieux X, Campagne-Loiseau S, de Tayrac R, Blanc S, Fournet S, Wattiez A, Villet R, Ravit M, Jacquetin B, Fritel X, Fauconnier A. Safety of Vaginal Mesh Surgery Versus Laparoscopic Mesh Sacropexy for Cystocele Repair: Results of the Prosthetic Pelvic Floor Repair Randomized Controlled Trial. Eur Urol. 2018 Aug;74(2):167-176. doi: 10.1016/j.eururo.2018.01.044. Epub 2018 Feb 19.
PubMed 29472143
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery in Cystocele Repair
- ClinicalTrials.gov ID
- NCT01637441
- Acronym / sponsor ID
- PROSPERE / 2011_24
- Conditions
- Cystocele
- Keywords
- bladder prolapse (cystocele), Pelvic organ prolapse repair, coelioscopic, prosthetic surgery, vaginal approach, Randomized study, laparoscopic sacropexy, vaginal mesh surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 11 Jul 2012 (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.
The cystocele is the most frequent clinical shape of the genital prolapse. It is a frequent pathology in woman which can impair quality of life and generates pelvic, urinary or sexual functional disorders.
It's considered that 8 % of women will be undergo surgery in this indication before the age of 80 years. Numerous surgical techniques have been described and we distinguish the interventions according to the route (vaginal or abdominal), and according to the use or not of synthetic mesh (non-absorbable) to increase the anatomical results.
Detailed description
This is a multicenter, randomized, comparative, 2-parallel-arm study in patients with pelvic organ prolapse (cystocele) Approximately 260 patients aged from 45 to 75 years will be allocated to have laparoscopic sacropexy or vaginal mesh surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic sacropexy | Experimental | Procedure: laparoscopic sacropexyunder laparoscopic vision, the vesico-vaginal space is dissected until the level of the bladder neck. a synthetic non absorbable mesh is placed between the bladder and the vagina. the mesh is sutured to the vagina and the apex (vaginal apex or uterus) and anchored to the prevertebral ligament in front of the promontorium. |
| vaginal mesh | Experimental | Procedure: vaginal meshafter anterior sagittal colpotomy, the bladder is dissected under the fascia layer, and the paravesical fossa are entered. a synthetic non absorbable mesh is placed with 4 arms suspension (trans obturator or not). treatment of the apex is mandatory. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cystocele superior or equal to stage II of the international classification POP-Q, isolated or associated with other elements of prolapse.
- Patient must have provided written informed consent form prior to enrolment
- Patient must be insured
Key exclusion criteria (9 listed)
- Previous of surgery for prolapse
- Unfavourable conditions to one or other of the 2 evaluated procedure
- Pelvic malignancy in the course of evolution
- Contraindication to the use of mesh
- Women not reading French
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 |
|---|---|---|
| laparoscopic sacropexyAlso: laparoscopic surgeryunder laparoscopic vision, the vesico-vaginal space is dissected until the level of the bladder neck. a synthetic non absorbable mesh is placed between the bladder and the vagina. the mesh is sutured to the vagina and the apex (vaginal apex or uterus) and anchored to the prevertebral ligament in front of the promontorium. | Procedure or surgery | laparoscopic sacropexy |
| vaginal meshAlso: medical vaginal deviceafter anterior sagittal colpotomy, the bladder is dissected under the fascia layer, and the paravesical fossa are entered. a synthetic non absorbable mesh is placed with 4 arms suspension (trans obturator or not). treatment of the apex is mandatory. | Procedure or surgery | vaginal mesh |
Primary outcome
Morbidity (Dindo Classification)
Time frame: 12 months
Compare the morbidity of the sub-vesical synthetic mesh according to the route between laparoscopic sacropexy or vaginal in the symptomatic superior stage II cystoceles at 1 year follow-up.
3 secondary outcomes
Specific complications
Time frame: 12 months
Medium-term tolerance
Time frame: 12 months
Clinical Efficiency
Time frame: 12 months
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 22 Apr 2026.
- Results publication: PubMed 29472143Lucot JP, Cosson M, Bader G, Debodinance P, Akladios C, Salet-Lizee D, Delporte P, Savary D, Ferry P, Deffieux X, Campagne-Loiseau S, de Tayrac R, Blanc S, Fournet S, Wattiez A, Villet R, Ravit M, Jacquetin B, Fritel X, Fauconnier A. Safety of Vaginal Mesh Surgery Versus Laparoscopic Mesh Sacropexy for Cystocele Repair: Results of the Prosthetic Pelvic Floor Repair Randomized Controlled Trial. Eur Urol. 2018 Aug;74(2):167-176. doi: 10.1016/j.eururo.2018.01.044. Epub 2018 Feb 19.
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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.
Jean-Philippe LUCOT, MD principal investigator
CHRU de LILLE
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic sacropexy and vaginal mesh in people with Cystocele, run by University Hospital, Lille at 12 sites 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 3 inclusion and 9 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 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
Morbidity (Dindo Classification) (time frame: 12 months). 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 NCT01637441, 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 22 Apr 2026.