NCT03911778

Completed

Evolution of Symptoms After Sacrospinofixation With Posterio...

Hospices Civils de Lyon Source

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Other study identifiers

Sponsor study identifier

69HCL19_0256

Secondary identifiers

2019-A01044-53

OTHER · ID-RCB

Study Type

observational

Actual enrollment (reported)

33

Locations

1 country

Sites

1

Timeline

Study Start

September 2, 2019

Actual (reported)

Primary Completion

November 15, 2023

Actual (reported)

Study Completion

November 15, 2023

Actual (reported)

Brief Summary

Prolapse is a condition that can cause disabling pelvic, urinary or sexual function disorders and impaired quality of life. Regarding the prolapse of the middle floor, the vaginal sacrospinofixation according to Richter is the reference technique for the suspension of the vaginal fundus. But the technique of sacrospinofixation vaginally is not without several difficulties in the short term but also in the medium and long term. Recently, anchoring devices have been developed to limit the dissection of the sacrospinous ligament and the operative exposure by the sometimes traumatic valves. The investigating team uses a technical variant in the form of an isthmic posterior strip of light weight and whose arms are sutured to the sacrospinous ligaments. The advantages of this isthmic strip are based on its small size, its very low basis weight and its wide mesh (improvement of tolerance) via a mini-invasive vaginal approach (thus allowing ambulatory care). Patient functional discomfort is the main problem related to the presence of a prolapse, therefore, the researchers wish to evaluate patient feelings following the use of this isthmic band. The researchers' hypothesis is that the sacrospinofixation technique with posterior isthmic band Bilateral Sacrospinous Colposuspension (BSC) Mesh (Agency for Medical Innovations (AMI) laboratory) improves symptoms experienced by patients with mid-level prolapse.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 33 participants
Study completion date: November 15, 2023
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
April 10, 2019
Actual (reported)
First Posted
April 11, 2019
Actual (reported)
Study Start
September 2, 2019
Actual (reported)
Primary Completion
November 15, 2023
Actual (reported)
Study Completion
November 15, 2023
Actual (reported)

Last Updated: January 11, 2024
Status Verified: January 2023
Last Update Submitted: January 10, 2024

Conditions

Apical Prolapse

Outcome Measures

Primary Outcomes (1)

Improvement of symptoms
Percentage of patients with improvement of their symptoms on the Patient Global Impression of Improvement Index (PGI-I) scale (score 1, 2, or 3)
6 weeks postoperatively

Study Arms (1)

Sacrospinofixation

Patients with apical symptomatic prolapse ≥ II in the POP-Q classification and for whom sacrospinofixation with posterior isthmic BSC Mesh is planned

Other: Improvement of symptoms

Interventions

Improvement of symptomsOther

Improvement of symptoms on the Patient Global Impression of Improvement Index (PGI-I) scale (score 1, 2, or 3) at 6 weeks postoperatively

Sacrospinofixation

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients with apical symptomatic prolapse ≥ II in the Pelvic Organ Prolapse Quantification (POP-Q) classification and for whom sacrospinofixation with posterior isthmic Bilateral Sacrospinous Colposuspension (BSC) Mesh is planned

You may qualify if:

women over 18

Sponsors & Collaborators

Hospices Civils de Lyon
Otherlead

Study Sites (1)

Service de gynecologie Hôpital Femme mère enfant

Bron, 69500, France

Study Officials

Gautier CHENE, Ph.D.
Hospices Civils de Lyon, Hôpital Femme Mère Enfant
PRINCIPAL INVESTIGATOR

Enrollment

33 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE CONTROL
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 10, 2019

First Posted

April 11, 2019

Study Start

September 2, 2019

Actual (reported)

NCT04551859

Concordance of Pelvic Organ Mobility Measurements Between the Finite Element Model and the Dynamic Pelvic Floor MRI in Patients Undergoing a Sacrospinofixation Surgery

Not ApplicableUnknown

NCT06872983

Evaluation of the Use of Synthetic Glue for Mesh Fixation in Laparoscopic Sacrocolpopexy

Not ApplicableRecruiting

apical prolapse requiring surgical correction of grade II or greater in the Pelvic Organ Prolapse Quantification (POP-Q) classification

patients who wish an intervention because of the discomfort caused by prolapse

sacrospinofixation procedure with posterior isthmic band Bilateral Sacrospinous Colposuspension (BSC) Mesh provided

person having expressed his non-opposition

You may not qualify if:

apical prolapse of stage \< II in the Pelvic Organ Prolapse Quantification (POP-Q) classification, and prolapse without functional discomfort
disorders leading to an unacceptable risk of postoperative complications sought during the interrogation of the patient (disorders of blood coagulation, disorders of the immune system, progressive diseases ....)
reduced mobility of the lower limbs (not allowing positioning for surgery)
pregnancy or any plans for pregnancy during the study period
evolutionary or latent infection
known hypersensitivity to polypropylene
inability to understand the information given
person deprived of liberty, under guardianship.

Contact the study team to confirm eligibility.

Primary Completion

November 15, 2023

Actual (reported)

Study Completion

November 15, 2023

Actual (reported)

Last Updated

January 11, 2024

Record last verified: 2023-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03911778
Data provider: ClinicalTrials.gov
Source updated: 2024-01-11
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:33:31 UTC

Locations

FR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Sacrospinofixation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations