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CompletedNCT03582410Updated Mar 31, 2020

Different Types of Suture for Sacral Colpopexy

An interventional study of laparoscopic sacral colpopexy with absorbable suture and laparoscopic sacral colpopexy with non absorbable suture in Pelvic Organ Prolapse, sponsored by Catholic University of the Sacred Heart. Completed at 1 site in Italy. Open to female participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-03-31.

Sponsored by Catholic University of the Sacred Heart · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
Female
01

Study summary

This randomized controlled study is designed to test absorbable suture compared to non absorbable suture in laparoscopic sacral colpopexy in terms of anatomical correction of the prolapse, post-operative and long term morbidity, rate of recurrence, subjective satisfaction of the patient and rate of mesh erosion.

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Conditions studied

  • Pelvic Organ Prolapse
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In context

Prolapse

676 studies on the registry are indexed under Prolapse; 79 are open to participants now.

This study's enrollment of 150 is above the median of 74 across 435 interventional studies indexed under Prolapse.

Browse Prolapse studies →

Lead sponsor

Catholic University of the Sacred Heart is the lead sponsor of 227 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • patients who required surgical treatment for symptomatic pelvic organ prolapse stage ≥ 2 with or without stress urinary incontinence

Exclusion criteria

Exclusion Criteria:

  • Age > 75 years
  • Severe cardiovascular or respiratory disease
  • Pregnancy
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
150 participants (actual)

Study arms

  • Active comparator
    Absorbable suture

    laparoscopic sacral colpopexy with absorbable suture

    Procedure: laparoscopic sacral colpopexy with absorbable suture

  • Active comparator
    Non absorbable suture

    laparoscopic sacral colpopexy with non absorbable suture

    Procedure: laparoscopic sacral colpopexy with non absorbable suture

Interventions

  • Procedurelaparoscopic sacral colpopexy with absorbable suture

    laparoscopic sacral colpopexy to correct pelvic organ prolapse with anterior and posterior meshes with absorbable suture

  • Procedurelaparoscopic sacral colpopexy with non absorbable suture

    laparoscopic sacral colpopexy to correct pelvic organ prolapse with anterior and posterior meshes with non absorbable suture

06

What researchers measure

Primary outcomes

  1. Number of patients with anatomical correction of the prolapse

    Anatomical correction of the prolapse evaluated by gynecological visit

    Time frame: 1 year

Secondary outcomes

  1. rate mesh erosion

    Time frame: 1 year

  2. long term outcomes

    development of nicturia, dysuria, obstructed defecation , urinary incontinence

    Time frame: 1 year

  3. Rate of recurrence

    de novo anterior or central or posterior compartment prolapse

    Time frame: 1 year

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Study locations

1 site
  • ospedale regionale Miulli
    Acquaviva delle Fonti, Bari 70021, Italy
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03582410
Lead sponsor
Catholic University of the Sacred Heart
Collaborators
Miulli General Hospital
Responsible party
Maurizio Guido (Clinical Professor, Catholic University of the Sacred Heart) — Principal investigator
First posted
Jul 11, 2018
Start date
Jul 10, 2018
Primary completion
Feb 10, 2020
Completion
Feb 10, 2020
Last update
Mar 31, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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