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Single Incision Pelvic Floor Mesh Implants

Single Incision Pelvic Floor Mesh Implants

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01909700
Enrollment
157
Registered
2013-07-26
Start date
2011-07-31
Completion date
2012-02-29
Last updated
2016-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intra-operative Complications, Post Operative Complications

Keywords

Single Incision, Mesh, Complications

Brief summary

Objectives: To evaluate whether the use of single incision un-anchored small mesh implants is feasible, safe and effective for women with moderate pelvic organ prolapse. Design: Patients diagnosed with moderate pelvic organ prolapse were enrolled to undergo a single incision un-anchored mesh operation. Follow-up was 4 to 23 months. The outcome measures for this study were the operative safety and post-operative pain, adverse effects and anatomical as well as functional cure. Setting: The operations were performed under general anesthesia according with the reported surgical techniques at university and private hospitals.

Detailed description

Eligibility criteria: female patients with moderate pelvic organ prolapse Outcome measures: intra operative safety and surgical complications, post operative complications and objective as well as subjective cure rates

Interventions

DEVICESingle Incision Mesh

Single Incision Mesh is implanted for pelvic floor reconstruction

Sponsors

Western Galilee Hospital-Nahariya
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

\* Patients with Gr 2-3 Pelvic Organ Prolapse

Exclusion criteria

\*Previous Pelvic irradiation

Design outcomes

Primary

MeasureTime frame
Operative mesh related complications12 Months

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026