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Single Incision Pelvic Floor Mesh Implants

W

Western Galilee Hospital-Nahariya

Status and phase

Completed
Phase 3
Phase 2

Conditions

Post Operative Complications
Intra-operative Complications

Treatments

Device: Single Incision Mesh

Study type

Interventional

Funder types

Other

Identifiers

NCT01909700
2011041

Details and patient eligibility

About

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.

Full 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

Enrollment

157 patients

Sex

Female

Ages

30 to 90 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

* Patients with Gr 2-3 Pelvic Organ Prolapse

Exclusion criteria

*Previous Pelvic irradiation

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

157 participants in 1 patient group

Single Incision Mesh
Experimental group
Description:
intervention: single incision mesh implantation
Treatment:
Device: Single Incision Mesh

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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