Single Incision Pelvic Floor Mesh Implants

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)

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157 participants in 1 patient group

Single Incision Mesh

Experimental group

Description:

intervention: single incision mesh implantation

Treatment:

Device: Single Incision Mesh