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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01909700
Other study ID # 2011041
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received July 24, 2013
Last updated May 4, 2016
Start date July 2011
Est. completion date February 2012

Study information

Verified date July 2013
Source Western Galilee Hospital-Nahariya
Contact n/a
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 157
Est. completion date February 2012
Est. primary completion date November 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 30 Years to 90 Years
Eligibility Inclusion Criteria:

* Patients with Gr 2-3 Pelvic Organ Prolapse

Exclusion Criteria:

*Previous Pelvic irradiation

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Device:
Single Incision Mesh
Single Incision Mesh is implanted for pelvic floor reconstruction

Locations

Country Name City State
Israel Assuta MC Tel Aviv

Sponsors (1)

Lead Sponsor Collaborator
Western Galilee Hospital-Nahariya

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Operative mesh related complications 12 Months Yes
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