search
Back to results

Small Stitch Study

Primary Purpose

Anterior Vaginal Wall Prolapse

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
small stitch anterior colporrhaphy
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Vaginal Wall Prolapse focused on measuring prolapse, anterior colporrhaphy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • women older than 18 years of age
  • Able to read, understand and sign informed consent
  • symptomatic cystocele described as Points Aa or Ba >= 0 according to the International Continence Society pelvic organ prolapse quantification system (POP-Q)

Exclusion Criteria:

  • previous urogynecological operation
  • gynecologic malignancy
  • planned concomitant incontinence operation
  • other contraindications for surgery
  • pregnancy
  • systemic glucocorticoid treatment
  • contraindication for the surgery

Sites / Locations

  • Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

symptomatic cystocele described as Points Aa or Ba >= 0 according to the International Continence Society pelvic organ prolapse quantification system (POP-Q). The changes in POPQ score preoperatively and three months after the anterior colporrhaphy with the new small stitch technic will be analyzed.

Outcomes

Primary Outcome Measures

the most distal point of the anterior vaginal wall- postoperative anterior vaginal support described as Point Ba (POP-Q score)
The changes in POPQ score preoperatively and three months after the anterior colporrhaphy with the new small stitch technic will be analyzed.

Secondary Outcome Measures

Full Information

First Posted
June 5, 2015
Last Updated
June 8, 2015
Sponsor
Medical University of Vienna
search

1. Study Identification

Unique Protocol Identification Number
NCT02469584
Brief Title
Small Stitch Study
Official Title
Continuous Small Stitch Technique for Anterior Colporrhaphy: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A descent of the anterior vaginal wall is the most common form of female pelvic organ prolapse (POP). Although anterior colporrhaphy (AC) is accepted worldwide as a "standard procedure", its exact steps are not well standardized. We developed a small stitch anterior colporrhaphy (SSTAC) in an effort to increase the strength and durability of AC Objectives The aim of this pilot study is to demonstrate the feasibility and complication rate of the SSTAC and to assess the anatomical and functional outcomes after this method of cystocele repair.
Detailed Description
A prospective case series evaluation of SSTAC following the recommendations of IDEAL-Collaboration (www.ideal-collaboration.net) will be performed. The newly developed procedure will be tested in a group of 10 patients, who equals stage 2a in the development and innovation of surgical innovations. In this stage safety and technical success is the main outcome. As technical modifications may be common during stage 2a and their nature and timing should be meticulously recorded, the videotaping during all surgical procedures will be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Vaginal Wall Prolapse
Keywords
prolapse, anterior colporrhaphy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
symptomatic cystocele described as Points Aa or Ba >= 0 according to the International Continence Society pelvic organ prolapse quantification system (POP-Q). The changes in POPQ score preoperatively and three months after the anterior colporrhaphy with the new small stitch technic will be analyzed.
Intervention Type
Procedure
Intervention Name(s)
small stitch anterior colporrhaphy
Intervention Description
A midline plication will be performed with continuous delayed absorbable sutures (3-0 polydioxanone) and the distance between the sutures will be 0.5 cm.
Primary Outcome Measure Information:
Title
the most distal point of the anterior vaginal wall- postoperative anterior vaginal support described as Point Ba (POP-Q score)
Description
The changes in POPQ score preoperatively and three months after the anterior colporrhaphy with the new small stitch technic will be analyzed.
Time Frame
4-6 weeks, 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: women older than 18 years of age Able to read, understand and sign informed consent symptomatic cystocele described as Points Aa or Ba >= 0 according to the International Continence Society pelvic organ prolapse quantification system (POP-Q) Exclusion Criteria: previous urogynecological operation gynecologic malignancy planned concomitant incontinence operation other contraindications for surgery pregnancy systemic glucocorticoid treatment contraindication for the surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ksenia Halpern, Dr
Phone
00431404040029150
Email
ksenia.halpern@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Engelbert Hanzal, DR
Phone
004314040029150
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Engelbert Hanzal, Dr
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ksenia Halpern, Dr
Phone
004314040029150

12. IPD Sharing Statement

Learn more about this trial

Small Stitch Study

We'll reach out to this number within 24 hrs