Skip to content

Prospective study of single incision transvaginal mesh with apical fixation to treatment of anterior vaginal wall prolapses

Prospective study of single incision transvaginal mesh with single incision polipropilene mesh with transfascial midurethral and apical fixation for treatment of anterior and apical vaginal wall prolapses

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000879066
Enrollment
60
Registered
2010-10-19
Start date
2010-10-20
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

The primary porpose of this study is the assesment of stress urinary incontinence and pelvic organ prolapses healing after new technique of mesh fixation in single incision surgery

Interventions

The procedure is performed with the patient in lithotomy position. After doing a hydrodissection, anterior vaginal wall incision is made from midurethra towards the uterine cervix and the pubocervical fascia is carefully dissected. Blunt dissection is performed towards the ischial spine, and coccigeous muscle, identifying the ischial spines and the sacrospinous ligaments. Then the retractable insertion guide is primed with the tissue anchoring system and is introduced into the sacrospinous ligam

The procedure is performed with the patient in lithotomy position. After doing a hydrodissection, anterior vaginal wall incision is made from midurethra towards the uterine cervix and the pubocervical fascia is carefully dissected. Blunt dissection is performed towards the ischial spine, and coccigeous muscle, identifying the ischial spines and the sacrospinous ligaments. Then the retractable insertion guide is primed with the tissue anchoring system and is introduced into the sacrospinous ligament 1.5 cm medial from the ischial spine. The tissue anchoring system is released and the insertion guide is gently retracted. The same maneuvers are repeated on the other side. For insertion of the implant, first, the retractable insertion guide is connected to the multipoint fixation arm and is introduced towards the internal obturator muscle, one centimeter above the vaginal fornix, guided by surgeon’s index finger. When the centering mark of the implant is at the midurethra at a properly position, the trigger at the handle is retracted to release in place the fixation arm. The multipoint fixation arms design provides strong and stable primary fixation. Cystoscopy is not mandatory. Then, the polypropylene stitches are attached to the arms of the implant bilaterally. Stitches are placed at the posterior body of the implant and fixed at the remanents of cardinal ligaments or pericervical ring in order to avoid high cystocele reccurence. Finally, the vaginal incision is closed in the usual manner. This procedure is performed about 1 hour

Sponsors

Promedon
Lead SponsorCommercial sector/Industry

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No

Inclusion criteria

female pregnancies defined no diseases with contraindications for anesthesia anterior vaginal prolapse with point Ba > +1 (POP-Q classification)

Exclusion criteria

point Bp > -1 or point C > -1 (POP-Q classification), without tumoral diseases without urinary infections without vaginal infections no previous radioterapy no pregnancy no blood dyscrasias or immunosuppression no psychiatric or neurological diseases

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026