Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of Transvaginal Mesh (PROLIFT) Versus Anterior Colporrhaphy in Anterior Vaginal Wall Prolapse
Brief Summary: Pelvic organ prolapse is characterized by a lack of pelvic floor support causing the pelvic organs and vaginal walls to protrude. For decades, suture repair techniques have been the primary choice of surgical treatment when indicated.

Traditional surgical techniques are frequently associated with unsatisfying anatomical recurrence rates and it is plausible that inherently weak, or damaged, pelvic floor supportive tissues need to be reinforced by a permanent support to avoid the high rates of recurrences commonly described using traditional techniques. Over the years sporadic attempts have been made to introduce novel surgical techniques using a variety of biomaterials with varying success. Despite a lack of clinical safety data, or compelling clinical evidence demonstrating that it improves outcomes compared to traditional suture techniques, use of biomaterials in pelvic reconstructive surgery has become widespread in just a few years .

It is likely that biomaterials need to be "anchored" in tissues not afflicted by the disease, in order to provide the intended pelvic floor support. This has given rise to transvaginal surgical techniques using a transobturator approach passing the mesh through the arcus tendineous fascia pelvis, or the sacrospinous ligaments through a transgluteal approach. Short term data from concluded and on-going safety assessments of these techniques has provided promising results and satisfying clinical outcomes. The aim of the present study is to compare anterior mesh repair (PROLIFT®) with traditional suture repair in a randomised trial.


Options:
A: Inclusion Criteria:

* Women over the age of 18 seen at the urogynecology clinic at Geisinger with primary or recurrent pelvic organ prolapse including an anterior vaginal wall relaxation with or without urinary incontinence who are scheduled to have pelvic reconstructive surgery will be eligible to participate in the trial.

Exclusion Criteria:

* Patients with at least 2 previous prolapse surgeries
* Patients who are pregnant or planning to have a pregnancy
B: Inclusion Criteria:

* recurrent anterior and/or posterior prolapse POP-Q stage 2 or more
* patient has agreed to undergo implantation of TVM (prolift) or fascial plication
* patient is willing to return for follow-up evaluation at 6 weeks, 6 months and 12 months
* patient is willing to complete quality of life questionnaires at 6 and 12 months

Exclusion Criteria:

* patient is or wants to become pregnant
* patient has had previous synthetic mesh procedure (a previous mid-urethral sling procedure is NOT an exclusion criterion)
* patient has current urinary tract or vaginal infections
* patient has a blood coagulation disorder
* patient has a compromised immune system or any other condition that would compromise healing
* patient has renal insufficiency and/or upper urinary tract obstruction
* patient is unwilling or unable to return for evaluation
* patient has had previous irradiation
* patient has any malignancy
* patient has large ovarian cysts of large myoma
C: Inclusion Criteria:

* Postmenopausal women with symptomatic anterior vaginal wall prolapse to the hymen or beyond when under strain and referred for reconstructive pelvic surgery

Exclusion Criteria:

* an apical defect indicating concomitant vaginal fixation, or stress urinary incontinence necessitating surgery, or her main symptomatic prolapse component was in the posterior vaginal wall.
D: Inclusion Criteria:

* Reproductive years in the past (biologically or reproductive decision)
* Prolapse of the anterior vaginal wall ≥POPQ-stadium II
* Prolapse specific pelvic symptom
* Being able to make an informed consent on participation
* Physically and cognitive capable of participating in the required follow-up
* No other pelvic floor surgery performed at the time of anterior repair
* No exclusion criteria fulfilled

Exclusion Criteria:

* Previous or current pelvic organ cancer (regardless of treatment)
* Severe rheumatic disease
* Insulin treated diabetes mellitus
* Connective tissue disorders (SLE, Sjögrens syndrome, Marfans syndrome, Ehlers Danhlos, collagenosis, polymyositis eller rheumatic myalgia)
* Current systemic steroid treatment

Answer: D