A Randomized Controlled Trial of Permanent vs Absorbable Suture for Uterosacral Ligament Suspension
Condition: Pelvic Organ Prolapse; Cystocele; Uterine Prolapse
MeSH terms: Cystocele; Uterine Prolapse; Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      Uterosacral ligament suspension (USLS) is a commonly performed, vaginal surgery for the
      correction of female pelvic organ prolapse. The original description of this procedure
      included the use of permanent sutures. However, permanent suture use in this vaginal
      application can result in some minor complication such as persistent vaginal spotting,
      vaginal discharge and dyspareunia. Subsequent reports on this procedure have utilized
      delayed-absorbable sutures in order to avoid these complications. Retrospective studies are
      conflicting as to whether or not absorbable suture provides as durable an anatomic outcome as
      permanent suture. There are currently no high-quality, prospective studies that have
      evaluated outcomes of permanent and absorbable suture for uterosacral ligament suspension.

      This study will recruit women scheduled to undergo USLS with or without other prolapse or
      anti-incontinence procedures. Participants will be randomized 1:1 to permanent or absorbable
      suture. Follow up will occur at 6 weeks and 12 months post-operatively. The primary outcome
      will be Pelvic Organ Prolapse Quantification Exam (POP-Q) point C as measured at the 12 month
      follow up visit. Subjects and assessors will be blinded.
    

Detailed description: 
      Patient demographics, relevant histories, baseline physical exam including POP-Q and PFDI-20
      data will be abstracted from the electronic medical record following enrollment. This
      information will be placed into a secure database.

      The randomization sequence will be generated by randomize.net, a web-based service that
      provides comprehensive randomization services for randomized controlled trials. The sequence
      will be randomized 1:1 with blocks of 4 and stratified by surgeon. Concealment will be
      completely opaque as group allocation will not be revealed until the subject is enrolled on
      the web-based service and the surgeon has elected to randomize the patient from an internet
      connection in the operating room.

      Subjects and assessors will be blinded to study group. The surgeons will, necessarily, not be
      blinded. Subjects will only be informed of their assigned group upon request following
      completion of the entire study.

      USLS with the assigned suture and any scheduled concomitant prolapse and anti-incontinence
      procedures will be performed. All procedures will be performed by one of two
      fellowship-trained, Female Pelvic Medicine and Reconstructive Surgery board-certified
      surgeons. USLS will be performed as initially described by Shull et al with two important
      differences in technique. First, 2 sutures will be placed through the intermediate portion of
      each uterosacral ligament instead of 3. Second, when absorbable suture (polydioxanone) is
      used, the suture will be placed through the full thickness of the anterior and posterior
      vaginal walls.

      Follow up exams will occur at 6 weeks and 12 months post-operatively and will include a POP-Q
      exam. The 6 week follow up visit will include the Patient Global Impression of Improvement
      (PGI-I) and an additional survey. The 12 month follow up visit will include a the PGI-I,
      PFDI-20 and an additional survey. All participants will also be assessed for any
      suture-related complications, such as erosion or granulation tissue. Follow up exams will be
      completed by one of two urogynecology nurse practitioners who will be blinded to the surgery
      and suture choice. Both nurse practitioners have extensive experience in performing POP-Q
      exams. The examiners will complete a follow up data abstraction form for each follow up
      appointment (6 weeks and 12 months).

      The follow up clinic appointments at 6 weeks and 12 months are the times of usually scheduled
      post-operative follow up for USLS procedures. Additionally, completion of the PFDI-20
      questionnaire and a POP-Q exam constitute routine clinical care for these patients. As such,
      there is no additional time commitment for subjects compared to routine clinical care.
    

Intervention name(s): Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment