Materials and Methods

From the end of 2005, consecutive women referred to Wesley, Royal Brisbane’s and Mater tertiary referral Urogynaecology unit with symptomatic stage 2 or greater (point C ≥ −1 pelvic organ prolapse quantification [POP-Q]) vaginal vault prolapse were eligible for inclusion. Recruitment was completed at the end of 2007. Exclusion criteria included those younger than 18 years of age, inability to comprehend questionnaires, to give informed consent or to return for review, vault prolapse < stage 2, unable to undergo general anesthesia, body mass index (BMI) >35, ≥5 previous laparotomies, prior sacral colpopexy, or vaginal mesh prolapse procedure or vaginal length less than 6 cm. Before surgery women were examined (POP-Q) by consultant and fellows in Urogynaecology, completed patient administered validated pelvic floor and quality of life questionnaires (Australian Pelvic Floor Questionnaire [APFQ] and Kings College Pelvic Organ Prolapse quality of life [P-QoL] ) and underwent multichannel urodynamics with bladder filling to maximum of 500 mL, without and with prolapse reduction. Prolapse was reduced using sponge-holding forceps at the vault. Women without symptoms of urinary stress incontinence (USI) and with positive stress test with or without prolapse reduction were considered as having occult stress urinary incontinence (SUI).

Those who were eligible and agreed to participation completed written consent forms and were enrolled by consultant and Urogynaecology fellows. After completion of study consent, research support staff were telephoned and allocation to the laparoscopic or vaginal surgery group from randomization list that were computer generated by the study statistician, stratified for urodynamic stress incontinence (SUI and occult USI) with full allocation concealment, was completed.

The LSC was performed identically to our open sacral colpopexy reported in 2004 ³ with the exception of the entry technique in which a nondisposable Hassan entry with 3 additional trocars (Applied Medical, Rancho Sante Margarita, CA) was used. The retroperitoneum was opened using monopolar diathermy from sacral promontory to vault with the incision just medial to the uterosacral ligament. With an Apple vaginal probe (Applemed, Marlborough, MA) in position, the bladder was mobilized from the vagina to the level of the trigone creating the vesicovaginal space anteriorly and the bowel was mobilized 7-8 cm along the posterior vagina to create the rectovaginal space. A self-styled Y-shaped piece monofilament polypropylene large pore mesh (Prolene 15 × 15cm; Ethicon) was secured to the anterior and posterior vagina with two to three 2.0 polydiaxone sutures (PDS Ethicon; Ethicon) and to the sacral promontory using the Hernia tacker (ProTack 5 mm; Tyco Healthcare, Mansfield, MA). The mesh was crafted to suit the individual with the anterior leaf typically 7-8 cm long and 4.5 cm wide. The posterior leaf was 4.5 cm wide and 22 cm long. The retropertioneal space was closed continuous 2.0 PDS suture. All women with SUI or occult SUI underwent colposuspension and those with significant anterior compartment prolapse without SUI underwent paravaginal repair. Those with low posterior compartment prolapse underwent a distal midline fascial plication as previously described at the end of the surgery.

In the TVM procedure, a Total Prolift (Gynecare, Ethicon) was performed as described by Fatton et al with the addition of a tacking 2.0 polyglactin absorbable suture (Vicryl; Ethicon) at the distal anterior and posterior tails to the vaginal fascia without breaching the mucosa to minimize the possibility of the mesh retracting proximally or folding in the early postoperative days. In the rare case of minimal anterior or posterior compartment prolapse, the anterior or posterior leaf of the total prolift was removed and this decision was made intraoperatively. An inside-out transvaginal obturator suburethral tape (TVT-O; Gynecare, Ethicon) was performed in all women with USI or occult stress incontinence. Surgery was performed by C.M. (consultant Urogynaecologist) or by E.D. (Urogynaecology fellow) with C.M. assisting and both authors had completed at least 30 laparoscopic and vaginal prolapse mesh surgical procedures before commencing the study. Before commencing vaginal mesh surgery, C.M. underwent training in Lille, France, with the developers of the TVM technique. Before the trial commencing LSC and vaginal mesh procedures were used for the management of vaginal vault prolapse.

Perioperative parameters were defined as follows: operating time was from knife to skin to cessation of cystoscopy. Intraoperative blood loss was defined in milliliters by the consultant anesthetist. All patients had the indwelling catheter removed at 0600 on day 1 and completed a 24-hour trial of void. Patients were discharged after a successful trial of void or successful teaching of clean intermittent self-catheterization (CISC) and not requiring narcotics injection in the last 12 hours. Catheters days were defined as days indwelling catheter or CISC was used. Admission days equaled number of nights in hospital at midnight. Pain score at 1 month was recorded on a visual analogue scale of 0-10 (0 nil; 10 worst). Return to activities of daily living was defined as days to return to driving, preparing meals, and shopping. Mesh contraction has previously been defined. All other definitions complied with the ICS terminology and urodynamic voiding dysfunction was defined as maximum urinary flow rate <15 mL/sec on 2 occasions with a voided volume >150 mL and residual urine >100 mL.

The 6-week examination and review was performed by the surgeon with all study data and future visits (6 months and annually thereafter) completed by blinded coauthors (Urogynaecology fellows × 2 and research nurse) who remained unaware of group allocation. Women with problems were referred by the reviewers to our clinic for management. The complete presurgical evaluation was repeated at all reviews, excluding multichannel urodynamic analysis that was performed only at 6 months. Self-assessed patient satisfaction (circle a score that describes your satisfaction with surgery) was completed on a visual analogue scale of 0-100 with 0 being lowest as previously described.

Given a 76% 2-year objective success rate for open sacral colpopexy and 92% with vaginal mesh Prolift, the sample size required to detect a 30% difference in success rates with a power of 80% and alpha = .05 was 47 per group. To allow for drop of 15% and to ensure an adequately powered study 110 were recruited. The aim of the study was to compare the LSC and TVM in the management of vaginal vault prolapse at 2 and 5 years with the null hypothesis being that no significant differences existed between the 2 surgical procedures.

Primary outcome measures were objective success rates at POP-Q sites Aa, Ba, C, Bp, and Ap defined as less than −1 cm individually and as a total. Secondary outcome measures included perioperative outcomes, patient satisfaction, quality of life outcomes, complications, and reoperations.

The study protocol was approved by the institutional review boards at the Royal Women’s (2004067), Wesley (200445), and Mater hospitals (776A) and written informed consent was obtained from all participants on enrollment. The study has been registered at ANZCTR clinical trials registry after the enrollment of patients had commenced (ACTRN12609000119291).

Frequency and percentages were used to describe categorical variables, Fisher’s exact test used to compare treatment groups, and logistic regression used to estimate odds ratios (ORs), and associated 95% confidence intervals (95% CIs). Matched analyses for pre- and postconsistency for urodynamic characteristics used McNemar test. Means and standard deviations (SDs) were used to describe approximately normally distributed continuous data. Analysis of covariance (ANCOVA) was used to compare treatment groups at 2 years postintervention adjusting for preintervention values and to estimate mean differences between treatment groups and associated (95% CI). Medians and range (minimum, maximum values) were used to describe non-normally distributed continuous data, Wilcoxon rank sum test used to compare treatment groups and Student t test to estimate mean differences and associated (95% CI). Paired t tests were used for differences between pre- and postmeasurements. All analyses were undertaken using Stata version 10.0 (StataCorp, College Station, TX) and SAS version 9.1 (SAS Institute Inc, Cary, NC); and α = .05 defined statistical significance for all tests. Data was analyzed on an intention-to-treat basis.

Results

The Figure details patients’ progress through the study with 108 women of 142 potentially eligible, consenting to randomization and participation with 53 allocated LSC and 55 vaginal mesh repair. All completed at least 6 months follow-up. The randomization process was adequate with no differences between the 2 groups in demographics and preoperative variables as seen in Table 1 . Wilcoxon test indicate no significant difference between treatment groups for preoperative POP-Q measurements except for perineal body ( P = .046), but this mean difference of 0.10 cm was not clinically significant. Perioperative outcomes indicate that the LSC surgery took approximately twice as long to perform as the TVM but was associated with a significantly lower blood loss, shorter hospitalization and quicker return to activities of daily living ( Table 2 ).

Randomized trial flow diagram

The randomized trial flow diagram including total sample size, enrollment, intervention allocation, follow-up, and analysis.

Maher. Laparoscopic sacral colpopexy vs vaginal mesh repair. Am J Obstet Gynecol 2011.

TABLE 2

Perioperative details

	LSC			TVM
Variable	n	Median	[min, max]	n	Median	[min, max]	P value a	Mean difference	(95% CI) b
Operating time, min	53	97	[36, 280]	55	50	[30, 96]	< .001	52.0	(41.4–62.6)
Blood loss, mL	53	100	[20, 300]	55	150	[21, 500]	.004	−32.0	(−59.4 to −4.5)
In-patient stay, d	53	2	[2, 10]	55	3	[2, 6]	.01	−0.52	(−0.93 to −0.10)
Catheterization, d	53	1	[1, 42]	55	2	[1, 21]	.44	0.22	(−1.87 to 2.31)
Pain score	53	0	[0, 80]	54	0	[0, 50]	.10	0.20	(−5.06 to 5.45)
Return to normal activity, d	53	21	[7, 50]	54	21	[5, 63]	<.001	−5.34	(−8.36 to −2.32)

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