Older Surgical Procedure for Pelvic Prolapse Repair Prevails in Randomized Trial

A long-time surgical standard for pelvic organ prolapse repair prevailed in a comparison against a newer technique that currently predominates in some parts of the world.

Sacrospinous hysteropexy failed to meet noninferiority criteria versus the Manchester procedure for the primary composite outcome of treatment success, with the latter achieving success in 87.3% of patients compared with 77.0% at 2 years. The trial design had a predefined noninferiority margin of 9%.

The Manchester procedure led to absence of prolapse beyond the hymen -- one of the components of the primary outcome -- significantly more often than did sacrospinous hysteropexy, and patient-reported and quality-of-life outcomes did not differ between the two treatment groups, reported Rosa A. Enklaar, MD, of Radboud University Medical Center in Nijmegen, the Netherlands, and co-authors in JAMA.

"In this large, multicenter randomized clinical trial comparing two uterus-sparing pelvic organ prolapse operations in patients undergoing their first surgical treatment, patients who underwent the Manchester procedure had a better composite outcome of success after 2-year follow-up, consistent with inferiority of sacrospinous hysteropexy," they concluded.

A second study added new evidence to the debate regarding use of vaginal estrogen during prolapse repair. The results showed that administration of topical estrogen before surgery and for 12 months afterward had no measurable impact on surgical outcomes, reported David D. Rahn, MD, of the University of Texas Southwestern Medical Center in Dallas, and co-authors.

The author of an accompanying editorial said the two studies provided informative results for two clinically relevant issues in urogynecology.

"Surgeons should reconsider the modified Manchester procedure as a uterine-conserving surgical procedure for mild uterovaginal prolapse," wrote Charles W. Nager, MD, of UC San Diego Health in La Jolla. "Vaginal estrogen has many beneficial effects on the vaginal epithelium and patient symptoms, but surgeons should not prescribe vaginal estrogen with the expectation that it will improve surgical success."

Historically, the primary surgical approach to pelvic organ prolapse has been transvaginal, involving removal of the uterus and suspension of the upper vagina, Enklaar and co-authors noted. Over the past decade, uterus-sparing procedures have become more common. In some parts of the world, including the Netherlands, a majority of gynecologists favor sacrospinous hysteropexy over the Manchester procedure.

No Previous Randomized Studies

Recent studies regarding uterus-sparing surgery have shown increased use of the older Manchester procedure. No direct comparisons of the Manchester procedure and sacrospinous hysteropexy had previously been reported. To examine the relative safety and efficacy of the two procedures, gynecologic surgeons at 26 hospitals in the Netherlands participated in a randomized clinical trial. Each surgeon had performed at least 20 prolapse-repair surgeries using each technique.

Eligible patients planned to undergo a first surgery for symptomatic pelvic organ prolapse in any stage, associated with uterine descent and a Pelvic Organ Prolapse Quantification (POP-Q) point D at or proximal to -1 cm. Surgeons were queried in advance to reach a consensus on prolapse quantification. POP-Q point D was chosen as a measure that allows differentiation between presumed failure of uterine suspensory ligaments and cervical elongation, the authors explained.

From July 2018 to February 2020, investigators randomized 434 patients to the two procedures. Follow-up ended Sept. 19, 2022. The primary endpoint was success at 2 years, defined as absence of pelvic organ prolapse beyond the hymen in any compartment, absence of bothersome bulge symptoms, and absence of prolapse retreatment (pessary or surgery).

Data analysis included 393 randomized patients. The results showed an absolute difference in success rate of 10.3% in favor of the Manchester procedure, exceeding the 9.0% prespecified margin for noninferiority (P=0.63).

The treatment groups did not differ significantly for any of the key secondary outcomes. Bothersome bulge symptoms occurred in 10.5% of the sacrospinous hysteropexy group and 9.0% of the Manchester group. Bulge symptoms without any reintervention for prolapse occurred in 9.1% and 7.1% of the two groups, respectively. Patient Global Impression of Improvement scores at 2 years showed 80.0% of the sacrospinous hysteropexy group and 82.1% of the Manchester group reported "much" or "very much" improvement.

No patient in the Manchester group versus 4.3% in the sacrospinous hysteropexy group underwent reoperation for prolapse recurrence in a previously treated vaginal compartment. One year after surgery, 2.5% and 4.0% of patients, respectively, had used a pessary.

The authors acknowledged several limitations of the study: results are applicable only to patients without uterine prolapse past the hymen, women with higher-stage prolapse were excluded, and applicability of the results is limited in other regions.

Vaginal Estrogen

Use of vaginal estrogen during surgery has become a "widespread clinical practice based on dogma and expert opinion," Nager stated in his editorial. A systematic review of vaginal estrogen in postmenopausal women with pelvic floor disorders found little evidence that the practice affects surgical outcomes.

Rahn and colleagues reported findings from a randomized trial involving patients undergoing native-tissue vaginal apical prolapse repair. They randomized the patients to apply vaginal estrogen or placebo cream for 5 weeks before surgery and then for 12 months afterward. The primary endpoint was time to failure of prolapse repair within 12 months of surgery.

Investigators enrolled 206 patients, of whom 199 were randomized, and 186 underwent surgery. The results showed a 12-month failure rate of 19.0% in the group that used vaginal estrogen versus 9% for the placebo group. The difference translated into a twofold increase in the hazard for prolapse repair failure (HR 1.97, 95% CI 0.92-4.22). In a subset of 109 patients with at least moderately bothersome vaginal atrophy symptoms at baseline, the vaginal atrophy score improved significantly at 12 months in patients who used topical estrogen.

"Perioperative vaginal estrogen does not reduce prolapse recurrence following native tissue vaginal repair, as performed in this study," the authors concluded. "Vaginal estrogen appears beneficial for reducing atrophy-related symptoms in the postoperative period."