Altman (Nordic TVM): Anterior Colporrhaphy versus Transvaginal Mesh for Pelvic-Organ Prolapse
Altman (Nordic TVM) was a multicenter, patient-blinded superiority randomized trial of Gynecare Prolift anterior transvaginal polypropylene mesh repair versus traditional anterior colporrhaphy in women with symptomatic stage 2 or higher cystocele; mesh improved one-year composite anatomic and bulge-symptom success but increased operative and mesh-related harms.[1]
- Design and population
- Multicenter, patient-blinded superiority randomized trial. Women aged at least 18 years with symptomatic primary or recurrent POP-Q stage 2 or higher anterior vaginal wall prolapse who did not need concomitant surgery.
- Arms
- Gynecare Prolift anterior transvaginal polypropylene mesh repair versus traditional anterior colporrhaphy
- Report and follow-up
- 2011 · 12 months after surgery
| Endpoint | Results | Effect | Finding |
|---|---|---|---|
| One-year POP-Q anterior stage 0 or 1 plus no vaginal bulge; absolute risk difference in percentage points | 107/176 (60.8%) vs 60/174 (34.5%) | difference 26.3; CI 15.6–37; P <0.001 | Met |
Harms: Bladder perforation: 7/200 (3.5%) vs 1/189 (0.5%); New stress urinary incontinence: 22/179 (12.3%) vs 11/176 (6.2%); Vaginal wound revision for mesh exposure: 6/186 (3.2%)
Design
Women with primary or recurrent anterior prolapse and vaginal bulging or pelvic heaviness were enrolled at 53 Nordic hospitals. A need for concomitant surgery excluded participation. Patients were unaware of assignment through the one-year visit, but postoperative examiners could see the different incisions and were not blinded. The primary outcome required both anterior POP-Q stage 0 or 1 (point Ba more than 1 cm above the hymen) and no reported vaginal bulge. The randomized groups comprised 200 mesh and 189 colporrhaphy patients; evaluable denominators differed by endpoint.[1]
Results
The primary composite was met by 107/176 mesh patients (60.8%) and 60/174 colporrhaphy patients (34.5%). Its prespecified comparison favored mesh; the adjusted odds ratio was 3.6 (95% CI 2.2–5.9), and a sensitivity analysis assigning missing outcomes against mesh still favored mesh. These analyses supported the trial's primary superiority finding.[1]
As separate secondary outcomes, anterior stage 0 or 1 was recorded in 153/186 (82.3%) versus 87/183 (47.5%; difference 34.8 percentage points, 95% CI 25.1–44.3), and absence of bulge in 135/179 (75.4%) versus 108/174 (62.1%; difference 13.3 points, 95% CI 3.2–23.5). The broader anatomic difference and smaller symptom difference describe different components of the composite.[1]
In a randomized urodynamic substudy assessed two months after surgery, maximum urethral closure pressure decreased after mesh repair but did not change significantly after colporrhaphy. That analysis included 23 mesh and 27 colporrhaphy patients.[2]
Surgery and treatment delivery
Participating surgeons were qualified for both standardized operations. The implant was the Gynecare Prolift Anterior Pelvic Floor Repair System, placed with trocars to support the anterior vaginal wall; postmenopausal participants received topical estrogen before and after surgery. The 58 surgeons performed a median of three operations of each type during the trial. Assigned treatment was received by 191/200 mesh patients (95.5%) and 182/189 colporrhaphy patients (96.3%).[1]
Mean operative time was 52.6 versus 33.5 minutes and mean blood loss was 84.7 versus 35.4 mL, both greater with mesh (P < 0.001). Five mesh patients lost more than 500 mL, including one who lost more than 1,000 mL.[1]
Adverse events
Bladder perforation occurred in 7/200 mesh patients (3.5%) versus 1/189 colporrhaphy patients (0.5%; P = 0.07). New stress urinary incontinence occurred in 22/179 (12.3%) versus 11/176 (6.2%; P = 0.05). By one year, 6/186 mesh patients (3.2%) had vaginal wound revision for mesh exposure, and 5/186 (2.7%) had surgery for stress incontinence. Severe pelvic pain at two months affected five mesh patients and one colporrhaphy patient; it resolved by one year in all but one mesh patient.[1]
Limitations
The strict composite counted an anterior wall at stage 2 as failure even when bulge symptoms were absent. Examiners were unblinded, and the number with complete composite data was smaller than the randomized population. The trial's planned follow-up ended at one year, while mesh exposure and prolapse recurrence may emerge later. Few participants had clinically important apical descent, and the anterior kit did not suspend the apex.[1]
The manufacturer reviewed the protocol and a manuscript draft as cosponsor. A subsequent correction clarified that it did not provide the devices or participate in data collection, analysis, or the submission decision.[3]
In conversation
Same setting PROSPECT (2016)
Guidelines and approvals
ACOG/AUGS Practice Bulletin 214 (2019) concludes that polypropylene mesh augmentation of anterior vaginal wall repair improves anatomic and some subjective outcomes over native tissue repair but increases morbidity . Its synthesis cites the systematic review of randomized trials that includes Altman.[4]
FDA (April 16, 2019). The agency ordered manufacturers of the remaining surgical mesh products for transvaginal prolapse repair to stop selling and distributing them after their premarket applications did not establish reasonable assurance of safety and effectiveness. That order addressed the transvaginal prolapse product category.[5]
Report history
| Published | Report | Cutoff | Headline results | Citation |
|---|---|---|---|---|
| 2009-09-03 | Urodynamic substudy · secondary | — | Change from baseline at 2 months in 23 mesh and 27 colporrhaphy patients: Significant decrease vs No significant change; — | Ek M, Tegerstedt G, Falconer C, et al. "Urodynamic assessment of anterior vaginal wall surgery: a randomized comparison between colporraphy and transvaginal mesh." *Neurourol Urodyn.* 2010;29(4):527-531. doi:10.1002/nau.20811 DOI |
| 2011-05-12 | One-year primary report · primary | — | One-year POP-Q anterior stage 0 or 1 plus no vaginal bulge; absolute risk difference in percentage points: 107/176 (60.8%) vs 60/174 (34.5%); difference 26.3; CI 15.6–37; P <0.001 Met One-year anterior POP-Q stage 0 or 1; absolute risk difference in percentage points: 153/186 (82.3%) vs 87/183 (47.5%); difference 34.8; CI 25.1–44.3; P <0.001 One-year absence of vaginal bulge; absolute risk difference in percentage points: 135/179 (75.4%) vs 108/174 (62.1%); difference 13.3; CI 3.2–23.5; P 0.008 | Altman D, Väyrynen T, Engh ME, et al. "Anterior Colporrhaphy versus Transvaginal Mesh for Pelvic-Organ Prolapse." *N Engl J Med.* 2011;364(19):1826-1836. doi:10.1056/NEJMoa1009521 DOI |
| 2013-01-24 | Sponsor-disclosure correction · correction | — | — | "Correction: Anterior Colporrhaphy versus Transvaginal Mesh for Pelvic-Organ Prolapse." *N Engl J Med.* 2013;368(4):394. doi:10.1056/NEJMx130001 DOI |
References
1. Altman D, Väyrynen T, Engh ME, et al. "Anterior Colporrhaphy versus Transvaginal Mesh for Pelvic-Organ Prolapse." N Engl J Med. 2011;364(19):1826-1836. doi:10.1056/NEJMoa1009521
2. Ek M, Tegerstedt G, Falconer C, et al. "Urodynamic assessment of anterior vaginal wall surgery: a randomized comparison between colporraphy and transvaginal mesh." Neurourol Urodyn. 2010;29(4):527-531. doi:10.1002/nau.20811
3. "Correction: Anterior Colporrhaphy versus Transvaginal Mesh for Pelvic-Organ Prolapse." N Engl J Med. 2013;368(4):394. doi:10.1056/NEJMx130001
4. American College of Obstetricians and Gynecologists and American Urogynecologic Society. "Pelvic Organ Prolapse: ACOG Practice Bulletin, Number 214." Obstet Gynecol. 2019;134(5):e126-e142. doi:10.1097/AOG.0000000000003519
5. U.S. Food and Drug Administration. "FDA's Activities: Urogynecologic Surgical Mesh." April 16, 2019 order to stop selling and distributing transvaginal POP mesh products.