Scandinavian Urethroplasty Study: Transecting Excision and Primary Anastomosis Versus Buccal Mucosa Graft
The Scandinavian Urethroplasty Study was a four-center, open-label randomized superiority trial in 151 patients with a bulbar urethral stricture of 2 cm or less and no previous open urethroplasty that compared transecting excision and primary anastomosis (tEPA) with buccal mucosa graft (BMG) urethroplasty, with patient-reported penile complications and erectile function (IIEF-5) as co-primary endpoints at 12 months. One or more penile complications were reported by 33% after tEPA and 16% after BMG (p = 0.02), and IIEF-5 scores did not differ (p = 0.14).[1]
- Design and population
- Four-center, open-label randomized superiority trial. Patients aged 18 to 70 years with a bulbar urethral stricture of 2 cm or less and no previous open urethroplasty (median age 35 years, median stricture length 10 mm).
- Arms
- Buccal mucosa graft urethroplasty versus transecting excision and primary anastomosis
- Report and follow-up
- 2022 · 12 months; 144/151 completed the 12-month visit; final follow-up visit 9 February 2021
| Endpoint | Results | Effect | Finding |
|---|---|---|---|
| One or more penile complications on the penile complications questionnaire (PCQ questions 2 to 5: glans filling, glans sensation, penile length, penile direction) at 12 months; risk difference (tEPA minus BMG), percentage points | 12 (16%) vs 23 (33%) | difference 17; CI 3–30; P 0.02 | Met |
| Mean IIEF-5 score at 12 months; between-arm difference from analysis of covariance | 23.0 vs 21.8 | difference 1.2; CI -0.4–2.7; P 0.14 | Not met |
Harms: Postoperative bleeding (scrotal or perineal hematoma): 3/76 (3.9%) vs 18/75 (24%); Wound infection after discharge or at catheter removal: 0/76 vs 3/75 (4.0%); Urinary tract infection at 12 months: 5/75 (6.7%) vs 1/71 (1.4%)
Design
Centers in Helsinki, Gothenburg, Örebro and Oslo enrolled patients aged 18 to 70 years with a bulbar stricture of 2 cm or less, estimated by urethrography or endoscopy. Exclusions were previous open urethroplasty, hypospadias surgery, surgery for congenital curvature or Peyronie disease, pelvic irradiation, a bleeding diathesis, a grave psychiatric disorder and use of phosphodiesterase type 5 inhibitors or intracavernous injections during the study. Patients were randomized 1:1 at each site before surgery, after written consent, through a web-based database.[1]
The trial was designed to show superiority of either method. Its two primary endpoints were the odds of reporting one or more complications on a penile complications questionnaire (PCQ) and the difference in mean IIEF-5 change. The PCQ was written for the study from earlier questionnaires and asks about ejaculation (question 1), glans filling (question 2), glans sensation (question 3), penile length (question 4) and penile direction (question 5). Question 1 was left out of the one-or-more-complications analysis because the authors did not consider ejaculation a penile problem. IIEF-5 was completed before surgery and at follow-up in validated local-language versions. Secondary endpoints were stricture recurrence, defined as need for additional surgery, and complications. The report presents risk differences with chi-square tests for categorical data and analysis of covariance for continuous data, without correction for multiple testing.[1]
The target was 300 patients, 134 per group, for 80% power at an alpha of 0.05 to detect 30% versus 15% penile complications. Analysis was by intention to treat.[1]
Results
The 151 patients (75 randomized to tEPA, 76 to BMG) were enrolled between 1 September 2015 and 31 December 2019, 95 of them in Oslo. Median age was 35 years in both arms, median stricture length 10 mm in both, median preoperative IIEF-5 score 25 in both, and 12 (16%) of the tEPA arm and 10 (13%) of the BMG arm had a suprapubic tube. At 12 months, 144 patients had completed follow-up.[1]
At 12 months, 23 (33%) of the tEPA arm and 12 (16%) of the BMG arm reported one or more of the penile complications in questions 2 to 5 (risk difference 17 percentage points, 95% CI 3 to 30; p = 0.02). At 3 months the figures were 26 (38%) and 10 (14%) (risk difference 24 points, 95% CI 10 to 38; p = 0.001). Among individual questions at 12 months, reduced glans filling was reported by 13 (19%) after tEPA and 5 (6.8%) after BMG (p = 0.03), and a shorter erect penis by 18 (26%) and 4 (5.4%) (p = 0.001). Loss of glans sensation (9 [13%] versus 9 [12%]) and changed erection direction (4 [5.7%] versus 3 [4.1%]) did not differ at 12 months. Worse ejaculation was reported by 18 (26%) after tEPA and 2 (2.8%) after BMG at 3 months (p < 0.001) and by 5 (7.1%) and 6 (8.1%) at 12 months (p = 0.8). Changed erection direction at 3 months occurred in 7 (10%) after tEPA and in none after BMG (p = 0.005).[1]
Mean IIEF-5 scores at 12 months were 21.8 after tEPA and 23.0 after BMG (difference 1.2, 95% CI −0.4 to 2.7; p = 0.14); at 3 months they were 21.1 and 22.3 (difference 1.2, 95% CI −0.01 to 2.4; p = 0.051). The authors concluded that the penile complications were not reflected in a clinically significant IIEF-5 difference and that the questionnaire may not suit sexual-function assessment after urethroplasty.[1]
Recurrence data were available for 147 patients, and 19 (12.9%) had a recurrence: 9 (12.0%) in the tEPA arm and 10 (13.2%) in the BMG arm (risk difference −1 point, 95% CI −12 to 10; p = 0.8). Mean maximum flow at 12 months was 28 mL/s after tEPA and 27 mL/s after BMG (p = 0.8), and mean residual volume was 64 and 81 mL (p = 0.2).[1]
A 2026 clinical trial update reported 12-month recurrence of 12.2% after tEPA and 13.0% after BMG (12.9% overall), with 74 tEPA and 77 BMG procedures performed. It stated that participants would be invited for long-term follow-up with the same endpoints, with a minimum of 6 years of observation after surgery; those data are not yet reported.[2]
Surgery and treatment delivery
The centers agreed the operative techniques before the study began. For tEPA, the corpus spongiosum was transected, the stricture excised and the ends anastomosed in two layers. For BMG, the corpus spongiosum was incised along the stricture, ventrally or dorsally according to surgeon preference, and a buccal mucosa graft was placed on the urethral defect without transection. Of the 77 BMG operations, 59 were ventral and 18 dorsal, with no difference in penile complications between the two positions.[1]
Three patients (2%) were not operated as assigned: two randomized to tEPA had BMG because of unexpectedly long strictures (one of them with an augmented end-to-end anastomosis) and one randomized to BMG had tEPA, so 74 patients had tEPA and 77 had BMG. The authors reported that analysis by the operation actually performed changed results negligibly.[1]
All patients had an indwelling Foley catheter for 2 to 3 weeks, with antibiotics, antithrombotic prophylaxis and physical limitations at each center's discretion and the same postoperative treatment in both groups at each center. Retrograde urethrography at the first catheter-removal attempt was performed in 136 patients; contrast leaked in eight, with no difference between groups, and the catheter stayed another 2 weeks in all eight. It was then removed without repeat urethrography in six, and urethrography in the other two showed no leakage.[1]
Adverse events
Postoperative bleeding, defined as a scrotal or perineal hematoma, occurred in 18/75 (24%) after tEPA and 3/76 (3.9%) after BMG (p < 0.001). All were Clavien-Dindo grade I except three tEPA patients (one grade II, one IIIa, one IIIb). Three tEPA patients (3/75, 4.0%) had a wound infection after discharge or at catheter removal (grade II in two, IIIa in one), and none occurred in the BMG arm. Urinary tract infections were all grade I to II and did not differ significantly; at 12 months they affected 1/71 (1.4%) after tEPA and 5/75 (6.7%) after BMG.[1]
One patient had a myocardial infarction 6 days after surgery that required coronary stenting (grade IVa), and no patient had deep venous thrombosis or compartment syndrome. Perineal or lower-extremity pain, anesthesia or dysesthesia, all grade I to II, was reported by six patients early after surgery, ten at 3 months and three at 12 months; the report does not give these by arm.[1]
After graft harvest, 26 patients (34%) reported oral discomfort during the hospital stay (15 mild, 11 moderate), 4 (5.2%) at catheter removal and 3 (3.9%) at 3 and at 12 months, all mild. One patient (1.3%) had grade I donor-site bleeding, and there was no Stensen duct occlusion or donor-site infection.[1]
Limitations
Enrollment reached 151 of the 300 planned. Inclusion was stopped after more than 4 years, without interim analysis, because the Danish site did not join and the Swedish sites could not operate on as many patients as intended; reaching the target would have taken 8 to 10 years. Neither patients nor surgeons were blinded, and most patients were treated in one center (Oslo, 95 of 151).[1]
The PCQ is not a validated instrument, its questions detect impairment without showing whether a condition was stable or improved, and IIEF-5 was developed for sildenafil trials and is not validated for urethral surgery. The p values were not adjusted for multiple testing. Lumen patency was not assessed by endoscopy or urethrography at follow-up, and follow-up was 12 months; the authors considered the sample too small and follow-up too short to detect a recurrence difference.[1]
In conversation
The comparator that carries the penile-complication result is a graft onlay, not non-transecting excision and primary anastomosis; the 2026 update states that no randomized trial has compared transecting with non-transecting anastomotic repair.[2] Stricture recurrence was a secondary endpoint here, so recurrence comparisons with trials whose primary endpoint is recurrence are indirect.
Guidelines and approvals
- AUA (Urethral Stricture Disease, 2016; amended 2023), statement 7. Surgeons may offer urethral dilation, direct visual internal urethrotomy or urethroplasty for initial treatment of a short (<2 cm) bulbar urethral stricture . The supporting discussion cites this trial for fewer penile complications (poor glans filling, penile shortening) after non-transecting substitution urethroplasty than after transecting urethroplasty, and for no difference in erectile dysfunction by IIEF at 12 months.[3]
- EAU (Urethral Strictures, 2026 limited update), section 6.3.2. Use non-transecting excision and primary anastomosis or free graft urethroplasty instead of tEPA for short bulbar strictures not related to straddle injury . The guideline describes this trial as its randomized comparison of tEPA with free graft urethroplasty and rates that comparison level of evidence 1b.[4]
Report history
| Published | Report | Cutoff | Headline results | Citation |
|---|---|---|---|---|
| 2022-01-08 | Initial 12-month report · primary | 2021-02-09 | One or more penile complications on the penile complications questionnaire (PCQ questions 2 to 5: glans filling, glans sensation, penile length, penile direction) at 12 months; risk difference (tEPA minus BMG), percentage points: 12 (16%) vs 23 (33%); difference 17; CI 3–30; P 0.02 Met Mean IIEF-5 score at 12 months; between-arm difference from analysis of covariance: 23.0 vs 21.8; difference 1.2; CI -0.4–2.7; P 0.14 Not met One or more penile complications (PCQ questions 2 to 5) at 3 months; risk difference (tEPA minus BMG), percentage points: 10 (14%) vs 26 (38%); difference 24; CI 10–38; P 0.001 PCQ question 2 'yes' (less stiffness of the penis head during erection) at 12 months; risk difference (tEPA minus BMG), percentage points: 5 (6.8%) vs 13 (19%); difference 12; CI 1–23; P 0.03 PCQ question 4 'yes' (erect penis has become shorter) at 12 months; risk difference (tEPA minus BMG), percentage points: 4 (5.4%) vs 18 (26%); difference 20; CI 9–32; P 0.001 PCQ question 3 'yes' (lost feeling in the head of the penis) at 12 months; risk difference (tEPA minus BMG), percentage points: 9 (12%) vs 9 (13%); difference 0.7; CI -10.1–11.5; P 0.9 PCQ question 5 'yes' (erect penis points in a different direction) at 12 months; risk difference (tEPA minus BMG), percentage points: 3 (4.1%) vs 4 (5.7%); difference 1.7; CI -5.4–8.7; P 0.6 PCQ question 1 'yes' (ejaculation has become worse) at 3 months; risk difference (tEPA minus BMG), percentage points: 2 (2.8%) vs 18 (26%); difference 24; CI 12–35; P <0.001 PCQ question 1 'yes' (ejaculation has become worse) at 12 months; risk difference (tEPA minus BMG), percentage points: 6 (8.1%) vs 5 (7.1%); difference -1; CI -10–8; P 0.8 Mean IIEF-5 score at 3 months; between-arm difference from analysis of covariance: 22.3 vs 21.1; difference 1.2; CI -0.01–2.4; P 0.051 Recurrence, defined as need for additional surgery, within 12-month follow-up; risk difference (tEPA minus BMG), percentage points: 10 (13.2%) vs 9 (12.0%); difference -1; CI -12–10; P 0.8 Mean maximum flow at 12 months: 27 mL/s vs 28 mL/s; P 0.8 Mean residual volume at 12 months: 81 mL vs 64 mL; P 0.2 | Nilsen OJ, Holm HV, Ekerhult TO, et al. To Transect or Not Transect: Results from the Scandinavian Urethroplasty Study, A Multicentre Randomised Study of Bulbar Urethroplasty Comparing Excision and Primary Anastomosis Versus Buccal Mucosal Grafting. *Eur Urol.* 2022;81(4):375-382. DOI |
| 2026-05-21 | Clinical trial update (12-month data) · secondary | — | One or more penile complications (PCQ questions 2 to 5) at 12 months: 12 (16%) vs 23 (33%); P 0.02 Descriptive Recurrence, defined as need for retreatment; overall 12.9%: 13.0% vs 12.2%; — Descriptive | Holm HV, Ohnesorge SS, Nilsen OJ. Long-term Outcomes of Transecting Versus Nontransecting Bulbar Urethroplasty: Results from the Scandinavian Urethroplasty Study. *Eur Urol Focus.* 2026;12(3):316-318. DOI |
References
1. Nilsen OJ, Holm HV, Ekerhult TO, et al. "To Transect or Not Transect: Results from the Scandinavian Urethroplasty Study, A Multicentre Randomised Study of Bulbar Urethroplasty Comparing Excision and Primary Anastomosis Versus Buccal Mucosal Grafting." Eur Urol. 2022;81(4):375-382. doi:10.1016/j.eururo.2021.12.017
2. Holm HV, Ohnesorge SS, Nilsen OJ. "Long-term Outcomes of Transecting Versus Nontransecting Bulbar Urethroplasty: Results from the Scandinavian Urethroplasty Study." Eur Urol Focus. 2026;12(3):316-318. doi:10.1016/j.euf.2026.05.007
3. Wessells H, Angermeier KW, Elliott SP, et al. Urethral Stricture Disease: AUA Guideline. American Urological Association; 2016, amended 2023. Statement 7 and discussion.
4. Lumen N, Campos-Juanatey F, Dimitropoulos K, et al. EAU Guidelines on Urethral Strictures (limited update 2026). Arnhem: EAU Guidelines Office; 2026. Section 6.3.2.