TVT vs PAHG: Tension-Free Vaginal Tape versus Polyacrylamide Hydrogel Injection for Primary Stress Incontinence
TVT vs PAHG was a single-center, open-label noninferiority randomized trial at Helsinki University Hospital comparing transurethral polyacrylamide hydrogel (PAHG, Bulkamid) injection with retropubic tension-free vaginal tape (TVT) in women with primary stress urinary incontinence (SUI), with satisfaction of at least 80/100 as the primary outcome.[1] Hydrogel did not meet the 20% noninferiority limit: satisfaction at 1 year was 59.8% versus 95.0%, and the gap persisted at 3 and 5 years, while complications before crossover were more frequent after tape.[1][2][3]
- Design and population
- Single-center, open-label noninferiority randomized trial. Women with primary stress urinary incontinence unresponsive to conservative treatment, a positive cough stress test without urge-type leakage and no previous incontinence procedure.
- Arms
- Transurethral polyacrylamide hydrogel (Bulkamid) injection versus retropubic tension-free vaginal tape (TVT-Exact)
- Report and follow-up
- 2019 · 1 year
| Endpoint | Results | Effect | Finding |
|---|---|---|---|
| 1-year patient satisfaction of at least 80/100 on a visual analogue scale; risk difference (TVT minus hydrogel), percentage points | 64/107 (59.8%) vs 96/101 (95.0%) | difference 35.2; CI 24.4–45.1; P <0.001 | Not met |
Harms: Perioperative complications (cases cited in the abstract): 3 cases vs 19 cases; Reoperations due to complications: 0 vs 6
Design
Women were referred from primary care between September 28, 2015 and March 1, 2017 after an inadequate response to pelvic floor muscle training and were eligible for TVT. Inclusion required age over 18 years, no previous incontinence procedure, a positive cough stress test without urge-type leakage, a post-void residual below 100 mL and a bladder capacity above 300 mL; a pad test was used to confirm SUI.[4] Women with clinically significant prolapse and obese women were not included. Invasive urodynamics were not routine, and women were not separated by urethral hypermobility or intrinsic sphincter deficiency.[2]
Allocation was 1:1 by a computer-assisted random block system run by an assistant outside the study, with sealed, opaque, sequentially numbered envelopes opened by the recruiting physician and a nurse after consent. Participants and investigators were not masked.[4] The 1-year report counted 224 women entered (111 TVT, 113 hydrogel); the later reports count 223 randomized (110 and 113).[1][2] One woman accidentally received two randomization envelopes.[5]
The primary outcome was the proportion of women with a satisfaction score of at least 80 on a visual analogue scale from 0 (extremely unsatisfied) to 100 (extremely satisfied) at the follow-up visits, with a noninferiority limit of 20%. The sample-size calculation assumed satisfaction of 80% with TVT and 75% with hydrogel, 5% significance and 80% power; 192 women (96 per group) were required, 212 were planned allowing for 10% dropout, and 223 were randomized because several physicians recruited at the same time.[2]
Secondary outcomes were subjective cure on a 5-point Likert scale, objective cure (cough stress test at a bladder volume of 250 to 300 mL in the semilithotomy position, and a pad stress test) and complications, graded by Clavien-Dindo. Intervals are two-sided Newcombe intervals, although one-sided intervals were planned in the protocol. The primary analysis is intention to treat on observed outcomes among women attending each visit; complications are counted before any crossover.[2]
Results
At 1 year, 95.0% of women after TVT and 59.8% after hydrogel reported satisfaction of at least 80/100, and hydrogel did not meet the noninferiority criterion. The cough stress test was negative in 95.0% versus 66.4% (difference 28.6 percentage points, 95% CI 18.4 to 38.5).[1]
At 3 years, 188 of 223 women (84.3%) attended (92 TVT, 96 hydrogel). Satisfaction of at least 80/100 was reported by 87/92 (94.6%) after TVT and 65/96 (67.7%) after hydrogel (difference 26.9 percentage points, 95% CI 16.7 to 36.8); median scores were 98.5 and 90.0. The cough stress test was negative in 88/92 (95.7%) versus 75/96 (78.1%) (difference 17.5 percentage points, 95% CI 8.6 to 26.9), and both the cough stress and pad tests were negative in 76 (82.6%) versus 47 (50.0%). Symptoms were rated cured in 55/92 (59.8%) versus 24/96 (25.0%) and cured or improved in 92/92 (100%) versus 85/96 (88.5%). In the per-protocol analysis excluding crossover, both objective tests were negative in 74/89 (83.1%) versus 22/66 (33.3%). Would choose the treatment again: 88/92 (95.7%) versus 78/96 (81.3%).[2]
At 5 years, 195 of the 212 women treated as randomized (92.0%) attended. Satisfaction of at least 80/100 was reported by 89 (92.7%) after TVT and 74 (74.7%) after hydrogel, a difference of 18.0 percentage points (95% CI 7.7 to 28.0); median scores were 98 (interquartile range 86 to 100) and 90 (75 to 99). The point estimate is inside the 20% limit but the interval extends beyond it, and the authors report that hydrogel did not meet the noninferiority criteria.[3]
Quality-of-life outcomes were secondary. The Urogenital Distress Inventory (UDI-6) total score at 1 year was 7.89 (SD 7.65) after TVT and 18.96 (SD 13.20) after hydrogel, from baselines of 31.48 and 34.57 (P < 0.001 between groups); at least 75% improvement in UDI-6 was reached by 62/104 (59.6%) versus 21/108 (19.4%), and in the Incontinence Impact Questionnaire (IIQ-7) by 93/104 (89.4%) versus 52/108 (48.1%).[5] At 3 years the UDI-6 total was 10.74 (SD 9.88) versus 18.75 (SD 13.40) (between-group difference −8.01, 95% CI −11.39 to −4.64) and the IIQ-7 total 4.46 (SD 8.87) versus 16.91 (SD 19.56) (difference −12.44, 95% CI −16.81 to −8.08).[4] Both groups improved from baseline except on difficulty emptying the bladder and pain or discomfort.[4] Sexual function scores improved in both groups at 1 year, and the physical subscale score was higher after TVT at 1 and 3 years.[5][4]
Surgery and treatment delivery
Both procedures were done in an outpatient setting under local anesthesia. TVT used the TVT-Exact retropubic tape (Ethicon) with 70 to 100 mL of 0.25% prilocaine with epinephrine. Hydrogel (Bulkamid, Contura) was injected under endoscopic control after 10 mL of periurethral lidocaine, 1.5 cm from the vesicourethral junction at 10, 2, 5 and 7 o'clock. Women went home after successful micturition with a post-void residual below 200 mL. Nine urogynecologists with a strong background in SUI surgery performed the TVT procedures and two performed the injections.[2]
The protocol offered one additional injection at the 3-month visit for persisting symptoms. Follow-up visits (3 months, 1 year, 3 years) were done by a doctor other than the operator, and women with persisting SUI who were not satisfied could choose the alternative treatment.[2]
By 3 years, 30 women assigned to hydrogel had crossed over to TVT (16 before and 14 after the 1-year visit), and 3 assigned to TVT had received hydrogel. Among the 96 hydrogel attenders, 31 (32.3%) had received one injection only, 35 (36.5%) two injections, 15 (15.6%) TVT after one injection and 15 (15.6%) TVT after two. No woman had a second TVT.[2]
Adverse events
Before crossover, any peri- or postoperative complication within 3 years occurred in 40/92 (43.5%) after TVT and 23/96 (24.0%) after hydrogel (difference 19.5 percentage points, 95% CI 6.8 to 31.4), and two or more complications in 10/92 (10.9%) versus 2/96 (2.1%).[2] At 5 years the corresponding counts were 42 (43.8%) and 22 (22.2%) (difference 21.5 percentage points, 95% CI 8.4 to 33.8).[2][3] At 1 year, 19 TVT and 3 hydrogel cases of perioperative complications were cited, and all 6 complication-related reoperations were associated with TVT.[1]
The 3-year report details the pattern. Perioperative complications occurred in 18/104 (17.3%) after TVT, including bladder perforation in 7/104 (6.7%), hematoma in 6/104 (5.8%) and acute urinary retention in 10/104 (9.6%), versus 2/108 (1.9%) after hydrogel, both acute retention. Vaginal tape extrusion before 3 months occurred in 3/104 (2.9%) and erosion between 3 months and 3 years in 3/92 (3.3%), with reoperation for erosion in all three; none of the women had the sling removed. Complication-related reoperation was needed in 7 women after TVT (hematoma 1, retention 3, erosion 3) and 2 after hydrogel (removal for persisting pain and dysuria about 20 months after injection, and aspiration of fibrotic resistance at the bladder neck). Tape or implantation-site pain was reported by 6/92 (6.5%) versus 1/96 (1.0%), de novo urgency requiring medication by 9/92 (9.8%) versus 12/96 (12.5%), and urinary infection within 3 months by 7/104 (6.7%) versus 9/108 (8.3%). Clavien-Dindo grade III events occurred in 6/92 (6.5%) after TVT and 2/96 (2.1%) after hydrogel; one grade IV event after TVT was ischemic heart symptoms possibly related to local anesthesia.[2]
Among the 30 women who crossed over from hydrogel to TVT, 12 had complications: two reoperations (hematoma and tape loosening), one erosion, one tape-site pain, three with dysuria, two with retention and three with de novo urgency.[2]
Limitations
The primary endpoint is a patient-reported satisfaction score, and the trial was open label; blinding was not practical because both procedures were done under local anesthesia. Crossover was much more frequent from hydrogel (30 by 3 years) than from tape (3), so complications were attributed to the first treatment and counted before crossover, and the per-protocol comparison rests on the 66 women who stayed on hydrogel.[2] The trial was done at one university hospital by experienced urogynecologists, with one tape (TVT-Exact) and one bulking agent (Bulkamid), and the authors note that the results may not carry to other slings or agents. Invasive urodynamics were not routine, and women with significant prolapse or obesity were excluded.[2] The Bulkamid manufacturer, Contura, provided an unrestricted research grant alongside Helsinki University Hospital; the authors state the funders had no influence on design, analysis or reporting.[2] Quality-of-life, sexual-function and most complication comparisons are secondary analyses of a trial powered for satisfaction.[4]
In conversation
SISTEr and TOMUS judged slings by composite or objective success criteria; here the primary endpoint was a satisfaction score, and cough stress and pad test results were secondary.
Guidelines and approvals
- AUA/SUFU (2017, amended 2023). Clinicians should counsel index patients considering surgery for SUI about the efficacy and safety of each option, including bulking agents . The guideline text cites the 1-year and 3-year reports: hydrogel showed lower satisfaction than TVT, and most women treated with hydrogel were cured or improved at 3 years.[6]
- EAU (limited update, March 2026). The guideline text cites the 1-year report for better satisfaction and higher objective cure, such as negative cough stress tests, with TVT than with Bulkamid. It recommends offering urethral bulking agents to women seeking surgical management of SUI after a thorough discussion of risks and benefits relative to other surgical modalities , and to women who request a low-risk procedure, with the understanding that efficacy is lower than with other surgical procedures, repeat injections are likely and long-term durability and safety are not established .[7]
Report history
| Published | Report | Cutoff | Headline results | Citation |
|---|---|---|---|---|
| 2019-09-04 | 1-year primary report · primary | — | 1-year patient satisfaction of at least 80/100 on a visual analogue scale; risk difference (TVT minus hydrogel), percentage points: 64/107 (59.8%) vs 96/101 (95.0%); difference 35.2; CI 24.4–45.1; P <0.001 Not met Negative cough stress test at 1 year; risk difference (TVT minus hydrogel), percentage points: 66.4% vs 95.0%; difference 28.6; CI 18.4–38.5 | Itkonen Freitas AM, Mentula M, Rahkola-Soisalo P, Tulokas S, Mikkola TS. Tension-free vaginal tape surgery versus polyacrylamide hydrogel injection for primary stress urinary incontinence: a randomized clinical trial. *J Urol.* 2020;203(2):372-378. DOI |
| 2020-12-04 | 1-year quality of life and sexual function · pro | — | 1-year mean UDI-6 total score (0-100, higher is worse distress; baseline 34.57 hydrogel, 31.48 TVT): 18.96 ± 13.20 vs 7.89 ± 7.65; P <0.001 Women reaching at least 75% improvement in UDI-6 at 1 year: 21/108 (19.4%) vs 62/104 (59.6%); P <0.001 Women reaching at least 75% improvement in IIQ-7 at 1 year: 52/108 (48.1%) vs 93/104 (89.4%); P <0.001 | Itkonen Freitas AM, Mikkola TS, Rahkola-Soisalo P, Tulokas S, Mentula M. Quality of life and sexual function after TVT surgery versus Bulkamid injection for primary stress urinary incontinence: 1 year results from a randomized clinical trial. *Int Urogynecol J.* 2021;32(3):595-601. DOI |
| 2022-08-09 | 3-year follow-up · updated | — | 3-year satisfaction of at least 80/100; risk difference (TVT minus hydrogel), percentage points: 65/96 (67.7%) vs 87/92 (94.6%); difference 26.9; CI 16.7–36.8 Not met 3-year median satisfaction score, 0-100 (interquartile range): 90.0 (70-100) vs 98.5 (90-100); — Would come again for the treatment; risk difference (TVT minus hydrogel), percentage points: 78/96 (81.3%) vs 88/92 (95.7%); difference 14.4; CI 5.9–23.4 Negative cough stress test at 3 years; risk difference (TVT minus hydrogel), percentage points: 75/96 (78.1%) vs 88/92 (95.7%); difference 17.5; CI 8.6–26.9 Both cough stress test and pad test negative at 3 years (intention to treat); risk difference (TVT minus hydrogel), percentage points: 47 (50.0%) vs 76 (82.6%); difference 33.7; CI 20.3–45.3 Symptoms cured on a 5-point Likert scale at 3 years; risk difference (TVT minus hydrogel), percentage points: 24/96 (25.0%) vs 55/92 (59.8%); difference 34.8; CI 20.8–46.9 Symptoms cured or improved at 3 years; risk difference (TVT minus hydrogel), percentage points: 85/96 (88.5%) vs 92/92 (100%); difference 11.5; CI 5.1–19.4 Both tests negative at 3 years, treatment-received analysis excluding crossover; risk difference (TVT minus hydrogel), percentage points: 22/66 (33.3%) vs 74/89 (83.1%); difference 49.8; CI 34.7–61.8 | Itkonen Freitas AM, Isaksson C, Rahkola-Soisalo P, Tulokas S, Mentula M, Mikkola TS. Tension-free vaginal tape and polyacrylamide hydrogel injection for primary stress urinary incontinence: 3-year followup from a randomized clinical trial. *J Urol.* 2022;208(3):658-667. DOI |
| 2023-09-06 | 3-year quality of life and sexual function · pro | — | 3-year mean UDI-6 total score (0-100, higher is worse distress; baseline 34.57 hydrogel, 31.48 TVT); between-group mean difference (TVT minus hydrogel): 18.75 ± 13.40 vs 10.74 ± 9.88; difference -8.01; CI -11.39–-4.64; P <0.001 3-year mean IIQ-7 total score (0-100, higher is worse impact; baseline 54.50 hydrogel, 50.79 TVT); between-group mean difference (TVT minus hydrogel): 16.91 ± 19.56 vs 4.46 ± 8.87; difference -12.44; CI -16.81–-8.08; P <0.001 | Itkonen Freitas AM, Isaksson C, Rahkola-Soisalo P, Mentula M, Mikkola TS. Quality of life and sexual function after tension-free vaginal tape and polyacrylamide hydrogel injection for primary stress urinary incontinence: 3-year follow-up from a randomized clinical trial. *Int Urogynecol J.* 2023;34(12):2977-2984. DOI |
| 2025-04-22 | 5-year follow-up · updated | — | 5-year satisfaction of at least 80/100; risk difference (TVT minus hydrogel), percentage points: 74 (74.7%) vs 89 (92.7%); difference 18; CI 7.7–28 Not met 5-year median satisfaction score, 0-100 (interquartile range): 90 (75-99) vs 98 (86-100); — | Itkonen Freitas AM, Isaksson C, Rahkola-Soisalo P, Mentula M, Mikkola TS. Tension-free vaginal tape versus polyacrylamide hydrogel injection for stress urinary incontinence: 5-year follow-up. *NEJM Evid.* 2025;4(5):EVIDoa2400216. DOI |
References
1. Itkonen Freitas AM, Mentula M, Rahkola-Soisalo P, et al. "Tension-Free Vaginal Tape Surgery versus Polyacrylamide Hydrogel Injection for Primary Stress Urinary Incontinence: A Randomized Clinical Trial." J Urol. 2020;203(2):372-378. doi:10.1097/JU.0000000000000517
2. Itkonen Freitas AM, Isaksson C, Rahkola-Soisalo P, et al. "Tension-Free Vaginal Tape and Polyacrylamide Hydrogel Injection for Primary Stress Urinary Incontinence: 3-Year Followup from a Randomized Clinical Trial." J Urol. 2022;208(3):658-667. doi:10.1097/JU.0000000000002720
3. Itkonen Freitas AM, Isaksson C, Rahkola-Soisalo P, Mentula M, Mikkola TS. "Tension-Free Vaginal Tape versus Polyacrylamide Hydrogel Injection for Stress Urinary Incontinence — 5-Year Follow-Up." NEJM Evid. 2025;4(5):EVIDoa2400216. doi:10.1056/EVIDoa2400216
4. Itkonen Freitas AM, Isaksson C, Rahkola-Soisalo P, Mentula M, Mikkola TS. "Quality of life and sexual function after tension-free vaginal tape and polyacrylamide hydrogel injection for primary stress urinary incontinence: 3-year follow-up from a randomized clinical trial." Int Urogynecol J. 2023;34(12):2977-2984. doi:10.1007/s00192-023-05626-x
5. Itkonen Freitas AM, Mikkola TS, Rahkola-Soisalo P, Tulokas S, Mentula M. "Quality of life and sexual function after TVT surgery versus Bulkamid injection for primary stress urinary incontinence: 1 year results from a randomized clinical trial." Int Urogynecol J. 2021;32(3):595-601. doi:10.1007/s00192-020-04618-5
6. American Urological Association and Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction. Surgical Treatment of Female Stress Urinary Incontinence: AUA/SUFU Guideline. 2017; amended 2023. Statement 12 and the bulking agents discussion.
7. European Association of Urology. EAU Guidelines on Management of Non-neurogenic Female Lower Urinary Tract Symptoms (LUTS). Limited update, March 2026. Section 4.2.4.c.2.c.