Evidence map›Paper›PMID 35942796›Full record

Trial reportThe Journal of urology2022

Tension-Free Vaginal Tape and Polyacrylamide Hydrogel Injection for Primary Stress Urinary Incontinence: 3-Year Followup from a Randomized Clinical Trial.

Anna-Maija Itkonen Freitas, Camilla Isaksson, Päivi Rahkola-Soisalo, Sari Tulokas, Maarit Mentula, Tomi S Mikkola

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of urology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
4.6field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 28 citations in OpenAlex.

  1. Trial
  2. Review
  3. CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2026
    Review
  4. Article
  5. Article
  6. Diagnosis and management of urinary incontinence in females.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2026
    Review
  7. Article
  8. Review
  9. Article
  10. Article
  11. 2024 Canadian Urological Association guideline: Female stress urinary incontinence.Canadian Urological Association journal = Journal de l'Association des urologues du Canada · 2024
    Article
  12. Review
  13. Article
  14. Article
  15. Urinary Incontinence and Pelvic Organ Prolapse in Women.Deutsches Arzteblatt international · 2023
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 2 countries.

Anna-Maija Itkonen FreitasHelsinki University, Department of Obstetrics and Gynaecology, Helsinki University Hospital, Helsinki, Finland.
Camilla IsakssonHelsinki University, Department of Obstetrics and Gynaecology, Helsinki University Hospital, Helsinki, Finland.
Päivi Rahkola-SoisaloHelsinki University, Department of Obstetrics and Gynaecology, Helsinki University Hospital, Helsinki, Finland.
Sari TulokasHelsinki University, Department of Obstetrics and Gynaecology, Helsinki University Hospital, Helsinki, Finland.
Maarit MentulaHelsinki University, Department of Obstetrics and Gynaecology, Helsinki University Hospital, Helsinki, Finland.
Tomi S MikkolaHelsinki University, Department of Obstetrics and Gynaecology, Helsinki University Hospital, Helsinki, Finland.ORCID 0000-0003-2049-088X
Helsinki University Hospital · FIGTx (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe sought to determine whether polyacrylamide hydrogel (PAHG) is noninferior to tension-free vaginal tape (TVT) in the treatment of women with primary stress urinary incontinence (SUI). MATERIALS AND

methodsIn this noninferiority trial, 223 women eligible for operative SUI treatment were randomized for TVT (110) or PAHG (113). Primary outcome was patient satisfaction and the noninferiority margin for the difference was 20%. Secondary outcomes were effectiveness and complications.

resultsAt 3 years, 188 (84.3%) women attended the followup. The satisfaction score (visual analogue scale 0-100) median was 98.5 (IQR 90-100) in the TVT group and 90.0 (IQR 70-100) in the PAHG group, whereas a score ≥80 was reached in 87 (94.6%) and 65 (67.7%), respectively (difference 26.9%, 95% CI 16.7% to 36.8%). Thus, PAHG did not meet the noninferiority criteria set in our study. The cough stress test was negative in 88 (95.7%) of TVT patients vs 75 (78.1%) of PAHG patients (difference 17.5%, 95% CI 8.6% to 26.9%). Any peri- or postoperative complication before crossover between the groups was detected in 40 (43.5%) women in the TVT group and 23 (24.0%) women in the PAHG group (difference 19.5%, 95% CI 6.8% to 31.4%).

conclusionsIn midterm followup, PAHG did not reach in patient satisfaction the noninferiority set in our study. Furthermore, mid urethral TVT slings show better subjective and objective cure rates than PAHG. However, complications were more often associated with TVT. Since the majority of PAHG treated women were also cured or improved, primary SUI women can be offered PAHG as a safe and durable alternative treatment.

Indexed as

Suburethral SlingsUrinary Incontinence, StressAcrylic ResinsFemaleFollow-Up StudiesHumansTreatment OutcomeAcrylic Resinspolyacrylamide gelspolyacrylamide gelssuburethral slingssurgical mesh

Identifiers

PMID35942796
PMCPMC12721665
OpenAlexW4291019520

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.