Evidence map›Paper›PMID 40140061›Full record

ArticleWorld journal of urology2025

Application of human breast acellular dermal matrix (hbADM) in sling surgery for female stress urinary incontinence: a phase 1 clinical trial.

Amir Kian Moaveni, Mahtab Zargham, Simin Vahidi, Masoumeh Majidi Zolbin, Maryam Amiri, Mozaffar Mahmoodi, Mohammad Nazir Menbari, Masoumeh Ekhtiari, Ashkan Azimzadeh, Reyhane Ebrahimi and 2 more

Abstract readClinical Trial, Phase IMulticenter Study
PubMed Publisher
In one paragraph

Article in World journal of urology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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

2 citing papers in PubMed.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Amir Kian MoaveniPediatric Urology and Regenerative Medicine Research Center, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran.
Mahtab ZarghamDepartment of Female Urology of Alzahra Hospital, Isfahan Kidney Transplantation Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.
Simin VahidiPediatric Urology and Regenerative Medicine Research Center, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran.
Masoumeh Majidi ZolbinPediatric Urology and Regenerative Medicine Research Center, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran.
Maryam AmiriPediatric Urology and Regenerative Medicine Research Center, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran.
Mozaffar MahmoodiDepartment of Molecular Medicine, School of Medicine, Kurdistan University of Medical Sciences, Sanandaj, Iran.
Mohammad Nazir MenbariDepartment of Molecular Medicine, School of Medicine, Kurdistan University of Medical Sciences, Sanandaj, Iran.
Masoumeh EkhtiariPediatric Urology and Regenerative Medicine Research Center, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran.
Ashkan AzimzadehPediatric Urology and Regenerative Medicine Research Center, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran.
Reyhane EbrahimiPediatric Urology and Regenerative Medicine Research Center, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran.
Nazanin RajipourPediatric Urology and Regenerative Medicine Research Center, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran.
Abdol-Mohammad KajbafzadehPediatric Urology and Regenerative Medicine Research Center, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran. kajbafzd@sina.tums.ac.ir.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate the safety and feasibility of human breast acellular dermal matrix (hbADM) as an alternative to synthetic mesh and autologous fascia in sling surgery for female stress urinary incontinence (SUI), and to assess its preliminary efficacy in a phase 1 clinical trial.

methodsTwenty-five women with pure SUI underwent hbADM sling surgery at two centers. The primary outcomes were safety (adverse events) and feasibility. Secondary outcomes included changes in International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) scores, Patient Global Impression of Improvement (PGI-I), cough stress test results, and uroflowmetry parameters. Patients were followed up for 3 years. Statistical analysis included descriptive statistics, paired t-tests, and Wilcoxon signed-rank tests.

resultsThe hbADM sling procedure was performed as planned in all patients. Adverse events occurred in 10 patients (40%). Intraoperative and early postoperative events (9/25, 36%) were mild and consistent with standard sling procedures. Late complications, observed in 2 patients (8%), were limited to recurrent urinary tract infections (UTIs); one of these patients had also presented a UTI in the early phase. No cases of sling erosion or chronic pain were observed. Objective cure rates (negative cough stress test) remained high at 100% at 1 year and 95% at 3 years. However, patient-reported success (PGI-I ≤ 2) declined from 92% at 1 month to 65% at 3 years. The mean ICIQ-SF score improved significantly from 15.3 ± 3.4 at baseline to 5.8 ± 2.4 at 3 years post-surgery (p < 0.001). Uroflowmetry parameters remained stable throughout the follow-up. The recurrence rate was 10% at 3 years.

conclusionThis phase 1 trial demonstrates the safety and feasibility of hbADM slings for female SUI treatment, with promising efficacy outcomes up to 3 years post-surgery. These results support further investigation of hbADM sling in larger, randomized controlled trials. CLINICAL

trial registrationThis study was registered in the Iranian Registry of Clinical Trials (IRCT). REGISTRATION NUMBER: IRCT201611278554N3 Registration Date: 2017-05-28.

Indexed as

Acellular DermisSuburethral SlingsUrinary Incontinence, StressAdultAgedBreastFeasibility StudiesFemaleHumansMiddle AgedPostoperative ComplicationsTreatment OutcomeUrologic Surgical ProceduresAcellular dermisClinical trialPhase ISlingStress urinary incontinenceTissue engineering

Identifiers

PMID40140061

What OpenQuestion holds

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Registered trials

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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.