The Follow-up After Shorter Tapes Study. Effectiveness and Safety of Shorter Trans-obturator Tapes.

NCT06731985 | Recruiting DMC

• 1 other identifier: FAST 2 and 3
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

Brief Summary

Urinary incontinence after pregnancy and labor affects 1 in 3 women and has a negative impact on quality of life (QOL), limiting women's physical activity and impairing sexual function. The traditional surgical method treating female urinary incontinence is to implant a sub-urethral synthetic sling, the currently preferred method in Norway. The majority of women treated with synthetic slings obtain great improvement in QOL, but a few experience severe complications including chronic pelvic pain. Several countries, therefore, have reverted to older, less effective surgical methods to avoid synthetic material. Awareness of severe complications has, in some Norwegian hospitals, led to a shift in technique towards shorter slings. With shorter slings, the goal is to achieve the same grade of continence as traditional slings, but with fewer serious complications. The long-term results and complications of these shorter slings are mostly unknown. Akershus University Hospital (AHUS) shifted to shorter slings early, in 2009, using a single incision mini-sling (SIMS) Ajust. Due to costs, AHUS changed to the intermediate sling TVT-O Abbrevo in 2016. Through this study, we hope to establish if shorter slings have the same long-term results as traditional slings, and to investigate if shorter slings are safer than traditional slings, with less long-term complications, such as chronic pelvic pain. We plan to perform a long-term follow-up of women having had surgery with shorter slings at AHUS. All patients operated with either SIMS Ajust or TVT-O Abbrevo at AHUS between 2009 and 2020 will be invited to a long-term follow-up. The study participants will be asked to fill in validated questionnaires regarding symptoms of urine leakage, QOL, any chronic pain related to the surgery, debut of pain, level of pain and any treatments for the pain. All women treated with the current used sling Abbrevo is invited to a physical examination including testing of their voiding function and a gynecologic examination to check for complications. 2D- and 3D ultrasound scans will be done on the TVT-O Abbrevo group to evaluate the position-, attachment- and any misplacement of the sling. Women experiencing insufficient long-term results, such as chronic pain, will be offered a full examination and treatment.

Conditions

Stress Urinary Incontinence; Postsurgical Pain; Follow-Up Studies

Keywords

Long-term Follow-Up of shorter incontinence tapes

Outcome Measures

Primary Outcomes (2)

• NFIR questionnaire subjective cure rate

  Rate of subjective cure defined as a stress urinary incontinence index score \<3 estimated by calculating a stress urinary incontinence index score from 4 clusters of questions in the NFIR questionnaire measuring degree of symptom bother from 0 to 12.

  From 2009 to 2020 and evaluation in 2024

• Objective cure rate on validated NFIR stress test

  Objective cure defined as 0g leakage at a cough-jump pad weighing stress test.

  From 2009 to 2020 and evaluation in 2024.

Secondary Outcomes (4)

• NFIR questionnaire quality of life score

  From 2009 to 2020 and evaluation in 2024

• Long-term complications

  From 2009 to 2020 and evaluation in 2024.

• NFIR treatment satisfaction rate

  From 2009 to 2020 and evaluation in 2024.

• NFIR total complication rate

  From 2009 to 2020 and evaluation in 2024.

Study Arms (1)

Women operated with shorter incontinence tapes

Women operated at AHUS between 2009 and 2020 for stress urinary incontinence with shorter incontinence tapes.

Eligibility Criteria

• Age: 25 Years - 90 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female incontinence patients operated at AHUS between 2009 and 2021, aged between 25 and 90.

You may qualify if:

• All women operated for stress-urinary incontinence with TVT-O Abbrevo of Ajust incontinence sling between 2009 and 2020.

You may not qualify if:

• Women operated with other incontinence operations or slings.

Sponsors & Collaborators

• University Hospital, Akershus: lead

Study Sites (1)

Akershus University Hospital

Lorenskog, 1478, Norway

RECRUITING

Related Publications (19)

• Ford AA, Rogerson L, Cody JD, Aluko P, Ogah JA. Mid-urethral sling operations for stress urinary incontinence in women. Cochrane Database Syst Rev. 2017 Jul 31;7(7):CD006375. doi: 10.1002/14651858.CD006375.pub4.

  PMID: 28756647 BACKGROUND

• Ebbesen MH, Hunskaar S, Rortveit G, Hannestad YS. Prevalence, incidence and remission of urinary incontinence in women: longitudinal data from the Norwegian HUNT study (EPINCONT). BMC Urol. 2013 May 30;13:27. doi: 10.1186/1471-2490-13-27.

  PMID: 23721491 BACKGROUND

• Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 1996;7(2):81-5; discussion 85-6. doi: 10.1007/BF01902378.

  PMID: 8798092 BACKGROUND

• Delorme E, Droupy S, de Tayrac R, Delmas V. Transobturator tape (Uratape): a new minimally-invasive procedure to treat female urinary incontinence. Eur Urol. 2004 Feb;45(2):203-7. doi: 10.1016/j.eururo.2003.12.001.

  PMID: 14734007 BACKGROUND

• Svenningsen R, Staff AC, Schiotz HA, Western K, Kulseng-Hanssen S. Long-term follow-up of the retropubic tension-free vaginal tape procedure. Int Urogynecol J. 2013 Aug;24(8):1271-8. doi: 10.1007/s00192-013-2058-2. Epub 2013 Feb 16.

  PMID: 23417313 BACKGROUND

• Warro A, Ojala J, Ala-Nissila S, Laurikainen E. Nine years follow-up after TVT-O; the mesh still available for women suffering from urinary incontinence. J Gynecol Obstet Hum Reprod. 2023 Mar;52(3):102534. doi: 10.1016/j.jogoh.2023.102534. Epub 2023 Jan 13.

  PMID: 36642377 BACKGROUND

• Schraffordt Koops SE, Bisseling TM, Heintz AP, Vervest HA. Quality of life before and after TVT, a prospective multicentre cohort study, results from the Netherlands TVT database. BJOG. 2006 Jan;113(1):26-9. doi: 10.1111/j.1471-0528.2005.00809.x.

  PMID: 16398767 BACKGROUND

• Betschart C, Scheiner D, Hess E, Seifert B, Fink D, Perucchini D. Patient satisfaction after retropubic and transobturator slings: first assessment using the Incontinence Outcome Questionnaire (IOQ). Int Urogynecol J. 2011 Jul;22(7):805-12. doi: 10.1007/s00192-011-1366-7. Epub 2011 Feb 12.

  PMID: 21318441 BACKGROUND

• Pace N, Artsen A, Baranski L, Palcsey S, Durst R, Meyn L, Moalli PA. Symptomatic improvement after mesh removal: a prospective longitudinal study of women with urogynaecological mesh complications. BJOG. 2021 Nov;128(12):2034-2043. doi: 10.1111/1471-0528.16778. Epub 2021 Jun 27.

  PMID: 34047446 BACKGROUND

• Waltregny D, de Leval J. New surgical technique for treatment of stress urinary incontinence TVT-ABBREVO from development to clinical experience. Surg Technol Int. 2012 Dec;22:149-57.

  PMID: 23109075 BACKGROUND

• Rudnicki M, von Bothmer-Ostling K, Holstad A, Magnusson C, Majida M, Merkel C, Prien J, Jakobsson U, Teleman P. Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence. A randomized controlled trial. Acta Obstet Gynecol Scand. 2017 Nov;96(11):1347-1356. doi: 10.1111/aogs.13205. Epub 2017 Sep 15.

  PMID: 28815547 BACKGROUND

• Alexandridis V, Rudnicki M, Jakobsson U, Teleman P. Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence: a 3-year follow-up of a randomized controlled trial. Int Urogynecol J. 2019 Sep;30(9):1465-1473. doi: 10.1007/s00192-019-04004-w. Epub 2019 Jun 20.

  PMID: 31222572 BACKGROUND

• Abdel-Fattah M, Cooper D, Davidson T, Kilonzo M, Boyers D, Bhal K, McDonald A, Wardle J, N'Dow J, MacLennan G, Norrie J. Single-incision mini-slings versus standard synthetic mid-urethral slings for surgical treatment of stress urinary incontinence in women: The SIMS RCT. Health Technol Assess. 2022 Dec;26(47):1-190. doi: 10.3310/BTSA6148.

  PMID: 36520097 BACKGROUND

• Canel V, Thubert T, Wigniolle I, Fernandez H, Deffieux X. Postoperative groin pain and success rates following transobturator midurethral sling placement: TVT ABBREVO(R) system versus TVT obturator system. Int Urogynecol J. 2015 Oct;26(10):1509-16. doi: 10.1007/s00192-015-2723-8. Epub 2015 May 12.

  PMID: 25963058 BACKGROUND

• Dyrkorn OA, Staff AC, Kulseng-Hanssen S, Dimoski T, Svenningsen R. The completeness and accuracy of the Norwegian Female Incontinence Registry. Acta Obstet Gynecol Scand. 2020 Dec;99(12):1618-1625. doi: 10.1111/aogs.13951. Epub 2020 Jul 20.

  PMID: 32640493 BACKGROUND

• Shek KL, Dietz HP. Ultrasound imaging of slings and meshes in urogynecology. Ultrasound Obstet Gynecol. 2021 Apr;57(4):526-538. doi: 10.1002/uog.23545.

  PMID: 33206433 BACKGROUND

• Dietz HP. Pelvic floor ultrasound: a review. Am J Obstet Gynecol. 2010 Apr;202(4):321-34. doi: 10.1016/j.ajog.2009.08.018.

  PMID: 20350640 BACKGROUND

• Berild GH, Kulseng-Hanssen S. Reproducibility of a cough and jump stress test for the evaluation of urinary incontinence. Int Urogynecol J. 2012 Oct;23(10):1449-53. doi: 10.1007/s00192-012-1733-z. Epub 2012 Apr 19.

  PMID: 22527539 BACKGROUND

• Hegde A, Nogueiras M, Aguilar VC, Davila GW. Dynamic assessment of sling function on transperineal ultrasound: does it correlate with outcomes 1 year following surgery? Int Urogynecol J. 2017 Jun;28(6):857-864. doi: 10.1007/s00192-016-3234-y. Epub 2016 Dec 26.

  PMID: 28025681 BACKGROUND

Related Links

• FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence

MeSH Terms

Conditions

Urinary Incontinence, Stress; Pain, Postoperative

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations

Study Officials

• Anna Marie Ellstrom Engh Professor, PhD

  Akershus university hospital HC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kjersti Rimstad Rimstad, Cand.Med.

CONTACT

+4748159564; kjerstri@uio.no

Anna Marie Ellstrom Engh Professor, PhD

CONTACT

+4767960000; a.m.e.engh@medisin.uio.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Medicine

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 13, 2024
• Study Start: October 24, 2024
• Primary Completion (Estimated): May 18, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)