Mechanism of Incontinence Before and After Genital Prolapse Surgery

NCT02050568 | Unknown

• 1 other identifier: H-4-2013-069
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Since year 2003, Glostrup/Herlev Hospital has devised a novel technique, urethral pressure reflectometry (UPR), for measurements of pressure and cross-sectional area in the female urethra. UPR has been able to separate continent women from women with stress urinary incontinence (SUI, defined by involuntary leakage during increased abdominal pressure). The method stands alone in its field. 9.5 % of all women undergo genital prolapse surgery during their lives (genital prolapse is characterized by a portion of the vaginal canal protruding from the opening of the vagina). However, 10-30 % of these women develop SUI after surgery, while approximately 40 % with preoperative SUI actually experience an improvement in their condition. Efforts have been made to predict the likelihood of a patient having SUI after genital prolapse surgery; however the tests have shown disappointing positive and negative predictive values. A mid-urethral sling is gold standard for treatment of SUI and to avoid SUI after genital prolapse surgery, some clinics choose to treat all their patients with a sling, simultaneously. However, not all patients with SUI require surgery and the sling is associated with some risks, such as bleeding and bladder injury. There is no international consensus on the use of mid-urethral slings in women undergoing genital prolapse surgery. Thus, there is great need for knowledge and know-how regarding the mechanism of continence in women with genital prolapse, before and after surgery. The hypothesis is that UPR may be used to uncover the changes in the female urethra before and after genital prolapse surgery, revealing significant differences in the parameters in women who develop SUI after surgery. UPR may become an important tool in the preoperative assessment, helping clinicians give better information and guidance to their patients.

Conditions

Genital Prolapse

Keywords

Genital prolapse; Genital prolapse surgery; Stress urinary incontinence; Urethral Pressure Reflectometry

Outcome Measures

Primary Outcomes (1)

• Changes in UPR parameters before and after surgery.

  The purpose is to see if and how the patients' parameters change after surgery.

  Before surgery and minimum 6 weeks postoperatively.

Study Arms (2)

Anterior genital prolapse

Women with anterior genital prolapse ≥ grade 2, who are awaiting genital prolapse surgery.

Posterior genital prolapse

Women with posterior genital prolapse ≥ grade 2, who are awaiting genital prolapse surgery.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The suitable women are invited to volunteer at the outpatient clinic, at the Department of Gynaecology, at Herlev hospital.

You may qualify if:

• \- Women with anterior genital prolapse ≥ grade 2 (according to the pelvic-organ-prolapse quantification system (POP-Q) (19)), who are awaiting genital prolapse surgery
• \- women with posterior genital prolapse ≥ grade 2 who are awaiting genital prolapse surgery,

You may not qualify if:

• Simultaneous prolapse ≥ grade 2 in the anterior or posterior part of the vagina
• Former genital prolapse surgery
• Former surgical removal of the uterus
• Former surgical treatment of urinary incontinence
• Neurological disorder
• Bladder overactivity
• Pregnancy
• Women under the age of 18

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

Department of Gynaecology and Obstetrics, Herlev Hospital

Herlev, 2730, Denmark

RECRUITING

Related Publications (20)

• Saaby ML, Klarskov N, Lose G. Urethral pressure reflectometry during intra-abdominal pressure increase-an improved technique to characterize the urethral closure function in continent and stress urinary incontinent women. Neurourol Urodyn. 2013 Nov;32(8):1103-8. doi: 10.1002/nau.22368. Epub 2013 Mar 26.

  PMID: 23532678 BACKGROUND

• Klarskov N. Urethral pressure reflectometry. A method for simultaneous measurements of pressure and cross-sectional area in the female urethra. Dan Med J. 2012 Mar;59(3):B4412.

  PMID: 22381095 BACKGROUND

• Aagaard M, Klarskov N, Sonksen J, Bagi P, Colstrup H, Lose G. Urethral pressure reflectometry; a novel technique for simultaneous recording of pressure and cross-sectional area: a study of feasibility in the prostatic urethra. BJU Int. 2012 Oct;110(8):1178-83. doi: 10.1111/j.1464-410X.2012.10997.x. Epub 2012 Mar 15.

  PMID: 22416900 BACKGROUND

• Hornung BR, Mitchell PJ, Carlson GL, Klarskov N, Lose G, Kiff ES. Comparative study of anal acoustic reflectometry and anal manometry in the assessment of faecal incontinence. Br J Surg. 2012 Dec;99(12):1718-24. doi: 10.1002/bjs.8943.

  PMID: 23132420 BACKGROUND

• Mitchell PJ, Klarskov N, Telford KJ, Hosker GL, Lose G, Kiff ES. Anal acoustic reflectometry: a new reproducible technique providing physiological assessment of anal sphincter function. Dis Colon Rectum. 2011 Sep;54(9):1122-8. doi: 10.1097/DCR.0b013e318223fbcb.

  PMID: 21825892 BACKGROUND

• Abdel-Fattah M, Familusi A, Fielding S, Ford J, Bhattacharya S. Primary and repeat surgical treatment for female pelvic organ prolapse and incontinence in parous women in the UK: a register linkage study. BMJ Open. 2011 Nov 14;1(2):e000206. doi: 10.1136/bmjopen-2011-000206. Print 2011.

  PMID: 22102637 BACKGROUND

• Ek M, Tegerstedt G, Falconer C, Kjaeldgaard A, Rezapour M, Rudnicki M, Altman D. Urodynamic assessment of anterior vaginal wall surgery: a randomized comparison between colporraphy and transvaginal mesh. Neurourol Urodyn. 2010 Apr;29(4):527-31. doi: 10.1002/nau.20811.

  PMID: 19731311 BACKGROUND

• Marinkovic SP, Stanton SL. Incontinence and voiding difficulties associated with prolapse. J Urol. 2004 Mar;171(3):1021-8. doi: 10.1097/01.ju.0000111782.37383.e2.

  PMID: 14767263 BACKGROUND

• Mouritsen L, Larsen JP. Symptoms, bother and POPQ in women referred with pelvic organ prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2003 Jun;14(2):122-7. doi: 10.1007/s00192-002-1024-1. Epub 2003 Apr 26.

  PMID: 12851756 BACKGROUND

• Visco AG, Brubaker L, Nygaard I, Richter HE, Cundiff G, Fine P, Zyczynski H, Brown MB, Weber AM; Pelvic Floor Disorders Network. The role of preoperative urodynamic testing in stress-continent women undergoing sacrocolpopexy: the Colpopexy and Urinary Reduction Efforts (CARE) randomized surgical trial. Int Urogynecol J Pelvic Floor Dysfunct. 2008 May;19(5):607-14. doi: 10.1007/s00192-007-0498-2. Epub 2008 Jan 9.

  PMID: 18185903 BACKGROUND

• Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798.

  PMID: 19941278 BACKGROUND

• Pradhan A, Jain P, Latthe PM. Effectiveness of midurethral slings in recurrent stress urinary incontinence: a systematic review and meta-analysis. Int Urogynecol J. 2012 Jul;23(7):831-41. doi: 10.1007/s00192-012-1803-2. Epub 2012 May 11.

  PMID: 22576328 BACKGROUND

• Dwyer PL. Women with occult stress incontinence should not routinely have a mid-urethral sling with prolapse surgery. Int Urogynecol J. 2012 Jul;23(7):827-9. doi: 10.1007/s00192-012-1690-6. Epub 2012 Mar 14.

  PMID: 22415701 BACKGROUND

• Lensen EJ, Withagen MI, Kluivers KB, Milani AL, Vierhout ME. Urinary incontinence after surgery for pelvic organ prolapse. Neurourol Urodyn. 2013 Jun;32(5):455-9. doi: 10.1002/nau.22327. Epub 2012 Sep 28.

  PMID: 23024012 BACKGROUND

• Schraffordt Koops SE, Bisseling TM, Heintz AP, Vervest HA. Prospective analysis of complications of tension-free vaginal tape from The Netherlands Tension-free Vaginal Tape study. Am J Obstet Gynecol. 2005 Jul;193(1):45-52. doi: 10.1016/j.ajog.2004.11.004.

  PMID: 16021057 BACKGROUND

• Leruth J, Fillet M, Waltregny D. Incidence and risk factors of postoperative stress urinary incontinence following laparoscopic sacrocolpopexy in patients with negative preoperative prolapse reduction stress testing. Int Urogynecol J. 2013 Mar;24(3):485-91. doi: 10.1007/s00192-012-1888-7. Epub 2012 Jul 24.

  PMID: 22825418 BACKGROUND

• Ridgeway B, Barber MD. Midurethral slings for stress urinary incontinence: a urogynecology perspective. Urol Clin North Am. 2012 Aug;39(3):289-97. doi: 10.1016/j.ucl.2012.06.002.

  PMID: 22877711 BACKGROUND

• Ennemoser S, Schonfeld M, von Bodungen V, Dian D, Friese K, Jundt K. Clinical relevance of occult stress urinary incontinence (OSUI) following vaginal prolapse surgery: long-term follow-up. Int Urogynecol J. 2012 Jul;23(7):851-5. doi: 10.1007/s00192-012-1765-4. Epub 2012 May 12.

  PMID: 22581237 BACKGROUND

• Bump RC, Mattiasson A, Bo K, Brubaker LP, DeLancey JO, Klarskov P, Shull BL, Smith AR. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol. 1996 Jul;175(1):10-7. doi: 10.1016/s0002-9378(96)70243-0.

  PMID: 8694033 BACKGROUND

• Klarskov N, Lose G. Urethral pressure reflectometry vs urethral pressure profilometry in women: a comparative study of reproducibility and accuracy. BJU Int. 2007 Aug;100(2):351-6. doi: 10.1111/j.1464-410X.2007.06922.x. Epub 2007 May 14.

  PMID: 17501964 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress

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

Study Officials

• Niels Klarskov, MD Lecturer

  University of Copenhagen, Department of Gynaecology and Obstetrics, Herlev Hospital, Denmark

  STUDY DIRECTOR

• Yasmine SS Khayyami, MD

  University of Copenhagen, Department of Gynaecology and Obstetrics, Herlev hospital, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Niels Klarskov, MD Lecturer

CONTACT

0045 38 68 14 06; niels.klarskov@regionh.dk

Yasmine SS Khayyami, MD

CONTACT

0045 26 96 72 26; yasmine.khayyami@regionh.dk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Ph.D. student

Study Record Dates

• First Submitted: January 29, 2014
• First Posted: January 30, 2014
• Study Start: October 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2016
• Last Updated: March 18, 2015

Record last verified: 2015-03

Locations

DK (1)