Advanced Genital Prolapse Surgery With and Without Mid Urethral Sling to Prevent Stress Urinary Incontinence

NCT02578056 | Unknown

• 1 other identifier: IUOc
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 1

Brief Summary

Pelvic organ prolapse (POP) is a public health problem worldwide, affecting about 30 %. It implies physical, psychological and social losses. A frequent complication after surgeries for POP is developing de novo stress urinary incontinence (SUI). SUI and POP have similar pathophysiology and therefore it is common to coexist in the same patient. De novo SUI has a prevalence 11-44 % after surgical correction of genital prolapse. Occult urinary incontinence (OUI) is considered the major risk factor for postoperative SUI. Studies on this topic show conflicting results. In a recent meta-analysis on this subject, Maher et al concluded that the value of performing any anti- incontinence procedure in continent women undergoing prolapse surgery remains unknown. The aims of this study are to evaluate whether the association of a transvaginal tape (TVT®) in continent patients undergoing surgery for prolapse decreases the risk of de novo SUI and if it implies an improvement in their quality of life. The secondary endpoints are to assess the complications associated with this procedure, as irritative symptoms and voiding dysfunction postoperatively and assessing the ability of stress testing with reduced POP and urodynamics in predicting the risk of de novo SUI. This study will be a prospective, multicentric, randomized experimental study. Patients with anterior or apical prolapse stages 3 and 4 (POP - Q) will be invited to participate in the study. The study will assess these patients for staging of prolapse, the presence of occult urinary incontinence and quality of life. Selected patients will be randomized to perform correction of genital prolapse and prophylactic anti-incontinence procedure or correction of genital prolapse only. Patients will be assessed 3, 6 and 12 months after surgery. Postoperative evaluation will be similar to preoperative. The exclusion criteria are: complaint or diagnosis of stress urinary incontinence before reduction of the prolapse, previous surgery for incontinence or pelvic organ prolapse, hypocontractility detrusor in urodynamics and inability to understand and give informed consent.

Conditions

Pelvic Organ Prolapse; Urinary Stress Incontinence

Keywords

pelvic organ prolapse; urinary incontinence

Outcome Measures

Primary Outcomes (1)

• Incidence of de novo stress urinary incontinence

  Number of participants presenting with de novo stress urinary incontinence as assessed by simple clinical examination (3 and 12 months) or with an standadized effort test (6m) and by the Incontinence Quality of Life Questionnaire (not answering NO to the question number 2).

  3, 6 and 12 months postoperatively

Secondary Outcomes (8)

• Complications related to the surgical procedure (s)

  7 days postoperatively

• Incidence of overactive bladder and urinary obstruction symptoms

  3, 6 and 12 months postoperatively

• Positive predictive value of urodynamics and Standadized Effort Test to detect patients who will became incontinence after surgery.

  3, 6 and 12 months postoperatively

• Negative predictive value of urodynamics and Standadized Effort Test to detect patients who will remain continents after surgery.

  3, 6 and 12 months

• Impact of urinary incontinence on patient´s quality of life

  3, 6 and 12 months

Study Arms (2)

Mid-urethral sling

EXPERIMENTAL

Patients randomized to anti-incontinence surgery will undergo TVT sling placement as the standard technique at the same time of genital prolapse surgery.

Device: Midurethral sling; Procedure: Genital prolapse surgery

POP

SHAM COMPARATOR

Patients randomized to the sham group will be submitted to genital prolapse surgery and sham incisions as if they had undergone the TVT procedure (two small incisions of 0.5 cm in the suprapubic region in a similar way to that used for the insertion of the sling). These incisions intended to keep the raters blind to the achievement or otherwise of the sling during the postoperative evaluation.

Procedure: Genital prolapse surgery

Interventions

Midurethral sling DEVICE

Anti-urinary incontinence procedure, in a prophylactic way.

Also known as: TVT Exact

Mid-urethral sling

Genital prolapse surgery PROCEDURE

Surgical correction of genital prolapse

Mid-urethral sling; POP

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• genital prolapse POP-Q stages 3 or 4
• surgical treatment planning.

You may not qualify if:

• signals or symphtoms of stress urinary incontinence before prolapse reduction
• previous surgery for stress urinary incontinence
• previous surgery for genital prolapse
• inability to understand and give informed consent

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

University of sao Paulo General Hospital

São Paulo, São Paulo, 05403-010, Brazil

Location

Related Publications (10)

• Swift SE. The distribution of pelvic organ support in a population of female subjects seen for routine gynecologic health care. Am J Obstet Gynecol. 2000 Aug;183(2):277-85. doi: 10.1067/mob.2000.107583.

  PMID: 10942459 BACKGROUND

• Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6. doi: 10.1016/S0029-7844(97)00058-6.

  PMID: 9083302 BACKGROUND

• Malak M. The role of anti-incontinence surgery in management of occult urinary stress incontinence. Int Urogynecol J. 2012 Jul;23(7):823-5. doi: 10.1007/s00192-011-1563-4. Epub 2011 Sep 17.

  PMID: 21927940 BACKGROUND

• Brubaker L, Nygaard I, Richter HE, Visco A, Weber AM, Cundiff GW, Fine P, Ghetti C, Brown MB. Two-year outcomes after sacrocolpopexy with and without burch to prevent stress urinary incontinence. Obstet Gynecol. 2008 Jul;112(1):49-55. doi: 10.1097/AOG.0b013e3181778d2a.

  PMID: 18591307 BACKGROUND

• Wei JT, Nygaard I, Richter HE, Nager CW, Barber MD, Kenton K, Amundsen CL, Schaffer J, Meikle SF, Spino C; Pelvic Floor Disorders Network. A midurethral sling to reduce incontinence after vaginal prolapse repair. N Engl J Med. 2012 Jun 21;366(25):2358-67. doi: 10.1056/NEJMoa1111967.

  PMID: 22716974 BACKGROUND

• Maher CM, Feiner B, Baessler K, Glazener CM. Surgical management of pelvic organ prolapse in women: the updated summary version Cochrane review. Int Urogynecol J. 2011 Nov;22(11):1445-57. doi: 10.1007/s00192-011-1542-9. Epub 2011 Sep 17.

  PMID: 21927941 BACKGROUND

• Stanton SL, Hilton P, Norton C, Cardozo L. Clinical and urodynamic effects of anterior colporrhaphy and vaginal hysterectomy for prolapse with and without incontinence. Br J Obstet Gynaecol. 1982 Jun;89(6):459-63. doi: 10.1111/j.1471-0528.1982.tb03637.x.

  PMID: 7082603 BACKGROUND

• Schierlitz L, Dwyer PL, Rosamilia A, De Souza A, Murray C, Thomas E, Hiscock R, Achtari C. Pelvic organ prolapse surgery with and without tension-free vaginal tape in women with occult or asymptomatic urodynamic stress incontinence: a randomised controlled trial. Int Urogynecol J. 2014 Jan;25(1):33-40. doi: 10.1007/s00192-013-2150-7. Epub 2013 Jun 28.

  PMID: 23812579 BACKGROUND

• Souza CC, Rodrigues AM, Ferreira CE, Fonseca ES, di Bella ZI, Girao MJ, Sartori MG, Castro RA. Portuguese validation of the Urinary Incontinence-Specific Quality-of-Life Instrument: I-QOL. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Oct;20(10):1183-9. doi: 10.1007/s00192-009-0916-8. Epub 2009 Jun 9.

  PMID: 19506791 BACKGROUND

• de Oliveira MS, Tamanini JT, de Aguiar Cavalcanti G. Validation of the Prolapse Quality-of-Life Questionnaire (P-QoL) in Portuguese version in Brazilian women. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Oct;20(10):1191-202. doi: 10.1007/s00192-009-0934-6. Epub 2009 Jul 4.

  PMID: 19578803 BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse; Urinary Incontinence, Stress; Urinary Incontinence

Interventions

Suburethral Slings

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; 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

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Luciana p gomes, MD

  University of Sao Paulo Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Chef of Urogynecology Section - University of Sao Paulo General Hospital

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: October 16, 2015
• Study Start: February 1, 2014
• Primary Completion: July 1, 2020
• Study Completion: September 1, 2024
• Last Updated: October 16, 2015

Record last verified: 2015-10

Locations

BR (1)