Objectives: To assess subjective success rates, complications and impact on quality of life (QoL) in women treated by Tension Free Vaginal Tape for urinary incontinence.
Methods: A retrospective cohort analysis was made on 30 consecutive women undergoing TVT procedure alone or as concomitant to other pelvic surgical procedures, from June 2004 to October 2007. All the Patients were evaluated by history, clinical examination with POP-Q (pelvic organ prolapse-quantification) scoring for uterovaginal prolapse and urodynamic testing. Improvement of health-related QoL (quality of life) was assessed by incontinence impact questionnaire-short form (IIQ-7) and urogenital distress inventory-short form (UDI-6). The success of surgery was evaluated by asking whether the incontinence was cured, improved or had no change after the operation. Data was computed and analyzed by using SPSS version 13.
Results: Concomitant surgery was performed in 14 (46.6%) cases. Median age was 47 years and duration of follow up was 14 months (range 4-37 months). Eight (26.6%) women had mixed Urinary Incontinence with Detrusor Overactivity. Previous pelvic surgery like MMK (Marshall-Marchetti-Krantz along with TAH (total abdominal hysterectomy) was found in 5 (16.6%) cases. Complications were listed as per-operative, short-term and long-term. Among the short-term complications Bladder perforation was seen in 2 cases (6.7%) and overt urinary retention in 2 cases (6.7%). Long-term complications as voiding dysfunction occurred in only 1(3.3%) case. Symptoms were labeled as completely cured in 27 (90%) patients, significantly improved in 2(6.6%) and one with mixed incontinence regarded as having worsening of urge symptoms and dysuria.
Conclusion: A median follow up of 14 months showed that our surgical results of TVT alone or with concomitant surgery were similar to internationally published results and TVT can be safely performed with concomitant procedures

Rizvi, Raheela Mohsin

eCommons@AKU

eCommons@AKUDepartment of Obstetrics & Gynaecology Division of Woman and Child HealthMay 2009Clinical and quality-of-life (QoL) outcomes inwomen treated by tension free vaginal tape (TVT)Raheela Mohsin RizviAga Khan UniversityFollow this and additional works at: http://ecommons.aku.edu/pakistan_fhs_mc_women_childhealth_obstet_gynaecolPart of the Obstetrics and Gynecology CommonsRecommended CitationRizvi, R. (2009). Clinical and quality-of-life (QoL) outcomes in women treated by tension free vaginal tape (TVT). Journal of thePakistan Medical Association, 59(5), 274-7.Available at: http://ecommons.aku.edu/pakistan_fhs_mc_women_childhealth_obstet_gynaecol/1611 J Pak Med AssocIntroductionStress incontinence is a symptom or sign indicatingthat the woman has involuntary urine loss associated withexertion. Urodynamic stress incontinence (previously knownas genuine stress incontinence) is a solely urodynamicdiagnosis which occurs when an incompetent urethra allowsleakage of urine in the absence of a detrusor contraction.1Rapid progress has been achieved in stress urinaryincontinence treatment after the description of minimallyinvasive sling Tension free tape(TVT) in 1995 by Ulmsten,2because of minimal morbidity and high initially success rateand more than one million procedures have been performedworldwide. The starting point for development of the TVTprocedure was the introduction of new pathophysiologicalconcepts of female stress urinary incontinence, known as the"integral theory", by Petros and Ulmsten and Hammockhypothesis by De Lancey.3,4 Both of these new hypothesisshared the common concept that strong supportive suburethral tissue was essential for maintaining an adequatecontinence mechanism in women. Restoration of the suburethral supportive tissue and increasing the urethralresistance under stress condition were achieved by a specificprolene tape in this procedure. High success rates reported inmid and long-term studies has popularized this procedure, andTVT-type procedures are gradually becoming the new goldstandard treatment for female stress urinary incontinence.5The objectives of this retrospective study were toassess subjective success rates, complications, and impact onpatient's quality of life (QoL) before and after the surgicalprocedure in our setup.Patients and MethodsA retrospective cohort analysis was conducted on 30patients who had Tension free vaginal Tape alone or incombination with other pelvic surgeries at Aga KhanUniversity Hospital, Karachi from June 2004 to October 2007.Original ArticleClinical and Quality-of-Life (QoL) outcomes in women treatedby Tension Free Vaginal Tape (TVT)Raheela Mohsin RizviDepartment of Obstetrics & Gynaecology, The Aga Khan University Hospital, Karachi.AbstractObjectives: To assess subjective success rates, complications and impact on quality of life (QoL) in womentreated by Tension Free Vaginal Tape for urinary incontinence.Methods: A retrospective cohort analysis was made on 30 consecutive women undergoing TVT procedure aloneor as concomitant to other pelvic surgical procedures, from June 2004 to October 2007.All the Patients wereevaluated by history, clinical examination with POP-Q(pelvic organ prolapse-quantification) scoring foruterovaginal prolapse and urodynamic testing. Improvement of health -related QoL (quality of life) was assessedby incontinence impact questionnaire-short form (IIQ-7) and urogenital distress inventory -short form (UDI-6).Thesuccess of surgery was evaluated by asking whether the incontinence was cured, improved or had no changeafter the operation. Data was computed and analyzed by using SPSS version 13.Results: Concomitant surgery was performed in 14 (46.6%) cases. Median age was 47 years and duration offollow up was 14 months (range 4-37 months). Eight (26.6%) women had mixed Urinary Incontinence withDetrusor Overactivity. Previous pelvic surgery like MMK (Marshall-Marchetti-Krantz along with TAH (totalabdominal hysterectomy) was found in 5 (16.6%) cases. Complications were listed as per-operative, short termand long-term. Among the short term complications Bladder perforation was seen in 2 cases (6.7%) and overturinary retention in 2 cases (6.7%). Long-term complications as voiding dysfunction occurred in only 1(3.3%) case.Symptoms were labeled as completely cured in 27 (90%) patients, significantly improved in 2(6.6%) and one withmixed incontinence regarded as having worsening of urge symptoms and dysuria.Conclusion: A median follow up of 14 months showed that our surgical results of TVT alone or with concomitantsurgery were similar to internationally published results and TVT can be safely performed with concomitantprocedures (JPMA 59:274; 2009).The initial pre-operative evaluation included a history,clinical examination with POP-Q (pelvic organ prolapse-quantification) scoring for uterovaginal prolapse andurodynamic testing.1 All of the above had an objectiveassessment of symptoms by stress test and urodynamic stressincontinence. All the women had a negative urine culturebefore the urodynamic testing and eight women withconcomitant urinary urge incontinence gave a 24 hours recordof urinary diary as well.Urodynamic stress incontinence wasseen as observation of urinary leak with rise of valsalva leakpoint pressure> 60 cm water in 25 women (urethral hypermobility) while five women showed a low leak point pressure<60 cm water (Intrinsic sphincter defect). Detrusor overactivity was also recorded in 8 women (mixed UI).Improvement of health-related QoL was assessed byincontinence impact questionnaire-short form (IIQ-7) andurogenital distress inventory -short form (UDI-6).6 Responseto each item were originally rated between 0 (not affected atall) and 3 (greatly affected). Post operatively IIQ-7 and UDI-6 were re-evaluated along with objective assessment by stresstest at each follow up visit. Patients were advised to have visitsafter one, 4, 8 and 12 weeks. Women having more than 3months duration of surgery and no further follow up visits andwere interviewed by Telephone. Criteria for Cure:The success of surgery was evaluated by askingwhether the incontinence was cured, improved or had nochange after the operation. We also questioned if urinaryurgency worsened or appeared de-novo after the procedure.Voiding dysfunction was defined as having dysuriaand inability to void or post void residual >200 ml requiring aFoleys catheter or intermittent self catheterization at dischargefrom hospital. Postoperatively the patients were regarded ascured if they had negative stress test results and if QoL hadimproved > 90%.To be regarded as improved the patient hadto have a > 75 improved QoL. Data analysis was performedusing statistical program SPSS version 14. Descriptivestatistics were presented as a percentage of the total numbers.ResultsPatient characteristics are shown in Table 1. All thepatients were assessed by POP-Q scoring for uterovaginalprolapse and 16 patients had minor degree of prolapse (stage1 and 2) while 6 patients had major degree of prolapse (stage3 and 4). Median duration of follow up was 14 months (4-37).TVT alone patients were discharged after 24 hours of surgeryand mean duration of stay with concomitant surgery was 3days. Fifteen women were menopausal and 10 were usinglocal application of estrogen vaginal cream. Table 2 shows the types of surgery performed.Concomitant surgery was performed in 14 women (70%).These procedures included: posterior vaginal repair,9 vaginalsacropexy1 and vaginal hysterectomy with anterior andposterior vaginal repair1 and with pelvic floor repair.3Complications are shown in Table 3. Bladderperforation occurred in two patients. Urinary retentionoccurred in 2 cases. All the patients received only prophylactic antibioticbut one patient with concomitant surgery developed acute UTIand was treated by therapeutic antibiotics. Long term followup showed voiding dysfunction   in only one patient.No patient so far complained of de-novo urinaryurgency and with median follow up for 16 months (range 4-37months) no patient has shown any signs of tape infection/erosion or tape rejection. All of the patients had a negativestress test soon after surgery and during subsequent visits.During the first 3 months post-operatively results and QoL hadimproved > 90% in 27 patients (90%) and > 75% in 2 patients(6.6%) while in one patient (3.3%) there was voidingdysfunction which persisted after 6 months of surgery.DiscussionSeveral reports have been published claiming thatTVT (tension free vaginal tape) is a safe and effectivetreatment for female urinary incontinence.7,8Vol. 59, No. 5, May 2009 275Table 1: Patient characteristics. (n=30).Age (years) 47 (30-74)Parity 4 (2-9)BMI 30(23-40)Menopausal 50%Urge symptoms (pre-operative) 36.7%Duration of incontinence symptoms (years) 5.5(1-20)Follow -up time (months) 14(4-37)Previous pelvic surgery 5(16.6%)Recurrent UTI 3(10%)POP-Q     stage o 8(26.6%)POP-Q     stage 1 7(23.3%)POP-Q    stage 2 9(30%)   POP-Q    stage 3 2(6.7%)POP-Q    stage 4 4(13%) *Values are given as median (range) or percent.Table 2: Types of surgery performed (n=30).Variable n %TVT surgery alone 16 53.3%TVT and Posterior repair 9 30.3%TVT, Vaginal hysterectomyand pelvic Floor repair 3 10.0%Vaginal hysterectomy andanterior and posterior repair 1 3.3%TVT and Sacropexy repair 1 3.3%TVT = Tension Free Vaginal Tape.Our objective success rate by stress test and subjectivesuccess rates by IIQ-7 scoring at 4, 8 and 12 weeks showed >90% improvement in symptoms in 27 (90%) patients and >75% improvement in symptoms in 2 (6.6%) patients while inone patient (3.3%) there was long term voiding dysfunction.There is no local study for comparison; the Ward/Hilton trial9measured both objective and subjective cure at 6 months, oneyear and 2 year. Subjective cure of stress incontinenceamongst those assessed at 6 months was 65%, the rates forobjective cure varied between 65 and 95% and all the patientswere subjected to urodynamic testing post-operatively.9Usingboth the subjective and objective assessment criteria, the long-term results after 5 years by Nilsson et al showed 84.7%patients as completely cured, 10.6% had significantlyimproved and 4.7% were regarded as failures.10Bladder perforation rate has been reported to bebetween 1.1 and 15% after TVT procedures.11 No consensusexists on concomitant surgery as being a risk factor forpostoperative urinary retention and bladder perforation.11Bladder perforation occurred in only 2 (6.7%) patients.One patient had TVT and posterior repair, with Body MassIndex of 40 and hence obesity can be considered as anotherrisk factor for bladder perforation. Another patient had onlyTVT but she had previous two Caesarean Sections and onedifficult abdominal hysterectomy. The results of the studiesregarding previous pelvic surgery as a risk factor for bladderperforation are conflicting12,13 as the numbers are relativelyvery small, and it is not possible to derive any meaningfulresults regarding these risk factors. The coexisting rate of stress urinary incontinence inpatients having a prolapse is as high as 63%.14 Weperformed 14 TVT procedures in combination withhysterectomy, hysteropexy and posterior colporraphy andpelvic floor repair.Short-term voiding disorder is described in 4% to 11 %of women and retention requiring transaction of tape occurs in1% to 2.8%.15A multi-institutional review has shown urinaryretention (>24 hours after) in 19.7% of women16 while aretrospective controlled study by Tayrac et al showed urinaryretention in 46.2% of patients having concomitant surgerywith TVT within first seven days and in 11.5% after the firstweek.17The cure rate for stress urinary incontinence with TVTand concomitant surgery was 96.2%.Long-tern voiding dysfunctions like urgency anddysuria persisted for >12 weeks in one patient with history ofMarshal Marchetti Krantz surgery in the past. She wasdiagnosed as having mixed urinary incontinence and recurrentUTI as well. The incidence of mixed UI ranges from 30% to50%. Duckett and Tamilselvi have shown subjective cure ofurge symptoms in 63% women of mixed UI following TVTwhile overactive bladder symptoms persisted in 37%.18 Forpost-operative overactive bladder symptoms prior to anti-incontinence surgery and old age were found to be possiblerisk factors.11A relatively low rate of complications is an importantadvantage of the TVT-type procedure. The incidence ofintraoperative blood loss of over 200 cc was reported as1.9%, major vessel injury, 0.07% and vaginal haematoma0.07%.19 Fortunately we did not encounter any case of intra-operative haemorrhage or post-operative vaginal haematomaand this could be related to the use of general or regionalanaesthesia. Wang, in his article has commented that apossibility with light sedation is that some patients canbecome agitated and not cooperate with the surgeon duringtrocar insertion, in which case persistent attempts to pass thetrocar could result in bladder perforation or even a lacerationof the external iliac vessels.20After TVT procedure, 4.1, 0.8 and 0.7% of thepatients had urinary tract infection, wound infection ofabdominal incision and defective healing of vaginalincision, respectively.21 One of our patient (3.3%) after TVTand vaginal hysterectomy developed urinary tract infectionand Tayrac et al have reported postoperative urinaryinfection in 11.5% in patients with concomitant surgery vs4.5% in patients with TVT alone (p>0.05).17None of our patients developed mesh infection orshowed urethral and vaginal erosions over a median followup of 14 months (range4-37 months) and this could be dueto relatively younger age group, median age 47 (range 30-74 years).ConclusionAlthough we have a small and short term data but ourresults are comparable to those published by Westerncountries. Our results indicate that TVT is a safe and effective276 J Pak Med AssocTable 3: Procedures Complications.Complications n %I. Per-operative   Haemorrhage 0 0Bladder perforation 2.0 6.7%II. Short term complications 2 6.7%Urinary retention UTI 1 3.3%Voiding dysfunction(dysuria with retention)III. Long term complications Voiding 1 3.3%dysfunction 0 0%De-novo urgency 0 0%Urethral and vaginal erosionstreatment for stress urinary incontinence and concomitantsurgeries can be safely performed. The women in the studyhad a median age of 47 years and hence no age-relatedcomplications like mesh infection, erosion and De novourgency were observed. All patients were assessedobjectively and subjectively for urinary incontinence pre-operatively but post-operatively only subjective was done.The objective assessment was made by cough test. Aprospective study with post-operative objective assessmentby urodynamic testing is warranted.References 1. Abrams P, Cardozo L,Fall M,et al: Standardisation of terminology of lowerurinary tract function: report from the standardization sub -committee of theinternational continence society. Neurol. Urodyn 2002; 21:167-78.2. Ulmsten U.Intravaginal slingplasty (IVS);an ambulatory surgical procedure fortreatment of urinary incontinence. Scan Journal Urol and Nephrol 1995; 29: 75-82.3. Delancy JOL, structural support of the urethra as it relates to stress urinaryincontinence: the hammock hypothesis. AM J obster Gynecol 1994; 170:1713-23.4. Petros PE Ulmsten UI. An integral theory of female urinary incontinence:Experimental and clinical considerations. Acta Obstet Gynecol Scand 1990;153(suppl):7-31.5. Bemelmana BLH, Chapple CR. Are sling now the gold standard treatment for themanagement of female urinary stress incontinence and if so which technique?curr Opin urol2003; 13:301-7.6. Uebersax JS, Wyman JF, Shumaker SA McClish DK, Fantl JA. Short form toassess life quality and symptom distress for urinary incontinence in women:the incontinence impact Questionnaire and the urogenital distress inventory.Continence Program for women research Group.NeurourolUrodyn1995;14:131-9. 7. Ulmsten U, Johnson P, Rezapour M.A three year follow up of tension freevaginal tape for surgical treatment of female stress incontinence, Br J ObstetGynecol 1999; 106:345-50.8. Olsson I, Kroon U.A three year postoperative evaluations of tension free vaginaltape .Gynecol Obstet Invest 1999; 48:267-9.9. Cody J, Wyness L. Wallace S, Glazner C, Kilonzo M, StearneS, et al. Systematicreview of the clinical effectiveness and cost-effectiveness of tension-free vaginaltape for treatment of stress urinary incontinence. Health Technol Assess 2003;7:1-202.10. Nilsson CG, Falconer C, Ulmsten U, et al.Long-term results of Tension freevaginal tape (TVT) Procedure for surgical treatment of female stressincontinence. Int Urogynecol J 2001; (suppl 2) S5-S8.11. Centinel B, Demirkesen O. Risk factors influencing the complication rates oftension -free vaginal tape procedures. Curr Opin Obstet Gynecol 2005; 17:530-4.12. Mazouni C, Karsenty G, BrettelleF, et al. Urinary complications and sexualfunction after tension -free vaginal tape procedures. Acta Obstet Gynecol Scand2004; 83:955-61.13. Darai E, Jeffry L, Deval B, et al. Results of tension free vaginal tape in patientswith or without vaginal hysterectomy, Eur J Obstet Gynecol Reprod Biol 2002;103:163-7.14. Bai SW, Jeon MJ, Kim JY, et al. Relationship between stress urinaryincontinence and pelvic organ prolapse. Int Urogynecol J Pelvic Floor dysfunct2002; 13:256-60.15. Smith AR, Daneshgari F, Dmochowski R et al. Surgery for urinaryincontinence in women. In: Abrams Paul, Cardozo L Khoury Saad (Editors)Incontinence Management. 3rd International Consultation on Incontinence.21 Edition Health Publication Ltd 2005; pp1299-372.16. Abouassaly R, Steinberg J Lemieux M, et al .Complication of tension-freevaginal tape surgery: a multi-institutional review.Br J Urol Int 2004; 94:110-3.17. Tayrac R, Gervaise A, Fernandez H et al. Combined genital prolapse repairreinforced with a polypropylene mesh and tension-free vaginal tape in womengenital prolapse and stress urinary incontinence: a retrospective case-controlled study with short-term follow-up. Acta Obstet Gynecol Scand 2004;83:950-4.18. Duckett J, Tamilselvi A .Effects of tension free vaginal tape in women with aurodynamic diagnosis of idiopathic detrusor overactivity and stress incontinence.Br J Obstet Gynecol 2006; 113:30-3.19. Kuuva n, Nilsson CG. A nationwide analysis of complications associated thetension free vaginal tape (TVT) procedure. Acta Obstet Gynecol Scand 2002;81:72-7.20. Wang AC .The technique of trocar insertion and intraoperative urethrocystoscopyin tension free vaginal tape: an experience of 60 cases. Acta Obstet GynecolScand 2004; 83:293-8.21. Karram MM, Bhatia NN. Management of coexistent stress and urge urinaryincontinence. Obstet Gynecol 1989; 73:407-12.Vol. 59, No. 5, May 2009 277

Clinical and quality-of-life (QoL) outcomes in women treated by tension free vaginal tape (TVT)

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Clinical and quality-of-life (QoL) outcomes in women treated by tension free vaginal tape (TVT)

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