A comparison of native vaginal and ligament surgery for cure of pelvic organ prolapse and overactive bladder.

The key messages from the Shkarupa et al. native cardinal/uterosacral ligament (CL/USL) study, was that, in premenopausal women, ligament repair alone is sufficient for cure of pelvic organ prolapse (POP) and urgency, achieving cure rates of 85.7% for POP and 81.6% for urgency at 12 months. However, in postmenopausal women, the cure rates were 20.5% for POP and 33.3% for urge at 12 months. The Lancet Prospect Trial recorded 21% for native vaginal repair at 12 months. The poor POP cure rate in the Prospect Trial, and the rapid deterioration in the post-menopausal CL/USL repair group, can be explained by known biomechanics. The vagina has little structural strength. Ligaments, with a much higher breaking strain, are the main structural support of pelvic organs. Yet, even native ligament repair reported very low cure rates at 12 months. The poor results in postmenopausal women with native ligament repair can be explained by collagen breakdown after the menopause, as collagen is the key structural component of ligaments. An important question posed in the ligament repair study was, "What happens to women cured by ligament repair after the menopause when the collagen leaches out of the ligaments?". One recommendation was that collagen creating tapes be routinely applied in prolapse surgery and OAB, at least in postmenopausal women. The recommendation for routine collagen-creating ligament repair methods, especially in older women, are supported by high 5-year surgical cure rates in 70-year-old Japanese women, 91.2% for POP, at 12 months, falling to 79.0 at 60 months, using collagen creating Tissue Fixation System (TFS) minislings.

Peripheral muscle force balance/imbalance in neurological binary control of bladder function and dysfunction.

Bladder control is not from the bladder itself but from muscles and ligaments outside of it. Bladder control is binary, either closed or open. Control is exerted cortically, directly and via a peripheral pelvic mechanism comprising three reflex pelvic muscles which contract (variously) against pubourethral ligaments (PULs) anteriorly and uterosacral ligaments (USLs) posteriorly. Directed efferent impulses from the cortex close the urethra, open it, and stretch the vagina in opposite directions to prevent urothelial impulses inappropriately activating micturition (urge incontinence). Normally, the opposite muscles are equivalent in force, and balance at the bladder neck. Weak PULs weaken the forward closure force: the posterior forces become relatively more powerful; balance shifts behind bladder neck; the posterior urethral wall is pulled open like a trapdoor, and urine is lost on effort (stress urinary incontinence). Weak USLs weaken the posterior muscle forces; the balance of forces shifts forwards, and the urethra is closed relatively more tightly by slow-twitch forward muscle vector forces (pubococcygei), which stretch each side of the distal vagina forwards to compress the posterior urethral wall; in consequence, the weakened posterior muscle forces cannot easily open the posterior urethral wall; the bladder has to contract against a relatively unopened urethra, perceived as "obstructed micturition". Nor can weakened posterior forces stretch the vagina sufficiently to support the urothelial stretch receptors from below; these may fire off excess afferent impulses to cause urgency. As bladder control is strictly binary, in women with urgency, control swings between open and closed modes. This condition is known as an "unstable bladder", which is defined symptomatically as "overactive bladder", and urodynamically as "detrusor overactivity". In summary, bladder control is binary, either closed or open. How the cortex integrates and computes multiple inputs determines the type of closure, opening or unstable control which is experienced by the patient.

Validation of the Russian Version of the Prolapse Quality-of-life Questionnaire and its Application to Assess the Impact of Pelvic Organ Prolapse on Quality of Life and the Effect of Treatment in Women Undergoing Reconstructive Surgery.

INTRODUCTION AND HYPOTHESIS: The objective was to validate the translated Russian version of the prolapse quality-of-life (P-QoL) questionnaire and test its applicability to assess the impact of pelvic organ prolapse (POP) on QoL and the effect of treatment in women undergoing reconstructive surgery. METHODS: Following a forward- and back-translation of the original English P-QOL questionnaire into Russian, the translated questionnaire was reviewed by a group of patients as well as an expert panel. Women with POP who were admitted to a university hospital for reconstructive surgery were recruited. All the women completed the P-QoL questionnaire, Pelvic Floor Distress Inventory (PFDI-20) and 36-Item Short Form Survey (SF-36) questionnaires before surgery. Clinical data and POP Quantification (POP-Q) Index according to the International Continence Society were obtained. Psychometric properties of the questionnaire were assessed. RESULTS: A total of 303 women with POP were included in the study. Most patients presented with POP-Q >2. The P-QoL questionnaire demonstrated good psychometric properties. High internal consistency was shown in all domains (Cronbach's alpha coefficient from 0.65 to 0.92). The test-retest reliability confirmed a highly significant stability between the total scores for each domain. Significant correlations of the P-QoL domains with the PFDI-20 and SF-36 scales (p < 0.05) were obtained, demonstrating satisfactory convergent validity. Discriminative construct validity was proved by the differences in the mean scores for P-QoL domains across POP-Q stages (p < 0.05): general health perceptions, role limitations, physical limitations, social limitations and severity measures were significantly higher for POP-Q stages 3 and 4 than for POP-Q stage 2 (p < 0.01); general health perceptions and severity measures were higher for POP-Q stage 4 than for POP-Q stage 3 (p < 0.05); sleep/energy was higher for POP-Q stage 3 than for POP-Q stage 2 (p < 0.05). Significant improvement of QoL in the 2 months after surgery (p < 0.05) indicated that the P-QoL questionnaire is sensitive to change. CONCLUSIONS: The Russian version of the P-QoL questionnaire is characterized by appropriate psychometric properties. The P-QoL questionnaire is a useful tool for describing the QoL profile in women with POP before reconstructive surgery and evaluating treatment outcomes after the procedure.

Tunable tension tape versus transobturator tape in treatment of stress urinary incontinence in women: Randomized controlled trial.

INTRODUCTION: The synthetic mid-urethral slings are currently considered to be the most widely used technique for the surgical treatment of stress urinary incontinence (SUI). The most challenging aspect of the existing approaches is to achieve the optimal tension of the sling which treatment results are directly dependent on. To solve this problem, sling systems enabling an adjustment of the tension in the early postoperative period were created. A comparative study of the effectiveness and safety of such a system and a nonadjustable sling seems to be a relevant task. MATERIALS AND METHODS: A double-blind, randomized, multicenter trial enrolled 320 patients with a mean age of 55.2 ± 11.2 years and confirmed SUI. Patients were randomized into two groups: the first group underwent a standard synthetic suburethral sling (transobturator tape [TOT]) procedure and the second group underwent a tunable tension tape sling (TTT) procedure. All patients underwent stress test, uroflowmetry and ultrasound scan to determine the postvoid residual volume. Urinary Distress Inventory Short Form 6, International Consultation on Incontinence Questionnaire-Short Form, Pelvic Organ Prolapse Incontinence Sexual Questionnaire 12 questionnaires were used to assess subjective efficacy. RESULTS: Enhancement of prosthesis tension in the second group was required in 44 (28%) patients. Due to the possibility of tightening of the sling in the early postoperative period, the operation was effective in 143 (89%) patients in the adjustable sling group and in 109 (68%) patients in Group 1, p < 0.001. Loosening of the sling tension was performed in 25 (16%) patients in Group 2. The signs of obstructive voiding symptoms at the follow-up time of 36 months remained in Group 1 in 13 (8%) patients. Subjective satisfaction with treatment on the PGI-I scale was higher in Group 2: 100 (62%) versus 132 (82%), p < 0.001. CONCLUSION: A synthetic mid-urethral TTT is superior to a standard nonadjustable sling in long-term effectiveness and safety.

Native tissue repair of cardinal/uterosacral ligaments cures overactive bladder and prolapse, but only in pre-menopausal women.

INTRODUCTION: The aim of this article was to study the effect of native tissue cardinal/uterosacral ligament repair on overactive bladder (OAB) and pelvic organ prolapse (POP). MATERIAL AND METHODS: Inclusion criteria included decrease of urge symptoms following insertion of a gauze tampon in the posterior fornix of vagina ('simulated operation'). Exclusion criteria included SUI, POP grades 3-4. The surgery consisted of plication of cardinal/uterosacral ligaments. Post-operative assessment was performed at3, 6, 12 and 18 months after surgery and included evaluation by stage of prolapse, Urinary Distress Inventory Short Form 6 (UDI-6), Overactive Bladder Questionnaire (OAB-q), Pelvic Floor Impact Questionnaire- Short Form 7 (PFIQ-7), and International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-SF) questionnaires and voiding diary. RESULTS: At 3 months, cure rates for frequency, urgency, nocturia and prolapse were comparable. By the 6-month review, catastrophic failure commenced in the postmenopausal group, parallel for all pa-rameters, starkly contrasting with premenopausal group. At 18 months, % cure rates for pre-menopausal (post-menopausal in brackets) were 79.6 (15.4) for POP, 67.3 (20.5) for urgency, 87.7 (20.5) for nocturia and 59.2 (15.4) for frequency. CONCLUSIONS: We hypothesize the stepwise parallel recurrence of POP and symptoms in the menopausal group was a consequence of collagen deficiency in the plicated ligaments. Nevertheless, plication of uterosacral-cardinal ligament complex is simple, inexpensive, effective, especially applicable pre-menopausally for POP and as an alternative treatment option in that difficult group of pre-menopausal women who have major OAB/nocturia symptoms but only minimal prolapse.

Full-thickness vascularized vaginal flap as the fixation point in the surgical treatment of vaginal vault prolapse.

INTRODUCTION AND HYPOTHESIS: Post-hysterectomy vaginal vault prolapse is quite frequent and at the same time a challenging surgery for pelvic organ prolapse. METHODS: One of the most popular methods of treatment is sacrospinous fixation, including its mesh modification. RESULTS: Despite the high efficiency in the apical compartment, the incidence of the anterior compartment prolapse is quite high. Erosion remains an unsolved problem. A 44-year-old patient with grade IV post-hysterectomy prolapse underwent a sacrospinous fixation procedure with mesh according to the described technique. Surgery was performed successfully without complications. The duration of the operation was 40 min. A year after the operation, the recurrence of POP was not recorded in any compartments of the pelvic floor. It was possible to maintain the length of the vagina. Dyspareunia and vaginal erosion were not detected. The patient also noted a significant improvement in her quality of life. CONCLUSION: The demonstrated approach allows performing minimally invasive reconstruction of all three compartments of the pelvic floor. Moreover, the use of a full-thickness vascularized vaginal flap allows safely fixing the mesh to the vaginal vault, minimizing the risk of erosion and pain syndrome due to excessive tension.

The resurrection of sacrospinous fixation: unilateral apical sling hysteropexy.

INTRODUCTION AND HYPOTHESIS: The apical compartment is a keystone in POP treatment. Sacrospinous fixation, suggested half a century ago, today is still one of the most popular and efficient methods of colpo-hysteropexy. However, it has specific side effects: chronic pain syndrome, dyspareunia and а high rate of cystocele de novo. We aimed to evaluate the efficacy and safety of unilateral sacrospinous hysteropexy with a synthetic apical sling combined with anterior subfascial colporrhaphy. METHODS: Following the suggested technique, 174 women with anterior-apical prolapse underwent surgery. The follow-up period took 12 months. Pre- and postoperative examination included: urogynecological examination (POP-Q), uroflowmetry, ultrasound of the bladder and filling in of validated questionnaires (PFDI-20, PISQ-12). RESULTS: The mean surgery time was 26 ± 7.84 min. No cases of damage of the bladder or rectum or of intraoperative clinically significant bleeding were noted. At the 12-month follow-up, the recurrence rate in the apical compartment was 0.7% (1/147) and in the anterior compartment 7.4% (11/147). The efficacy of the surgery reached 96.5%. During 12 months of follow-up, no cases of mesh exposure or chronic pelvic pain syndrome were detected. The incidence of dyspareunia de novo was observed in just one patient. CONCLUSIONS: A unilateral sacrospinous fixation with a synthetic mesh (apical sling) combined with anterior subfascial colporrhaphy enhances the anatomical efficacy of surgery. It also helps to avoid specific side effects of traditional sacrospinous fixation.

Adjustable transobturator sling for the treatment of primary stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: The purpose of the study was to evaluate the rate of postoperative voiding dysfunction after the insertion of an adjustable transobturator sling for the treatment of primary stress urinary incontinence (SUI). The secondary aim was to assess the objective and subjective cure rates and the impact of the surgery on quality of life. METHODS: This prospective study included 171 patients with primary SUI who underwent insertion of an adjustable transobturator tape. A postoperative tension adjustment algorithm that included a cough stress test (CST), uroflowmetry and postvoid residual volume (PVR) measurement was applied in all patients the day after surgery. The baseline and control postoperative evaluations included vaginal examination, CST, Q-tip test, uroflowmetry and PVR measurement, 1-h pad test and administration questionnaires (UDI-6, IIQ-7, PISQ-12, ICIQ-SF). RESULTS: The day after surgery 65 patients (38.0%) required tape tension adjustment: an increase in tension in 53 patients (31.0%) and a decrease in 12 (7.0%). Continence was achieved in all patients. No patients showed voiding dysfunction after adjustment. Follow-up data for 12 months were available in 157 patients (91.8%). The objective and subjective cure rates were 96.2% and 97.5%, respectively. There was no statistically significant decrease in Qmax (p = 0.899) or increase in PVR (p = 0.187). According to the questionnaires scores, quality of life was improved in all patients. CONCLUSION: The adjustable transobturator sling minimizes the risk of postoperative voiding dysfunction and allows high objective and subjective cure rates to be achieved in patients with primary SUI. The technique also improves the patient's quality of life.

The novel technique of post-hysterectomy vaginal vault prolapse repair: Apical sling and "neocervix" formation.

OBJECTIVE: We primarily aimed to evaluate the effectiveness of the novel technique: bilateral sacrospinous fixation by monofilament polypropylene apical sling combined with "neocervix" formation in surgical treatment of post - hysterectomy vaginal vault prolapse. The secondary objective was to estimate the impact of the surgery on voiding function and quality of life. STUDY DESIGN: This prospective study involved 61 women suffering from post-hysterectomy prolapse. We used the following criteria to evaluate the results of surgical treatment: results of vaginal examination (POP-Q system), uroflowmetry, bladder ultrasound, validated questionnaires were used. All listed parameters were determined before the surgery and at control examinations in 1, 6, 12 months after the treatment. RESULTS: Mean operation time was 35min. No cases of intraoperative damage to the bladder/rectum, as well as clinically significant bleeding were noted.At 12-month follow-up anatomical cure rate (≤stage I, POP-Q) was 100%, 94,4% and 100% for vaginal apex, anterior and posterior vaginal walls, respectively. The following long-term complications were noted stress urinary incontinence de novo and urgency de novo were noted in 6.5% and 4,9%, respectively. Statistically significant (P<0.05) improvement in peak flow rate was observed according to uroflowmetry. Comparison of the scores by the questionnaires revealed a significant improvement in the quality of life in the postoperative period. CONCLUSION: The novel technique: combination of the apical sling and purse-string "neocervix" formation appears to be effective and safe method for treatment patients with vaginal vault prolapse. The technique improves voiding function and quality of life.

The hybrid technique of pelvic organ prolapse treatment: apical sling and subfascial colporrhaphy.

INTRODUCTION AND HYPOTHESIS: The majority of patients with cystocele undergoing reconstructive surgery have combined defects of pubocervical fascia and uterosacral/cardinal ligament complex. In this regard, the simultaneous correction of both defects is rational. Furthermore, decreasing the use of synthetic materials in pelvic floor surgery is an important goal. The aim was to evaluate the objective and subjective cure rate of a hybrid technique: bilateral sacrospinous fixation using modern monofilament synthetic tape (apical sling) combined with the original technique of subfascial colporrhaphy. MATERIALS AND METHODS: This prospective study involved 148 women suffering from cystocele combined with apical prolapse. We used the following criteria to evaluate the results of surgical treatment: results of the vaginal examination (POP-Q system), urodynamic tests, bladder ultrasound, special questionnaires (Pelvic Floor Distress Inventory [PFDI-20], Pelvic Floor Impact Questionnaire [PFIQ-7], Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire [PISQ-12], International Consultation on Incontinence Modular Questionnaire Short Form [ICIQ-SF]). All listed parameters were determined before the surgery and at control examinations at 1, 6, and 12 months after the treatment. RESULTS: At the 1-year follow-up, the objective cure rate for prolapse was 97.8%. The rate of anatomical recurrence was 2.2% (3 out of 138). The following long-term complications were noted: de novo urgency and stress urinary incontinence de novo in 2 (1.4%) and 4 (2.9%) patients, respectively. Comparison of the scores by the questionnaires also revealed a significant improvement in the quality of life in the postoperative period. Patient satisfaction rate was 97.1%. CONCLUSION: The hybrid technique is an effective and safe uterus-sparing method for patients with advanced forms of cystocele combined with apical prolapse. This technique improves voiding function, quality of life, and provides a high satisfaction rate.