Christian Falconer

Long-term results of the tension-free vaginal tape (TVT) procedure for surgical treatment of female stress urinary incontinence.

Abstract: In a prospective long-term Nordic multicenter study, 90 consecutive patients who had a tension-free vaginal tape (TVT) operation performed because of stress urinary incontinence were evaluated according to a strict protocol after approximately 5 years (range 48–70 months). Eighty-five patients could be evaluated according to the protocol. Another 5 elderly patients had to be interviewed by telephone at the final check-up after 5 years. The study protocol involved pre- and postoperative objective and subjective evaluation. The median follow-up time was 56 months. Seventy-two of the 85 patients who were fully evaluated (84.7%) were both objectively and subjectively completely cured. Another 9 patients (10.6%) were significantly improved and 4 (4.7%) were regarded as failures. No patient complained of long-term voiding difficulties and there were no signs of defective healing or rejection of the tape material. All patients had suffered from primary stress incontinence, and 25 also had preoperative complaints of urge. In 14 of these (56%) the urge symptoms were relieved postoperatively. We conclude that the TVT procedure seems to fulfil the expectations of high long-term cure rates, as suggested in previous short-term reports.

A multicenter study of tension-free vaginal tape (TVT) for surgical treatment of stress urinary incontinence

The aim of the study was to evaluate the safety and efficacy of TVT (tension-free vaginal tape) for the surgical treatment of stress urinary incontinence. The design was a prospective open multicenter study including six centers, each operating an approximately 20 patients. In total 131 patients suffering from genuine stress incontinence were included. They were followed for at least 1 year using a specific protocol for objective and subjective evaluation of the outcome. All patients underwent the operation under local anesthesia. Mean operation time was 28 minutes (range 19–41 minutes); 119 (91%) of the patients were cured according to the protocol and another 9 (7%) were significantly improved. There were 3 (2%) failures. The majority of the patients (about 90%) were operated upon on a day-care basis, which implied that they were released from the hospital within 24 hours, with no postoperative catheterization. No defect healing and no tape rejection occurred. Three patients needed an indwelling catheter for 3 days. In 1 patient catheterization was necessary for more than 10 days. Two uncomplicated hematomas and one uncomplicated bladder perforation occurred. Based on the results, we conclude that TVT is a safe and effective ambulatory procedure for surgical treatment of genuine stress urinary incontinence.

Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse

BACKGROUND The use of standardized mesh kits for repair of pelvic-organ prolapse has spread rapidly in recent years, but it is unclear whether this approach results in better outcomes than traditional colporrhaphy. METHODS In this multicenter, parallel-group, randomized, controlled trial, we compared the use of a trocar-guided, transvaginal polypropylene-mesh repair kit with traditional colporrhaphy in women with prolapse of the anterior vaginal wall (cystocele). The primary outcome was a composite of the objective anatomical designation of stage 0 (no prolapse) or 1 (position of the anterior vaginal wall more than 1 cm above the hymen), according to the Pelvic Organ Prolapse Quantification system, and the subjective absence of symptoms of vaginal bulging 12 months after the surgery. RESULTS Of 389 women who were randomly assigned to a study treatment, 200 underwent prolapse repair with the transvaginal mesh kit and 189 underwent traditional colporrhaphy. At 1 year, the primary outcome was significantly more common in the women treated with transvaginal mesh repair (60.8%) than in those who underwent colporrhaphy (34.5%) (absolute difference, 26.3 percentage points; 95% confidence interval, 15.6 to 37.0). The surgery lasted longer and the rates of intraoperative hemorrhage were higher in the mesh-repair group than in the colporrhaphy group (P<0.001 for both comparisons). Rates of bladder perforation were 3.5% in the mesh-repair group and 0.5% in the colporrhaphy group (P=0.07), and the respective rates of new stress urinary incontinence after surgery were 12.3% and 6.3% (P=0.05). Surgical reintervention to correct mesh exposure during follow-up occurred in 3.2% of 186 patients in the mesh-repair group. CONCLUSIONS As compared with anterior colporrhaphy, use of a standardized, trocar-guided mesh kit for cystocele repair resulted in higher short-term rates of successful treatment but also in higher rates of surgical complications and postoperative adverse events. (Funded by the Karolinska Institutet and Ethicon; ClinicalTrials.gov number, NCT00566917.).

Seven-year follow-up of the tension-free vaginal tape procedure for treatment of urinary incontinence.

OBJECTIVE: To evaluate the long-term cure rates and late complication rates after treatment of female urinary stress incontinence with the minimally invasive tension-free vaginal tape operation. METHODS: Prospective observational, 3-center cohort study originally of 90 women requiring surgical treatment for primary urinary stress incontinence. Assessment variables included a 24-hour pad weighing test, a stress test, visual analog scale for assessing the degree of bother, and a questionnaire assessing the subjective perception of the women on their continence status. RESULTS: The follow-up time was a mean of 91 months (range 78–100 months). Both objective and subjective cure rates were 81.3% for the 80 women available for follow-up. Asymptomatic pelvic organ prolapse was found in 7.8%, de novo urge symptoms in 6.3%, and recurrent urinary tract infection in 7.5% of the women. No other long-term adverse effects of the procedure were detected. CONCLUSION: The tension-free vaginal tape procedure for treatment of female urinary stress incontinence is effective over a period of 7 years. LEVEL OF EVIDENCE: II-3

Tension-free vaginal tape (TVT) in stress incontinent women with intrinsic sphincter deficiency (ISD) - A long-term follow-up.

Abstract: In a prospective long-term study 49 women with stress incontinence and ISD (intrinsic sphincter deficiency) were followed for a mean of 4 years (range 3–5) after TVT operation. Preoperatively all patients underwent urodynamic investigations, quality of life evaluation, a 24-hour pad test and a gynecologic examination to properly verify the incontinence symptoms. The same protocol was used for postoperative evaluation. The mean age of the women was 66 years (± 11) and mean parity 2 (range 0–4). A standard TVT operation was performed under local anesthesia. At the postoperative evaluations 36 patients (74%) were completely cured of their incontinence problems. In addition, 6 women (12%) were significantly improved. In 7 patients (14%) no improvement was found. The majority of these not cured patients were >70 years of age and had urethral resting pressure of <10 cmH2O. Few intra- and postoperative complications occurred. It is concluded that TVT can be used for surgical treatment of patients with ISD and stress incontinence. However, older patients (>70 years) with a very low resting urethral pressure and an immobile urethra seem to constitute a risk group where TVT surgery is less successful.

Increased Intraepithelial Innervation in Women with Vulvar Vestibulitis Syndrome

Women with vulvar vestibulitis syndrome (VVS) suffer from severe pain and discomfort in the area around the introitus at almost any stimulus that causes pressure within the vestibule. In spite of the severe sensory symptoms present in these women, the influence of the peripheral nerves in the vulvar vestibulum has not been clarified before. In this study the nerve supply in the vestibular mucosa in women with VVS and in healthy women free from vulvar symptoms has been revealed by PGP 9.5 immunohistochemistry. The results show a significant increase in the number of intraepithelial nerve endings in women with VVS, indicating an alteration in the nerve supply in the afflicted area.

Influence of different sling materials on connective tissue metabolism in stress urinary incontinent women.

Abstract: The aim of this study was to investigate the influence on the paraurethral connective tissue of different sling materials used in incontinence surgery. Biopsies from the paraurethral connective tissue were obtained intraoperatively from 16 women with stress urinary incontinence; all were operated on with the TVT procedure, 6 with Mersilene as the sling material and 10 with Prolene. Biopsies from 4 continent women with uterine bleeding irregularities, matched for age and parity, served as controls. New biopsies were obtained from all women after 2 years. The biopsies were examined histologically and analyzed for collagen concentration and solubility. An obvious inflammatory reaction with a significant increase in collagen extractability by pepsin was identified in patients where Mersilene was used as the sling material. A minimal inflammatory reaction without a significant change in collagen solubility was found in the Prolene group. In the control group no inflammatory reaction was seen. Mersilene gave rise to a significant foreign-body reaction in the paraurethral connective tissue after surgery. Such a reaction was not found with Prolene.

Clinical outcome and changes in connective tissue metabolism after intravaginal slingplasty in stress incontinent women

The intravaginal slingplasty procedure (IVS) was carried out on 75 patients with genuine stress urinary incontinence. The main aims of the operation are to create an artificial pubourethral ligament and to tighten the suburethral vaginal wall. An important ingredient in the supportive structures of the genitourinary region is fibrous connective tissue, consisting mainly of collagen. To analyse thi component biopsies were obtained transvaginally, close to the position of the sling, both preoperatively and 2 years after surgery, from 6 patients. Collagen was analysed for concentration and extractability. Extractability by pepsin digestion was increased by 60% 2 years following surgery. Postoperative follow-up studies from 12 months to 3 years showed complete restoration of continence in 63 patients (84%) and considerable improvement in 4 others (5%). The 8 failures (9%) were all related to early rejection of the sling. The IVS procedure is an attractive surgical procedure as it necessitates minimum invasion and can be performed under local anesthesia, with a short hospital stay and sick-leave period. The enhanced collagen extractability indicates a changed metabolism, most likely induced by the implanted sling, resulting in a restoration of the elastic properties of the connective tissue.

Hysterectomy and risk of stress-urinary-incontinence surgery: nationwide cohort study

BACKGROUND Hysterectomy for benign indications has been associated with an increased risk for lower-urinary-tract sequela, but results have been inconclusive. We aimed to establish the risk for stress-urinary-incontinence surgery after hysterectomy for benign indications. METHODS We did a nationwide, population-based, cohort study from 1973 to 2003 in Sweden. We identified our population from the Swedish Inpatient Registry. We selected 165 260 women who had undergone hysterectomy (exposed cohort) and a control group of 479 506 individuals who had not had this procedure (unexposed cohort), matched by year of birth and county of residence. In both cohorts, occurrence of stress-urinary-incontinence surgery was established from the Swedish Inpatient Registry. Hazard ratios with 95% CIs were calculated by Coxs proportional-hazards regression. FINDINGS During the 30-year observational period, the rate of stress-urinary-incontinence surgery per 100,000 person-years was 179 (95% CI 173-186) in the exposed cohort versus 76 (73-79) in the unexposed cohort. Correspondingly, individuals in the exposed cohort were at increased risk for stress-urinary-incontinence surgery compared with those in the unexposed cohort (hazard ratio 2.4; 95% CI 2.3-2.5), irrespective of surgical technique. Risk for stress-urinary-incontinence surgery varied slightly with time of follow-up: the highest overall risk was recorded within 5 years of surgery (2.7; 2.5-2.9) and the lowest risk was seen after an observation period of 10 years or more (2.1, 1.9-2.2). INTERPRETATION Hysterectomy for benign indications, irrespective of surgical technique, increases the risk for subsequent stress-urinary-incontinence surgery. Women should be counselled on associated risks related to hysterectomy, and other treatment options should be considered before surgery.

Perioperative morbidity using transvaginal mesh in pelvic organ prolapse repair

OBJECTIVE: To describe the perioperative morbidity associated with transvaginal mesh repair of pelvic organ prolapse. METHODS: During a 6-month time period, 25 centers registered all surgical procedures using a commercially available mesh. The frequency and type of perioperative complications, during surgery and the associated hospital stay, were documented using a standardized protocol. RESULTS: During the inclusion period, 248 women underwent transvaginal mesh surgery: anterior repair in 106 patients (43%), posterior repair in 71 (29%), combined anterior and posterior repair in 20 (8%), and total repair in 51 (21%). Mean age was 67.8 years (±10.3 standard deviation) and median parity was 2 (range 0–6). Surgery for prolapse recurrence was performed in 56% of the patients (n=140), and 91% (n=225) had undergone at least one previous pelvic floor surgical procedure. Serious complications occurred in 4.4% of patients (n=11) and were dominated by visceral injury (10 of 11 cases). One case of bleeding in excess of 1,000 mL occurred. Minor complications occurred in 14.5% of patients (n=36), and the majority were urinary tract infections, urinary retention, and postoperative fever. A multivariable risk analysis showed that concurrent pelvic floor surgery was associated with an increased risk for minor complications, odds ratio 2.8 (95% confidence interval 1.1–6.9). There were no other predictors of outcomes when assessing the association with age, parity, weight, previous pelvic floor surgery, previous hysterectomy, or concurrent hysterectomy. CONCLUSION: Perioperative serious complications are uncommon after transvaginal mesh procedures although particular care should be taken to detect visceral injury at the time of surgery. LEVEL OF EVIDENCE: III