Long-term follow-up after urethral injection with polyacrylamide hydrogel for female stress incontinence.

Urethral injection therapy for treatment of stress urinary incontinence has been in use for years, but only a few long-term follow-up studies have been published. Twenty-five women, injected with polyacrylamide hydrogel 8 years earlier, were invited for follow-up. Twenty-four could be contacted; 15 had had no further treatment, seven had been re-operated with placement of mid-urethral slings, and two had been re-injected with polyacrylamide hydrogel. Eleven women attended for objective examination; all non-attenders were interviewed by telephone. Subjectively, in 44% the stress incontinence was cured or much improved, with a positive outcome according to the King's Health Questionnaire. Objectively, all patients had visible polyacrylamide hydrogel deposits on vaginal ultrasonography. No local adverse reactions were seen in the vaginal mucosa. The results of a later mid-urethral sling were unaffected by previous polyacrylamide hydrogel injection.

The inter-system association between the simplified pelvic organ prolapse quantification system (S-POP) and the standard pelvic organ prolapse quantification system (POPQ) in describing pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: The objective of this study is to determine the association between the POPQ and a simplified version of the POPQ. METHODS: This was an observational study. The subjects with pelvic floor disorder symptoms underwent two exams: a POPQ exam and a simplified POPQ. To compare with the simplified POPQ, vaginal segments of the POPQ exam were defined using points Ba, Bp, C, and D. Primary outcome was the association between the overall ordinal stages from each exam. RESULTS: One hundred forty-three subjects with mean age of 56 +/- 13 years. Twenty three subjects were status post-hysterectomy. The Kendall's tau-b statistic for overall stage was 0.80, for the anterior vaginal wall the Kendall's tau-b was 0.71, for the posterior vaginal wall segment the Kendall's tau-b was 0.71, for the cervix the Kendall's tau-b was 0.88, for the posterior fornix/vaginal cuff the Kendall's tau-b was 0.85. CONCLUSIONS: There is substantial association between the POPQ and a simplified version of the POPQ.

Long-term results of vaginal repairs with and without xenograft reinforcement.

INTRODUCTION AND HYPOTHESIS: The aim of this paper is to study if xenograft reinforcement of vaginal repair reduces recurrence of prolapse. METHODS: Results 1-5 years after vaginal repair were studied in 41 cases with xenograft and in 82 matched controls without. Symptoms were evaluated by a validated questionnaire and anatomy by pelvic organ prolapse quantification (POPQ). RESULTS: Significant more cases, 97% versus 81% controls, felt cured or much improved (p = 0.02); 11% of cases and 19% of controls had POP symptoms, POPQ > -1 was found in 31% cases and 24% controls. Defining recurrence as POPQ > -1 plus symptoms revealed recurrence in 3% of cases and 12% controls. None of the recurrence rates was significantly different for cases versus controls. No vaginal erosions were seen. Previous surgery was a significant risk factor with odds ratio 7.3 for another recurrence. CONCLUSIONS: Recurrence rates defined by POPQ plus symptoms were low compared to literature. Xenograft reinforcement might improve results.

Tissue integration of polyacrylamide hydrogel: an experimental study of periurethral, perivesical, and mammary gland tissue in the pig.

BACKGROUND Polyacrylamide hydrogel (PAAG) is a nondegradable water-based polymer with high viscoelasticity. The gel is used as a tissue filler, the only risk being prolonged infection with anaerobic, contaminating microorganisms if not treated early with broad-spectrum antibiotics. OBJECTIVE With silicone gel as reference, PAAG tissue integration and migration was studied in a longitudinal study of the pig. MATERIALS AND METHODS Forty-one pigs were used. PAAG and silicone gel were injected into mammary tissue, and PAAG was injected into urethral or bladder wall or the anal canal. Tissues and regional lymph nodes were examined at 1, 1(1/2), 3, 3(1/2), 6, 12, and 14 months, and other lymph nodes and organs were examined at 1, 6, 12, and 14 months. RESULTS PAAG was invaded by macrophages and giant cells that were gradually replaced by a network of fibrous tissue. Silicone gel was seen inside these cells or as large vacuoles, surrounded by a fibrous capsule. Regional lymph nodes contained PAAG only at 1 1/2 months and silicone gel at 12 months. CONCLUSION PAAG is a stable, viscoelastic bulking agent, which unlike silicone gel is slowly integrated within its host tissue via a thin fibrous network. Long-term risk of fibrosis and migration is minimal.

Classification and evaluation of prolapse.

Pelvic organ prolapse is prevalent among older women. Milder stages of prolapse, cranial to the hymen, are common and usually symptomless. A specific symptom is a bulge outside the vagina. Functional symptoms from the bladder, bowel and sexual life frequently coexist without a known cause/effect relationship to prolapse. Prolapse should be measured by the validated internationally approved pelvic organ prolapse quantification (POPQ) system that can measure prolapse in the three compartments and three levels of the vagina. We should work on a common classification system and agreement in which symptoms should be recorded as related to prolapse and expected to improve by prolapse surgery.

Pathophysiology of sexual dysfunction as related to pelvic floor disorders.

Female sexual dysfunction must be evaluated in the context of age, marital status, and general health status of the woman. Questionnaires evaluating the four domains of female sexual dysfunction can be used as a screening tool to evaluate the effect of pelvic floor disorders and coital leakage, as well as the effect of surgical methods and medical treatment on sexual function. Sexual problems are seldom volunteered symptoms, and only recording whether the woman has dyspareunia and frequency of sexual activity must be considered end-point parameters of a complex function. These parameters cannot explain the pathophysiological causes of the problem. There is a paucity of validated, easily accessible methods and parameters to objectively assess female sexual function.

Vaginal pressure during daily activities before and after vaginal repair.

The objective of the study was to measure vaginal pressure during various daily activities in patients before and after vaginal surgery for pelvic organ prolapse, searching data for evidence-based activity guidelines. Vaginal pressure (VP) was studied in 23 patients during activities such as rest, pelvic floor contraction (PFC), coughing, Valsalva, rising from sitting to standing and lifting 2 and 5 kg with four different lifting techniques. VP was measured before, 1-5 days and 4-6 weeks after vaginal repair. Mean VP was four to five times higher during coughing and Valsalva compared to PFC and lifting 2 and 5 kg. Lifting in the walking position created a slightly higher VP compared to other lifting techniques, which did not differ. The VP did not increase when lifting 5 kg compared to 2 kg. Mean VP during coughing and Valsalva were significantly lower 1-5 days after the operation. VP was not related to the type of vaginal repair. The results imply that post-operative counselling should concentrate more on treating chronic cough and constipation than restrictions of moderate physical activities.

A new bulking agent (polyacrylamide hydrogel) for treating stress urinary incontinence in women.

OBJECTIVE: To evaluate the efficacy and safety of a transurethral injection with polyacrylamide hydrogel (PAHG) for treating stress urinary incontinence (SUI) in women. PATIENTS AND METHODS: The study comprised 17 women with pure SUI and eight with mixed incontinence (age range 35-84 years). Between November 2001 and November 2003, the women were injected into the urethral wall with a PAHG (Aquamid, Contura International A/S, Denmark), a homogenous, highly biocompatible, atoxic, nonresorbable sterile watery gel consisting of approximately 2.5% cross-linked polyacrylamide and 97.5% nonpyrogenic water. The women were followed prospectively (assessed at 1, 3 and 12 months after treatment) and their clinical outcome documented. RESULTS: Four women did not complete the study, and of the remainder, eight (38%) were subjectively dry and a further nine (43%) improved. Objectively, urine leakage/24 h was decreased by 93% and the number of incontinence episodes by 87%. Quality-of-life measures improved significantly in all domains other than general health perception. There were no significant changes of urodynamic variables. Treatment-related adverse events were recorded in 16 women. Urinary tract infection (10 cases) and urinary retention (five cases) were most common. There were no injection site reactions. CONCLUSION: PAGH seems to be a promising new bulking agent for the treatment of SUI.

Symptoms, bother and POPQ in women referred with pelvic organ prolapse.

The aim of this study was to evaluate symptoms and bother in patients with pelvic organ prolapse (POP) and to compare symptoms with POP-Q grading and measurements. One hundred and ten women with POP filled in a symptom-bother questionnaire concerning frequency of mechanical, bladder, bowel and sexual problems, and a 4-point bother score. The POP was grouped grade 0-1 versus grade >or=2 in each compartment. Symptoms more than once per week were associated with a higher bother score. Mechanical symptoms, reported in 70%, were the most troublesome. Various bladder, bowel and sexual symptoms were reported in 5%-52%, 5%-39%, and 35%-57%, respectively. We concluded that symptoms from all domains were frequent and reported generally and with little relation to prolapse in a specific compartment or POP-Q value.

How important is TVT location?

BACKGROUND: The tension-free vaginal tape (TVT) is claimed to be a midurethral procedure, but data on sling placement are scarce to date. The aim of this study was to investigate tape position and mobility and correlate this with postoperative symptoms of bladder dysfunction. METHODS: One hundred and forty-one women 5 weeks to 2.1 years (mean 0.66 years) after TVT placement took part in a prospective clinical observational study. Appointments consisted of standardized symptom questionnaire, clinical stress test flowmetry and translabial ultrasound. The main outcome measures were patient symptoms, subjective satisfaction and cure/improvement. Paired t-test and anova statistics were employed for continuous, normally distributed parameters. RESULTS: Tape position varied from 30 mm above to 12.7 mm below the symphysis at rest and between 15 mm above to 18.7 mm below the symphysis on Valsalva. The horizontal distance of the tape from the symphysis pubis was weakly associated with recurrent stress incontinence (p = 0.048). More cranial tapes were weakly associated with urge incontinence (p = 0.03), frequency (p = 0.048) and symptoms of voiding dysfunction (p = 0.029). There was no association between tape placement and patient satisfaction or subjective cure/improvement. CONCLUSIONS: Position and mobility of the TVT vary markedly. This may be explained by varying degrees of dissection, localization of incisions and the preoperative degree of anterior vaginal wall prolapse. However, variations in placement seem to have relatively little effect on symptoms.

Does the tension-free vaginal tape stay where you put it?

OBJECTIVE: The tension-free vaginal tape (TVT) is a widely used procedure for the surgical treatment of urodynamic stress incontinence. Long-term follow-up data remain scarce. It has been speculated that scar formation leads to tape shortening and stiffening. This study was designed to longitudinally investigate tape position and mobility. STUDY DESIGN: An observational clinical study was performed using ultrasound parameters of tape position and mobility on Valsalva maneuver as main outcome parameters. RESULTS: Of 92 women eligible for a minimum of two postoperative assessments, 72 (78%) attended at least twice after TVT placement, at a median interval of 1.6 years. Sixty-eight data sets remained after exclusion of 4 patients who had undergone tape division. At the last visit, the tape was found to be more caudal, at rest (P <.001) and on Valsalva maneuver (P =.002). Tape mobility on Valsalva maneuver remained virtually unchanged. CONCLUSION: The TVT does not seem to contract or shorten over a median observation period of 1.6 years. On the contrary, it appears to slowly migrate caudally.