Sage Journals: Discover world-class research

Abstract

A transurethral radiofrequency collagen denaturation system was recently approved by the US FDA for nonsurgical, outpatient treatment of women with stress urinary incontinence associated with urethral hypermobility. Controlled radiofrequency energy applied through a transurethral probe heats submucosal tissue to produce collagen denaturation, resulting in reduced tissue compliance without necrosis, thus distinguishing this procedure from transvaginal radiofrequency tissue ablation. Treatment can be administered in 30 min under local anesthesia, without incisions, use of cystoscopy or other visualization of the treatment site. Safety and efficacy have been demonstrated in several studies, including a 12-month, multicenter, sham-procedure-controlled clinical trial in 173 women with mild-to-moderate stress urinary incontinence. In patients receiving active treatment, two of the four groups experienced significant quality-of-life changes (p = 0.004; p = 0.02), and all women exhibited significant increases in Valsalva leak point pressure (p = 0.02 vs sham group).

Keywords

bladder collagen female urogenital diseases Renessa®urinary incontinence

Urinary incontinence affects an estimated 38% of women in the USA [1]. Stress urinary incontinence (SUI) accounts for most cases [101] and is characterized by the involuntary loss of urine during physical activity, coughing, sneezing, laughing, lifting or any body movement that puts pressure on the bladder [2,3,102]. The most common type of SUI is associated with bladder outlet (or urethral) hypermobility, defined as the rotational descent of the bladder neck and proximal urethra that occurs during periods of increased intra-abdominal pressure causing inappropriate opening of the proximal urethral lumen [3]. This is a consequence of weakening of the pelvic floor muscles that support the bladder, which is often attributable to childbirth or menopause.

Although SUI is not a life-threatening disorder, it can have a profound impact on a woman's quality of life (QoL), often limiting her professional, social, sexual and recreational activities, as well as diminishing her self-esteem.

Treatment options

A broad spectrum of treatment options for SUI developed over the last century range from noninvasive physical and behavioral techniques, such as pelvic floor muscle retraining, electrical stimulation, biofeedback and vaginal cones, to more than 160 surgical interventions of varying degrees of invasiveness [4]. Due to their noninvasive nature, physical and behavioral techniques are commonly used as first-line therapy for SUI.

While these methods can be effective, outcomes are dependent on patient understanding, training, motivation and persistence, and may still be suboptimal [4,5].

Although pharmacologic therapy, primarily with antimuscarinic agents, is used in the management of urge incontinence, pharmacologic treatment options for patients with SUI alone have been limited to the off-label use of several classes of medications, including estrogens, α-adrenergic receptor agonists, β-adrenergic receptor antagonists, tricyclic antidepressants and anticholinergics [6]. These agents have limited effectiveness in the treatment of SUI.

Open retropubic suspensions and slings are currently the standard techniques. Their success rates are more than 80% at 48 months [4,7], but may be associated with voiding difficulties and detrusor overactivity [4]. Furthermore, the inherent need for general anesthesia, short-term hospitalization and a recuperation period have fueled the development of less invasive forms of procedures utilizing laparoscopic approaches. Another less invasive technique, the injection of periuretheral bulking agents, has also been developed as an alternative to surgical procedures. However, the success rates of these techniques are limited. Alternative materials and supporting methods and devices have all been developed to decrease operative time and peri-operative morbidity, while still approximating results obtained with standard approaches for these procedures.

A recent study of women's expectations and acceptance of various treatment options for SUI found that only 17% of respondents would expect a complete cure of all bladder symptoms and 43% would accept a good improvement that would no longer interfere with their life [8]. Regarding the acceptability of treatment options, 60% would accept limited term (6 months) of pelvic floor exercises, but only 41% would do so if this treatment was required for life. Only 14% would be willing to take drugs for life [8]. Assuming an 85% cure rate, the acceptability of major and minor surgical procedures were 23 and 38%, respectively. However, a clinical (i.e., nonsurgical) procedure with 60% improvement was acceptable to 57% of the women. Another recent study found that patients would choose a less invasive procedure over surgery, despite a much lower cure rate [9].

New office-based option

A new treatment option has been cleared by the US FDA for patients who have SUI owing to bladder outlet hypermobility. The office-based transurethral radiofrequency (RF) energy collagen denaturation system (Renessa®, Novasys Medical Inc., CA, USA) administers RF energy through a transurethral probe to induce submucosal collagen denaturation, a structural change in collagen that leads to reduction in tissue compliance. This RF treatment greatly differs from an older, surgical RF treatment: transvaginal RF tissue ablation (SURx, Cooper Surgical, CA, USA). The RF transurethral collagen denaturation treatment does not produce tissue necrosis, while the RF transvaginal ablation procedure intentionally destroys cells to produce gross shrinkage or vascular destruction [10 –13]. Rather, RF collagen denaturation aims to reduce regional dynamic tissue compliance without creating strictures or reducing luminal caliber, thus resulting in a functional rather than a gross anatomic change [14 –16]. The treatment can be administered in approximately 30 min in an outpatient or office setting using local anesthesia. Patients generally can return to normal activity the same or the next day, with minimal limitations.

Mechanism of action

Ablation via the application of high levels of RF energy has long been used for the destruction of arrhythmic cardiac tissue, shrinkage of excessive soft palate tissue, shortening of injured spine and joint ligaments and reduction of benign hyperplastic prostatic tissue. These procedures utilize relatively high levels of RF energy and higher temperatures for longer time periods to heat various body tissues to the point of necrosis, resulting in gross tissue shrinkage.

The application of lower levels of RF energy generates lower, subnecrotic tissue temperature (65–75°C) and requires less application time. As a result, tissue necrosis and gross shrinkage do not occur. Instead, such controlled RF energy collagen denaturation results in focal, microscopic restructuring of collagen (denaturation) without associated tissue necrosis or vascular or nerve injury. After healing, denatured collagen results in reduced dynamic compliance of the surrounding untreated tissue. Thus, RF collagen denaturation is well suited for the treatment of barrier function disorders in which luminal dynamic compliance must be reduced, but luminal narrowing (stricture) must be avoided.

RF collagen denaturation has been used successfully in the treatment of fecal incontinence [16], gastroesophageal reflux disorder [17] and shoulder ligament repair [18]. Initial animal studies of transurethral RF collagen denaturation evaluated its physiologic and gross and histologic impact effect, and demonstrated that this procedure was feasible and safe, as well as suggesting a beneficial effect such as an increase in Valsalva leak point pressure (LPP) [19].

Procedure

The procedure is performed in an outpatient setting under local anesthesia, without the assistance of cystoscopy, fluoroscopy or any other visualization or imaging technique. The transurethral RF collagen denaturation system uses a special 21 French transurethral probe with a balloon on the proximal end and an insufflation port on the handle (Renessa Probe, Novasys Medical Inc.) that is connected to a commercially available compact RF generator (Novasys Medical Inc.). The system is monopolar and uses a standard return electrode (‘grounding pad’) appropriately placed on the patient and connected to the RF generator. Just distal to the balloon, four curved, 23-gauge, nickel-titanium needle electrodes are deployed by advancing a sliding ring on the handle.

With the patient in the lithotomy position, the bladder is emptied via catheterization and then refilled with sterile water to a set volume. The lubricated probe is passed through the urethra into the bladder, inflated with 30 cc of sterile water, and then palpably anchored within the bladder outlet (identical to the anchoring of a Foley catheter). Normal saline should not be used as this is a conductive fluid. Since the treatment applies electrical energy into the tissues, a conductive fluid would draw energy away from the targeted tissues, thereby reducing treatment effectiveness. Four needle electrodes are deployed through the urethral mucosa into the submucosa (Figure 1). RF and irrigation are delivered simultaneously to the four needles for 60 s, creating four circumferential lesions. The location of lesions, as well as the depth of needle deployment, are controlled by a series of rotational and other simple maneuvers of the probe. RF energy is delivered a total of nine times for 60 s in each location, thus collagen is denatured at 36 tissue sites for a total of 9 min. The entire procedure, including a periurethral block, device placement and treatment, requires approximately 30 min. No bandages or dressings are required, and the patient can be discharged after spontaneous voiding.

Figure 1.

Transurethral radiofrequency probe with inflated balloon positioned in the bladder, with two needles deployed into the submucosa.

Both the probe and the RF generator have numerous safety features that independently monitor needle tip (submucosal) and needle penetration site (mucosal) temperatures, along with tissue impedance associated with each needle, every 1 s during RF delivery. If any of these parameters exceed preset safety threshold levels, RF delivery to the associated needle is automatically and immediately terminated. As an additional safety measure, room-temperature sterile water flowing from channels within the shaft adjacent to the needle exit sites irrigates the mucosa during RF delivery.

Clinical experience

Efficacy

An early human trial of the transurethral RF collagen denaturation procedure was a pilot trial in women with moderate-to-severe SUI [20,21]. This study was performed to evaluate safety and the effect on patient QoL and incontinence episode frequency. In addition, this trial sought to analyze the outcomes of four treatment regimens that differed in total number and anatomic locations of RF applications within the lower urinary tract.

A total of 41 women with a clinical diagnosis of SUI and evidence of bladder outlet hypermobility on physical examination were sequentially entered into one of four treatment groups who received different RF treatment regimens ( Table 1 ) [20]. After undergoing RF collagen denaturation treatment, preexisting urinary tract infections were identified from the screening urine cultures from three women, and a fourth patient admitted to an active history of urge symptoms and use of anticholinergic medication at baseline [20]. Consequently, these four patients were excluded from efficacy analysis but were included in the safety analysis. Patients were evaluated at 2 weeks, 2 or 3 months and 6 months after treatment [20].

Table 1.

Transurethral radiofrequency collagen denaturation regimens of a pilot study that sequentially entered women with a clinical diagnosis of stress urinary incontinence (n = 41) into one of four treatment groups.

	Group 1 (n = 10)	Group 2 (n = 10)	Group 3 (n = 11)	Group 4 (n = 10)
Total number of RF energy application sites	24	36	48	60
Site locations (n)	Proximal urethra (24)	Vesicourethral junction (12); proximal urethra (24)	Distal bladder outlet (24); proximal urethra (24)	Distal bladder outlet (24); vesicourethral junction (12); proximal urethra (24)
Total duration of RF energy delivery (min)	7.5	10.5	12.0	15.0

RF: Radiofrequency.

The primary efficacy variable was change from baseline in the Incontinence QoL (I-QoL) score [20,21]. The I-QoL instrument, a disorder-specific, validated questionnaire [22,23], generates an overall score from 0–100 (0 indicates worst possible incontinence QoL), and three subscale scores, namely avoidance and limiting behavior, psychosocial impact and social embarrassment [23]. In addition to being validated and simple for patients to use, a major advantage of the I-QoL instrument is the demonstrated association between specific numeric improvements in the overall score and specific objective and subjective clinical improvements. For example, a 10-point increase in the overall score is associated with patient perception of being ‘much better’ on a global perception of change scale, and a 25% or greater reduction in incontinence episode frequency, and nine-point increase correlates with a 25% or greater reduction in incontinence pad weight [23]. Secondary efficacy variables included incontinence episode frequency and incontinence pad use during the week preceding each follow-up visit [20]. The use of urinary diaries and pad weight data as a primary efficacy end point can be problematic, as the nonuniformity of testing techniques in different trials makes it difficult to compare results between trials. However, use of I-QoL scores as primary variables correlates with defined responsiveness in urinary frequency and pad use.

At 6 months, there were increases in mean overall I-QoL scores in all four treatment groups, although the improvements were significant only in groups 2 and 4 ( Table 2 ) [20]. Furthermore, the majority of patients in all groups experienced a mean 10-point or greater increase in overall score, thereby indicating good efficacy in terms of improvement in patient QoL [20]. With the exception of those in treatment group 1, who had the fewest number of injections, all isolated to the proximal urethra, patients reported varying reductions in daily incontinence episodes, with significant decreases in groups 2 and 4 ( Table 2 ) [20]. In addition, daily pad use decreased to some degree in all groups and was significant in group 4 ( Table 2 ) [20].

Table 2.

Summary of changes from baseline to 6 months post-treatment in a pilot study of transurethral radiofrequency collagen denaturation in women with stress urinary incontinence.

	Group 1 (n = 8)	Group 2 (n = 9)	Group 3 (n = 11)	Group 4 (n = 9)
Mean incontinence QoL scores
Baseline	44.1	53.9	54.9	53.6
6 months	54.3	76.6	66.4	80.6
Increase ≥10 points (%)	63	78	70	67
p-value	NS	0.004	NS	0.02
Mean daily incontinence episodes
Baseline	2.6	4.6	2.9	3.9
6 months	2.6	2.1	1.9	0.7
Change from baseline*	0.0	−2.5	−1.0	−3.2
p-value	NS	0.04	NS	0.004
Mean daily pad usage
Baseline	1.9	2.1	1.6	2.0
6 months	2.0	1.4	0.8	0.0
Change from baseline‡	0.1	−0.7	−0.8	−2.0
p-value	NS	NS	NS	0.03

Negative numbers indicate decrease in incontinence episodes.

‡

Negative numbers indicate decrease in pad usage.

NS: Not significant.

Data from [20].

A recent paper reported the results of this pilot trial after 12 months of follow-up [21]. The incidence of I-QoL overall score improvement of 10 points or more ranged from 44 to 70% of patients ( Table 3 ). The percentage of patients who experienced at least a 50% reduction in daily incontinence episode frequency ranged from 63 to 89%, and the ‘cure’ rate (defined as no incontinence episodes or any use of pads between 6 and 12 months) ranged from 22 to 67% ( Table 3 ) [21].

Table 3.

Summary of changes from baseline to 12 months in a pilot study of women with stress urinary incontinence treated with nonsurgical radiofrequency collagen denaturation.

Mean incontinence QoL scores	Mean daily incontinence episode frequency

	Group 1 (n = 8)	Group 2 (n = 9)	Group 3 (n = 10)	Group 4 (n = 9)
Improvement	23	16	17	24
(standard deviation)	29	21	22	27
Any increase (%)	75	78	70	78
Increase ≥10 points (%)	63	44	70	67
p-value	NS	0.05	0.04	0.03
Any IEF reduction (%)	88	67	70	89
≥50% IEF reduction (%)	63	67	70	89
Patients considered cured*	40	22	40	67

Cured was defined as no incontinence episodes and no use of pads between 6 and 12 months post-treatment. IEF: Incontinence episode frequency: NS: Not significant; QoL: Quality of Life. Data from [21].

A subsequent 12-month, randomized, controlled trial compared the safety and efficacy of the transurethral RF collagen denaturing system with a sham procedure [24]. A total of 173 women with various degrees of SUI were prospectively randomized to receive active (n = 110) or sham treatment (n = 63) [24]. Randomization was computer generated and targeted a 2:1 treatment:sham treatment ratio as well as age comparability between the treatment arms. The sham treatment differed from active treatment in that the probes lacked needle electrodes, and the generator, while appearing and sounding similar, did not actually deliver RF energy. The RF collagen denaturation regimen entailed the production of 36 microscopic, circumferential, submucosal lesions ranging from the bladder neck, cranially, to the middle aspect of the proximal urethra, caudally. All procedures were performed in an outpatient setting under conscious sedation. The entire procedure, including positioning and treatment, took approximately 20 min.

One subjective and one objective measure were used in the analysis of efficacy. Impact on patient subject QoL was based on the incidence of 10-point or greater improvement in I-QoL score at 6 and 12 months. Objective treatment efficacy was evaluated through LPP testing at 6 and 12 months [24]. In addition, immediately prior to discharge, patients indicated their level of pain or discomfort by circling a number from zero (no pain) to 10 (terrible pain) on a visual analog scale.

Immediately prior to discharge, the mean visual analog scale pain/discomfort score in the active treatment group was 1.3 (range: 0–8), not significantly different than the mean score in the sham treatment group. Of patients in the active treatment group, 51% rated their discomfort as zero [24].

At 12 months, the evaluable population for QoL analysis comprised 89 (80.1%) patients in the active treatment arm and 53 (84.1%) patients in the sham treatment group [24]. This analysis did not include: 12-month data from 21 women who were lost to follow-up; data from eight women whose change in I-QoL, either favorable or unfavorable, could not clearly be attributed to the treatment or sham procedure because of a change in medical history (e.g., hysterectomy during the trial period or urinary tract infection at 12 months); and data from two women whose baseline I-QoL scores were at least 90 points and who therefore could not numerically achieve a 10-point or greater score improvement. Among RF-treated patients with moderate-to-severe SUI, 74% experienced a 10-point or greater improvement in I-QoL scores compared with the 50% who underwent sham treatment, a significant difference (p = 0.03) [24]. This ‘placebo response’ by patients undergoing sham treatment could have resulted simply by participating in this trial. Multiple physician visits, responding to the I-QoL questionnaire, and undergoing urodynamic testing may have resulted in an increased patient awareness and understanding of SUI and prompted beneficial behavioral modification.

The results of LPP testing at 12 months were available for 87 (79.1%) patients in the active treatment group and for 49 (77.8%) of those in the sham treatment arm. There were no significant differences regarding demographic or other baseline characteristics between these two evaluable populations. Women in the RF collagen denaturation group, irrespective of baseline incontinence severity, experienced a 13.2 cmH₂O increase in LPP at 12 months compared with a 2.0 cmH₂O decrease in those who underwent sham treatment (p = 0.02).

Secondary end point results from the treatment group in this study revealed that 76% of women experienced a reduction in daily incontinence episodes, 68% used fewer pads daily and 58% no longer used pads [24 –26]. Additionally, 67% reported improved QoL and 35% became continent [27].

Safety

In the pilot study, there were no serious adverse events (SAEs) associated with the procedure or identified up to 6 months following the procedure [20]. All minor clinical events (MCEs) were recorded, regardless of severity and possible relationship to the procedure. Those MCEs recorded during the procedure and recovery and during the 30-day post-treatment period are listed in Table 4 and, with the exception of one case of urinary retention presenting 24 h following discharge that required an indwelling catheter for 48 h, with no further retention episodes, none of these MCEs required therapeutic intervention and no patient found her symptoms distressing enough to request an unscheduled physician visit.

Table 4.

Adverse events reported in patients (n = 37) during the pilot trial of transurethral radiofrequency collagen denaturation in women with stress urinary incontinence.

Adverse event	n (%)
During procedure or in recovery room
Any serious event	0 (0)
Dysuria	1 (3)
Gross hematuria	1 (3)
Anesthetic reaction	1 (3)
30 days post-treatment
Any serious event	0 (0)
Dysuria	23 (62)
Urgency or pain	19 (51)
Gross hematuria	16 (43)
Urinary retention (requiring 48-h indwelling catheter)	1 (3)

Data from [20].

Through the 12 months following the pilot study procedure, there remained a 0% incidence of SAEs [21]. Between the 6- and 12-month visits, 8% of patients experienced at least one episode of dysuria and 22% reported at least one episode of urgency, although none of these experiences was considered problematic to the patient in terms of QoL.

In the randomized, controlled trial, safety was evaluated by recording all AEs at 1 week and at 1, 3, 6 and 12 months. Postvoid residual imaging was performed at 1, 3, 6 and 12 months, and cystometrograms were repeated at 6 and 12 months. No SAEs occurred during this 12-month trial. Except for the incidence of dysuria, which was greater among women in the RF-treated group, there were no significant between-group differences in the incidence of all other minor AEs ( Table 5 ) [24]. All cases of dysuria, hematuria and hesitancy were transient and mild to moderate, and all urinary tract infections were simple and resolved with antibiotic therapy [24].

Table 5.

Prevalence of adverse events in a randomized, controlled 12-month study of transurethral radiofrequency collagen denaturation in women with stress urinary incontinence.

Adverse event	Active treatment, n (%) (n = 110)	Sham treatment, n (%) (n = 63)	p-value
Dysuria	10 (9.1)	1 (1.6)	0.06
Hematuria	1 (0.9)	0 (0.0)	NS
Urinary retention	1 (0.9)	0 (0.0)	NS
Urinary tract infection	5 (4.5)	3 (4.8)	NS
Hesitancy	0 (0.0)	1 (1.6)	NS
Asymptomatic detrusor overactivity	2 (1.8)	4 (6.3)	NS
‘Dry’ overactive bladder	8 (7.3)	2 (3.2)	NS
‘Wet’ overactive bladder	11 (10.0)	6 (9.5)	NS

NS: Not significant.

Data from [24]

Conclusion

Results up to 3 years postprocedure in these clinical trials demonstrate the safety, relative simplicity and durability of favorable outcomes of nonsurgical transurethral RF collagen denaturation for women with SUI [27]. The results of the randomized, sham-controlled trial are of particular note since both subjective and objective outcomes were assessed and the study used a sham procedure in the control arm. The significant improvements in QoL in women with moderate-to-severe SUI were of a magnitude associated with patient satisfaction with this procedure. There was a significant increase in LPP in the RF treatment group compared with a decrease in sham-treated patients. The safety profile for the RF treatment was no different than that after brief bladder catheterization with the needless probe in sham-treated patients, and there was no significant difference in the prevalence of any AE [24]. These characteristics make RF collagen denaturation a promising new option in the management of SUI.

Future perspective

Since transurethral RF collagen denaturation is an office-based, outpatient procedure requiring only local anesthesia and minimal recuperation, it could become an acceptable alternative for women with SUI. Since the procedure does not alter anatomic relationships of the endopelvic region, future surgical interventions would not be precluded in women who might choose to pursue other treatment options in the future.

Additional studies of transurethral RF collagen denaturation are ongoing. A 3-year follow-up analysis from the 12-month, randomized, controlled trial is being prepared for publication. A 3-year prospective trial is evaluating the durability of response with this procedure. In addition, a study to expand the indication for transurethral RF collagen denaturation in patients who experienced a suboptimal response to surgical intervention is under way.

Information resources

Chaliha C, Stanton SL: Complications of surgery for genuine stress incontinence. Br. J. Obstet. Gynaecol. 106, 1238–1245 (1999).

Diokno AC, Burgio K, Fultz H et al.: Prevalence and outcomes of continence surgery in community dwelling women. J. Urol. 170, 507–511 (2003).

Lenihan JP: Comparison of the quality of life after nonsurgical radiofrequency energy tissue micro-remodeling in premenopausal and postmenopausal women with moderate-to-severe stress urinary incontinence. Am. J. Obstet. Gynecol. 192, 1995–1998 (2005).

Lenihan JP, Palacious P, Sotomayor M: Oral and local anesthesia in the nonsurgical radiofrequency-energy treatment of stress urinary incontinence. J. Minimal Invas. Gynecol. 12, 415–419 (2005).

Nygaard I, Thom DH, Calhoun EA: Urinary incontinence in women. In: Urologic Diseases in America. Litwin MS, Saigal CS (Eds). US Government Publishing Office, Washington, DC, USA, 69–103 (2004).

Ramsay IN: The treatment of stress incontinence – is there a role for laparoscopy? BJOG 111(Suppl. 1), 49–52 (2004).

Schuessler B, Baessler K. Pharmacologic treatment of stress urinary incontinence: expectations for outcome. Urology 62, 31–38 (2003).

Taub DA, Hollenbeck BK, Wei JT et al.: Complications following surgical intervention for stress urinary incontinence: a national perspective. Neurourol. Urodyn. 24, 659–665 (2005).

Vella M, Robinson D, Cardozo L, Cartwright R: New developments in the treatment of urinary incontinence. Minerva Urol. Nefrol. 58, 299–310 (2006).

Executive summary

The transurethral radiofrequency (RF) collagen denaturation system was recently approved for the treatment of stress urinary incontinence owing to bladder outlet hypermobility in women who have failed conservative treatment and who are not candidates for surgery.

Controlled low-temperature RF energy is delivered via a single-use probe to heat tissue targets within the lower urinary tract, denaturing collagen at multiple small treatment sites. After healing, the areas of denatured collagen decrease tissue compliance, thereby resisting involuntary urinary leakage.

This office-based procedure requires no incisions, cystoscopic or other visualization of the treatment site, and can be performed in approximately 30 min in an outpatient setting with only conscious sedation and oral analgesia.

The efficacy and safety of transurethral RF collagen denaturation was demonstrated in a 12-month, randomized, sham-procedure-controlled clinical trial of 173 women.

With transurethral RF collagen denaturation, women with stress urinary incontinence now have an effective, minimally invasive treatment option.

References

Papers of special note have been highlighted as either of interest (•) or of considerable interest (••) to readers.

Anger

Saigal

Litwin

: The prevalence of urinary incontinence among community dwelling adult women: results from the National Health and Nutrition Examination Survey J. Urol. 175(2), 601–604 (2006).

Abrams

Cardozo

Fall

: The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology 61(1), 37–49 (2003).

Blaivas

Appell

Fantl

: Definition and classification of urinary incontinence: recommendations of the Urodynamic Society. Neurourol. Urodyn. 16(3), 149–151 (1997).

Balmforth

Cardozo

: Trends toward less invasive treatment of female stress urinary incontinence. Urology 62(4 Suppl. 1), 52–60 (2003).

Excellent overview of the evolution of surgical treatment of stress urinary incontinence (SUI).

Talseth

Holme

: Single blind, randomised controlled trial of pelvic floor exercises, electrical stimulation, vaginal cones, and no treatment in management of genuine stress incontinence in women. BMJ 318(7182), 487–493 (1999).

Appell

Davila

: Treatment options for patients with suboptimal response to surgery for stress urinary incontinence. Curr. Med. Res. Opin. 23(2), 285–292 (2007).

Scarpero

Dmochowski

: Sling failures: what's next? Curr. Urol Rep. 5(5), 389–396 (2004).

10.

Robinson

Anders

Cardozo

: What women want – their interpretation of the concept of cure [abstract] Neurourol. Urodyn. 21, 429–430. (2002).

11.

Results of a study of women's expectations and acceptability of various treatment options for SUI.

12.

Petrou

Lisson

Crook

Lightner

: An exploration into patient preference for injectable therapy over surgery in the treatment of female urinary incontinence. Int. Braz. J. Urol. 32(5), 578–582 (2006).

13.

Cooper

Gimpelson

Laberge

: A randomized, multicenter trial of safety and efficacy of the NovaSure system in the treatment of menorrhagia. J. Am. Assoc. Gynecol. Laparosc. 9(4), 418–428 (2002).

14.

Gallinat

: NovaSure impedance controlled system for endometrial ablation: three-year follow-up on 107 patients. Am. J. Obstet. Gynecol. 191(5), 1585–1589 (2004).

15.

Larson

: Rationale and assessment of minimally invasive approaches to benign prostatic hyperplasia therapy. Urology 59, 12–16 (2002).

16.

Minardi

Garofalo

Yehia

: Pressure-flow studies in men with benign prostatic hypertrophy before and after treatment with transurethral needle ablation. Urol. Int. 66, 89–93 (2001).

17.

Efron

Corman

Fleshman

: Safety and effectiveness of temperature-controlled radio-frequency energy delivery to the anal canal (Secca procedure) for the treatment of fecal incontinence. Dis. Colon Rectum 46(12), 1606–1616 (2003).

18.

Efron

: The SECCA procedure: a new therapy for treatment of fecal incontinence. Surg. Technol. Int. 13, 107–110 (2004).

19.

Takahashi

Garcia-Osogobio

Valdovinos

Belmonte

Barreto

Velasco

: Extended two-year results of radio-frequency energy delivery for the treatment of fecal incontinence (the Secca procedure). Dis. Colon Rectum 46(6), 711–715 (2003).

20.

Yeh

Triadafilopoulos

: Endoscopic antireflux therapy: the Stretta procedure. Thorac. Surg. Clin. 15(3), 395–403 (2005).

21.

Liao

Hedman

Vangsness

Jr : Thermal profile of radiofrequency energy in the inferior glenohumeral ligament. Arthroscopy 20(6), 603–608 (2004).

22.

Edelstein

: A preclinical study of nonsurgical radiofrequency collagen remodeling for the treatment of stress urinary incontinence. Expert Rev. Med. Devices 3(6), 743–738 (2006).

23.

Results of preclinical trials of radiofrequency (RF) collagen remodeling.

24.

Sotomayor

Bernal

: Transurethral delivery of radiofrequency energy for tissue micro-remodeling in the treatment of stress urinary incontinence. Int. Urogynecol. J. Pelvic Floor Dysfunct. 14(6), 373–379 (2003).

25.

6-month results of the pilot trial of RF collagen remodeling in women with SUI.

26.

Sotomayor

Bernal

: Twelve-month results of nonsurgical radiofrequency energy micro-remodeling for stress incontinence. Int. Urogynecol. J. Pelvic Floor Dysfunct. 16(3), 192–196 (2005).

27.

12-month results of the pilot trial of RF collagen remodeling in women with SUI.

28.

Yalcin

Bump

: Validation of two global impression questionnaires for incontinence. Am. J. Obstet. Gynecol. 189(1), 98–101 (2003).

29.

Patrick

Martin

Bushnell

Yalcin

Wagner

Buesching

: Quality of life of women with urinary incontinence: further development of the incontinence quality of life instrument (I-QoL). Urology 53, 71–76 (1999).

30.

Appell

Juma

Wells

: Transurethral radiofrequency energy collagen micro-remodeling for the treatment of female stress urinary incontinence. Neurourol. Urodyn. 25(4), 331–336 (2006).

31.

Results of a randomized, controlled clinical trial of RF collagen remodeling in women with SUI.

32.

Lenihan

: Comparison of the quality of life after nonsurgical radiofrequency energy tissue micro-remodeling in premenopausal and postmenopausal women with moderate-to-severe stress urinary incontinence. Am. J. Obstet. Gynecol. 192(6), 1995–1998 (2005).

33.

Wells

Kanellos

Impact of menopausal status on leak point pressure following nonsurgical radiofrequency energy tissue micro-remodeling in women suffering from stress urinary incontinence [abstract]. Presented at The Annual Meeting of the International Continence Society, Paris, France, August 25–27, 2004.

34.

Appell

Juma

: Long-term durability of a nonsurgical transurethral radiofrequency treatment for female stress urinary incontinence: a retrospective analysis. Presented at: The 35th Annual Meeting of the AAGL, Las Vegas, NV, USA, November 6–9, 2006.

35.

FDA Consumer Magazine, September–October 2005 www.fda.gov/fdac/features/2005/505_incontinence.html.

36.

National Association for Continence. Stress Urinary Incontinence www.nafc.org/about_incontinence/types.htm

Nonsurgical Transurethral Radiofrequency Treatment of Stress Urinary Incontinence in Women

Abstract

Keywords

Treatment options

New office-based option

Mechanism of action

Procedure

Clinical experience

Efficacy

Safety

Conclusion

Future perspective

Information resources

References