Indian Journal of Obstetrics and Gynecology Research

Print ISSN: 2394-2746

Online ISSN: 2394-2754

CODEN : IJOGCS

Indian Journal of Obstetrics and Gynecology Research (IJOGR) open access, peer-reviewed quarterly journal publishing since 2014 and is published under auspices of the Innovative Education and Scientific Research Foundation (IESRF), aim to uplift researchers, scholars, academicians, and professionals in all academic and scientific disciplines. IESRF is dedicated to the transfer of technology and research by publishing scientific journals, research content, providing professional’s membership, and conducting conferences, seminars, and award more...

  • Article highlights
  • Article tables
  • Article images

Article statistics

Viewed: 441

PDF Downloaded: 377


Get Permission Pancholiya, Pandya, and Patel: Non-ablative Er:YAG laser treatment for stress urinary incontinence (SUI)


Introduction

Urinary incontinence (UI) is the involuntary loss of urine, which is objectively demonstrable and with such degree of severity that it is social or hygienic problem is defined by the International Continence Society (ICS).1 Urinary incontinence is one of the manifestations of the pelvic floor dysfunction.2 Stress urinary incontinence (SUI) is the most common form of urinary incontinence. SUI is one of the most common seen health problems among the women of a certain age, and is defined as an involuntary urinary leakage during coughing, sneezing, or physical exertion such as sports activities or sudden change in the position.1, 3, 4

The exact etiology of the SUI is not completely understood, although the causes of urethral support insufficiency may be a loss of pelvic muscle strength due to damage of pelvic floor innervation after vaginal delivery, altered composition of connective tissue and supporting ligaments due to insufficient and decreased collagen production, or alteration of mucosa due to the menopausal decrease of estrogen and other identifiable risk factors for the condition include pregnancy, cognitive impairment, obesity and advance age.5, 6 Insufficient support of urethra and bladder or impairment of the urethral sphincter and the reduction of the urethral closure pressure are the anatomical causes of SUI.7

Pelvic floor dysfunction (PFD) can lead to pelvic organ prolapse- a condition in which organs, such as uterus, fall or slip out of the original position. In about 15 to 80% of women with PFD, pelvic organ prolapse and Stress urinary incontinence coexists.8 Among these conditions, one may be mild or asymptomatic, because these conditions are often concurrent. Sometimes, pelvic floor surgery may expose previously asymptomatic conditions; specifically, in previously continent women with pelvic organ prolapse, SUI may develop or worsen after repair of prolapse.9

Sometimes due to constipation and vaginal infection, when the muscles of the bladder contract or relax involuntarily there is temporary problem for urinary incontinence. It becomes chronic when there are addition of medical problems like weakened pelvic floor muscles, overactive bladder muscles, etc. Although this is common in women but in some cases due to enlarged prostate men also suffer from this problem. Incontinence can be of different types like functional incontinence, stress incontinence, and urge incontinence, overactive bladder and mixed incontinence.

Figure 1

(a) Normal pelvic anatomy of bladder and female urethra; (b) bladder and urethra cut-section in which sphincter muscles are squeezed and shut; (c) bladder and urethra cut-section in which sphincter muscles are relaxed

https://s3-us-west-2.amazonaws.com/typeset-prod-media-server/840e3d83-4d9e-4179-a502-6dfe48851b9bimage1.jpeg

Initial management of SUI may be done by nonsurgical management, such as weight reduction, hormonal substitution, and physiotherapy, use of pessaries or pelvic floor exercise (e.g. Kegel exercise), etc.10

An operative intervention is indicated if above treatments do not lead to improvement within 3-6 months. The tension-free sub urethral slings (TVT- tension-free vaginal tape) were the gold standard for the operative treatment of SUI for the past two decades.10 It is recommended for moderate to severe cases of SUI preferentially for women after the child-bearing age.

Especially for elder, multi-morbid patients or for recurrent SUI after midurethral sling failure; the trans- or periurethral injection of bulking agents can be an alternative, less invasive treatment option.11, 12 There are, so far, however, limited treatment alternatives for younger, active women between pregnancies with disturbing incontinence, for example, during physical exercise.

The laser’s medical effects are well established in terms of biochemical, ablative and thermal effects. Especially in moist environment, thermal energy from the laser source, not only effectively enhances collagen structure but also stimulates neocollagenesis. The intermolecular cross-links of the triple helix of collagen shorten, which leads to the immediate tightening of collagen fibrils by two-thirds of their length in comparison to the pre-intervention state as a result of laser irradiation.13 Currently, minimally invasive intravaginal laser therapy can be the new option for management. There are three different laser modalities have been published for treating SUI, which are as follows: the microablative fractional carbon dioxide (CO2) laser therapy (10,600 nm);14 dual-phase erbium-doped yttrium aluminium garnet (Er:YAG) laser therapy (2,940 nm) combining fractional cold ablation and thermal ablation,15 and non-ablative Er:YAG laser therapy (2,940 nm) with SMOOTH mode thechnology.16, 17 In above all the three cases, laser therapy works by inducing neocollagenesis, thickens and strengthens the anterior vaginal wall, which therefore leads to an improved support of the bladder and the urethra, and consequently, to the continence.14, 18

Among all the minimally invasive laser techniques, there is novel laser treatment known as IncontiLase®, which enables collagen remodelling. IncontiLase® is a patent-pending, non-invasive Er: YAG laser therapy. It is used for the treatment of mild and moderate stress urinary incontinence. It is based on non-ablative photo thermal stimulation of collagen neogenesis, shrinking and tightening of vaginal mucosa tissue and collagen-rich endopelvic fascia, and subsequently greater support to the bladder.19

IncontiLase® works by following way:

  1. Fotona’s 2.94 µm Er:YAG non-ablative laser with proprietary SMOOTHTM mode technology.

  2. It improves urethral support by photo thermal strengthening of the vaginal wall.

  3. It works on connective tissue in the vaginal mucosa with emphasis on the anterior vaginal wall.

A major advantage of IncontiLase is that the procedure is incisionless. Also it is virtually painless, with no ablation, cutting, bleeding, or sutures. Recovery is extremely quick without need for the use of analgesics or antibiotics.

Two sessions are recommended to alleviate mild or even moderate stress urinary incontinence usually. Special pre-op preparation or post-op precautions are not necessary. Patients can return to their normal everyday activities immediately.

Studies confirm that IncontiLase is an effective, safe and comfortable treatment option in patients with mild and moderate SUI for symptom relief.

Figure 2

Use of IncontiLase®

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/f8840917-6a78-4296-8601-adfe92f45077/image/e11912a2-8417-4681-a851-1fff5a29417a-uimage.png

Materials and Methods

In this prospective, single-centre study, total 96 patients suffering from stress urinary incontinency underwent treatment with a 2940 nm Er:YAG laser (Fotona) by IncontiLase® Treatment Protocol.

Inclusion criteria

  1. Normal cell cytology (PAP smear)

  2. Negative urine culture

  3. Vaginal canal, introitus and vestibule free of injuries and

  4. Sexual active and non-active women

Exclusion criteria

  1. Pregnancy

  2. Intake of photosensitive drugs

  3. Injury or/and active infection in the treatment area

  4. Undiagnosed vaginal bleeding

  5. Active menstruation

Assessment tools used for this study

  1. KHQ (King‘s health questionnaire)

  2. UDI-6 (Urogenital distress inventory, short form) Questionnaire

  3. 3D voiding diary

  4. Satisfaction questionnaire (0-3)

Treatment procedure

  1. IncontiLase® Treatment Protocol with using SClear and MClear speculum

Total duration of Treatment: 20-30 minutes

Step 1

Insertion and initial positioning of the laser speculums SClear and MClear

Insert the G-set SClear or MClear laser speculum into the patient’s vagina to serve as the guide for the laser handpiece with the G-set adapter. After the insertion of the laser speculum into the vaginal canal, rotate it till the single mark is positioned downwards, as shown in Figure 3.

Figure 3

Insertion and initial positioning of the laser speculum

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/f8840917-6a78-4296-8601-adfe92f45077/image/1d7148db-6ccf-41e4-9044-50c323effa52-uimage.png

Insertion and initial positioning of the laser handpiece

When the laser speculum is properly positioned into the patient’s vagina, assemble the laser handpiece PS03 or PS05-9 with the G-set angular (GA) adapter (PS03-GAc or PS05-9GAc). Insert the GA adapter into the laser speculum. Position the mirror of the GA adapter in an upwards direction, as shown in Figure 4, and align the horizontal scale line of the GA adapter with the far left mark on the laser speculum on upwards position, and push the GA adapter into the laser speculum up to its full length.

Figure 4

Insertion and initial positioning of the laser beam delivery syste

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/f8840917-6a78-4296-8601-adfe92f45077/image/3bb270d6-84c4-48dc-9cb9-07e97792f7ae-uimage.png

Select IncontiLase 1 step on the right hand side and select appropriate handpiece PS03-GAc or PS05-9GAc on the left-hand side. The engraved ring on the handpiece PS03-GAc must be set to 7 mm spot size.

Figure 5

Applications library screen for the 1. step of IncontiLase Treatment protocol

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/f8840917-6a78-4296-8601-adfe92f45077/image/02d12302-d1eb-4f87-beaf-7ec66370d25d-uimage.png

Laser action: angular irradiation of the anterior vaginal wall – first pass

Laser irradiation of the anterior vaginal wall starts from the proximal end of the vaginal canal towards its entrance. With the GA adapter fully inserted and the mirror properly oriented upwards, the practitioner starts delivering laser energy in bursts of six (6) SMOOTH pulses per each location. After the first burst has been delivered, the GA adapter is pulled outwards by 5 mm, as measured by the scale engraved on the GA adapter, and the next burst of 6 SMOOTH pulses is delivered. The burst of 6 pulses is preset as shown on the picture 6 or the practitioner can switch of burst by pressing on the number and then count the pulses by listening to the characteristic soft sound that can be heard each time the laser pulse interacts with the mucosa tissue in the vaginal canal.

Figure 6

Application screen for IncontiLase showing burst of six SMOOTH pulses per each location

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/f8840917-6a78-4296-8601-adfe92f45077/image/e0d69ce0-e3ed-484e-8be9-37285e0a1648-uimage.png

Figure 7

Deposition of laser energy along the anterior vaginal wall during the first pass

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/f8840917-6a78-4296-8601-adfe92f45077/image/6aeb274e-4dc4-4314-9ca6-77b92348ce79-uimage.png

Keep repeating the procedure as shown in Figure 7 until the entrance to the vaginal canal is reached.

When the laser speculum is initially inserted all the way into the vaginal canal, there should be up to 19 activation positions until the exit of the vaginal canal is reached. For shorter vaginal canals, fewer activation locations will be required and thus a smaller number of laser pulses will be delivered.

Laser action: angular irradiation of the anterior vaginal wall – second to sixth pass

After the first pass has been completed, rotate the GA adapter clockwise until its central (longitudinal) marking line is lined up with the next upwards marking on the SClear speculum as shown in Figure 8b.

After the GA adapter have been properly positioned for the seconds pass, irradiate the vaginal canal using the same procedure as during the first pass: delivering a burst of 6 SMOOTH pulses every 5 mm of the anterior vaginal wall. Complete this procedure four more times, each time on different marking on the S-clear speculum as shown on Figure 8.

Figure 8

Positioning of the adapter for the first pass (a) second pass (b), third pass (c), fourth pass (d), fifth pass (e) and sixth pass (f).

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/f8840917-6a78-4296-8601-adfe92f45077/image/af03c653-6d3b-4db1-8f57-f5bb2a7ec63c-uimage.png

Step 2

Handpiece exchange

Remove the laser beam delivery system (handpiece PS03 with the GA adapter, PS03-GAc, or similar) from the laser speculum and replace it with the handpiece R11 assembled with the G-set circular (GC) adapter R11-GCc or R11-9GCc.

Insert the GC adapter into the full length of the laser speculum.

Select IncontiLase2 step on the right-hand side and select appropriate handpiece R11-GCc or R11-9GCc on the left-hand side. The engraved ring on the handpiece R11-GCc must be set to 7 mm spot size.

Figure 9

Applications library screen for the 2. step of IncontiLase Treatment protocol

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/f8840917-6a78-4296-8601-adfe92f45077/image/8a7369aa-fd81-4f04-8dd2-78d56a52ed14-uimage.png

Laser action: circular irradiation of the vaginal wall – first pass

Laser irradiation of the whole vaginal wall starts from the proximal end of the vaginal canal towards its entrance. With the GC adapter fully inserted, the practitioner starts delivering laser energy in bursts of six (6) SMOOTH pulses per each location – as during Step 1. After the first burst has been delivered the GC adapter is pulled outwards by 5 mm, as measured by the scale engraved on the GC adapter, and the next burst of 6 SMOOTH pulses is delivered. The burst of 6 pulses is preset or the practitioner can switch of burst and count the pulses by listening to the characteristic soft sound that can be heard each time the laser pulse interacts with the mucosa tissue in the vaginal canal.

Figure 10

Circular irradiation of the vaginal wall

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/f8840917-6a78-4296-8601-adfe92f45077/image/8637efbf-dbd9-4909-8f8f-e3e9a7b5b125-uimage.png

Laser action: circular irradiation of the vaginal wall – second pass

After the completion of the first full circumference pass make one more pass repeating the above described procedure for the first circular irradiation pass.

Step 3

Removal of laser speculum and handpiece exchange

Remove the adapter from the speculum and withdraw the speculum from the vagina. Exchange the R11 handpiece with the PS03 or PS05-9 handpiece equipped with the standard straight adapter.

Laser action: straight irradiation of the vestibule and introitus

Select IncontiLase3 step on the right hand side and select appropriate handpiece PS03 or PS05-9 on the left-hand side. The engraved ring on the handpiece PS03 must be set to 7 mm spot size.

Figure 11

Applications library screen for the 3 step of IncontiLase Treatment protocol

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/f8840917-6a78-4296-8601-adfe92f45077/image/b5e7502e-de4f-4be3-b9a6-c9f0909f1fa9-uimage.png

Apply laser pulses on the exposed vestibule, including the urethra meatus, by depositing a patterned laser beam across the whole vestibule and introitus area (Figure 12). On each spot location, 2-3 SMOOTH pulses should be delivered before moving to the next spot. Slightly overlap the spots (by approx. 10%). As the urethra orifice is more sensitive, less SMOOTH pulses should be delivered to this area, depending on the patient’s sensitivity. Three full passes across the vestibule and introitus area should be performed.

Figure 12

Irradiation of the vestibule and introitus

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/f8840917-6a78-4296-8601-adfe92f45077/image/3c2c2026-5e4f-4980-8414-12b3a730c6e1-uimage.png

Depending on the severity of the incontinence, a second treatment after a one month period might be necessary.

Post treatment guidelines

  1. The patient does not require any special after care in the way of medications or special accessories.

  2. It is recommended to respect standard precautions connected with stress urinary incontinence, such as avoiding efforts which may cause pressure to the bladder. This is especially important during the first month after the treatment, i.e. during the period of most intensive neocollagenesis and further collagen remodelling.

  3. It is also recommended that the patient abstain from sexual activities for at least one week after the treatment.

  4. The patient should report and return for check-up at an occurrence of any adverse effects aside from transient mild erythema and edema.

  5. The patient should carry a diary to register changes in incontinence behaviour and any events of leakage.

Repitition

  1. In case the incontinence is still present, a second treatment can be performed one month after the first treatment.

  2. Usually, Two to three sessions are administered in a year followed by a single maintenance session in subsequent year

  3. The measurements were performed before, at 2 months (FU-1) and at 9 months (FU-2).

    1. IncontiLase® Treatment Protocol with G-Runner Robotic scanner

Total Treatment time: 20-30 minutes

Step 1

Setting laser parameters and the G-runner adapter

G-runner laser treatments can be performed with speculums of two different sizes: the larger GClear30 or smaller GClear25. Choose the speculum which fits better to the size of the vaginal opening and the elasticity of the vaginal walls – the speculum should be in contact with the vaginal walls, but not overstretching them.

Clean and disinfect or sterilize the speculum prior to use. Refer to the Cleaning, Disinfection and Sterilization section in the G-runner Operator Manual.

Note that disinfected single-use speculums can be used in contact only with intact mucous tissue.

Set the laser system to the IncontiLase1 mode and the Top Pixel 30 or Top Pixel 25 handpiece, according to the selected speculum. Use the preset parameters, as presented on the laser system’s touchscreen (Figure 13).

Figure 13

Applications library screen for the first step of the G-runner IncontiLase Treatment protocol with the GClear 25 speculum. The image at the centre of the screen shows the correct configuration of the components needed for this step

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/f8840917-6a78-4296-8601-adfe92f45077/image/7b9b9e87-c195-47d6-a4e7-719af5c2ab4f-uimage.png

Attach the yellow GRA-PY adapter on to the G-runner and insert it into the speculum. Start the forward movement of the G-runner by pressing the forward pointing arrow on the G-runner control panel and wait until the adapter reaches the final position. At this point the G-runner will stop and switch direction automatically.

Moisten the speculum with distilled water and, while it is attached to the G-runner adapter, insert it into the patient’s vagina. Keep the orientation of the G-runner in the upright position (control panel up).

Position the speculum so that the observing groove is in the upright position.

Figure 14

Insertion and initial positioning of the G-runner

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/f8840917-6a78-4296-8601-adfe92f45077/image/9703e39f-69d1-428b-912a-afea6735dae7-uimage.png

Table 1

Suggested treatment parameters for Step 1 of the IncontiLase procedure with GClear25 or GClear30 speculums

Incontilase Procedure Step 1

User Interface Mode

Er: YAG Pulse

Hand piece

G- runner with yellow GRA-PY Adapter

Pulse width

SMOOTH

Pulse Number

4

Frequency

2 Hz

Speculum

GClear 25

GClear30

Fluence

10 J/cm2

11 J/cm2

Laser action: angular treatment of the anterior vaginal wall

Press your foot on the footswitch. This simultaneously initiates laser emission and the G-runner’s rotation. Laser treatment of the anterior vaginal wall starts from the proximal end of the vaginal canal and automatically moves toward the vaginal opening. Laser energy is delivered in bursts of four SMOOTH pulses per each position along the anterior vaginal wall.

Be sure to hold the base of the speculum with one hand and to support the G-runner with your other hand during the treatment. The speculum should not rotate during the treatment.

Figure 15

Application screen for the G-runner IncontiLase1 treatment showing a burst of four SMOOTH pulses per each position

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/f8840917-6a78-4296-8601-adfe92f45077/image/71d32354-b8e9-40db-a681-0e24c5ddcd44-uimage.png

Figure 16

Deposition of laser energy along the anterior vaginal wall during the IncontiLase1 procedure

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/f8840917-6a78-4296-8601-adfe92f45077/image/87c67215-6b9a-48dd-b0ca-b41a425b2507-uimage.png

Proceed with the treatment until the vaginal opening is reached. If at any time the patient shows discomfort, stop the treatment by lifting your foot off the footswitch. Wait for a few seconds before continuing the procedure or decrease the laser fluence. Normally the patient starts feeling discomfort when the scanner reaches the sensitive area one or two centimetres from the vaginal canal opening. At this point it is recommended to stop the laser emission and take out the G-runner adapter by pressing the backward button on the Grunner control board.

Leave the speculum in the vagina while ensuring that it does not accidentally slip out of the vagina during the preparation for the next step.

Step 2

Setting the laser parameters and the G-runner Adapter:

Set the laser system to the IncontiLase2 mode and the ContFull 30 or ContFull 25 handpiece according to the selected speculum. Use the preset parameters as presented on the laser system’s touchscreen (Figure 5). Attach the green GRA-FG adapter to the G-runner and insert it into the speculum. Start the forward movement and wait until the adapter reaches the final position. Set the backward direction of G-runner.

Figure 17

Applications library screen for the second step of the G-runner IncontiLase Treatment protocol with GClear25 speculum. The image at the centre of the screen shows the correct configuration of the components needed for this step

https://s3-us-west-2.amazonaws.com/typeset-prod-media-server/840e3d83-4d9e-4179-a502-6dfe48851b9bimage3.png

Laser action: continuous treatment of the entire vaginal canal – first pass

Press your foot on the footswitch. This simultaneously initiates laser emission and the G-runner’s rotation. Laser treatment starts from the proximal end of the vaginal canal and moves automatically toward the vaginal opening. Laser energy is delivered homogeneously in continuous SMOOTH pulses across the entire vaginal canal.

Be sure to hold the speculum with one hand and support the G-runner with the other hand during the treatment. The speculum should not rotate during the treatment.

Proceed with the treatment until the entrance to the vaginal canal is reached. If at any time the patient shows discomfort, stop the laser by taking your foot off the footswitch. Wait for a few seconds before continuing the procedure or continue after decreasing the laser fluence on the laser system touchscreen. Normally the patient starts feeling discomfort when the scanner reaches the sensitive area one or two centimetres from the vaginal canal opening. At this point it is recommended to stop the laser emission along the first pass and start with the second pass (step 2.3).

Table 2

Suggested treatment parameters for Step 2 of the IncontiLase procedure with GClear25 or GClear30 speculums

Incontilase Procedure Step 2

User Interface Mode

Er: YAG Pulse

Handpiece

G- runner with green GRA-FG Adapter

Pulse width

SMOOTH

Frequency

3.3Hz

Speculum

GClear 25

GClear30

Fluence

3.5 J/cm2

4.5 J/cm2

Laser action: continuous treatment of the entire vaginal canal – second pass

Move the GRA-FG adapter to the final position by pressing the forward pointing arrow on the G-runner control panel and wait until the adapter reaches the final position. At this point the G-runner will stop and switch direction automatically.

Press your foot on the laser footswitch and start the treatment as described in the previous section 2.2. Be sure to hold the base of the speculum with one hand and to support the Grunner with your other hand during the treatment. The speculum should not rotate during the treatment.

If you have ended the treatment before reaching the vaginal opening because of discomfort, press the downward arrowhead on the G-runner control panel to remove the adapter from the speculum. Wait for 10 seconds and slowly remove the speculum.

Figure 18

Continuous coverage of the whole vaginal canal

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/f8840917-6a78-4296-8601-adfe92f45077/image/e7b82294-fab7-4518-9eb0-80f991b19300-uimage.png

Step 3

Setting laser parameters and the G-runner adapter

Set the laser system to the IncontiLase3 mode and the direct pixel handpiece. Use the preset parameters as presented on the laser system’s touchscreen (Figure 19).

Figure 19

Applications library screen for the third step of the G-runner IncontiLase Treatment. The image at the centre of the screen shows the G-runner configuration

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/f8840917-6a78-4296-8601-adfe92f45077/image/32acd756-2902-4317-aa3e-b0f240baec7e-uimage.png

Table 3

Suggested treatment parameters for Step 3 of the IncontiLase procedure

Incontilase Procedure Step 3

User Interface Mode

Er: YAG Pulse

Handpiece

G- runner with green GRA-PG Adapter

Pulse width

SMOOTH

Frequency

1.6Hz

Fluence

10 J/cm2

Attach the red GRD-PR adapter to the G-runner. Two red indicator lights should light up and continuously stay lit on the control panel. In this mode, rotation of the G-runner is blocked and it can be used as a manual handpiece.

Apply laser pulses on the exposed vestibule, excluding the urethra meatus; by depositing a patterned laser beam across the whole vestibule and introitus area (Figure 8). On each spot location, 2-3 SMOOTH pulses should be delivered before moving to the next spot. Slightly overlap the spots (by approx. 10%). Three full passes across the vestibule and introitus area should be performed.

Figure 20

Treatment of the vestibule and introitus

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/f8840917-6a78-4296-8601-adfe92f45077/image/218e2ede-46a9-49d7-84cc-814859934727-uimage.png

Post-treatment guidelines

  1. The patient does not require any special after care in the way of medications or special accessories.

  2. It is recommended to respect standard precautions connected with stress urinary incontinence, such as avoiding efforts which may cause pressure to the bladder. This is especially important during the first month after the treatment, the period of most intensive neocollagenesis and further collagen remodelling.

  3. It is also recommended that the patient abstain from sexual activities for at least one week after the treatment.

  4. The patient should report and return for check-up upon any occurrence of adverse effects, aside from transient mild erythema and edema.

  5. The patient should carry a diary to register changes in incontinence behaviour and any events of leakage.

  6. If the incontinence is still present, a second treatment can be performed one month after the first treatment.

Repitition

  1. One month after the first treatment the second treatment is recommended.

  2. Depending on the severity of the incontinence, additional treatment after a one month period might be necessary.

  3. Usually, two to Three sessions are administered in a year followed by a single maintenance session in subsequent years.

Results

A total of 96 (100%) women had stress urinary continence present. They underwent treatment with an Er:YAG (2940 nm) laser in non-ablative fractional mode at Vcare laser centre state of art centre for cosmetic gynaecology, Indore, Madhya Pradesh. The Enrolment of study participants was started in September 2017 and completed in April 2019. An informed consent from the patient is recommended.

The age of the patients ranges from 24 to 70 years of age (average- 47.3 years) and BMI ranges from 19.3-37.2 (average - 25.2). The parity of total women ranges from 1 to 7 (average- 2.5). Here, we excluded nulliparous women. Among 96 women, 83 women were delivered vaginally, 16 were undergone cesarean section and 3 women were delivered by vaginal and cesarean section in subsequent pregnancies. Among 96 women total 86(89.8%) women had vaginal infection among whom 9 (9.4%) women had infection with candiada sp., 43 (44.8%) women had infection with E.coli and 34 (35.4%) had infection with klebsiella.

A total of 96 Patients were treated with IncontiLase protocol, which requires 2-3 sessions with one month interval.

  1. 96 patients completed the first session

  2. 72 patients completed two sessions

  3. 30 patients completed three sessions

Before the treatment, KHQ (King‘s Health Questionnaire); UDI-6 (Urogenital Distress Inventory, Short Form) Questionnaire; 3D Voiding Diary were performed. At 2 months and at 9 months after treatment patients were clinically examined, answered above questionnaires and satisfaction questionnaire for SUI severity and sexual function assessment. A total of 72 patients underwent a 2-month follow-up and 30 patients underwent a 9-month follow-up.

KHQ (King‘s health questionnaire)

Graph 1

KHQ (King‘s Health Questionnaire) used among patients before treatment and after follow-up 1 and follow-up 2

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/f8840917-6a78-4296-8601-adfe92f45077/image/90bdaad9-9321-4d0d-8bc2-16dc7a2cfc1c-uimage.png

  1. KHQ (King‘s health questionnaire) – individual results

Graph 2

KHQ (King‘s health questionnaire)- patient’s individual result before treatment and after follow-up 1 and follow-up 2

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/f8840917-6a78-4296-8601-adfe92f45077/image/edef3e5b-fc22-4b4b-a201-fb55a59ee10f-uimage.png

Figure 22 shows individual patient result before treatment and after follow up visits. It shows significant improvement in all 30 patients.

UDI-6 (Urogenital distress inventory, short form) questionnaire

UDI-6 (Urogenital Distress Inventory, Short Form) Questionnaire is the short question form used to assess life quality and symptom distress for urinary incontinence in women.

Graph 3

UDI-6 (Urogenital distress inventory, short form) questionnaire used among patients before treatment and after follow-up 1 and follow-up 2

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/f8840917-6a78-4296-8601-adfe92f45077/image/36c4d51c-c1ad-4004-adb4-f2e33cd308f6-uimage.png

  1. UDI-6 (Urinary Distress Inventory, Short Form Questionnaire – individual results

Graph 4

UDI-6 (Urogenital distress inventory, Short Form) questionnaire patient’s individual result before treatment and after follow-up 1 and follow-up 2

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/f8840917-6a78-4296-8601-adfe92f45077/image/dc462e6f-aedb-4d9a-ac16-5cea7205cd7c-uimage.png

3D Voiding Diary

Example of Voiding Diary is given below. Here, we give patients the bladder diary which contains following contents:

  1. Date & time

  2. Liquid intake in ml

  3. Volume of urine passed in ml

  4. Episode of any leakage of urine

  5. Pad change

This simple chart allows patient to record the fluid patient drinks and urine she passes over 3 days (not necessarily consecutive) in the week prior to her clinic appointment. We advised patients to fill this chart and mark with a * if patient has leaked or mark with ‘p’ if patient has needed to change her pad and to write total count.

Figure 21

3D voiding diary

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/f8840917-6a78-4296-8601-adfe92f45077/image/86262ba9-a85f-48ff-b872-bbd3a28fea01-uimage.png

3D voiding diary

Graph 5

3D voiding diary questionnaire used among patients before treatment and after follow-up 1 and follow-up 2

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/f8840917-6a78-4296-8601-adfe92f45077/image/331a01ba-affb-4d50-b50f-21ae49bf3a29-uimage.png

There were no significant differences in fluids intake at observed time points.

  1. 3D Voiding Diary – individual results

Graph 6

3D voiding diary questionnaire- patient’s individual result before treatment and after follow-up 1 and follow-up 2

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/f8840917-6a78-4296-8601-adfe92f45077/image/44380a0b-e815-41c5-9767-d8dfa76a1ddb-uimage.png

There were 15 patients reported about the use of pads. All of them significantly reduced the number of pads used which is shown in Figure 28.

Graph 7

3D voiding diary questionnaire- data of patient’s episode of leakage of urine and no. of pad change given before treatment and after follow-up 1 and follow-up 2

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/f8840917-6a78-4296-8601-adfe92f45077/image/55e81ba1-1db0-4ae2-a65c-3e3883cb668d-uimage.png

Patients‘ satisfaction questionnaire

Graph 8

Patients‘ satisfaction questionnaire

https://typeset-prod-media-server.s3.amazonaws.com/article_uploads/f8840917-6a78-4296-8601-adfe92f45077/image/69adb459-3f9b-4ba4-90e7-3de64cde500d-uimage.png

Among total of 96 women majority of women (75%) were very satisfied with the treatment and result.

Discussion

The initial management or most patients with SUI, involves a variety of non-invasive interventions, including behavioural therapy and pelvic floor muscle exercises (PFMEs) and for these therapies patience, motivation and time commitment are required. According to the several trials there is demonstrable improvement and satisfactory cure rates in patient adhering to a strict programme of behaviour modification and pelvic floor muscle tonus. However, for successful results, patient compliance and motivation are essential.6 Other non-surgical treatment options are electric stimulation; vaginal cones, occlusive and intravaginal devices and pharmacological treatments and the reports of the efficacy may vary according to some studies.20 Bo and colleagues, in a study of 107 patients with SUI, compared the efficacy of electrical stimulation, vaginal cones and a control group and concluded that pelvic floor exercise is superior to both electrical stimulation and vaginal cones in the treatment of genuine SUI in women.21

The surgical treatment options are very common, safe and effective option although they are much more invasive, have more complications. It requires a recovery period of several weeks before the patients can return to normal daily activities. 6 Most experts recommend that patients undergo non-surgical options first, as there is insufficient evidence to compare surgery with other interventions.22 The tension-free sub urethral slings (TVT- tension-free vaginal tape) were the gold standard for the operative treatment of SUI for the past two decades.10 It is recommended for moderate to severe cases of SUI preferentially for women after the child-bearing age. Especially for elder, multi-morbid patients or for recurrent SUI after midurethral sling failure; the trans- or periurethral injection of bulking agents can be an alternative, less invasive treatment option.11, 12

Despite its prevalence and associated distress, embarrassment and diminished quality of life, many women who experience symptoms of SUI choose to delay or do not seek medical treatment because of embarrassment, lack of knowledge about possible treatments or fear that it may require surgical methods.

Following these requirements, the IncontiLase® laser treatment was developed. In our study with 2 and 9 month follow-up of patients with mild-to-moderate stress urinary incontinence treated with non-ablative laser, we demonstrated the efficacy and safety of the procedure. The stress incontinence was measured by KHQ and showed score improvement after IncontiLase® treatment, also at 2 and 9 month follow-ups, indicating significant improvement of SUI.

The indications and contraindications for the use of Er:YAG laser in gynaecology are given below:

Table 4

Indication for use of Er:YAG Laser in Gynaecology

Gynaecology indications:

Genito Urinary indications:

Cosmetic Indications

  • Herpes simplex

  • Lesions on external genitilia, anus, urethra, scrotum, penis vulva

  • Stretch marks

  • Skin resurfacing ablative and non-ablative

  • Endometrial adhesion

  • Polyps and familial polyps of the Colon

  • CIN (Cervical Intraepithelial neoplasia)

  • Skin Rejuvenation

  • Cysts and Condiloma

  • Stress and mixed urinary incontinence (SUI)

  • Treatment of scars – Acne, Post Trauma, Episiotomy

  • Vaginal relaxation syndrome

  • Vulvo Vaginal Atrophy (VVA)

  • Genitourinary Syndrome of Menopause (GSM)

  • Treatment of keloids, warts, skin tags

  • Pelvic Organ Prolapse (POP)

  • Breast lifting

  • Lip enhancement and refreshing

  • Cheeks enhancement

Table 5

Contra-indications (Er:YAG)

  • Urinary tract infection (UTI)

  • Collagen, scarring and connective tissue disorders

  • Injuries or bleeding in areas of tissue to be treated (vestibule and anterior vaginal wall)

  • Clotting disorders

  • Heart or lung disease

  • One of the following urinary tract abnormalities: bladder overcapacity (<300 cc), post void residual >50 cc, spastic bladder, vesicouretral reflux, bladder stones, bladder tumours, ureteral stricture and bladder neck contracture

  • Vascular problems (incl. common circulation problems)

  • Endocrine disorders

  • Hypertension

  • Morbid obesity

  • Abnormal scarring

  • Wound healing disorders

  • Infection or inflammation of treatment area

  • Epilepsy

  • Excessive sun exposure (tanned skin)

  • Febrile state

  • A history of a photosensitivity disorder or use of photosensitizing medication

  • Use of iron supplements or an anticoagulant therapy

  • Pregnancy

  • Retin-A and similar products 3 days before and 7 days after treatment

  • Irradiation in the region of the gonads

  • Diabetes Insulin-dependent diabetes (need a written release from their family physician)

  • Accutane (Roaccutane) within 6 months

  • Systemic antifungal, oral antifungal therapy, or isotretinoin within 6 months

  • Cancer in the area to be treated

  • Autoimmune disorders, such as Lupus

  • Use of vasodilators

  • History of seizures

  • Gold therapy An inability to visualize the area to be treated

  • Herpes simplex infection in the treatment area

  • Anatomic findings not consistent with the diagnosis

  • Preoperative histology findings indicative of malignancy

Regarding the safety and tolerability, we have noticed some adverse effects throughout the whole course of treatment and during the follow-up period like increase in vaginal discharge, slight bleeding, light redness which may persist for few days after treatment. Mild to moderate discomfort or pain during the treatment was noticed in some patients; it was gone as soon as the treatment ended. After the IncontiLase® treatment, all patients returned to their daily activities immediately. The positive effect on the symptoms of SUI was due to neocollagenesis and collagen remodelling. The objective of minimally invasive laser treatment is to achieve selective, heat-induced denaturation of dermal collagen that leads to subsequent new collagen deposition with as little damage to epidermis as possible.23 Under the influence of specific temperatures from 61ºC to 63ºC, shortening of collagen to longitudinal axis occurs.13 The processes of collagen remodelling and neocollagenesis starts in addition to the instantaneous collagen and tissue shrinkage reaction24, 25, 26, 27 and at the end of the processes treated tissue becomes enriched with new collagen and is tighter and more elastic.

The non-ablative Er:YAG laser treatment procedure is easy to learn and does not require specialized surgical skill. This treatment procedure is well tolerated, there is no bleeding, and anaesthesia or hospital are not required. After vaginal Er:YAG treatment, patients are advised to avoid intra-abdominal pressure and sexual intercourse for about 3 days.28 Vaginal Er:YAG laser treatment offers a minimally invasive alternative treatment option for patients with mild to moderate SUI who do not wish to undergo any invasive procedure or have contraindications to surgery.

Conclusion

The non-ablative Er:YAG laser therapy by IncontiLase® improves the impact of stress urinary incontinence (SUI) symptoms on quality of life and sexual function in premenopausal parous women and provides a promising minimally invasive safe treatment alternative for SUI as per our study results, which, after further optimization, could reduce the need for surgery. It is a fast, simple and well tolerated procedure. It is associated with high level of safety with a short recovery period.

Source of Funding

None.

Conflict of Interest

The authors declare no conflict of interest.

References

1 

P Abrams JG Blaivas SL Stnton JT Andersen The standardization of terminology of lower urinary tract function. The International Continence Society Committee on Standardization of TerminologyScand J Urol Nephrol Suppl1988114519

2 

RC Blump PA Nortan Epidemiology and natural history of pelvic floor dysfunctionObstet Gynecol Clin North Am199825472346

3 

BT Haylen D Ridder RM Freeman SE Swift B Berghmans J Lee An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunctionNeurourol Urodyn2010291420

4 

M Cervigini M Gambacciani Female urinary stress incontinenceClimacteric201518Suppl 1306

5 

I Fistonic SF Gustek N Fistonic Minimally invasive laser procedure for early stages of stress urinary incontinence (SUI)J Laser Health Acad201216774

6 

ES Rovner AJ Wein Treatment options for stress urinary incontinenceRev Urol20046Suppl 3S29S47

7 

JO Delancey ER Trowbridge JM Miller DM Morgan K Guire DE Fenner Stress urinary incontinence: relative importance of urethral support and urethral closure pressureJ Urol20081796228690

8 

SW Bai MJ Jeon JY Kim KA Chung SK Kim KH Park Relationship between stress urinary incontinence and pelvic organ prolapseInt Urogynecol J Pelvic Floor Dysfunct200213425660

9 

L Brubaker GW Cundiff P Fine I Nygaard HE Richter AG Visco Abdominal sacrocolpopexy with Burch colposuspension to reduce urinary stress incontinenceN Engl J Med200635415155766

10 

C Reisenauer C Muche-Borowski C Anthuber D Finas T Fink B Gabriel Interdisciplinary s2e guideline for the diagnosis and treatment of stress urinary incontinence in women :short version- AWMF registry no. 015-005Geburtshilfe Frauenheilkd2013739899903

11 

M Elmelund ER Sokol MM Karram R Dmochowski N Klarskov Patient characteristics that may influence the effect of urethral injection therapy for female stress urinary incontinenceJ Urol2019202112531

12 

I Zivanovic O Rautenberg K Lobodasch G Bünau C Wasler V Viereck Urethral bulking for recurrent stress urinary incontinence after midurethral sling failureNeurourol Urodyn20173637226

13 

S Thomsen Pathologic analysis of photothermal and photomechanical effects of laser-tissue interactionsPhotochem Photobiol199153682535

14 

P Gonzalez Isaza K Jaguszewska JL Cardona M Lukaszuk Long-term effect of thermoablative fractional CO2 laser treatment as a novel approach to urinary incontinence management in women with genitourinary syndrome of menopauseInt Urogynecol J20182922115

15 

AR Mothes M Runnebaum IB Runnebaum An innovative dual-phase protocol for pulsed ablative vaginal erbium:YAG laser treatment of Urogynecological symptomsEur J Obstet Gynecol Reprod Biool201822916771

16 

N Fistonic I Fistonic SF Gustek IS Turina I Marton Z Vizintin Minimally invasive, non-ablative Er:YAG laser treatment of stress urinary incontinence in women- a pilot studyLasers Med Sci201631463543

17 

M Lukac A Gaspar F Bajd Dual tissue regeneration: non-ablative resurfacing of soft tissues with FotonaSmoothR mode Er:YAG laserJ laser Health Acad20181115

18 

GA Lapii AY Yakovleva AI Neimark Structural reorganization of the vaginal mucosa in stress urinary incontinence under conditions of Er:YAG laser treatmentBull Exp Biol Med 201716245104

20 

PD Wilson K BO JH Smith Conservative treatment in womenHealth Publication LtdPlymouth, UK2002

21 

K Bo T Talseth I Holme single blind, randomised controlled trial of pelvic floor exercises, electrical stimulation, vaginal cones, and no treatment in management of genuine stress continence in womenBMJ1999318718248793

22 

JM Holroyd-Leduc SE Straus Management of urinary incontinence in women: clinical applicationsJAMA200429189969

23 

K Kunzi-Rapp CC Dierickx B Cambier M Drosner Minimally invasive skin rejuvenation with Erbium: YAG laser used in thermal modeLasers Surg Med20063810899907

24 

DJ Goldberg JA Samady Intense pulsed light and Nd;YAG laser non-ablative treatment of facial rhytidsLasers Surg Med20012821414

25 

B Majaron SM Srinivas H Huang JS Nelson Deep coagulation of dermal collagen with repetitive Er:YAG laser irradiationLasers Surg Med200026221522

26 

B Drnovsek-Olup M Beltram J Pizem Repetitive Er:YAG laser irradiation of human skin: a histological evaluationLasers Surg Med200435214651

27 

B Kao KM Kelly B Majaron JS Nelson Novel model for evaluation of epidermal preservation and dermal collagen remodelling following photo rejuvenation of human skinLasers Surg Med20033221159

28 

JI Pardo VR Sola AA Morales Treatment of female stress urinary incontinence with Erbium-YAG laser in non-ablative modeEur J Obstet Gynecol Reprod Biol201620414



jats-html.xsl


This is an Open Access (OA) journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.

Article type

Original Article


Article page

162-175


Authors Details

Vidya Pancholiya, Manish R Pandya*, Khushbu K Patel


Article History

Received : 22-04-2022

Accepted : 12-05-2022


Article Metrics


View Article As

 


Downlaod Files