Interventional procedure overview of electrically stimulated intravesical therapy for interstitial cystitis or overactive bladder in adults

1

Gulpinar, 2014
Turkey

N=31 (male: female as reported by the study = 6:25)

16 intervention (3:13) and 15 comparator (3:12) intravesical hyaluronic acid via catheter

Mean in the EMDA group = 42.8

Mean in the catheter group = 43.5

Randomised prospective study

People who were diagnosed with BPS or IC between 2004 and 2005 according to the National Institute of Diabetes and Digestive and Kidney Diseases criteria for BPS or IC.

Exclusion criteria: any other medication for IC during the study period, neurogenic bladder, history of pelvic surgery or trauma to the pelvic region, presence of active urinary tract infection, frequency of urination less than 8 times, presence of bladder or lower ureteral calculi, benign or malignant bladder tumours, active genital herpes infection, or chemical or radiation cystitis.

40 mg hyaluronic acid (Cythyal) in 40 ml saline instillation in the bladder administered through a special 16‑Fr catheter for EMDA with a spiral silver electrode in the first part with EMDA: polarity positive, rise rate 30 to 60 mA/second, peak current 60 mA, pulsed output, and treatment time 25 minutes.

Comparator:

40 mg intravesical hyaluronic acid administered through a hydrophilic 12‑Fr Foley catheter, retained for at least 60 minutes.

Both groups had weekly instillations in the first month, and then monthly after 2 months.

24 months

2

Rosamilia, 1997
Australia

N=21 (male: female as reported by the study = 0:21)
N=24 procedures;
3 people had a repeat procedure

Median = 48 (range 22 to 80)

Cohort study

Females with IC diagnosed using National Institute of Arthritis, Diabetes, Digestive and Kidney Diseases Workshop

2% sodium chloride-free lidocaine hydrochloride, adrenaline 1.5 mg and dexamethasone 16 mg in 150 ml sterile water. Administered using a 18‑Fr catheter commercially fitted with a silver-coated anode, and EMDA with 30 mA current for 20 to 30 minutes

6 months

3

Riedl, 1998a
Austria

N=13 (male: female as reported by the study = 2:11)
N=42 procedures; between 1 and 7 procedures per person

Mean = 62.2

Cohort study

People who were diagnosed with IC between December 1993 and July 1995 according to the US National Institute of Health criteria

People with low capacity-bladders (less than 250 ml):

Lidocaine 2% 100 ml, dexamethasone 15 mg, epinephrine 0.5 mg. 15 mA current.

People with bladder capacities over 250 ml:

Lidocaine 2.6% 150 ml, dexamethasone 20 mg, epinephrine 0.75 mg.
22 mA current.

Both groups had EMDA with the pulsed direct current for 20 minutes, followed by hydrodistension of the bladder up to 200% of the cystometric bladder capacity for 1 to 5 minutes.

Retreatments performed at the person's request.

Mean 10 months (range: 3 to 22 months)

4

Gurpinar, 1996
US

N=6
(men: women = 0:6)

Mean = 44.8 (range 28 to 60)

Single-arm trial

People with long-standing IC who had multiple IC modalities

100 ml lidocaine-epinephrine solution instillation administered using an 18‑Fr, intraurinary silver-coated stainless-steel electrode catheter and through EMDA. A rise of current to 15 mA over 2 minutes, then 15 mA current maintained for additional 38 minutes.

Between 3 and 18 months

5

Hinkel, 2004 Germany

N=2 (male: female as reported by the study = 2:0)

Mean = 75 (range 72 to 78)

Case report

People with chronic non-infectious cystitis

100 ml lidocaine 4%, 2 ml epinephrine 1:1,000, 10 ml dexamethasone (40 mg), diluted in 100 ml Aquadest.

Positive polarity, rise-rate 50 mA/second, current 22 mA, and pulse modus. Treatment time 30 minutes.

Not reported

1

Bach, 2009
Germany

N=84 (men: women = 12:72)

Median = 63.1

Prospective cohort study

People with idiopathic detrusor overactivity who had previously had antimuscarinic (anticholinergic) treatment for at least 8 weeks with no improvement of urgency.

Exclusion criteria: neural deficiencies or symptoms during physical examination, previous spinal surgery, or an infectious urine sample

2,000 mg lidocaine-hydrochloride 4% (50 ml), 2 mg epinephrine (1:1,000) (2 ml), 40 mg dexamethasone‑21‑dihydrogen phosphate (10 ml) in a total volume of 100 ml administered via EMDA. 30 mA current for 30 minutes.

EMDA was done at least 3 times in 4‑weeks during 2‑day hospital stays.

8 weeks (after the third EMDA)

2

Gauruder-Burmester, 2008
Germany

N=72 (men: women = 0:72)

Mean = 63 (SD 11.2)

Prospective cohort study

History of persisting OAB for over 24 months and therapeutic attempts with at least 2 different anticholinergic medicines and at least 6 months of physiotherapy without improvement or cure of symptoms: frequency (voiding more than 8 times a day), nocturia (voiding more than once a night), and urge incontinence

100 ml 4% lidocaine hydrochloride (sodium chloride-free), 100 ml distilled water, 40 mg dexamethasone sodium phosphate, and 2 ml epinephrine.

15 to 25 mA current for 20 to 25 minutes.

3 EMDA cycles, each with 3 instillations at 2‑week intervals during a 3‑day hospital stay.

12 months (after the last treatment)

3

Schiotz, 2017
Norway

N=14 (men: women = 0:14)

Mean = 59.9

(SD 13.9, range 31 to 79)

Prospective cohort study

Women with severe, treatment resistant OAB, more than 3 months duration, failed conservative and pharmacological treatment and indication for standard cystoscopic injection of botulinum toxin.

Exclusion criteria: age under 18 years, mixed incontinence with dominant stress incontinence, ongoing UTI, and contraindication to treatment with botulinum toxin.

60 ml of normal saline with 200 Allergan units of botulinum toxin A administered via EMDA.

20 mA current for 30 minutes.

1 outpatient session.

6 months

4

Riedl, 1998b

Austria

N=14 (treatments n=29)
(male: female as reported by the study = 4:10)

Mean = 67.3 (range 22 to 84)

Prospective cohort study

People with detrusor hyperreflexia or urge incontinence who did not tolerate or improve on oral anticholinergic medicines.

15 mg to 50 mg oxybutynin hydrochloride in 0.3% saline.

15 mA for 20 minutes.

Not reported

Gulpinar, 2014

EMDA treatment associated with significantly higher treatment response (based on the global response assessment), HR: 2.457 (95% CI: 1.458 to 3.897), p=0.011.

Overall, there were statistically significant differences in frequency, nocturia, and VAS between the 2 groups at 6 months and 12 months, but no statistically significant difference in any of these outcomes at 1 month and 24 months.

Voiding frequency (per 24 hours):

Nocturia (per night):

VAS

No SAE reported.

No patients refused treatment because of side effects.

Rosamilia, 1997

85% (18 out of 21) had a good response (reduction in pain score by 3 or more and reduction in frequency at 2 weeks).

63% were still having a response at 2 months.

25% (4 out of 16) had an excellent response (pain score of 0) at 6 months.

Mean urinary frequency

Median pain score

No SAE reported.
Erythema at abdominal electrode site was common but resolved within a few hours.
Most people had haematuria at the end of draining the bladder.

Riedl, 1998a

8 out of 13 had complete response, 3 out of 13 had partial response, 2 out of 13 deteriorated.

Complete response: urgency and bladder pain in combination with a reduction of urinary frequency for at least 1 week.

Partial response: reduction of bladder symptom for less than 1 week.

Mean duration of symptom improvement: 4.5 months (0.75 to 17 range)

8 out of 13 people reported 'significant' QoL improvement.
12 people said EMDA was tolerable and they would undergo retreatment.

5 people said EMDA was ineffective, including 1 person who had a complete response for 2 months.

No SAE.

Everyone had skin erythema observed within hours at abdominal electrode, no skin blistering.

Two people showed bladder symptoms deterioration, occurred about 30 minutes after therapy, lasting for 1 to 4 days. Local anaesthesia was incomplete in both.

Gurpinar, 1996

Voiding symptoms decreased. Four people had durable and 'significant' response.

Voiding-specific quality of life scores improved.

2 people had temporary improvement but subsequently had additional local bladder treatments

No SAE reported.

No one experienced pain or significant discomfort. Some people reported a tingling sensation on the abdominal skin during the treatment.

Hinkel, 2004

Not reported

Both people showed signs of transient ischaemic attack signs, at 3 hours and 6 hours after having EMDA.

Bach, 2009

After second EMDA sessions (n=84),

Mean voiding frequency per day

Baseline= 14.1 (SE 7.7)

4 weeks= 9.4 (SE 6.2), p<0.0001

8 weeks= 9.3 (SE 4.1), p<0.0001

Nocturia per night

Baseline= 5.1 (SE 5.1)

4 weeks= 2.5 (SE 2.4), p=0.035

8 weeks= 4.3 (SE 4.1), p>0.1

Impact of QoL

Baseline= 11.8 (SE 3.2)

4 weeks= 7.3 (SE 4.1), p=0.018

8 weeks=10.1 (SE 3.5), p>0.1

No SAE reported.

2 people developed abdominal skin erythema underneath electrodes and complained about pain during the second EMDA session, resulting in the treatment being aborted.

Gauruder-Burmester, 2008

Voiding frequency per day decreased from 16 (SD 3) to 7 (SD 2). This was statistically significant (p=0.003).

Decreased nocturia from 5 (SD 2) to 2 (SD 1). No statistical significance or p-value was reported.

QoL was improved in 54 people (75%)
(p = 0.002).

Sexual sensations and sexual satisfaction was improved in 39 people (54%)
(p = 0.001)

No SAE reported.

12 women developed reactive hypertension during treatment, which returned to normal without any intervention.

21 people showed signs of dysuria and haematuria.

10 women experienced UTI

1 person developed urinary retention, which disappeared after 2 catheterisation procedures.

Schiotz, 2017

Mean voiding frequency per 24 hours

Mean incontinence episode per 24 hours

No SAE.

Most people had transient, mild, painless abdominal skin erythema for a few hours after treatment.

3 episodes of acute cystitis in 2 people with prior history of recurrent UTI.

Riedl, 1998b

3 people had improved bladder symptoms for more than 1 week, 4 people had improved bladder symptoms for less than 1 week, 4 people had no improvement.

No local or systemic side effects were observed.

Treatment was stopped in 3 people because of bladder contractions and leakage.