Urinary IncontinenceNCT07029087
The Effect of Ultrasound Guided Pudendal Block on Postoperative Analgesia in Urogynecological Surgeries
A study testing Pudendal Nerve Block in people with Urinary Incontinence, run by Giresun University at 1 site in Turkey (Türkiye).
Trial summary
Stress urinary incontinence (SUI) is one of the most common problems encountered in gynecology outpatient clinics and affects approximately 4% to 35% of women. Although it is a medical condition, it also negatively impacts women's quality of life, making successful treatment of this condition particularly important… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Pudendal Nerve Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: >18 years ASA I-II scores Clinical diagnosis of urinary incontinence The patients with consent to be included in the study - Exclusion Criteria: Patients who suffer from chronic pain Patients using regular analgesic drugs Pregnant patients Allergic reactions to local anesthetics ASA III and over patients Need for general anesthesia
-
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Giresun Training and Research Hospital
Giresun
About this study
Official title: The Effect of Pudendal Block on Postoperative Analgesia in Urogynecological Surgeries
Stress urinary incontinence (SUI) is one of the most common problems encountered in gynecology outpatient clinics and affects approximately 4% to 35% of women. Although it is a medical condition, it also negatively impacts women's quality of life, making successful treatment of this condition particularly important from the patient's perspective. Additionally, overactive bladder and pelvic organ prolapse are frequently seen, especially in older women, and surgical procedures such as transobturator tape (TOT), cystocele repair, and rectocele repair are commonly performed to address these issues. In general, any type of surgical procedure in elderly patients is considered to carry higher risks compared to the younger population. Specifically, in prolapse surgeries, longer hospital stays and higher rates of perioperative complications have been reported compared to younger patients . Moreover, postoperative pain is a significant barrier to the resumption of daily activities.
The innervation of the perineal portion of the pelvic floor muscles is provided by the pudendal nerve, which originates from the ventral roots of sacral segments S2 to S4. Pudendal nerve blocks are often preferred as an initial diagnostic and therapeutic method for chronic pelvic pain caused by pudendal neuralgia due to nerve entrapment. Additionally, the pudendal nerve block is a widely used regional anesthesia technique in gynecologic, obstetric, and anorectal procedures . It is particularly applied to provide perineal anesthesia during the second stage of vaginal delivery, vaginal repairs, and obstetric procedures including anorectal surgeries such as hemorrhoidectomy . Pudendal nerve blocks can effectively anesthetize the posterior perineum, anus, lower vagina, vulva/scrotum, and penis.
In this study, the investigators aimed to demonstrate the effectiveness of the pudendal nerve block in achieving postoperative analgesic control during urogynecological surgeries such as TOT, cystocele, and rectocele repairs, and thereby facilitating an earlier return to daily activities.
Read the detailed description
The study was planned to be conducted prospectively, in a randomized and controlled manner on female patients who were scheduled for elective urogynecological surgery in the obstetrics operating room of Giresun Women's and Children's Hospital. Written and verbal informed consent will be obtained from all patients who agree to participate in the study. Group allocation will be determined using a randomization method via sealed opaque envelopes. The patients' age, height, weight, and American Society of Anesthesiologists (ASA) physical status classification will be recorded.
All patients will receive spinal anesthesia before surgery in the obstetrics operating room. At the end of the surgery, patients in the block group will undergo pudendal nerve block under ultrasound guidance. For the block procedure, aseptic preparation will be performed on the perineal area of the patient in the lithotomy position. A 21-gauge, 100 mm Stimuplex peripheral nerve block needle will be used. A linear ultrasound probe will be placed on the perineum at the 3 and 9 o'clock positions relative to the anus to visualize the ischial tuberosity. The needle will be inserted in an out-of-plane approach, medially to the ischial tuberosity, to reach the area between the sacrotuberous and sacrospinous ligaments. A total of 10 ml of 0.25% plain bupivacaine, diluted with isotonic solution, will be administered bilaterally.
Postoperative pain assessments using the Visual Analog Scale (VAS) will be performed at 2, 4, 6, 12, 24, and 48 hours in both the block and control groups. If a patient reports a VAS score greater than 4, intramuscular diclofenac sodium will be administered and recorded. Additionally, the time at which patients can sit without pain, the time to return to daily activity, and length of hospital stay will also be documented.
- Conditions
- Urinary Incontinence
- Being tested
- Pudendal Nerve Block
- Keywords
- postoperative analgesia, pudendal block, urogynecological surgery
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pudendal Nerve BlockProcedure or surgery
Pudendal nerve blocks are often preferred as an initial diagnostic and therapeutic method for chronic pelvic pain caused by pudendal neuralgia due to nerve entrapment. Additionally, the pudendal nerve block is a widely used regional anesthesia technique in gynecologic, obstetric, and anorectal procedures . It is particularly applied to provide perineal anesthesia during the second stage of vaginal delivery, vaginal repairs, and obstetric procedures including anorectal surgeries such as hemorrhoidectomy . Pudendal nerve blocks can effectively anesthetize the posterior perineum, anus, lower vagina, vulva/scrotum, and penis.
| Study group | Role | What they receive |
|---|---|---|
| Pudendal | Experimental | We performed pudendal nerve block by using ultrasound at the end of the surgery. All patients were operated under spinal anesthesia. After surgery we followed up the hemodynamic changes and VAS values at different time points. Receives: Procedure: Pudendal Nerve Block |
| Control | No intervention | All patients were operated under spinal anesthesia. After surgery we followed up the hemodynamic values and VAS scores at different time points. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale
The primary endpoint was the postoperative pain on the visual analogue scale (VAS) at 24 h. The investigators evaluated the pain intensity by using the VAS, where 0 indicated no pain and 10 represented the worst imaginable pain.
Measured: 24 hours after surgery
Secondary outcomes (3)
Length of hospital stay
Length of hospital stay: The number of days that stayed in hospital
Measured: 14 days after surgery
The time of sitting without pain
The investigators recorded how many hours after the surgery the patients were able to sit without pain.
Measured: 24 hours after surgery
Analgesic need
Analgesic consumption: Total amount of analgesic need during first 24 hours on postoperative period.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start1 May 2023
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized-controlled, double-blind study
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azime Bulut, Giresun University
- Investigators
- Azime Bulut, Assoc.Prof., Principal investigator, Giresun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029087
- Sponsor's protocol ID
- Azime Bulut
- Status last verified
- Jun 2025
- First submitted
- 5 May 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators don't have any consent or permission for sharing the data.
Publications
Naja Z, El-Rajab M, Al-Tannir M, Ziade F, Zbibo R, Oweidat M, Lonnqvist PA. Nerve stimulator guided pudendal nerve block versus general anesthesia for hemorrhoidectomy. Can J Anaesth. 2006 Jun;53(6):579-85. doi: 10.1007/BF03021848.
PubMed 16738292He J, Zhang L, Li DL, He WY, Xiong QM, Zheng XQ, Liao MJ, Wang HB. Ultrasound-Guided Pudendal Nerve Block Combined with Propofol Deep Sedation versus Spinal Anesthesia for Hemorrhoidectomy: A Prospective Randomized Study. Pain Res Manag. 2021 Feb 26;2021:6644262. doi: 10.1155/2021/6644262. eCollection 2021.
PubMed 33727997Di Giuseppe M, Saporito A, La Regina D, Tasciotti E, Ghielmini E, Vannelli A, Pini R, Mongelli F. Ultrasound-guided pudendal nerve block in patients undergoing open hemorrhoidectomy: a double-blind randomized controlled trial. Int J Colorectal Dis. 2020 Sep;35(9):1741-1747. doi: 10.1007/s00384-020-03630-x. Epub 2020 May 30.
PubMed 32474710
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pudendal Block on Postoperative Analgesia in Urogynecological Surgeries
- ClinicalTrials.gov ID
- NCT07029087
- Acronym / sponsor ID
- Azime Bulut
- Conditions
- Urinary Incontinence
- Keywords
- postoperative analgesia, pudendal block, urogynecological surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stress urinary incontinence (SUI) is one of the most common problems encountered in gynecology outpatient clinics and affects approximately 4% to 35% of women. Although it is a medical condition, it also negatively impacts women's quality of life, making successful treatment of this condition particularly important from the patient's perspective. Additionally, overactive bladder and pelvic organ prolapse are frequently seen, especially in older women, and surgical procedures such as transobturator tape (TOT), cystocele repair, and rectocele repair are commonly performed to address these issues. In general, any type of surgical procedure in elderly patients is considered to carry higher risks compared to the younger population. Specifically, in prolapse surgeries, longer hospital stays and higher rates of perioperative complications have been reported compared to younger patients . Moreover, postoperative pain is a significant barrier to the resumption of daily activities.
The innervation of the perineal portion of the pelvic floor muscles is provided by the pudendal nerve, which originates from the ventral roots of sacral segments S2 to S4. Pudendal nerve blocks are often preferred as an initial diagnostic and therapeutic method for chronic pelvic pain caused by pudendal neuralgia due to nerve entrapment. Additionally, the pudendal nerve block is a widely used regional anesthesia technique in gynecologic, obstetric, and anorectal procedures . It is particularly applied to provide perineal anesthesia during the second stage of vaginal delivery, vaginal repairs, and obstetric procedures including anorectal surgeries such as hemorrhoidectomy . Pudendal nerve blocks can effectively anesthetize the posterior perineum, anus, lower vagina, vulva/scrotum, and penis.
In this study, the investigators aimed to demonstrate the effectiveness of the pudendal nerve block in achieving postoperative analgesic control during urogynecological surgeries such as TOT, cystocele, and rectocele repairs, and thereby facilitating an earlier return to daily activities.
Detailed description
The study was planned to be conducted prospectively, in a randomized and controlled manner on female patients who were scheduled for elective urogynecological surgery in the obstetrics operating room of Giresun Women's and Children's Hospital. Written and verbal informed consent will be obtained from all patients who agree to participate in the study. Group allocation will be determined using a randomization method via sealed opaque envelopes. The patients' age, height, weight, and American Society of Anesthesiologists (ASA) physical status classification will be recorded.
All patients will receive spinal anesthesia before surgery in the obstetrics operating room. At the end of the surgery, patients in the block group will undergo pudendal nerve block under ultrasound guidance. For the block procedure, aseptic preparation will be performed on the perineal area of the patient in the lithotomy position. A 21-gauge, 100 mm Stimuplex peripheral nerve block needle will be used. A linear ultrasound probe will be placed on the perineum at the 3 and 9 o'clock positions relative to the anus to visualize the ischial tuberosity. The needle will be inserted in an out-of-plane approach, medially to the ischial tuberosity, to reach the area between the sacrotuberous and sacrospinous ligaments. A total of 10 ml of 0.25% plain bupivacaine, diluted with isotonic solution, will be administered bilaterally.
Postoperative pain assessments using the Visual Analog Scale (VAS) will be performed at 2, 4, 6, 12, 24, and 48 hours in both the block and control groups. If a patient reports a VAS score greater than 4, intramuscular diclofenac sodium will be administered and recorded. Additionally, the time at which patients can sit without pain, the time to return to daily activity, and length of hospital stay will also be documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized-controlled, double-blind study
| Arm | Type | Receives |
|---|---|---|
| Pudendal | Experimental | Procedure: Pudendal Nerve BlockWe performed pudendal nerve block by using ultrasound at the end of the surgery. All patients were operated under spinal anesthesia. After surgery we followed up the hemodynamic changes and VAS values at different time points. |
| Control | No intervention | –All patients were operated under spinal anesthesia. After surgery we followed up the hemodynamic values and VAS scores at different time points. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pudendal Nerve BlockPudendal nerve blocks are often preferred as an initial diagnostic and therapeutic method for chronic pelvic pain caused by pudendal neuralgia due to nerve entrapment. Additionally, the pudendal nerve block is a widely used regional anesthesia technique in gynecologic, obstetric, and anorectal procedures . It is particularly applied to provide perineal anesthesia during the second stage of vaginal delivery, vaginal repairs, and obstetric procedures including anorectal surgeries such as hemorrhoidectomy . Pudendal nerve blocks can effectively anesthetize the posterior perineum, anus, lower vagina, vulva/scrotum, and penis. | Procedure or surgery | Pudendal |
Primary outcome
Visual analog scale
Time frame: 24 hours after surgery
The primary endpoint was the postoperative pain on the visual analogue scale (VAS) at 24 h. The investigators evaluated the pain intensity by using the VAS, where 0 indicated no pain and 10 represented the worst imaginable pain.
3 secondary outcomes
Length of hospital stay
Time frame: 14 days after surgery
The time of sitting without pain
Time frame: 24 hours after surgery
Analgesic need
Time frame: 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Results publication: PubMed 16738292Naja Z, El-Rajab M, Al-Tannir M, Ziade F, Zbibo R, Oweidat M, Lonnqvist PA. Nerve stimulator guided pudendal nerve block versus general anesthesia for hemorrhoidectomy. Can J Anaesth. 2006 Jun;53(6):579-85. doi: 10.1007/BF03021848.
- Results publication: PubMed 33727997He J, Zhang L, Li DL, He WY, Xiong QM, Zheng XQ, Liao MJ, Wang HB. Ultrasound-Guided Pudendal Nerve Block Combined with Propofol Deep Sedation versus Spinal Anesthesia for Hemorrhoidectomy: A Prospective Randomized Study. Pain Res Manag. 2021 Feb 26;2021:6644262. doi: 10.1155/2021/6644262. eCollection 2021.
- Results publication: PubMed 32474710Di Giuseppe M, Saporito A, La Regina D, Tasciotti E, Ghielmini E, Vannelli A, Pini R, Mongelli F. Ultrasound-guided pudendal nerve block in patients undergoing open hemorrhoidectomy: a double-blind randomized controlled trial. Int J Colorectal Dis. 2020 Sep;35(9):1741-1747. doi: 10.1007/s00384-020-03630-x. Epub 2020 May 30.
- Individual participant dataSharing planned: No. The investigators don't have any consent or permission for sharing the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azime Bulut, Assoc.Prof. principal investigator
Giresun University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pudendal Nerve Block in people with Urinary Incontinence, run by Giresun University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07029087, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.